Science Policy / Conflict of Interest
Experience of Participants in Clinical Trials
Sponsor: NIH – National Center for Nursing Research
September 2005 - December 2008
Principal Investigator: Joel Weissman, Ph.D.
This study seeks to:
- Describe post-trial access to care among participants in clinical trials, including access to the studied intervention or a therapeutic equivalent, and to assess whether insurance status is an independent predictor.
- Test associations between insurance status and selected aspects of the clinical trial experience, including reasons for enrollment/disenrollment, handling of adverse events, and participation in multiple trials as a means of obtaining access to care.
To accomplish these aims, we will survey a national sample of volunteers in late phase clinical trials of type phase IIIB and IV at three points in time: upon enrollment; upon exit from the trial, and approximately 6 months after the trial ends. The research is intended to gather empirical data on the experience of human subjects in clinical research that may reflect ethical aspects of the research enterprise (but not to assess ethical conduct of any particular trial), and to provide empirical information that will help to evaluate the just distribution of the risks and burdens of research.
Academic Industry Relationships in Genetics
Sponsor: Agency for Healthcare Research and Quality
September 2005 - August 2007
Principal Investigator: Eric Campbell, Ph.D.
To explore the phenomenon of Academic-Industry Relationships (AIRs) in the life-sciences, with an emphasis in the field of genetics. This study seeks to update previous work and explore how the prevalence and magnitude of AIRs have changed over the last two decades. Qualitative data from focus groups and personal interviews with investigators in research intensive medical schools and teaching hospitals will be used to refine existing and develop new survey items and hypotheses. The quantitative data will involve an anonymous mailed survey of a random sample of up to 3000 faculty researchers in genetics, other basic life sciences, and clinical departments. Survey responses will be analyzed to show how individual, departmental, institutional, and national policies and characteristics affect the propensity, scale, length, and type of industry affiliation, including research, consulting, licensing, equity, training, and gift relationships. Results will be disseminated through publications in peer-reviewed journals and presentations at scientific meetings.
Institutional Academic Industry Relationships in the Life and Health Sciences
Sponsor: Greenwall Foundation
January 2005 - December 2006
Principal Investigator: Eric Campbell, Ph.D.
The purpose of this research is to conduct the first comprehensive, national study to explore empirically the nature, extent, consequences and institutional regulation of IAIRs in the life and health sciences. The three specific objectives of the proposed study are 1. To measure the prevalence of institutional relationships between medical school leaders and department chairs and companies. 2.To explore policies towards IAIRs at medical schools and the attitudes of leaders of academic medicine towards those policies, including whether they are necessary, appropriate, comprehensive and adequate. 3. To explore leaders’ perceptions of the impact, if any, of IAIRs on the mission-related activities in medical schools.
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