United States private-sector physicians and pharmaceutical contract research: a qualitative study.

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�...

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Main Authors: Jill A Fisher, Corey A Kalbaugh
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2012-01-01
Series:PLoS Medicine
Online Access:http://europepmc.org/articles/PMC3404112?pdf=render
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author Jill A Fisher
Corey A Kalbaugh
author_facet Jill A Fisher
Corey A Kalbaugh
author_sort Jill A Fisher
collection DOAJ
description 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.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.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.
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spelling doaj.art-1951ec76443f4600954f877fcfc42e102022-12-22T03:43:24ZengPublic Library of Science (PLoS)PLoS Medicine1549-12771549-16762012-01-0197e100127110.1371/journal.pmed.1001271United States private-sector physicians and pharmaceutical contract research: a qualitative study.Jill A FisherCorey A KalbaughThere 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.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.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.http://europepmc.org/articles/PMC3404112?pdf=render
spellingShingle Jill A Fisher
Corey A Kalbaugh
United States private-sector physicians and pharmaceutical contract research: a qualitative study.
PLoS Medicine
title United States private-sector physicians and pharmaceutical contract research: a qualitative study.
title_full United States private-sector physicians and pharmaceutical contract research: a qualitative study.
title_fullStr United States private-sector physicians and pharmaceutical contract research: a qualitative study.
title_full_unstemmed United States private-sector physicians and pharmaceutical contract research: a qualitative study.
title_short United States private-sector physicians and pharmaceutical contract research: a qualitative study.
title_sort united states private sector physicians and pharmaceutical contract research a qualitative study
url http://europepmc.org/articles/PMC3404112?pdf=render
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