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PhUSE News | Winter 2015 1

PhUSE NewsWinter 2015

S H A R E – C O N T R I B U T E – A D V A N C E

2 PhUSE News | Winter 2015 PhUSE News | Winter 2015 3

Contents

Dear Colleagues,

Here we are again; winter has arrived, and in the UK, rain, fog and wind are here in abundance. Once again I am considering whether the need for a canoe is going to be a part of my commute in the not too distant future. However, as I type this, against a backdrop of dampness, I am thinking with excitement about the prospect of writing about the warmer climes of Barcelona in future Newsletter editions. A conference where wellington boots should not be required!

Before we look too far forward, let’s take a moment to review what has been happening since the last edition of the Newsletter. Of course, there was the hugely successful Conference in Vienna, and in addition four fabulous Single Day Events. We hear from Chris Price, this year’s Conference Chair, and there are some lovely photos of the Conference on pages 20 and 21. On page 5 find out how the 5th PhUSE Scriptathon went, the Q&A session with the Board on page 13, and the Best in Stream winners and Outstanding Contributors are on pages 8 and 9 respectively. There have been Single Day Events in Hyderabad, Bangalore, East Hanover and Upper Providence, which you can read more about on pages 26 to 29.

So what else do we have for you in this packed edition of the Newsletter? Having reviewed our successes, we now take the time to look forward, and we have a report on the Future Forum from Sascha Ahrweiler on pages 24 and 25. We hear from Åsa Carlsheimer on pages 10 and 11 about the Conference in sunny Barcelona in October 2016, the PhUSE Computational Science Working Groups on pages 16 to 18, and not forgetting the call for posters for the Computational Science Symposium on page 19. Our regular 10 Questions spotlight is shining on Yoichi Higashibeppu on page 4, and we have more hints and tips from Kirk on pages 30 and 31. We also have a book review of the latest offering from Phil Holland, long-time PhUSE collaborator, on page 23, and we hear from Sarvesh Singh, one of our newest Newsletter team members, on his experience with PhUSE on page 22.

Finally, I would like to mention that I was hugely honoured to be recognised with the Outstanding Contributor award. I work with a great team who provide a lot of ideas and support, and would like to thank them all. As always, if you have something to say or contribute, please feel free to get in touch at [email protected]. Best regards,Diana Stuart, Newsletter Editor

From The Editor

2 From The Editor

3 Thanks to our Annual Conference Sponsors

4 10 Questions with Yoichi (Beppy) Higashibeppu

5 PhUSE 2015 Scriptathon

6 PhUSE Annual Conference 2015

8 Best In Stream

9 Outstanding Contributor Award

10 PhUSE Annual Conference 2016

13 PhUSE Meet the Board 2015

14 Computational Science Symposium 2016

16 PhUSE Computational Science Working Groups

19 Call for Posters CSS 2016

20 Photos from the PhUSE Annual Conference 2015

22 My Experience with PhUSE

23 Book Review: SAS Programming and Data Visualization Techniques: A Power User’s Guide By Philip R. Holland

24 Future Forum

26 Hyderabad SDE

27 Bangalore SDE

28 East Hanover SDE

29 Upper Providence SDE

30 Kirk’s Korner

32 Welcome New Members

34 Membership Figures

35 Event Calendar Advertising Costs

Thanks to Our Annual Conference SponsorsPlatinum Sponsor

Conference Sponsors

PRAHEALTH SC I ENCES


What attracted you to your current position?The opportunity to share thoughts with others on the development of new medicines.

What is the most enjoyable part of your job?Attending the creation of new drugs.

And the least enjoyable?As a person who doesn’t speak English every day, understanding the humour of jokes by English people at meetings is tough, such as “Why are they laughing so much?” Even if I do finally ‘get it’, by that time they are usually onto the next topic, leaving me behind!

If you could only eat one food for the rest of your life, what would it be?If the rest of my life is long, I can’t imagine such a miserable world eating only one food. If it’s very short, there must be something else to do except eating.

What – to you – is the most irritating industry buzzword?Galapagosization: a Japanese business word referring to the widespread design of Japanese products specifically for the domestic market, which are therefore unsuccessful overseas and also vulnerable to competition from imports. I think this kind of excusatory word brings people to silo mentality.

If you weren’t doing this job, then what would you be doing?A pharmacist in a rural area.

If you could give your 18-year-old self one piece of advice, what would it be?Have conversations with as many kinds of people as you can and enjoy your days as a student.

Describe yourself in three words.Receptive, soft and happy.

Name one item you cannot live without.Glasses. They enlarge my horizon.

What is your musical guilty pleasure?A Japanese group called Babymetal. A brave attempt by young women in the world of heavy metal!

10 Questions with

Yoichi (Beppy) Higashibeppu

Have conversations with as many kinds of people as you can and enjoy your days as a student

By Dirk Spruck, Accovion

PhUSE 2015 Scriptathon Tuesday evening of this year’s Annual Conference in Vienna saw the fifth PhUSE Scriptathon. The Scriptathon provides the opportunity for Conference participants to do hands-on work on the PhUSE community’s projects. The group gathering, in the otherwise deserted conference area, worked in a very focused manner, for example on improving the PhUSE Wiki, the boxplot challenge, and some documentation around existing scripts in the GitHub-hosted PhUSE Script Repository. Good progress was made given the limited amount of time; and, hopefully, some of the activities will be carried over post-Conference.

Only a small number of people out of the 30 who had registered showed up at the event, and a lot of food was left over at the end; therefore, the CS Standard Scripts Working Group will be re-evaluating the timing and scope of the Scriptathon for future Conferences!

Thanks to the PhUSE attendees who were brave enough to show up for the Scriptathon! Also, many thanks to everybody involved in preparing the event, especially Dante Di Tommaso, Peter Schaefer, Mike Carniello, Chris Butler, Stijn Rogiers, Nicola Tambascia, and the PhUSE Office. Last but not least, many thanks to the Conference platinum sponsor SAS for providing access to a SAS programming platform.


By Chris Price, Roche

PhUSE Annual Conference 2015 The Annual Conference in Vienna is now over. With nearly 500 attendees, 32 exhibitors and 130 papers and posters selected from a record 240 submitted abstracts and 5 parallel streams, this was truly a huge event.

We were very fortunate this year to have such an eclectic mix of keynote speakers to start each day.

Alex Flynn, an adventurer and Parkinson’s disease sufferer, opened the Conference on Monday with an emotional and stirring speech about his struggle against personal adversity following his diagnosis. The challenge he set himself to cover 10 million metres (equivalent to crossing the Atlantic) to raise money for Parkinson’s research illustrated how much it is possible to achieve when you truly put your mind to it. His speech is something that will live long in the memory of all those in the room.

John Sall, the co-founder and Executive Vice President of SAS, brought a technical and statistical angle to Tuesday morning. John addressed the topic of big data and demonstrated how

some graphical and statistical approaches can help us interpret wide data in an effective and efficient manner.

Finally, on Wednesday, Simon Weston, a Falklands War veteran, brought tears to the eyes of many in the room with his extraordinary personal story. Simon’s overwhelming positive outlook on life and his message that you remain responsible for what you can achieve regardless of the challenges you face was inspirational to all those who heard him speak.

The hands-on workshops and discussion clubs were again very well received and interactively brought relevant information to the attendees. The new workshop on pharmacokinetics and associated data was a great opportunity for attendees to increase their knowledge about this important area of clinical research.

