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Management of COIin the Review of Clinical Trials
Archived FileArchived 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The file below has been archived for historical reference purposes only. The content and links are no longer
maintained and may be outdated.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.
MMANAGEMENT OF ANAGEMENT OF CCONFLICT ONFLICT OOF F IINTERESTNTEREST
IN THE IN THE RREVIEW OF EVIEW OF CCLINICAL LINICAL TTRIALSRIALS
January 23, 2006
Associate Director forScientific Review and Policy
DEA, NIAID, NIH
Dr. Hortencia Hornbeak, Ph.D.Dr. Hortencia Hornbeak, Ph.D.
PPEER REVIEW EER REVIEW AADVISORY DVISORY CCOMMITTEE OMMITTEE MMEETINGEETING
Management of COIin the Review of Clinical Trials
Re-engineering the Re-engineering the HIV/AIDS Clinical Research EnterpriseHIV/AIDS Clinical Research Enterprise
Management of COIin the Review of Clinical Trials
Current NIAID HIV/AIDSCurrent NIAID HIV/AIDS Clinical Research Networks 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
Management of COIin the Review of Clinical Trials
Linked RFAsLinked 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”
Management of COIin the Review of Clinical Trials
Difficulty finding unconflicted reviewers due to:Collaborative nature of clinical networksProduct competitionTrial oversight supportInstitutions and personnel involved
CHALLENGESCHALLENGES
Managementof COI
AppropriateExpertise
Management of COIin the Review of Clinical Trials
CHALLENGES (cont.)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
Management of COIin the Review of Clinical Trials
Clinical Trial Unit (CTU) Applications
2,094 TOTAL REVIEWABLE UNITS2,094 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-05-002RFA AI-05-002 “ “Units for HIV/AIDS Clinical Trials Networks”Units for HIV/AIDS Clinical Trials Networks”
Management of COIin 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 SOLUTIONSPOTENTIAL SOLUTIONS
Management of COIin 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 WAIVERCOI WAIVER