1. Donna W. Dorozinsky, RN, MSN, CCRC

2.  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.  Pharma sponsored sites  Hospital based  Healthy male volunteers  People writing the studies were part of the Unit’s operation  90 Day FTIM

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

5.  Majority of Phase I studies are independent of Pharma  Cost competitive environment  Complex studies  Patient studies  Professional volunteers  Biologics

6.  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

11.  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.  Recruitment of patient population ◦ 8 respondents identified in top 7  Adequate resources for employee development ◦ 5 sites identified in top 5

13.  Healthy subject recruitment  Planning bed occupancy  Funding staff training

14.  Complex study designs  Ability to function independently of your sponsoring organization  Site security  Access to emergency care  Storage space

15.  Cash payment milestones  PI recruitment  Finding capable monitors knowledgeable in GCPs  Low employee morale  Lack of leadership

16.  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.  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.  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.  Incomplete delegation logs  Missed procedures because of staff shortage  Clinical equipment old or in disrepair

20.  Emergency response capabilities  Illiterate research subjects

21.  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

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

28.  Recruitment of Patient Population  Staff Training  Data Queries  Security Issues

29.  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?

31.  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

33.  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.  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

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

37.  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

39.  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. Donna Dorozinsky ddorozinsky@dwassoc.com