Alongside the usual presentations, workshops, discussion clubs and networking that prove so popular at a PhUSE Conference were some new features and twists for delegates to enjoy and experience.

The Welcome Event and Poster Session on Sunday evening was a great way to kick off the Conference. The new-look Management stream included a session on change management, an experiential learning workshop addressing the topic of CRO collaboration, and a presentation from Mike Barton, the Chief Constable of Durham Police, providing a perspective on standardisation from outside of the pharmaceutical industry. We were delighted to be able to welcome Fergus Sweeney (EMA) and Yuki Ando (PMDA) in person to the Regulatory stream, with Lilliam Rosario (FDA) joining us by telephone. This session and the subsequent question and answer session were both an excellent opportunity for attendees to learn more and ask questions about the current regulatory environment.

The Scriptathon on Tuesday night was a great success. A roomful of programmers were able to continue the development of new scripts as well as many key activities relating to the metadata and qualification of existing scripts.

The Conference Committee faced a significant challenge this year in selecting only the very best abstracts, and this was reflected in the high quality of all the presentations and posters at the Conference. During the closing session, I had the pleasure to announce the Best Paper Awards for each stream. These, as in previous years, were selected following the feedback from both the audience and the Stream Chairs. This was also the occasion where I had the honour to announce Diana Stuart as the winner of the PhUSE 2015 Outstanding Contribution Award. Her dedication and involvement with PhUSE over the years, in particular as the editor of the Newsletter, made Diana a thoroughly warranted winner this year. Diana definitely represents everything that PhUSE stands for, and is a deserving winner of this award.

The success of the Annual Conference is the result of the collaboration and hard work of the PhUSE membership. I would like to thank all those who attended the 2015 Conference: all the individuals who submitted an abstract, those who were selected as presenters, the hands-on workshop providers, the discussion club facilitators and the Scriptathon organisers, and our sponsors and exhibitors for their continuous support.

The organisation of such a huge and successful Conference is very much the effort of a brilliant team. I would like to thank all those who have been involved in the preparation during the last 12 months, sharing in the excitement and the stresses, especially my Co-Chair Åsa Carlsheimer, the Conference Committee, the PhUSE Board of Directors and the PhUSE Office.

I am looking forward to meeting many of you again at PhUSE events during 2016 and, of course, in Barcelona for the next Annual Conference.


Best in Stream

Applications and Software Development (AD05) Statistical Analysis Reporting Tool (StART), From Concept to Table ProductionDavid Hartman, UCB

Coder’s Corner (CC03) Fun with FormatsSarah Berenbrinck, Quanticate

CDISC & Industry Standards (CD04) Access to CDISC SHARE Metadata: A La Carte, Prix Fixe or Table d’Hôte?Ken Stoltzfus, Accenture

Coding Solutions (CS06) Detecting Irregularities in Electronic Patient-reported DataJohn van Bemmelen, OCS Consulting

Data Handling (DH07) Study Anonymisation: From Request to DeliveryKelly Mewes & Sai Jandhyala, Roche

Industry Starters (IS01) WPP, Worst Programming Practice – Real-life Pitfalls in Everyday Clinical Programming: Why and How

Hannes Engberg Raeder, PRA Health Sciences & Rowland Hale, inVentiv Health Clinical

Professional Development and Training (PD03) The AQSCI Method Behind CRO Evaluation and Application to Pharmaceutical Company NeedsRoy Ward, PPD & James Gallagher, Novartis

Poster Presentations (PP13 & PP20) From Data Management to Statistical Programming: A Real-life ChangeBenjamin Lerbour, Novartis Exploratory Analysis vs Regulatory ReportingMijanur Rahman, Roche

Statistics and Pharmacokinetics (SP02) Adjusting Long-term Efficacy Estimates when Patients Cross Over to Experimental TreatmentSabine Lauer, Dr Lauer Research

Technical Solutions (TS05) Graphics in R – A Shiny Way to ProgramCarolyn Nixon, Roche

Trends & Technology (TT02) How to Create a Mobile App: Walkthrough Example Including SAS OutputKatja Glass, Bayer Pharma

By John Salter, Operations Director, PhUSE

For what is now a regular event in the PhUSE calendar, we opened the nominations for the Outstanding Contributor to PhUSE Award, with a view to encourage and reward the great work done by many in the organisation and to stimulate all our members to spend some valuable time considering all of the contributors throughout the year. As previously, the process was as follows:1. Call for the membership to make nominations2. The Board of Directors selected a shortlist of three

nominations (using a secret ballot)3. Publication of the three nominations using the online

voting tool and members asked to vote.The shortlist of nominees and the results are as follows:

Scott BahlavooniScott has been the backbone of the PhUSE CSS for the last four years. He has been a critical contributor to building the PhUSE/FDA relationship as well as developing the relationship with CDISC so that we now have quarterly meetings. Scott led the team in the first year of the CSS to develop the Study Data Reviewer’s Guide, which is now referenced in FDA documents. He then went on to serve on the CS Steering Committee, as Co-Lead of the Semantics Technology Working Group, and continues to be a great ambassador for PhUSE. I believe Scott is very deserving of this award.

Chris DeckerChris has been on the Steering Committee and led the Planning Committee for many years and has consistently attended/led the meetings. He has performed an exemplary service to PhUSE and has continued to drive us to achieve successful annual meetings.

Chris has been involved with the PhUSE Computational Science Symposium for over four years, leading the CSS Steering Committee and playing many roles supporting the CSS as FDA liaison, partner with standards data organisations, primary link between the SC and SC sub-teams/working groups and facilitator of PhUSE webinars, just to name a few. He takes on additional responsibilities

when needed, authoring CSS documentation, developing process flows for better methodologies, updating the PhUSE Wiki and leading initiatives to improve Wiki content and structure so as to attract more interest in PhUSE efforts. He is the glue behind the scenes at CSS that allows us to make progress.

Diana StuartDiana has edited the PhUSE Newsletter for five years. In my view, she has done a great job of this and put in a huge amount of effort, far more than the minimum requirements, for example researching Conference venues in detail so she can bring them alive in the editorials. The Newsletter is key to the communication across the society, one of the benefits of the PhUSE membership, and highly recognised by all.

In addition, Diana has always contributed to the Annual Conference with her excellent presentations. She is a reliable contributor to PhUSE; she is one of the faces that make PhUSE happen.

The results were close, and it is my pleasure to announce that the winner of the PhUSE Outstanding Contributor Award 2015 is the PhUSE News Editor herself, Diana Stuart.

I would like to pass on my thanks to all of the nominees for their contribution to PhUSE; you have all added such value that your fellow PhUSE members have chosen to nominate you for this award.

Well done, and thank you.

Outstanding Contributor Award


Annual Conference 2016By Åsa Carlsheimer, Trialbee, Annual Conference Chair 2016

My involvement in PhUSE started when I attended the Conference in Berlin in 2010. The following year I organised the Single Day Event in Scandinavia and continued to do so for the next three years. In 2011 I gave my first presentation at the Annual Conference and after a while got involved in the Conference Committee. I really enjoy working with PhUSE and helping to ensure knowledge-sharing across the industry. It is a great honour to be given the opportunity to chair the Annual Conference in beautiful Barcelona, especially considering the incredible successes of all the previous Conferences.

Over the past few years, we have talked about data standards, patient-centricity, data transparency and turning data into knowledge, which is very much focusing on science and changes in the pharmaceutical industry. This has been, and continues to be, very important to us; but the biggest challenge we face today in the pharmaceutical industry is time. It takes too long and costs too much money to get our drugs to market.

