1. Management of COI in the Review of Clinical Trials Archived File The file below has been archived for historical reference purposes only. The content and links are no longer maintained and may be outdated. See the OER Public Archive Home Page for more details about archived files.archivedOER Public Archive Home Page

2. M ANAGEMENT OF C ONFLICT O F I NTEREST IN THE R EVIEW OF C LINICAL T RIALS January 23, 2006 Associate Director for Scientific Review and Policy DEA, NIAID, NIH Dr. Hortencia Hornbeak, Ph.D. P EER REVIEW A DVISORY C OMMITTEE M EETING

3. Management of COI in the Review of Clinical Trials Re-engineering the HIV/AIDS Clinical Research Enterprise

4. Management of COI in the Review of Clinical Trials Current NIAID HIV/AIDS Clinical Research Networks  Adult AIDS Clinical Trials Group  Pediatric AIDS Clinical Trials Group  Community Program for Clinical Research on AIDS  HIV Vaccine Trials Network  HIV Prevention Trials Network  Evaluation Of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT)  Acute Infection/Early Disease Program

5. Management of COI in the Review of Clinical Trials Linked RFAs  Network: RFA-AI-05-001 “Leadership for HIV/AIDS Clinical Trials Networks”  Units: RFA AI-05-002 “Units for HIV/AIDS Clinical Trials Networks”

6. Management of COI in the Review of Clinical Trials OUTLINE  Challenges  Potential Solutions

7. Management of COI in the Review of Clinical Trials  Difficulty finding unconflicted reviewers due to:  Collaborative nature of clinical networks  Product competition  Trial oversight support  Institutions and personnel involved CHALLENGES Management of COI Appropriate Expertise

8. Management of COI in the Review of Clinical Trials CHALLENGES (cont.)  Securing appropriate scientific and in-country expertise on the committee  Multi-authored publications of network participants  Use of chartered committee versus special emphasis panels  Willingness of reviewers to travel for participation in review meetings

9. Management of COI in the Review of Clinical Trials Clinical Trial Unit (CTU) Applications 2,094 TOTAL REVIEWABLE UNITS  Associated Clinical Research Sites (CRS)  multiple CRS per Application  CTU Applications with Foreign Components  Representing ~58 Countries  Proposed Mentoring Partnerships  Numerous Personnel and Institutions Identified  >9,000 personnel  >650 associated institutions RFA AI-05-002 “Units for HIV/AIDS Clinical Trials Networks” “Units for HIV/AIDS Clinical Trials Networks”

10. Management of COI in the Review of Clinical Trials  Involve OER early in the process to develop strategy  Secure relaxation of selected COI regulations  Divide applications in multiple special emphasis panels  Set up an electronic system to facilitate tracking/determination of conflict  Use of electronic systems (IAR) and teleconferences to maximize reviewer participation POTENTIAL SOLUTIONS

11. Management of COI in the Review of Clinical Trials  Non-key CTU and Leadership Network personnel may review non-affiliated CTU applications.  Reviewers may be used who have published with key personnel applicants within the last 2 years (reduced from 3 years).  Diversity in gender/ethnic/geographic composition of the review panel should be sought, however these guidelines are relaxed if every effort is made to diversify where possible.  On any given SEP, more than one reviewer from an institution is allowed however they should not be assigned to the same application.  Mentors or mentees may review each other’s applications as long as the mentor/mentee is not the lead on an application. In these cases, every effort should be made to distance mentors and mentees from each others applications where possible.  Clinical staff from NIH co-sponsoring institutes to serve on review panels, but this should only occur as a last resort where no other reviewers are available. In addition, where possible, clinical staff should not be assigned as reviewers on applications where their own institution is a sponsor. COI WAIVER

12. Management of COI in the Review of Clinical Trials ACKNOWLEDGEMENT  Office of Extramural Research Staff provide guidance:  Norka Ruiz-Bravo, Ph.D.  Sally Rockey, Ph.D.  Anthony Coehlo, Ph.D.  Carlos Caban, Ph.D.