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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.

Methods and Findings:
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.


Vyšlo v časopise: United States Private-Sector Physicians and Pharmaceutical Contract Research: A Qualitative Study. PLoS Med 9(7): e32767. doi:10.1371/journal.pmed.1001271
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1001271

Souhrn

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.

Methods and Findings:
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.


Zdroje

1. Fisher JA (2009) Medical research for hire: the political economy of pharmaceutical clinical trials. New Brunswick: Rutgers University Press.

2. Petryna A (2009) When experiments travel: clinical trials and the global search for human subjects. Princeton: Princeton University Press.

3. ShuchmanM (2007) Commercializing clinical trials: risks and benefits of the CRO boom. N Engl J Med 357: 1365–1368.

4. SteinbrookR (2005) Gag clauses in clinical-trial agreements. N Engl J Med 352: 2160–2162.

5. BodenheimerT (2000) Uneasy alliance: clinical investigators and the pharmaceutical industry. N Engl J Med 342: 1539–1544.

6. Angell M (2004) The truth about the drug companies: how they deceive us and what to do about it. New York: Random House.

7. BiddleJ (2007) Lessons from the Vioxx debacle: what the privatization of science can teach us about social epistemology. Soc Epistemol 21: 21–39.

8. LemmensT, FreedmanB (2000) Ethics review for sale? Conflict of interest and commercial research ethics review. Milbank Q 78: 547–584.

9. LexchinJ, BeroL, DjulbegovicB, ClarkO (2003) Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 326: 1167–1170.

10. SismondoS (2007) Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry? PLoS Med 4: e286 doi:10.1371/journal.pmed.0040286.

11. AsharBH, MillerRG, GetzKJ, PoweNR (2004) Prevalence and determinants of physician participation in conducting pharmaceutical-sponsored clinical trials and lectures. J Gen Intern Med 19: 1140–1145.

12. BeroLA, RennieD (1996) Influences on the quality of published drug studies. Int J Technol Assess Health Care 12: 209–237.

13. MathesonA (2008) Corporate science and the husbandry of scientific and medical knowledge by the pharmaceutical industry. BioSocieties 3: 355–382.

14. DorseyER, ThompsonJP, CarrascoM, de RouletJ, VitticoreP, et al. (2009) Financing of U.S. biomedical research and new drug approvals across therapeutic areas. PLoS ONE 4: e7015 doi:10.1371/journal.pone.0007015.

15. LakoffA (2007) The right patients for the drug: managing the placebo effect in antidepressant trials. BioSocieties 2: 57–71.

16. LogdbergL (2011) Being the ghost in the machine: a medical ghostwriter's personal view. PLoS Med 8: e1001071 doi:10.1371/journal.pmed.1001071.

17. Starr P (1982) The social transformation of American medicine: the rise of a sovereign profession and the making of a vast industry. New York: Basic Books.

18. Cray E (1970) In failing health: the medical crisis and the AMA. New York: Bobbs-Merrill.

19. Kennedy EM (1972) In critical condition: the crisis in America's health care. New York: Simon & Schuster.

20. Tu HT, Ginsburg PB (2006) Losing ground: physician income, 1995–2003. Washington (District of Columbia): Center for Studying Health System Change.

21. Kassirer JP (2005) On the take: how America's complicity with big business can endanger your health. New York: Oxford University Press. 251 p.

22. PhamHH, DeversKJ, MayJH, BerensonR (2004) Financial pressures spur physician entrepreneurialism. Health Aff (Millwood) 23: 70–81.

23. Chin T (2005 November 21) Doctors' costs going up faster than revenues. American Medical News. Available: http://www.ama-assn.org/amednews/2005/11/21/bisb1121.htm. Accessed.

24. Robinson JC (1999) The corporate practice of medicine: competition and innovation in health care. Berkeley: University of California Press.

25. Gray BH (1993) The profit motive and patient care: the changing accountability of doctors and hospitals. Cambridge: Harvard University Press.

26. RelmanAS (2007) Medical professionalism in a commercialized health care market. JAMA 298: 2668–2670.

27. FisherJA (2008) Practicing research ethics: private-sector physicians & pharmaceutical clinical trials. Soc Sci Med 66: 2495–2505.

28. LaderEW, CannonCP, OhmanEM, NewbyLK, SulmasyDP, et al. (2004) The clinician as investigator: participating in clinical trials in the practice setting. Circulation 109: 2672–2679.

29. Korieth K (2011) Liability demands putting sites at risk. CenterWatch Monthly 18: 1,13–15.

30. GetzKA (2010) Sizing up the clinical research market. Appl Clin Trials 19: 32–34.

31. Parexel (2005) Pharmaceutical R&D statistical sourcebook 2005/2006. Waltham (Massachusetts): Parexel International Corporation.

32. HallMA, FriedmanJY, KingNMP, WeinfurtKP, SchulmanKA, et al. (2010) Commentary: per capita payments in clinical trials: reasonable costs versus bounty hunting. Acad Med 85: 1554–1556.

33. Gray T (2004) Getting the most out of community-based research. ACP Internist. Available: http://www.acpinternist.org/archives/2004/04/cbr.htm. Accessed 17 June 2012.

34. WeinfurtKP, HallMA, Chantelle HardyN, FriedmanJY, SchulmanKA, et al. (2010) Oversight of financial conflicts of interest in commercially sponsored research in academic and nonacademic settings. J Gen Intern Med 25: 460–464.

35. RainvilleB (2002) Strategic outsourcing with contract research organizations: targeting corporate goals. Drug Inf J 36: 77–81.

36. CenterWatch (2006) State of the clinical trials industry: a sourcebook of charts and statistics. Boston: Thomson CenterWatch.

37. DiCicco-BloomB, CrabtreeBF (2006) The qualitative research interview. Med Educ 40: 314–321.

38. FisherJA (2010) Re-inscribing gender in new modes of medical expertise: the investigator-coordinator relationship in the clinical trials industry. Gend Work Organ 17: 150–173.

39. Emerson RM, Fretz RI, Shaw LL (1995) Writing ethnographic fieldnotes. Chicago: University of Chicago Press.

40. Charmaz K (2006) Constructing grounded theory. London: Sage.

41. KleinJE, FleischmanAR (2002) The private practicing physician-investigator: ethical implications of clinical research in the office setting. Hastings Cent Rep 32: 22–26.

42. BourgeoisFT, MurthyS, MandlKD (2010) Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med 153: 158–166.

43. JonesWB, TaylorSM, KalbaughCA, JoelsCS, BlackhurstDW, et al. (2007) Lost to follow-up: a potential under-appreciated limitation of endovascular aneurysm repair. J Vasc Surg 46: 434–441.

44. SleightP (2004) Where are clinical trials going? society and clinical trials. J Intern Med 255: 151–158.

45. ApplbaumK (2009) Getting to yes: corporate power and the creation of a psychopharmaceutical blockbuster. Cult Med Psychiatry 33: 185–215.

46. MirowskiP, Van HornR (2005) The contract research organization and the commercialization of scientific research. Soc Stud Sci 35: 503–548.

47. BlumenthalD, CausinoN, CampbellE, LouisKS (1996) Relationships between academic institutions and industry in the life sciences: an industry survey. N Engl J Med 334: 368–374.

48. GlickmanSW, McHutchisonJG, PetersonED, CairnsCB, HarringtonRA, et al. (2009) Ethical and scientific implications of the globalization of clinical research. N Engl J Med 360: 816–823.

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Interné lekárstvo

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2012 Číslo 7
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