# Presentation: 176161

## MANAGEMENT OF CONFLICT OF INTEREST

**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**

## Re-engineering the HIV/AIDS Clinical Research Enterprise

## 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

## 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”

## OUTLINE

- Challenges
- Potential Solutions

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

- Collaborative nature of clinical networks
- Product competition
- Trial oversight support
- Institutions and personnel involved

**CHALLENGES**

## 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

## RFA AI-05-002

**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”**

## 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

- 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**

## COI WAIVER

- 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**

## 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.