MANAGEMENT OF CONFLICT OF INTEREST

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MANAGEMENT OF CONFLICT OF INTEREST IN THE REVIEW
OF CLINICAL TRIALS
PEER REVIEW ADVISORY COMMITTEE MEETING
January 23, 2006
Dr. Hortencia Hornbeak, Ph.D.
Associate Director for Scientific Review and
Policy DEA, NIAID, NIH
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Re-engineering the HIV/AIDS Clinical Research
Enterprise
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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

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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

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OUTLINE

• Challenges
• Potential Solutions

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CHALLENGES

• Difficulty finding unconflicted reviewers due to
• Collaborative nature of clinical networks
• Product competition
• Trial oversight support
• Institutions and personnel involved

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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

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RFA AI-05-002 Units for HIV/AIDS Clinical
Trials Networks
Clinical Trial Unit (CTU) Applications

• CTU Applications with Foreign Components
• Representing 58 Countries

• Proposed Mentoring Partnerships

• Associated Clinical Research Sites (CRS)
• multiple CRS per Application

• Numerous Personnel and Institutions Identified
• gt9,000 personnel
• gt650 associated institutions

2,094 TOTAL REVIEWABLE UNITS
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POTENTIAL SOLUTIONS

• 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

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COI WAIVER

• 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 others
  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.

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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.