United States private-sector physicians and pharmaceutical contract research: a qualitative study.
BACKGROUND
There have been dramatic increases over the past 20 years in the number of nonacademic, private-sector physicians who serve as principal investigators on US clinical trials sponsored by the pharmaceutical industry. However, there has been little research on the implications of these investigators' role in clinical investigation. Our objective was to study private-sector clinics involved in US pharmaceutical clinical trials to understand the contract research arrangements supporting drug development, and specifically how private-sector physicians engaged in contract research describe their professional identities.


RESULTS
We conducted a qualitative study in 2003-2004 combining observation at 25 private-sector research organizations in the southwestern United States and 63 semi-structured interviews with physicians, research staff, and research participants at those clinics. We used grounded theory to analyze and interpret our data. The 11 private-sector physicians who participated in our study reported becoming principal investigators on industry clinical trials primarily because contract research provides an additional revenue stream. The physicians reported that they saw themselves as trial practitioners and as businesspeople rather than as scientists or researchers.


CONCLUSIONS
Our findings suggest that in addition to having financial motivation to participate in contract research, these US private-sector physicians have a professional identity aligned with an industry-based approach to research ethics. The generalizability of these findings and whether they have changed in the intervening years should be addressed in future studies. Please see later in the article for the Editors' Summary.
Center for Biomedical Ethics & Society, Vanderbilt University, Nashville, Tennessee, United States of America. jill.fisher@vanderbilt.edu
Jill A
JA
Fisher
Corey A
CA
Kalbaugh
D032982:Contracts / Q000191:economics / Q000941:ethics / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000191:economics / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D009042:Motivation; D010820:Physicians / Q000941:ethics / Q000331:legislation & jurisprudence*; D017149:Private Sector / Q000191:economics / Q000941:ethics / Q000331:legislation & jurisprudence*; D036301:Qualitative Research; D014481:United States