Date post: | 23-Jan-2018 |
Category: |
Health & Medicine |
Upload: | sgs |
View: | 606 times |
Download: | 0 times |
INNOVATIVE HOSPITAL PARTNERSHIP MODEL
FOR HIGH QUALITY PATIENT CLINICAL TRIALS
– CENTRAL & EASTERN EUROPE ONCOLOGY
TRIAL CASE STUDY
Istvan Udvaros Bela E Toth
Medical Director and CEE Expert
Project Director Oncology Senior Consultant for SGS
SGS
2 SGS BIOPHARMA DAY – OCTOBER 25, 2016
SGS CONCEPT FOR PATIENT TRIALS –
THE SGS ADDED VALUE
SGS has the know-how in Early Phase as a
major player in the Phase I ground
SGS targets Phase I/b (-II/a) on patients as well
to cover all EP clinical services
To increase access to patients, satellite project
was initiated in cooperation with selected
hospitals
Functional ownership on operations via
SGS clinical teams present for trial execution
excellence
SGS quality documents are used for full
transparency
SGS inspected sites (by independent auditors)
3 SGS BIOPHARMA DAY – OCTOBER 25, 2016
AZSM – THE BELGIAN EXAMPLE
8 bed patient unit
Dedicated to Phase I trial requirements
Full access to CPU know-how, expertise, services
Dedicated CRC for AZSM projects
SGS CPU Investigator available for trial
SGS CPU SN/Lab techs could be available
All trainings will be done in /by CPU staff
CPU Pharmacy support
Large public hospital with good access to patients
Oncology (solid and hematology)
Respiratory
Neurology
Orthopedics
Organ impairment (hepatic and renal), etc.
Strong motivation to work with us
due to hospital development strategy
4 SGS BIOPHARMA DAY – OCTOBER 25, 2016
OUR SATELLITE PROJECT FOR CEE/HUNGARY
CEE as targeted region
In proximity
EU member countries
EU guidelines, customs, IMP imports, etc..
Centralized health care systems
Motivated investigators
Some limitations to new therapy access
Hungary as selected pilot country
10 million population
High morbidity rates (oncology)
Government initiative to support clinical trials
Improving regulatory conditions (45 days for
2017, targeting 28 days for 2018)
5 SGS BIOPHARMA DAY – OCTOBER 25, 2016
THE SGS PATIENT UNIT IN THE HEALTH
CENTER OF HUNGARIAN DEFENSE FORCES
Medical Center HDF is one of the largest
hospital complex in Hungary
Number of beds: • 1200 active
• 600 rehabilitation/chronic care
Access up to 2 million people • army, police , fire brigades, government
• northeastern districts of Budapest
• counties north of the capital
Oncology Department
44 standard plus 20 day-care beds
12 medical doctors (8 board certified, 4 residents),
45 clinical trials with 369 enrolled patients 2011-16
3 study nurses, 3 coordinators (part time)
supporting LP trials
6 SGS BIOPHARMA DAY – OCTOBER 25, 2016
SGS UNIT CHARACTERISTICS
5 bed / 2 patient room unit separated from
standard of care hospital area
Attached to oncology department
SGS office within department for permanent staff
Research physician, study nurse, CRC
ICU, pharmacy within same building
Access to other indications
Rheumatology
Dermatology
Neurology
Gastrointestinal diseases
Cardiology
Etc…
Suppose photo will be added
7 SGS BIOPHARMA DAY – OCTOBER 25, 2016
ACCESS TO OTHER SATELLITES / PHASE I UNITS
ON COUNTRY LEVEL
18 licensed Phase I Units in Hungary (including SGS) –
9 are pre-qualified as potential partners
Additional sites might be supported to fulfill Phase I /
EP requirements
SGS can use country team and their expertise to
Site selection / qualification
Investigator relations – feasibility accuracy
Start up support
Identifying all gaps and go for solutions with the site
Provide resources, equipment, tech training, etc…
Hospitalier Order of St John hospital – case study
Hospital: Phase I Unit, biologicals expert PI, pharmacy, hospital
services
SGS: clinical team for execution, SGS work docs and templates,
study coordination, spec equipment
8 SGS BIOPHARMA DAY – OCTOBER 25, 2016
TRENDS IN CLINICAL RESEARCH
Globalization of Industry-Sponsored Trials
The balance to Pharmamerging markets
• Trends of movement away from traditional destinations (NA, W-
Eu)
• CEE countries continues to dominate highest market share gain
over the last years
• The Industry-sponsored product development growth rate of
trials in trends does not necessarily follow product sales growth
More complex Regulatory/EC procedures
• Country specific, needs local knowledge
Highly integrated systems (EDC, CTMS, IT, DM, eCRF, QA)
• Need for on-site /data entry by assigned study personnel
• Site access for global remote / and RBM monitoring