Therefore, the theme of the 2016 Conference will be how to achieve a “fast track to approval”. The focus will be on time and efficiency. How can we standardise, automatise, design trials and utilise data more effectively to reduce the time to approval? We have to find new ways to optimise

time and ensure quality, meaning that we have all the required high-quality deliverables in place at the right time. If we can achieve this, we have the opportunity to transform the entire business and help our companies survive. We, as data scientists, are key in this process and must take responsibility for driving the development in the right direction.

In order to become more effective and to be able to reduce the time to approval, we have to discuss pooling strategies, data standards, supporting software, programming techniques, statistics and regulatory requirements early on in our projects. For example, we can look at performance in our code to reduce the execution time or we can look at providing regulatory agencies with analysis results metadata which may speed up their review process. There are so many things we can do if we focus on time and efficiency. We have an obligation to do whatever we can in our area of expertise to ensure we are on the fast track to approval.

We also have to work closely together with the regulatory agencies to ensure that we deliver the critical elements at the right time to facilitate their review and understanding of our clinical trial results. PhUSE has a very important role in bridging the gap between the pharma companies and the regulatory agencies. This gives the Conference a unique

Fast Track to Approval: Time and Efficiency9th - 12th October 2016

opportunity to add value and be a forum to discuss how we best support our submissions for market approval.

Everything that has made PhUSE so successful over the years will continue in 2016, along with some new influences. The streams remain the backbone of the Conference; inspiring keynote speakers will start each day of the Conference; interactive sessions open the floor for debate on relevant subjects; new topics will be identified for our popular hands-on workshops; and, of course, the Conference remains a unique chance to network and share knowledge with colleagues and friends. In 2016 we will introduce a new stream dedicated to real-world evidence, focusing on the handling of all kinds of observational

data including, but not limited to, registries, health claims and medical records databases and non-interventional prospective and retrospective studies.

Work has already started on the Conference preparations. If you are interested in helping us to run the streams and workshops or have other ideas for 2016, please contact [email protected]. With the support of the Conference Co-Chair Jules van der Zalm, all the members of the Committee, the Board of Directors, the PhUSE Office and you, I’m very much looking forward to an intense and interesting year of planning and preparing for the Conference.

I hope to see you in Barcelona in 2016!

Fast Track to Approval: Speed and Effi ciency

Barcelona 20169th–12th OctoberPrincesa Sofi a Gran Hotel, Barcelona

Conference Chair Åsa Carlsheimer, TrialbeeConference Co-Chair Jules Van der Zalm, OCS ConsultingFor more information visit the PhUSE website phuse.eu/annual-conference.aspx

Annual Conference

#12227 PhUSE Barcelona 2016 Poster June 2015 A4 v3.indd 1

28/10/2015 10:22


Quanticate is HiringAs an integral function within Biometrics, Quanticate programmers have supported clinical trials since 1994. Our clinical programming team is the largest department within Quanticate and its global reach offers great flexibility for our customers. Experienced programmers have detailed knowledge of all Phases and all therapeutic areas across the drug development spectrum making them an ideal fit with existing project teams at client sites or to form the basis of new teams.

By investing heavily in career development, we have built an adaptable workforce that monitors and adopts changing standards in both technology and the regulatory environment, enabling us to advise and guide our customers.

Due to continued growth, we are looking to expand our Programming team and we offer flexible working conditions, including home based opportunities.

VP, Portfolio DeliveryAs part of a new structure at Quanticate, we are looking for a senior level candidate to join us to provide overall management and lead of a large client portfolio ensuring that the projects are delivered on time, to budget and to the required quality standard, and to continually grow the portfolio of business the client expects. You will also manage a range of Programming and Statistical Reporting projects within the portfolio, working in partnership with the customer and acting as the main point of contact for the client.

Senior SAS Programmer (various levels)As we continue to grow, we are hiring a number of Statistical SAS Programmers and are offering opportunities for a range of different levels of experience. We are keen to speak with individuals who wish to add to their current skillsets, whether technical or managerial. Our Statistical SAS Programmers work cross functionally and collaboratively in project focussed global teams.

As a flexible employer we appreciate the need for work/life balance and therefore can offer flexible or home-based working. Please contact the internal team directly to discuss your needs.

For more information, please contact [email protected]

linkedin.com/company/quanticate twitter.com/Quanticate

PhUSE Meet the Board 2015

During lunch on the Wednesday of the Annual Conference, there is a traditional session where members can meet with the Board to put forward any issues they have. Here are the questions and answers that were discussed:

1. What is the current Board Strategy and where is it published – James McDermott The two days following the Conference is where the Board get together and discuss strategy. This will be written up in a separate newsletter article. The main discussion points will be the actions from previous meetings, conferences, Director reports and actions, Board structure and how we grow, positioning with regulatory bodies, and BHAG.

2. Single Day Events – Do we have a published list of registration versus attendance – Geoff Low We don’t monitor registration vs attendance, but typically in Europe, attendance is close to 95%. In India, the SDEs have consistently sold out, with 100% attendance. In the US, attendance appears to be a little lower at around 93%. We recognise that there was an issue with the recent New York event which affected travel. 2015 SDE Registration Numbers • Asia – 416 registered to date (7 events, 2 open) • EU – 307 registered to date (5 events, 1 open) • US – 474 registered to date (6 events, 1 open)

3. Communication has improved; do we have a strategy of aligning messages across Single Day Events with a single theme – Chris Decker This varies between region. In Europe, we have used one theme across all events successfully for several years; however, in 2015, it was felt that some SDEs wanted to adopt an individual theme based on the requests by local attendees. In the US, there has been no such coordination as it has been seen as a series of events, each with their own stand-alone theme. Whilst in Europe attendees only participate in their local event, US attendees will travel to multiple events.

4. Question to the audience: Does PhUSE deliver – John Salter It was the general opinion of the audience that PhUSE does deliver. Growing numbers of conference attendees and rising group membership numbers bear this out as well.

5. Cross-section of the Future Forum – Geoff Low There was a good section of both senior management from pharma and CROs. There is a write-up from the Forum elsewhere in this Newsletter. The organisers are considering the next steps from the information gained.

6. PhUSE Wiki – consider an alternative Anup Patel, PhUSE Technical Director, has identified that the content of the Wiki needs maintaining and is in need of general housekeeping to keep it up to date. He is in the process of putting a team together to do this; if you are interested in joining, please contact the Office.

By Adrienne M Bonwick, Special Projects Director, PhUSE


Computational Science SymposiumMarch 13th–15th 2016Silver Spring Civic Center, Silver Spring, Maryland, USA

Registration Opens November 2nd 2015Call for Posters Closes January 15th 2016Early Bird Registration Closes January 29th 2016

Smithsonian Institution Building

The 5th PhUSE and FDA Collaboration

phuse.eu/css

The conference will begin at 4pm on Sunday, March 13th and fi nish at 4pm on Tuesday, March 15th.

