Conflicts of Interest, Selective Inertia, and Research Malpractice in Randomized Clinical Trials: An Unholy Trinity.

Vance W Berger
Author Information
  1. Vance W Berger: National Cancer Institute and University of Maryland Baltimore County, Biometry Research Group, National Cancer Institute, 9609 Medical Center Drive, Rockville, MD, 20850, USA, vance917@gmail.com.

Abstract

Recently a great deal of attention has been paid to conflicts of interest in medical research, and the Institute of Medicine has called for more research into this important area. One research question that has not received sufficient attention concerns the mechanisms of action by which conflicts of interest can result in biased and/or flawed research. What discretion do conflicted researchers have to sway the results one way or the other? We address this issue from the perspective of selective inertia, or an unnatural selection of research methods based on which are most likely to establish the preferred conclusions, rather than on which are most valid. In many cases it is abundantly clear that a method that is not being used in practice is superior to the one that is being used in practice, at least from the perspective of validity, and that it is only inertia, as opposed to any serious suggestion that the incumbent method is superior (or even comparable), that keeps the inferior procedure in use, to the exclusion of the superior one. By focusing on these flawed research methods we can go beyond statements of potential harm from real conflicts of interest, and can more directly assess actual (not potential) harm.

References

  1. Control Clin Trials. 2002 Oct;23(5):502-14 [PMID: 12392864]
  2. Headache. 2006 Jul-Aug;46(7):1210-2 [PMID: 16866731]
  3. PLoS Med. 2005 Aug;2(8):e124 [PMID: 16060722]
  4. Stat Med. 2003 Oct 15;22(19):3017-28 [PMID: 12973784]
  5. J Crit Care. 2006 Jun;21(2):229; author reply 229-30 [PMID: 16769475]
  6. Int J Risk Saf Med. 2012;24(4):233-42 [PMID: 23135338]
  7. J Biopharm Stat. 2011 Mar;21(2):263-70 [PMID: 21391000]
  8. Sci Eng Ethics. 2012 Jun;18(2):247-61 [PMID: 21327723]
  9. J Rheumatol. 2006 Mar;33(3):567-73 [PMID: 16511925]
  10. CMAJ. 2004 Aug 17;171(4):333-8 [PMID: 15313991]
  11. Cochrane Database Syst Rev. 2012 Dec 12;12:MR000033 [PMID: 23235689]
  12. Qual Life Res. 2008 Nov;17(9):1121-3 [PMID: 18810655]
  13. Rev Recent Clin Trials. 2009 May;4(2):79-88 [PMID: 19463104]
  14. Stat Methods Med Res. 2010 Aug;19(4):415-24 [PMID: 20488837]
  15. Control Clin Trials. 1996 Feb;17(1):1-12 [PMID: 8721797]
  16. BMJ. 2002 Dec 14;325(7377):1391-2 [PMID: 12480854]
  17. J Gastrointest Surg. 2013 Jun;17(6):1170-1 [PMID: 23233271]
  18. Stat Med. 2000 May 30;19(10):1319-28 [PMID: 10814980]
  19. BMJ. 1994 Jan 29;308(6924):283-4 [PMID: 8124111]
  20. PLoS One. 2013 Jul 05;8(7):e66844 [PMID: 23861749]
  21. J Gastrointest Surg. 2012 Sep;16(9):1758-67 [PMID: 22777055]
  22. Control Clin Trials. 2003 Apr;24(2):156-66 [PMID: 12689737]
  23. Headache. 2006 Feb;46(2):343; author reply 343-5 [PMID: 16492254]
  24. Biometrics. 1998 Dec;54(4):1541-50 [PMID: 9988542]
  25. Control Clin Trials. 1981 May;2(1):31-49 [PMID: 7261638]
  26. Control Clin Trials. 2004 Dec;25(6):613-9 [PMID: 15588747]
  27. J Rheumatol. 2006 Aug;33(8):1710-1; author reply 1711-2 [PMID: 16881132]

Grants

  1. Z99 CA999999/Intramural NIH HHS

MeSH Term

Bias
Biomedical Research
Conflict of Interest
Humans
Malpractice
Randomized Controlled Trials as Topic
Research Design
Research Personnel

Word Cloud

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