• Access to patient data by Safety and Adaptive Design reasons
• High demand for qualified/trained professional staff at site-level
9 SGS BIOPHARMA DAY – OCTOBER 25, 2016
CEE: POTENTIALS AND THE PRACTICE
Patient access
National Healthcare and
Insurance system
Feasibility by epidemiology
related indicators
Access to patient data in
regional clinics/hospitals
Information and education
for patients: trial access
Investigators’ networking
Support patients access
Regulatory environment
Competent Regulatory
<60days
Improved efficiencies with
ethics review process (<45
days)
Reasonable Costs and
Benefits
„Ready to” EMA/FDA
Short, predictable timelines
10 SGS BIOPHARMA DAY – OCTOBER 25, 2016
CEE - PROVEN QUALITY IN CLINICAL RESEARCH
Countries where the Clinical Quality is properly defined
and maintained throughout clinical conduct
Transparency and regulatory compliance
The „oral and written culture” of clinical reseearch
Adherence to FDA Access to Risk Based Quality
Management
Compliance to EU-regulations/FDA -guidelines
Centralised supportive procedurals to remain competitive
Experiences accumulated in the CEE/ Hungary „… along with the outstanding scientific quality may enable the
country to maintain the current quality of clinical trials, moreover, …
is considered a major value in Europe…”
“CEE was also the region with the lowest percentage of inspections
that required official or voluntary action… quality standards that are
not inferior to those in Western regions.” FDA inspections data referred by Longtaal Oct 2008 – Sep 2015)
AIPM (2015); Calderon (2012); Dutton, G. (2015)
11 SGS BIOPHARMA DAY – OCTOBER 25, 2016
THE CONCEPT
Smart-transitioning into Late-Phase trial environment
Expanded coverage
Durable and do-able
Achievable
Consequent
the proven
concept of
satellite-
site
Late
Phase
Trials • trial-methodology
• trained staff
• systems/ QC
• tailored start-up
12 SGS BIOPHARMA DAY – OCTOBER 25, 2016
THE CONCEPT:
TRANSITION FOR LATE PHASE TRIALS 1/3
What is needed for success in Late-Phase clinical trials?
Considering the research trends and technology • Study design and advanced tools in use
Site selection methodology • Experience, proven track record of a therapeutic field
• Relationship, trust and providing trained staff
Scientific collaboration b/w partners • Scientifc values throughout in trial development
Startup timelines: included Regulatory and Contract • Manage complexity and provide ready-made resolution intergrated to systems
Patient access
Site and staff readiness
Clinical quality
fail to meet
enrolment targets*
to be terminated or
recruit for rescue*
fail to enroll a
single patient*
Li G. Site Activation: The Key to More Efficient Clinical Trials. PharmExec. 2008.
http://www.pharmexec.com/site-activation-key-more-efficient-clinical-trials?pageID=2. Accessed September 10, 2015.
13 SGS BIOPHARMA DAY – OCTOBER 25, 2016
THE CONCEPT: CONTINUED SCIENTIFIC SUPPORT
IN TRANSITION FOR LATE PHASE 2/3
Managing the scientific challenges in drug development
Scientific contributions during the early phase programs
• Adequate data prior the decision to move to Phase 3
• Impact of study design, endpoints
• Potential issues on patient recruitment: clinical benefits, timelines
The specific challenges vary with the therapeutic area
• The estimated success rate is fairly low (in oncology and some
other therapeutic areas)
• Problems resulting in inaccurate information from the Phase 1/2
• Potential issues with the design and implementation of the
Phase 3 programs
Anastassios D. Retzios,: Why Do So Many Phase 3 Clinical Trials Fail?. 2010 - Pavlou AK and Reichert JM: 2010. Nat Biotechnol 22: 1513-1519 - Kola I and Landis J: Nat Rev
3: 711-715, 2004 - Industry Success Rates 2004, Centre for Medicines Research International Ltd. CMR04-234R, May 2004
14 SGS BIOPHARMA DAY – OCTOBER 25, 2016
THE CONCEPT:
TRANSITION FOR LATE PHASE TRIALS 3/3
The patient enrollment is determined by Sponsor (internal
business planning process),
varies by Sponsor’s plan and therapeutic area/disease state
site activation accounts for about 70% of enrollment time
NOT driven by individual investigator sites
Duration of site activation process can be reduced
Site activation is the driver in patient enrollment
Site selection
Site activation
Patient recruitment
15 SGS BIOPHARMA DAY – OCTOBER 25, 2016
SITE ACTIVATION IS THE DRIVER
What is needed to add value for Late-Phase clinical trials?