Registration FeesTime Sunday, March 13th

16:00–17:00 On-site Registration Opens

17:00–19:00 Opening Session: Welcome and Working Group Overview

Time Monday, March 14th

08:30–10:00 FDA State of the Union

The PhUSE CSS Collaboration – Getting Involved and Getting it Done: A Regulatory PerspectiveSteve Wilson, Dr.PH, CAPT., USPHS Director of Division of Biometrics III, CDER, FDAeStudy Guidance – How Much Do You Know? FDA Representative – TBCData Integrity Overview: What CDER is Seeing with SDTM, ADaM and SEND FDA Representative – TBCReviewer’s Guides: State of Aff airs: SDRG, ADRG and Nonclinical SDRG FDA Representative – TBCSummary of Working Group Success and Projects Moving Forward CS Steering Committee

10:00–10:30 Break and Networking

10:30–12:00 Working Group Overview Session

12:00–13:00 Lunch and Networking

13:00–16:30 Working Group Breakout Sessions

17:00–18:30 Poster SessionSponsored by d-Wise

18:30–23:30 Scriptathon

Time Tuesday, March 15th

08:30–12:00 Working Group Breakout Sessions

12:00–13:00 Lunch and Networking

13:00–14:00 Working Group Wrap-up

14:00–14:30 Break and Networking

14:30–15:30 FDA Panel: Impact of the Guidance on Delivery of Data Standards

15:30–16:00 Poster Awards and Closing Session

Agenda

Government/Non Profi t/Academia$300

Industry Organizing Committee$350

Poster Presenter$375

Industry Full Conference PriceEarly Bird (before January 29th 2016)$550

Industry Full Conference PriceFrom January 30th 2016$750

Single Day Registration$650

On the Day RegistrationFull conference ticket$1250

#12738 PhUSE CSS 2016 Flyer August 2015 US Letter v5.indd 2 02/11/2015 10:37


PhUSE Computational Science Working Groups By Scott Bahlavooni, d-Wise

The 2016 Computational Science Symposium (CSS) will mark five years since the FDA and PhUSE began collaborating with the goal of bringing together academia, regulators, industry, and technology providers to address unmet product development and regulatory computational science needs.

In the words of Dr. Steve Wilson (FDA), the Computational Science

(CS) Collaboration has been an experiment in “building the plane while flying”. During this time, CS Collaboration working groups have “built” over 20 work packages. The following are a few examples of deliverables developed by CS working groups in 2015:

• Study Data Standardisation Plan – The FDA Study Data Technical Conformance Guide states the following: “For clinical and nonclinical studies, sponsors should include a plan (e.g. in the IND) describing the submission of standardised study data to the FDA. The Study Data Standardisation Plan assists the FDA in identifying potential standardisation issues early in the development program.” The Optimising the Use

of Data Standards Working Group published a draft Study Data Standardisation Plan Template and Sponsor Implementation Plan for public comment. The Working Group intends to publish the final work package prior to the 2016 CSS.

• CDISC Foundational Standards in RDF – In 2014, the Semantic Technology Working Group drafted an RDF representation of the CDISC Foundational Standards including CDASH, SDTM, ADaM, and CDISC Controlled Terminology. In 2015, the Working Group collaborated with CDISC to conduct a CDISC public review of the RDF representation and accompanying documentation. The CDISC Standards Review Council officially approved the work package in July 2015, and CDISC has started work to make the RDF representation available as part of the SHARE export.

• Analysis and Displays White Papers – The Standard Scripts Working Group finalised a white paper providing recommendations for displaying, summarising and/or analysing shifts with a focus on vital sign assessments, quantitative ECG findings, and laboratory analyte measurements. The Working Group has also published a number of draft Analysis and Displays White Papers for public review. At the 2015 CSS, Standard Scripts Working Group Co-Leads met with CDISC ADaM team representatives to foster increased collaboration between the two teams.

• Nonclinical Study Data Reviewer’s Guide (SDRG) – The FDA Study Data Technical Conformance Guide notes “The preparation of a Study Data Reviewer’s Guide (SDRG) is recommended as an integral part of a standards-compliant study data submission.” The Nonclinical Working Group built upon the work of the Optimising the Use of Data Standards Working Group and published a draft version of an SDRG work package for use with SEND submissions. The Working Group intends to finalise the Nonclinical SDRG work package prior to the 2016 CSS.

The PhUSE CS Catalog of Deliverables provides an index of all content developed by CS working groups. CS working group deliverables currently undergoing public review may also be found on the PhUSE website.

Computational Science Collaboration Working Group ProjectsAs of 1st October 2015, CS working groups are executing nearly 30 projects. The CS Steering Committee recognises the tireless efforts of the working group co-leads, project co-leads and industry and regulatory agency participants, and sincerely appreciates their commitment to the Collaboration. In 2015, several new projects launched including the following:

• Experiences with Statistical Computing Environments – This Emerging Trends & Technologies Working Group project explores expectations for Statistical Computing Environments (SCEs) including experiences within industry and regulatory agencies regarding implementation and compliance and their relationship to metadata repositories and clinical data repositories.

• Data Visualisation for Clinical Data – This Emerging Trends

& Technologies Working Group project examines use cases for which data visualisation is difficult or impossible. The project will look to answer the following questions: What visualisations are not possible and why? What visualisations are easily possible? What visualisations are possible but cumbersome, error-prone and/or require significant pre-work?


• Visualisation of Group-related Differences in Histopathology Data – This Nonclinical Working Group project investigates possible methods for consolidating tabular data into visualisations that identify organ-related group differences. The project will define a set of requirements and rationale for preferred visualisations.

• Application of SEND Data for Analysis – This Nonclinical Working Group project focuses on use cases for SEND data and identifies a set of data quality and data fitness analyses that would be performed on the SEND package.

• Use Cases for Linked Data – This Semantic Technology Working Group project will document use cases for linked data in the clinical trial life cycle. Industry and regulatory agencies have long been constrained by two-dimensional row and column structures. These two-dimensional data structures support multi-dimensional business processes and multi-dimensional data. The additional dimensions are often defined by non-executable human business knowledge. Knowledge differences or gaps contribute to inefficient and/or laborious business processes. Linked data expresses these additional dimensions in a well-defined, machine-processable, executable manner.

• Best Practices for Managing Changes Across Standards and Between Versions – This Optimising the Use of Data Standards project will be launching in Q4, 2015. The project will define best practices for addressing changes to CDISC standards between versions as well as addressing differences between Therapeutic Area User Guides and Foundational Standard Models and Implementation Guides.

The PhUSE CS Dashboard provides an index of all active CS working group projects. The Dashboard also includes the contact information for each CS working group. As the list of unmet product development and regulatory computational science needs is seemingly endless, the CS Steering Committee welcomes you to get involved in a project or submit a project request via the PhUSE website.

2016 FDA/PhUSE Computational Science Symposium:The FDA has been an integral contributor to and supporter of the CS Collaboration. PhUSE is pleased to welcome the FDA as a co-sponsor of the 2016 Computational Science Symposium. The 2016 CSS will once again bring together key stakeholders to continue working on existing projects, to explore new ideas, and share information and experiences. The Symposium will be held in Silver Spring, Maryland, USA from 13th to 15th March, 2016. Registration for the conference will open on 2nd November, 2015. Additional information about the Symposium, including other important dates, is available on the PhUSE website.

In the months leading up to the 2016 CSS, PhUSE will be hosting a series of webinars. These webinars will provide the community with the latest information from the CS Collaboration including new project launches, newly finalised deliverables, and deliverables out for review. The webinars will also help prepare for the 2016 CSS by providing an overview of the 2016 CSS agenda and planned CS working group activities. The webinar schedule and recordings of past webinars are available on the PhUSE website. The CS Steering Committee is looking forward to seeing you at the 2016 CSS. Register early as space is limited and spots fill up quickly!

