Researchers’ Views of the Acceptability of Restrictive Provisions in Clinical Trial Agreements with Industry Sponsors

Abstract

We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators’ academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.

This material is based on work supported by the National Institute of Neurological Disorders and Stroke and the Department of Health and Human Services’ Office of Research Integrity under Award Numbers 1-R01-NS46777-01 and 1-R01-NS42438-01A1. Any opinions, findings, and conclusions or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the National Institute of Neurological Disorders and Stroke or the Office of Research Integrity. Preliminary findings from this study were presented at the Research Conference on Research Integrity in San Diego, California in November 2004.

Dr. Mello conceived the study design, analyzed the data, and drafted the manuscript. Dr. Studdert participated in the study design, survey instrument development, and interpretation of findings, and critically revised the manuscript for important intellectual content. Dr. Clarridge led the development of the survey instrument and collected the data.

The authors thank Hershel Alexander, Hisashi Yamagata, and the Association of American Medical Colleges for making the Faculty Roster data available for this study. We are grateful to Matthew Jans for his efforts in administering the survey, Marin Levy and John Barkett for assistance with the sample selection, Troy Brennan for assistance convening focus groups, and John Abramson and Marcia Angell for helpful comments on the draft manuscript.

Keywords:

• clinical trials
• drug industry
• publications/standards
• research support
• conflict of interest

Notes

This material is based on work supported by the National Institute of Neurological Disorders and Stroke and the Department of Health and Human Services’ Office of Research Integrity under Award Numbers 1-R01-NS46777-01 and 1-R01-NS42438-01A1. Any opinions, findings, and conclusions or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the National Institute of Neurological Disorders and Stroke or the Office of Research Integrity. Preliminary findings from this study were presented at the Research Conference on Research Integrity in San Diego, California in November 2004.

Dr. Mello conceived the study design, analyzed the data, and drafted the manuscript. Dr. Studdert participated in the study design, survey instrument development, and interpretation of findings, and critically revised the manuscript for important intellectual content. Dr. Clarridge led the development of the survey instrument and collected the data.

The authors thank Hershel Alexander, Hisashi Yamagata, and the Association of American Medical Colleges for making the Faculty Roster data available for this study. We are grateful to Matthew Jans for his efforts in administering the survey, Marin Levy and John Barkett for assistance with the sample selection, Troy Brennan for assistance convening focus groups, and John Abramson and Marcia Angell for helpful comments on the draft manuscript.