Pre-selected sites
• Past experiences in specific indications
• Enhance staff readiness
• SGS-certified training modules
• The site’s potential for performance
Other conditions
• Investigator relationship
• Budget, scientific value, novelty etc..
Site activation is the driver in patient enrollment
Site selection
Site activation (start-up)
Patient recruitment
1.
16 SGS BIOPHARMA DAY – OCTOBER 25, 2016
STARTUP
What is needed to add value for Late-Phase clinical trial?
Site-tailored business model
Enhanced study start-up
• Contracting and legal terms
• Budget and parties
• Procedural elements for LEC/ MEC Ethics Boards (EC)
• Essential documents
• Clinical supplies
Site activation is the driver in patient enrollment
Site selection
Site activation (start-up)
Patient recruitment
2.
17 SGS BIOPHARMA DAY – OCTOBER 25, 2016
PATIENT ACCESS
What is needed to add value for Late-Phase clinical trials?
Pre-selected sites
• The smart reserach planning (SRT) tool for enrolment
• Staffing support (SC / SN level)
• Qualified local research staff
Advanced track record of high enrolment in the CEE-region
Centralised health-care system/ access to patients in specific
indications
Site activation is the driver in patient enrollment
Site selection
Site activation (start-up)
Patient recruitment 3.
18 SGS BIOPHARMA DAY – OCTOBER 25, 2016
TRANSITION FOR LATE PHASE TRIALS
Satellite site Phase I unit
SGS research methodology
and culture:
Site level SOP
Research staff
• Study coordinator/
study nurse
SGS training modules
Clinical Quality
Ongoing relationship
Oncology sites for Phase
II/III. trials
Site with a lack of proper:
Management and
methodology
Site level SOP
Research staff
• CRC, data entry, SN
Trainings /TNA plan
Quality Assurance
Build relationship
19 SGS BIOPHARMA DAY – OCTOBER 25, 2016
TRANSITION FOR LATE PHASE TRIALS
Staffing of Satellite site
Phase I. unit
Supporting the Oncology
Phase II/III. sites
SGS-certified Pre-selected sites
SGS staff support (SC/SN level)
SGS-Startup methodology
Scientific management by SGS
SGS Clinical Quality
SGS Clinical Training Modules
20 SGS BIOPHARMA DAY – OCTOBER 25, 2016
CASE STUDY ONCOLOGY
Phase 2 breast cc immunotherapy trial with
experimental PK profiling part within trial
Hungary (and Poland) involved from CEE region
4 Hungarian sites, 2 with Phase I capabilities
(including SGS) – approved to participate PK part of
trial
SGS clinical team has full control above its own site
and supports other site with training and logistics
SGS teams (clinical and clin ops plus quality) are
working together for excellent site management and
overall trial success
21 SGS BIOPHARMA DAY – OCTOBER 25, 2016
Life Sciences Istvan Udvaros MD MSc
Medical Director Clinical Research
Project Director Oncology
SGS Belgium NV Phone: + 32 (0)15 28 30 46
Generaal De Wittelaan 19A, Fax: + 32 (0)15 27 32 50
B-2800 E-mail : [email protected]
Mechelen
Belgium Web : www.sgs.com/lifescience
THANK YOU FOR YOUR ATTENTION
+ 41 22 739 9548
+ 1 866 SGS 5003
+ 65 637 90 111
+ 33 1 53 78 18 79
+ 1 877 677 2667
+ 33 1 41 24 87 87
22 SGS BIOPHARMA DAY – OCTOBER 25, 2016
QUESTIONS ?
23 SGS BIOPHARMA DAY – OCTOBER 25, 2016