Call for Posters CSS 2016Do you want to get more involved in CSS 2016? Then why not prepare and submit your own posterPosters can incorporate a wide variety of topics and are ideal for graphics, source code, statistical concepts and thought-provoking concepts. Posters will remain on display throughout the conference, and authors should be on-hand to answer questions and discuss the poster topic in more detail.

1. Submit an AbstractTopics should be relevant to the conference theme and audience. Submit the abstract for review no later than 15th January, 2016.

2. Poster Draft/Final ReviewOnce the poster has been accepted for presentation at the conference, a draft version is sent to the section Chair for review. Feedback will be relayed back to the author by 12th February, 2016.

3. Final Printed PosterThe final version of the poster is uploaded to the PhUSE submission system by 19th February, 2016. The section Chair will review again and refer any amendments to the author.

As a poster presenter, enjoy a reduced registration rate of only $375!

If you are interested in submitting a poster to the conference, please visit the PhUSE website for further details.


PhUSE Annual Conference 2015


My Experience with PhUSE

Book ReviewBy Sarvesh Singh, ICON

By Diana Stuart, VeramedI have been associated with PhUSE since January 2014, and have attended almost all Single Day Events (SDEs) held in India in the past two years. Every event has a new theme and a new location, so it provides an opportunity to learn as well as explore new places. I

have interacted with more than 100 participants at these events, and they have all appreciated PhUSE’s contribution. There are only a few platforms in India which provide an opportunity for statistical programmers, and people working in related fields, to come together and share their knowledge, so PhUSE is a great addition.

There are more than 100 CROs and pharmaceutical companies in India. Every year one CRO or another is setting up its office in India, and the existing ones seem to be increasing their team size. There is a huge demand for clinical literate staff, particularly statistical programmers; so, on the one hand, we have a huge demand for statistical programmers, and on the other, we have a huge supply of graduates who can be trained in the statistics, programming and pharmaceutical domain to become statistical programmers. This demand and supply has led to a mushrooming of statistical training institutes in India which train graduates in statistical programming and make them employable. Once these graduates have worked for a few years then organisations such as PhUSE provide them with a platform to learn new developments in the clinical area.

As of autumn 2015, we have around 1,000 PhUSE members in India (second only to the USA). Most of these members are very active and are making the best use of all the knowledge-sharing platforms of PhUSE such as the PhUSE Wiki, PhUSE Tube, PhUSE Blog and PhUSE archives. Many programmers in India lack presentation skills, so they find the videos and content related to presentation skills posted on PhUSE Tube really useful. Most programmers in India are

junior or mid-level, so they also learn a lot from the domain-related content on the PhUSE Wiki.

PhUSE has provided a platform for all statistical programmers in India, pharmaceutical companies and CROs to come together and learn new concepts. I really appreciate the openness with which all topics are discussed at these SDEs. There is a lot of energy in the participants throughout the events. Most of the India SDEs have panel discussions; all these discussions are very impressive, and participants are amazed by the knowledge of the people sitting on the panels.

During these SDEs I have met many presenters who thought that their presentations were not worthwhile, but after attending the previous SDEs they realised that it’s worthwhile to give it a try. They have then volunteered to present, and were mentored to improve the content as well as their presentation style by their companies because their topics were great. PhUSE in India has increased the confidence level of many first-time presenters, and now they have become regular attendees of all PhUSE SDEs in India.

All PhUSE events in India have been very successful, and I look forward to even more successful events in the coming years. Looking at the enthusiasm of the participants and the type of feedback which they are passing back to their companies and colleagues, I am quite confident that PhUSE membership in India will continue to increase. There are many global CROs and pharmaceutical companies which actively participate in PhUSE events in Europe, the USA, India, China and Japan. Many of them have operations in other Asian countries as well, so I see this as a great opportunity for taking their help in organising PhUSE events in Asia.

So far, I have been actively involved with PhUSE in India, but I am now looking forward to engaging more with PhUSE by participating in other SDEs in Asia. I am also looking forward to participating in the Computational Science Symposium (CSS) in the USA.

According to the “About the author” section of this book, Phil Holland has been programming for over 30 years, which is why so many of us know him. He is one of a handful of PhUSE members who has attended every conference since the first one in Heidelberg in 2005, and not only that, he has presented at every PhUSE conference. In addition, he has presented at 17 Single Day Events. This pretty much indicates that he knows what he’s talking about when it comes to SAS.

Phil’s latest book is separated into three parts: Part I Programming Efficiency Techniques, Part II External Interfaces and Part III Data Visualization. The first part discusses some of the idiosyncracies of the pharmaceutical and financial worlds when it comes to their approaches to dealing with data, and in particular, the approach to big data. There is a chapter on how to use lookup tables effectively, and I found the Epidemiology chapter which

looks at the programming techniques used by SAS programmers working with large data especially interesting. The second part looks at how SAS communicates with external applications. There are five chapters covering Enterprise Guide, SAS Studio, ODS and using Perl to create an interactive web interface. If you are a user of R, you may be interested in the chapter on SAS to R to SAS. The third part, as the title suggests, covers graphics, in fact six chapters of looking at the different aspects of graphics.

Overall, I found this book interesting and engaging. Let’s be honest here, it’s a SAS book not a page-turning crime thriller, so it’s a bit of challenge when it comes to attention holding; however, as a member of the target audience, I am very interested in the topics up for discussion, and Phil offers lots of code examples, which I always find useful. His approach to the topics drew me in, and I wanted to find out more. It is logical that there are three parts to this book as they are like three mini books, and the chapters themselves are not dissimilar to PhUSE conference presentations, which gives you an indication of the length. I think it is quite easy for programmers and statisticians to get a little stuck in their ways and not necessarily look for new ways of visualising data, and the third part of the book inspires one to look around.

In my review of Power User’s Guide to SAS Programming, I was a little critical of how much of the book was relevant to day-to-day programming. This is not the case with SAS Programming and Data Visualization Techniques; I found most of the book relevant, and the parts that weren’t directly relevant I could see how they could be, or they gave me ideas for application when looking at process improvement. All in all, a worthwhile read.

SAS Programming and Data Visualization Techniques: A Power User’s GuideBy Philip R. Holland


Future Forum

Since its inception, PhUSE has evolved from a conference for statistical programmers to a global community for data scientists. As of today, PhUSE has more than 6,500 members and with that, a powerful voice towards standards organisations, regulatory agencies and other stakeholder organisations.

The mission of PhUSE has always been to provide the industry with an exceptional and innovative platform for creating and sharing ideas, tools and standards about data and reporting technologies. As the biggest membership-driven organisation in the biometrical area, it is important to explore the vision and, in turn, develop the key themes for the future of clinical development and data science. As a truly global organisation, PhUSE also needs to explore possibilities to further support the FDA initiatives (CSS) and also to start expanding this support to both the EMA and PMDA. These mandates triggered the PhUSE Board of Directors to start the PhUSE Future Forum. The PhUSE Future Forum is an industry think tank, which is considered a key initiative to share, contribute and advance towards the future together. The Future Forum is based on the key principles of PhUSE but will address more forward-looking topics and will lay the foundation for PhUSE’s future working programme. It will be a framework of key topics that are defining the future of clinical development and data science, within the next 10 years. The main aim of the PhUSE Future Forum meeting is to rethink today’s model to be ready for the future.

PhUSE invited 20 thought leaders in the field; experienced professionals who are passionate about the advancement of clinical data science, have a clear vision of the future and want to share their ideas with the community. With representatives from big and mid-sized pharmaceutical companies, major and specialised contract research organisations, as well as software providers and independent consultants, the Future Forum had representatives from the entire PhUSE membership.

