Investigator Experiences with Financial Conflicts of Interest in Clinical Trials

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2011 Jan 14

PMID 21226951

Citations 15

Authors

Paula A Rochon

Melanie Sekeres

John Hoey

Joel Lexchin

Lorraine E Ferris

David Moher

Wei Wu

Sunila R Kalkar

Marleen Van Laethem

Andrea Gruneir

Jennifer Gold

James Maskalyk

David L Streiner

Nathan Taback

An-Wen Chan

Affiliations

Soon will be listed here.

Abstract

Background: Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience.

Methods: Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source.

Results: 844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials.

Conclusion: Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.

Citing Articles

Public reporting of clinical trial findings as an ethical responsibility to participants: a qualitative study.

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Analysis of conflicts of interest among authors and researchers of European clinical guidelines in cardiovascular medicine.

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PMID: 33762382 PMC: 8002771. DOI: 10.7861/clinmed.2020-0552.

Influence and management of conflicts of interest in randomised clinical trials: qualitative interview study.

Ostengaard L, Lundh A, Tjornhoj-Thomsen T, Abdi S, Gelle M, Stewart L BMJ. 2020; 371:m3764.

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Financial Conflicts of Interest Change After a High-Impact Clinical Trial Publication in Oncology.

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Relationships among commercial practices and author conflicts of interest in biomedical publishing.

Graham S, Majdik Z, Clark D, Kessler M, Hooker T PLoS One. 2020; 15(7):e0236166.

PMID: 32706798 PMC: 7380625. DOI: 10.1371/journal.pone.0236166.

References

Moher D, Bernstein A . Registering CIHR-funded randomized controlled trials: a global public good. CMAJ. 2004; 171(7):750-1. PMC: 517861. DOI: 10.1503/cmaj.1041299. View

Schulman K, Seils D, Timbie J, Sugarman J, Dame L, Weinfurt K . A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med. 2002; 347(17):1335-41. DOI: 10.1056/NEJMsa020349. View

Sim I, Detmer D . Beyond trial registration: a global trial bank for clinical trial reporting. PLoS Med. 2005; 2(11):e365. PMC: 1255763. DOI: 10.1371/journal.pmed.0020365. View

Laine C, Horton R, DeAngelis C, Drazen J, Frizelle F, Godlee F . Clinical trial registration--looking back and moving ahead. N Engl J Med. 2007; 356(26):2734-6. DOI: 10.1056/NEJMe078110. View

. Protecting subjects, preserving trust, promoting progress II: principles and recommendations for oversight of an institution's financial interests in human subjects research. Acad Med. 2003; 78(2):237-45. View

Ross J, Hill K, Egilman D, Krumholz H . Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA. 2008; 299(15):1800-12. DOI: 10.1001/jama.299.15.1800. View

Mello M, Clarridge B, Studdert D . Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med. 2005; 352(21):2202-10. DOI: 10.1056/NEJMsa044115. View

Steinman M, Bero L, Chren M, Landefeld C . Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Ann Intern Med. 2006; 145(4):284-93. DOI: 10.7326/0003-4819-145-4-200608150-00008. View

Flanagin A, Carey L, Fontanarosa P, Phillips S, Pace B, LUNDBERG G . Prevalence of articles with honorary authors and ghost authors in peer-reviewed medical journals. JAMA. 1998; 280(3):222-4. DOI: 10.1001/jama.280.3.222. View

10.

Hopewell S, Clarke M, Stewart L, Tierney J . Time to publication for results of clinical trials. Cochrane Database Syst Rev. 2007; 2):MR000011. PMC: 7437393. DOI: 10.1002/14651858.MR000011.pub2. View

11.

Gotzsche P, Hrobjartsson A, Krogh Johansen H, Haahr M, Altman D, Chan A . Ghost authorship in industry-initiated randomised trials. PLoS Med. 2007; 4(1):e19. PMC: 1769411. DOI: 10.1371/journal.pmed.0040019. View

12.

Weissman J, Koski G, Vogeli C, Thiessen C, Campbell E . Opinions of IRB Members and Chairs Regarding Investigators' Relationships with Industry. J Empir Res Hum Res Ethics. 2009; 3(1):3-13. DOI: 10.1525/jer.2008.3.1.3. View

13.

. The globalization of clinical trials: a growing challenge in protecting human subjects: executive summary (2001). J Int Bioethique. 2004; 14(1-2):165-9. View

14.

Schulz K, Altman D, Moher D . CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. Open Med. 2011; 4(1):e60-8. PMC: 3116666. View

15.

Gotzsche P, Hrobjartsson A, Krogh Johansen H, Haahr M, Altman D, Chan A . Constraints on publication rights in industry-initiated clinical trials. JAMA. 2006; 295(14):1645-6. DOI: 10.1001/jama.295.14.1645. View

16.

Rochon P, Hoey J, Chan A, Ferris L, Lexchin J, Kalkar S . Financial Conflicts of Interest Checklist 2010 for clinical research studies. Open Med. 2011; 4(1):e69-91. PMC: 3116675. View

17.

Naylor C . Early Toronto experience with new standards for industry-sponsored clinical research: a progress report. CMAJ. 2002; 166(4):453-6. PMC: 99356. View

18.

Chan A, Altman D . Epidemiology and reporting of randomised trials published in PubMed journals. Lancet. 2005; 365(9465):1159-62. DOI: 10.1016/S0140-6736(05)71879-1. View

19.

De Angelis C, Drazen J, Frizelle F, Haug C, Hoey J, Horton R . Is this clinical trial fully registered?--A statement from the International Committee of Medical Journal Editors. N Engl J Med. 2005; 352(23):2436-8. DOI: 10.1056/NEJMe058127. View

20.

. International Committee of Medical Journal Editors (ICMJE): Uniform Requirements for Manuscripts Submitted to Biomedical Journals: writing and editing for biomedical publication. Haematologica. 2004; 89(3):264. View