Management of COIin the Review of Clinical Trials

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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

OUTLINEOUTLINE

Challenges

Potential Solutions

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

Management of COIin the Review of Clinical Trials

ACKNOWLEDGEMENTACKNOWLEDGEMENT

Office of Extramural Research Staff provide guidance:Norka Ruiz-Bravo, Ph.D.Sally Rockey, Ph.D.Anthony Coehlo, Ph.D.Carlos Caban, Ph.D.