The first PhUSE Future Forum meeting took place on 26th August in London and was chaired by Ingrid Maes (Inovigate). In a thought-provoking introductory session, Ingrid presented the obstacles and challenges of the pharmaceutical industry in the coming years. New science such as model-based and virtual R&D, translational research and increased disease learnings due to Omics will be a key theme to defining the future. Tomorrow’s healthcare system will be connected and focused on outcomes and actionable healthcare data, incentivising prevention and cure. This implies that the opportunities for data science and clinical development will shift from developing products or services to developing prevention and managing outcomes.

The Future Forum reflected on the vision for the industry and the contribution PhUSE can make to help shape the future. During an intense and engaged ‘blue sky’ brainstorming session, the Forum agreed to focus on initiatives around data, analytics, interoperability, technology, processes and

people to be addressed by appointed groups. New skillsets in these areas are based around innovation, technology, partnerships and wider decision-making.

The PhUSE Future Forum results in three actionable outcomes:• 6 working groups around 2025 themes, focused on a set of

projects. Project charters per project are made• a visionary position paper reflecting PhUSE’s view on the

future for the industry, addressing key 2025 activity areas for PhUSE

• create relevance for PhUSE through a solid plan, as a “desirable partner” for members and various stakeholders.

The working group leads presented their project charters during a PhUSE webinar in November. In case you missed the webinar, the recording of this webinar is available via PhUSE Tube. The working groups are now looking for volunteers who want to actively contribute to setting the future of clinical data science. If you want to be part of a group and want to help shape the future, please contact [email protected]. You can also find more information about the PhUSE Future Forum on the PhUSE website: www.phuse.eu/Future_Forum.aspx.

By Sascha Ahrweiler, Bayer Pharma AG

Future Forum The Vision of Clinical Data ScienceWhere will we be in 2025?

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Hyderabad SDE Bangalore SDEBy Sarvesh Singh, ICON By Shashi Konanur, Quintiles

This was the second SDE in Hyderabad, and we were reminded that our first SDE in India also took place in Hyderabad and in the same venue. The SDE theme was “Understanding Submission Packages – Variation Across Regulators and Study Types”. It was chaired by Vishwanath Iyer (Mahesh) from Novartis, and professionals from a variety of companies in India were present. It was a day-long event where all speakers gave excellent speeches around submission packages. It was also good to hear about the variations we have across regulators and study types.

The event kicked off with a warm welcome by Ajay Sathe from Cytel, as he provided a general overview of PhUSE. Following this was a keynote speech from Vishwanath Iyer (Mahesh). This was supposed to be 15 minutes, as per the agenda, but the audience was so engaged that it lasted more than 30 minutes! Rajendra Wable of Sciformix then gave a presentation on clinical study reports. He explained variation across the study types and reporting formats across different health authorities. We then heard from Soujanya Konda & Vijaychand Alapati of inVentiv Health Clinical about PSUR (Periodic Safety Reports) for regulatory submissions; it was a great presentation.

After a short break we heard from Vinay Somashekar of PPD about variation across different therapeutic areas (TAs) in submission-ready clinical data standards. It was good to know the variation across therapeutic areas, and the audience started asking

questions on why there is so much variation when everyone is primarily concerned about safety of patients.

Rajesh Murarishetti from Navitas went on to explain about submission packages and changes to regulatory guidelines in the EU region.

After the presentations we had a 30-minute, innovative quiz. Questions were asked in the room, but responses were sent as SMS over a mobile number displayed on the screen. There was great enthusiasm and keen participation, as people debated over the correct answers, and it certainly increased the knowledge base of the audience. After lunch we had an interesting presentation from K.V. Palanichamy of PRA Health Sciences on validation. This was followed by a presentation on OSI requests in submission from Sarmistha Acharya &

Swetha Poondra from Novartis, before the event concluded.

In Ajay’s closing remarks he thanked everyone for making this SDE a great success.

This was my third PhUSE event and the first in which I got the opportunity to moderate the panel discussion. Vishwanath Iyer (Novartis), Anil Golla (Cytel), Praveen Madhusoodanan (Parexel) and Neeta Korlepara (Novartis) were all very knowledgeable and gave guidance to the young professional audience on acquiring knowledge of evolving requirements from regulators, in terms of submission packages. We all learnt a lot from these senior people in the industry, and many questions were asked and answered. I was pleased to be part of the SDE and am already looking forward to the next one!

Quintiles hosted the second Bangalore SDE at their premises, as they did last year, and although it was conceived and planned with only two weeks’ notice, the event attracted 114 attendees from 13 companies. This time, the focus was on a hot topic in the industry, “SDTM – Insights and Future”.

The day started with a speech from Shashi Konanur, talking about PhUSE and giving a robust introduction to Gary Walker, the main speaker of the event. This was followed by a video welcome from Ajay Sathe from Cytel.

Gary, a certified CDISC instructor and Associate Director at Quintiles, started with an interesting overview of SDTM/SDTMIG and CDISC standards. He then covered common mistakes made in SDTM and gave tips and tricks to follow, to ensure common sense is used while mapping data.

Following this was a discussion on RELREC, a not-so-common topic for the attendees, which was very informative and gave rise to more discussions amongst the audience, covering the SDRG (Study Data Reviewer’s Guide) and OpenCDISC documentation and rationale.

The last session of the day was on the next steps of CDISC-SDTM and the vision going forward. This session gave some niche insights into what is happening in the industry around CDISC.

All the sessions were very interactive. Gary, being an industry expert on this topic, shared his understanding and knowledge with the audience. There was good interaction among the participants which brought out knowledge exchange in the forum. The event was very well organised, with timely breaks and quality food!

The event concluded with closing remarks from Shashi Konanur, and Gary was presented with a token of appreciation from PhUSE.


East Hanover SDE Upper Providence SDE

By Suhas Sanjee, Novartis

By Terek J. Peterson, MBA, Chiltern

Novartis recently hosted a PhUSE Single Day Event (SDE) at our East Hanover, NJ site. The SDE was a huge success, with 100+ attendees and a “hungry” waiting list. The event was well represented with attendees from various pharmaceutical industries in the North East. The theme of the SDE was “Next Generation Programming: How New Requirements, Other Industries and Emerging Technologies will Change the Dynamics”. With today’s changing landscape of healthcare industry, organisations are challenged to meet tight timelines with limited resources. There is a great need to increase efficiency without compromising on the quality of deliverables. This SDE had industry experts present on how new tools and technologies can be used to take programming to the Next Generation.

The event began with a keynote from Olivier Leconte, Global Head of Novartis’ Data Analytics and Reporting. It was followed by the first

morning presentation, which focused on Dataset-XML, a new CDISC standard for exchanging data between sponsors and regulatory agencies. The presentation described an alternative for SAS version 5 transport files based on CDISC ODM and XML. These models support the FDA’s goal of developing open-source review tools. A very dynamic

presentation followed describing the generation of high-quality customised graphs using SAS GTL.

While the first two presentations provided use of technology and tools to increase efficiency, the third demonstrated how to apply “design thinking and ideation” to the very early stages of strategic disruption. This allows companies to ask the right questions in order to arrive at, and understand, the real problem that requires a solution. The morning presentations concluded with important recommendations for writing a nonclinical SDRG along with examples and a template that is expected to facilitate the FDA’s review of sponsors’ nonclinical (SEND) data sets.

