Challenges of Phase I Units in Today’s Changing Environment

1. Challenges of Phase I Units in Today’s Changing Environment Donna W. Dorozinsky, RN, MSN, CCRC

2. Objectives • 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

3. Where Have We Been? • Pharma sponsored sites • Hospital based • Healthy male volunteers • People writing the studies were part of the Unit’s operation • 90 Day FTIM

4. Where Have We Been? • Budget – What budget? • Monitor my study? Are you kidding? • Right of first refusal • Studies on the shelf • Simple molecules

5. Where are we today? • Majority of Phase I studies are independent of Pharma • Cost competitive environment • Complex studies • Patient studies • Professional volunteers • Biologics

6. Identifying the Chanllenges • 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

7. Demographics of Respondents

8. Sponsorship

9. Bed Capacity

10. Studies in Last 12 Months

11. Greatest Operational Challenges • 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

12. Greatest Operational Challenges • Recruitment of patient population • 8 respondents identified in top 7 • Adequate resources for employee development • 5 sites identified in top 5

13. Equal Distribution Operational Challenges • Healthy subject recruitment • Planning bed occupancy • Funding staff training

14. Not Considered to be an Operational Challenge • Complex study designs • Ability to function independently of your sponsoring organization • Site security • Access to emergency care • Storage space

15. Additional Operational Challenges • Cash payment milestones • PI recruitment • Finding capable monitors knowledgeable in GCPs • Low employee morale • Lack of leadership

16. 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.

17. Greatest Clinical 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

18. 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

19. Equal Distribution Clinical Challenges • Incomplete delegation logs • Missed procedures because of staff shortage • Clinical equipment old or in disrepair

20. Not of Clinical Concern • Emergency response capabilities • Illiterate research subjects

21. Additional Clinical Concerns • 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

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

23. Monitors are inexperienced in monitoring these complex studies

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

25. Quality Checks are built into every step of our operation

26. Across the Board • Everyone has a disaster plan • Everyone has a formal training program that includes an orientation program for new hires

27. Meeting these Challenges

28. Some Ideas for Meeting these Challenges • Recruitment of Patient Population • Staff Training • Data Queries • Security Issues

29. Recruitment of Patient Population • 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?

30. Suggestions from the Audience

31. Staff Training • 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

32. Suggestions from the Audience

33. Data Queries • 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

34. 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

35. Suggestions from the Audience

36. Security Issues • On-site security • Your reputation can drive subject behavior • Searches • Metal detectors • Separation of in patient and out patient areas

37. 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

38. Suggestions from the Audience

39. Next Steps • 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

40. Thank You!!! Donna Dorozinsky ddorozinsky@dwassoc.com