Challenges of Phase I Units in Today’s

Changing EnvironmentDonna W. Dorozinsky, RN, MSN, CCRC

Understand that we are not alone in the challenges that we face in Phase I

Identify some possible solutions to some of the most challenging issues

Objectives

Pharma sponsored sites Hospital based Healthy male volunteers People writing the studies were part of the Unit’s operation

90 Day FTIM

Where Have We Been?

Budget – What budget? Monitor my study? Are you kidding? Right of first refusal Studies on the shelf Simple molecules

Where Have We Been?

Majority of Phase I studies are independent of Pharma

Cost competitive environment Complex studies Patient studies Professional volunteers Biologics

Where are we today?

Non-scientific anonymous survey Sent to 40 individuals selected through ACPU membership, networks, meeting attendees

16 respondents – Thank You! 21 Operational Challenges 15 Clinical Challenges Some as expected Some Surprises

Identifying the Chanllenges

Demographics of Respondents

Sponsorship

6%

38%

31%

6%

19%

CPU Ownership

Investigator owned Part of a large CRO Part of a small CROPharma sponsored Academic afiliation

Bed Capacity

1-10 11-20 21-40 41-75 76-100 101-150 151+0

0.5

1

1.5

2

2.5

3

3.5

4

Studies in Last 12 Months

1-5 6-10 11-15 16-20 21-25 26-30 31+0

0.5

1

1.5

2

2.5

3

Last minute cancellation of studies by the sponsor◦8 respondents identified in the top 3

Adequate sponsorship funding◦6 respondents identified in top 5

Obtaining studies◦7 respondents identified in top 5◦4 respondents identified as #1 challenge

Greatest Operational Challenges

Recruitment of patient population◦8 respondents identified in top 7

Adequate resources for employee development◦5 sites identified in top 5

Greatest Operational Challenges

Healthy subject recruitment Planning bed occupancy Funding staff training

Equal Distribution Operational Challenges

Complex study designs Ability to function independently of your sponsoring organization

Site security Access to emergency care Storage space

Not Considered to be an Operational Challenge

Cash payment milestones PI recruitment Finding capable monitors knowledgeable in GCPs

Low employee morale Lack of leadership

Additional Operational Challenges

Several clinics phase I-IV have opened in the proximities of the site

Sponsor canceling and postponing the projects.

Staff retention The time to effectively train PRN, agency and night staff on all protocols.

Additional Operational Challenges

Security issues with subjects◦6 respondents identified in the top 5

Contraband◦6 respondents identified in the top 5

Excessive Data Queries◦6 respondents identified in the top 5

Greatest Clinical Challenges

Concern that subjects are participating in multiple studies◦7 respondents identified in the top 5

Abnormal laboratory values◦8 respondents identified in the top 5

Greatest Clinical Challenges

Incomplete delegation logs Missed procedures because of staff shortage

Clinical equipment old or in disrepair

Equal Distribution Clinical Challenges

Emergency response capabilities Illiterate research subjects

Not of Clinical Concern

Ensuring that staff address data issues (corrections)immediately after they are identified

Finding new staff to hire with Phase 1 Clinical Research Experience or even late phase experience that can be trained for Phase 1 staffing

Additional Clinical Concerns

Sponsors don’t understand the challenges of executing these complicated protocols

25.00%

43.75%

18.75%

12.50%

Strongly agreeAgreeNot sureDisagreeStrongly disagree

Monitors are inexperienced in monitoring these complex studies

12.50%

37.50%37.50%

12.50%

Strongly agreeAgreeNot sureDisagreeStrongly disagree

Sponsors are requiring physicians in-house for 24 hours after dosing in some studies

12.50%

18.75%

18.75%25.00%

25.00%

Strongly agreeAgreeNot sureDisagreeStrongly disagree

Quality Checks are built into every step of our operation

56.25%

18.75%

18.75%

6.25%

Strongly agreeAgreeNot sureDisagreeStrongly disagree

Everyone has a disaster plan Everyone has a formal training program that includes an orientation program for new hires

Across the Board

Meeting these Challenges

Recruitment of Patient Population Staff Training Data Queries Security Issues

Some Ideas for Meeting these Challenges

Consider your facilities – are they conducive to patient studies

Build relationships with medical community◦ Physician to physician◦ Ensure physician retains control◦ Provide the administrative support◦ Sub-I opportunity

Take your research to the patient Local health fairs Community support groups NIH partnerships?

Recruitment of Patient Population

Suggestions from the Audience

Build funding into your budgets Training prevents errors – errors cost $$ Annual GCP Training Webinars – one fee for multiple attendees In-house programs

◦ Lunch n Learn◦ Developmental opportunities for presenters

Off-shift training Monthly protocol training PowerPoint Slidesets – specific to clinic

activities

Staff Training

Suggestions from the Audience

Issues◦ High cost - $80/query◦ Tracking◦ Multiple people involved◦ Documenting

Understand causes◦ Monitor knowledge of site and processes◦ Missing source data◦ Careless error◦ Training◦ Lack of staff◦ Missing source data◦ CRF completion

Data Queries

QA tracking Analysis of data to identify causes that can be addressed

Create information package for monitors

Present findings from tracking to staff

Training based on identified causes

Data Queries

Suggestions from the Audience

On-site security Your reputation can drive subject behavior

Searches Metal detectors Separation of in patient and out patient areas

Security Issues

Scrubs Lockers away from subject area No cell phones or limited access to cell phones

House Rules Fines for behaviors Be good or be gone

Security Issues

Suggestions from the Audience

Revision to the Survey Wider audience Presentation of results to the ACPU board

◦ Can ACPU take a role in helping sites meet some of these challenges?

Explore other avenues for sharing

Next Steps

Donna Dorozinskyddorozinsky@dwassoc.com

Thank You!!!