The afternoon sessions followed a delicious hour filled with good food and plenty of interesting conversation. An exciting talk started things off, which covered how machine learning

and neural network concepts can be used to improve efficiencies in various aspects of the drug development process. This was followed by a presentation on RDF file format which described how applying linked data principles in clinical data reporting and review of results may help streamline and optimise production of results, facilitate a more efficient regulatory review process while also allowing reviewers greater insight into submitted data.

Continuing the afternoon sessions, we looked further into the benefits of standardisation with our final two presentations. In the first, we learned how harmonisation of clinical data standards has enabled organisations to standardise data review processes by enabling the use of tools such as Spotfire to support signal detection and patient safety monitoring. This was followed by a presentation from Mitra Rocca of the FDA, which provided an overview of the PhUSE Computational Science Semantic Technology Working Group. The event concluded with a little friendly competition which uncovered several SAS tips and techniques that could be used to improve programming efficiency.

This was a very nice venue, and the volunteers, presenters and sponsors made this a special day for our attendees. We thank them all for their contribution, and we appreciate the attendees for coming in such strong numbers to our event. We are looking forward to our last US SDE of the year, which will be in Foster City, CA on 2nd December. Please check the PhUSE website for details.

On 16th July, 2015 PhUSE held a Single Day Event at GlaxoSmithKline’s Upper Providence site in Pennsylvania titled “Regulatory Guidance: The Elephant in the Room”. Over ninety people registered, with more than two thirds in attendance. Asif Karbhari from AstraZeneca’s B&I programming co-chaired the event with Terek Peterson and Karen Curran from Theorem Clinical Research’s Clinical Analytics. Hats off to Asif, who successfully recruited three of the five speakers for this event! The pharmaceutical and biotech industry is bound by regulatory guidelines, but often we tend to lack clarity and/or knowledge about these guidelines. The event covered some of these guidelines and shed some light on how best to implement them. The morning session focused on de-identification, and the afternoon on reviewer’s guides. Kymberly Lee from AstraZeneca was one of the speakers. Her topic on de-identification was well presented and well received, as judged by the number of questions directed to her during the end-of-the-day panel discussion. Frank Senk from AZ also presented a PhUSE introduction and a de-identification overview from a SDE presentation given by Jean-Marc Ferran in Paris earlier in the year. We also had a speaker who was not able to make

it to the event due to serious family issues, but was kind enough to present remotely. It was a great presentation with regard to de-identification, and shared some important tools that could harmonise the pharma industry in regard to how and why we de-identify. A lot of questions were asked on the presentation during the panel discussion. Afternoon sessions focused on FDA-endorsed documents that have been articulated through recently issued guidance. Joe Kovach, Mike Stackhouse and Terek Peterson from Theorem Clinical Research and Todd Mailey from GlaxoSmithKline took the audience for a deep dive into the Study Data Reviewer’s Guide, discussing the importance of this document in achieving clarity of the SDTM data assets, how to use the

template and guidelines, and real-world examples. Mark Gummel and Cathy Michalsky from Theorem Clinical Research’s presentation highlighted the Analysis Data Reviewer’s Guide by detailing who, what, when, where and how a company should develop this document for analysis data assets during a submission. Everyone was included in a Speaker Panel discussion to end the day. Overall, the event was interactive, with many opportunities to build relationships and make connections. It was so successful that Asif volunteered to co-chair another PhUSE event in the future. PhUSE is very appreciative of everyone’s contribution to this successful event.


Kirk Paul Lafler, Senior SAS Consultant, Application Developer, Data Scientist, Trainer and Author Software Intelligence CorporationKirk Paul Lafler has been using SAS since 1979 and is consultant and founder of Software Intelligence Corporation. He is a SAS Certified Professional, application and tool developer, provider of IT consulting services, trainer to SAS users around the world, mentor, and sasCommunity.org emeritus Advisory Board member. As the author of six books including Google® Search Complete (Odyssey Press. 2014); PROC SQL: Beyond the Basics Using SAS, Second Edition (SAS Press. 2013); and PROC SQL: Beyond the Basics Using SAS (SAS Press. 2004), Kirk has written more than five hundred papers and articles, been an invited speaker and trainer at four hundred-plus SAS International, regional, special-interest, local, and in-house user group conferences, educational forums, and meetings, and is the recipient of 23 “Best” contributed paper, hands-on workshop (HOW) and poster awards.E-mail [email protected] LinkedIn http://www.linkedin.com/in/KirkPaulLafler Twitter @sasNerdTrademark Citations SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. ® indicates USA registration. Other brand and product names are trademarks of their respective companies.

Kirk’s KornerQuick & Simple TipsBy Kirk Paul Lafler, Software Intelligence Corporation, @sasNerd

Understanding Data Remerging in PROC SQLSAS® users are accustomed to seeing many informative notes displayed on the SAS Log. From the number of observations (or rows) read from a SAS dataset (or table) to the number of observations written to a SAS dataset, the amount of CPU, I/O and memory resources used by a SAS program to the many other informative messages, users are accustomed to seeing details about their running programs. While these types of messages provide useful information about the processing performed; not all messages are as easy to detect, understand and/or solve.

Apart from the many informational messages produced from a successfully running program, users often act surprised when the Log contains messages, warnings and/or errors about problems found in their programs. In fact, the first sign exhibited by many is one of disbelief followed by a, “this can’t be actually happening” moment, as if their code were a masterpiece by Michelangelo. But, the statistics along with the realities of programming and debugging say otherwise. As a result, users often become perplexed, confused and frustrated, producing a less than productive programming experience.

Because warnings and errors can, it seems, appear out of nowhere, the savvy SAS user knows that the most important rule to remember when debugging is to check the SAS Log immediately after each run. While this approach often helps to detect and understand the causes of warnings and/or errors, it does little to diminish the “punch to the gut” feeling that a SAS user gets when seeing those pesky warning and error messages appear on the Log in the first place. The one thing that all SAS users learn about the debugging process is that it can be a daunting, and sometimes humbling, experience.

This tip presents details about the not so obvious note, “The query requires remerging summary statistics back with

the original data,” that is produced in PROC SQL queries. While not a warning or error, this note does serve to alert users about the possibility of a query expending additional computing resources to complete a particular task. In my explanation of the causes and solutions to this note, the Movies table is used, shown below, consisting of six columns: title, length, category, year, studio, and rating. Title, category, studio, and rating are defined as character while length and year are defined as numeric.

Understanding Data RemergingData remerging involves the process of making two passes through the dataset (table). As might be imagined additional processing time (or resources), such as CPU, are required when data remerging occurs. Remerging is performed whenever one of the following conditions occurs:1. The SELECT statement specifies one or more columns that

don’t appear in a GROUP BY-clause;2. The SELECT statement specifies one or more columns that

don’t appear in a HAVING-clause;3. The values returned by a summary function are specified in

a calculation.

During the remerging process the following occurs while making two passes through the dataset (table):1. Summary functions are computed with values returned;2. The conditions specified in the GROUP BY-clause are

performed;

3. Rows and columns that are displayed in the output are retrieved;

4. The results from the summary functions are used to compute arithmetic expressions in which the summary function is involved with.

Let’s examine how the data remerging process works for the following query.

SQL Codeproc sql ; select title, rating, MIN(length) as Min_Length, length from movies where rating IN (“PG”, “PG-13”) group by rating ;quit ;

AnalysisPROC SQL computes and returns the value of the MIN function in the first pass of the dataset (table), and groups the results according to the GROUP BY-clause. In the second pass of the dataset (table), PROC SQL retrieves the rows and columns that are displayed in the output.

Log proc sql ; select title, rating, MIN(length) as Min_Length, length from movies where rating IN (“PG”,”PG-13”) group by rating ;

NOTE: The query requires remerging summary statistics back with the original data.

quit ;

Avoiding Data RemergingAt times it is difficult, if not unavoidable, to prevent PROC SQL from performing data remerging. But, one way to prevent PROC SQL from performing the data remerging process, and to avoid the additional costs associated with making two passes of the data, is to rewrite the query so the SELECT statement specifies only the column(s) specified in the GROUP BY-clause. The following query illustrates a SELECT statement that limits the columns specified to those identified in the GROUP BY-clause.

SQL Codeproc sql ; select rating, MIN(length) as Min_Length from movies where rating IN (“PG”, “PG-13”) group by rating ;quit ;

Another approach to avoid the data remerge process could be to remove the summary function from the SELECT statement altogether and to replace the GROUP BY-clause with an ORDER BY-clause, as follows.

SQL Codeproc sql ; select title, rating, length from movies where rating IN (“PG”, “PG-13”) order by rating ;quit ;

For More InformationReaders can find more unique application techniques using PROC SQL in the popular SAS Press book, PROC SQL: Beyond the Basics Using SAS, Second Edition by Kirk Paul Lafler.


David CunninghamCmed Research, UK

Sebastien BohnMerge Healthcare eClinical, France

Showkat AkbarBayer Healthcare, USA

Ann LeunginVentiv Health Clinical, Canada

Carrie Dundas-LuccaZencos Consulting, USA

Christoph CarlReal Life Sciences, Germany

Victor S SamuelNavitas, India

Manjinder DalamTheorem Clinical Research, India

Céline GehinElanco, Switzerland

Yoann MarsacSAS Institute, France

Dany GuerendoSTATPROG INC., USA

Rob NicholsAlgorics, UK

Michael KutchCytel, USA

Sheela KrishnanICON Clinical Research, India

Sameer DeshpandeinVentiv Health Clinical, India

Venkatesu BurruQuanticate International, India

Jane MarrerMerck & Co, USA

Welcome to our New MembersWe have previously mentioned, with delight, the growing number of PhUSE members, and a few months ago we passed the 6000 mark. If you look at the membership numbers on page 34, you can see from the distribution we truly are a global organisation.

The newsletter team thought it would be nice to hear from some of our new members, and here you can see who they are and where they are located. The newsletter team always like to hear from our members, and we encourage you to contact us with any articles. With new members comes a wealth of new experience.

Enjoy!

By Diana Stuart, Veramed


Advertising Costs

Event CalendarPhUSE Single Day Event2nd December 2015 Foster City, CA, USA

PhUSE Single Day Event3rd December 2015Tokyo, Japan

PhUSE Single Day Event5th December 2015Lonavala, India

PhUSE Single Day Event4th February 2016 Utrecht, Netherlands

PhUSE Computational Science Symposium13th–15th March 2016Silver Spring, MD, USA

DIA 28th Annual Euromeeting6th–8th April 2016 Hamburg, Germany

SAS Global Forum18th–21st April 2016Las Vegas, USA

PharmaSUG 2016 Conference8th–11th May 2016Denver, USA

PSI Annual Conference22nd–25th May 2016Berlin, Germany

PhUSE Annual Conference9th–12th October 2016Barcelona, Spain

Paper and Electronic Newsletter - PhUSE NewsFull page A4 . . . . . . £500Back cover A4 . . . . . £675If a company signs up for four consecutive issues, they will only be invoiced for the first three.

The Newsletter is published four times per annum. Copy dates for 2016 are listed below:Issue . . . . . . . . . . . . Copy deadline . . . . Publication dateSpring . . . . . . . . . . . 1st February . . . . . . 1st MarchSummer . . . . . . . . . . 3rd May . . . . . . . . . . 1st JuneAutumn . . . . . . . . . . 2nd August . . . . . . . 1st SeptemberWinter . . . . . . . . . . . 1st November . . . . . 1st December

PhUSE Monthly eMailshotBanner/job advertisement per monthly mailshot . . . . . £350Four consecutive mailshots in a 12-month period . . . £1,000

Advertising will be accepted for PhUSE Monthly eMailshots to all PhUSE members. This will comprise of one of the following:• a small banner in the body of the email, which will link to a

page on the advertising company’s website• a brief description of a job advertised, with a link to the full

job advertisement on the company’s website.

PhUSE Event BrochuresFull colour ad in the Annual Conference (hard copy) brochure . . . . . . . . . . . . . . . . . . . . . . . . . . . €800Flyer/booklet in the Annual Conference bag (650 copies) . . . . . . . . . . . . . . . . . . . . €800Full colour ad in the Computational Science Symposium (hard copy) brochure . . . . . . . . . . . . . . . . . . . . . . . . . . €1,000Artwork/flyers to be provided by the advertiser, at the advertiser’s cost.

PhUSE reserves the right to charge an administration fee if a confirmed order is cancelled.All prices quoted exclude VAT. Agency commission is not paid.Please send artwork to [email protected] | Tel: +44 (0)1843 609603

Membership FiguresCountry . . . . . . . . . . . . . .Membership figureUnited States . . . . . . . . . .2,183India . . . . . . . . . . . . . . . . .1,075United Kingdom . . . . . . .903Germany . . . . . . . . . . . . .378China . . . . . . . . . . . . . . . .365Switzerland . . . . . . . . . . .213Japan . . . . . . . . . . . . . . . .167Belgium . . . . . . . . . . . . . .120Denmark . . . . . . . . . . . . .96Sweden . . . . . . . . . . . . . .94South Africa . . . . . . . . . . .81France . . . . . . . . . . . . . . .79Russian Federation . . . . .65Taiwan . . . . . . . . . . . . . . .62Canada . . . . . . . . . . . . . .44Poland . . . . . . . . . . . . . . .36Netherlands . . . . . . . . . . .35Ireland . . . . . . . . . . . . . . .33Philippines . . . . . . . . . . . .32Spain . . . . . . . . . . . . . . . .16Mexico . . . . . . . . . . . . . . .8Romania . . . . . . . . . . . . .8Italy . . . . . . . . . . . . . . . . .6Australia . . . . . . . . . . . . . .3Austria . . . . . . . . . . . . . . .3Korea, Republic of . . . . . .3Ukraine . . . . . . . . . . . . . .3Czech Republic . . . . . . . .1Israel . . . . . . . . . . . . . . . .1Singapore . . . . . . . . . . . .1Total Members . . . . . . . .6,114

To change your details, please contact us: E-mail [email protected]

Mail PhUSEOffice Kent Innovation Centre Millennium Way Broadstairs Kent CT10 2QQ England, UK

Phone Tel: +44 1843 609600 Fax: +44 1843 265850 USA : +1 609 514 5105

Twitter.com/PhUSETwitta LinkedIn.com/PhUSE Facebook.com/PhUSE

Website www.PhUSE.eu

36 PhUSE News | Winter 2015

Cure the common clinical trial.

SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. ® indicates USA registration. Other brand and product names are trademarks of their respective companies. © 2014 SAS Institute Inc. All rights reserved. S119762US.0614

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SHARE – CONTRIBUTE – ADVANCE - PhUSE Wiki Newsletters/SIGNED OFF.pdf · SHARE – CONTRIBUTE...

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