Investigator experiences with financial conflicts of interest in clinical trials

Trials

Volumn 12, Issue , 2011, Pages

  Rochon, Paula A ^a   Sekeres, Melanie ^b   Hoey, John ^c   Lexchin, Joel ^b,d,e   Ferris, Lorraine E ^c   Moher, David ^f   Wu, Wei ^a   Kalkar, Sunila R ^a   Van Laethem, Marleen ^c,g   Gruneir, Andrea ^a   Gold, Jennifer ^h   Maskalyk, James ^c   Streiner, David L ^c   Taback, Nathan ^c   Chan, An Wen ^a  

^a WOMEN S COLLEGE HOSPITAL   (Canada)

^b UNIVERSITY OF TORONTO   (Canada)

^c UNIVERSITY OF TORONTO   (Canada)

^d YORK UNIVERSITY   (Canada)

^e UNIVERSITY HEALTH NETWORK   (Canada)

^f OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^g TORONTO REHABILITATION INSTITUTE   (Canada)

^h Ontario Medical Association   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CANADA; CLINICAL PRACTICE; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); DRUG INDUSTRY; FINANCIAL MANAGEMENT; FUNDING; HUMAN; QUESTIONNAIRE; CONFIDENTIALITY; CONFLICT OF INTEREST; E-MAIL; ECONOMICS; EPIDEMIOLOGY; ETHICS; EVIDENCE BASED MEDICINE; HEALTH CARE COST; INTERPERSONAL COMMUNICATION; METHODOLOGY; PRACTICE GUIDELINE; REGISTER; REPRODUCIBILITY; STANDARD;

BIAS (EPIDEMIOLOGY); CANADA; CLINICAL TRIALS AS TOPIC; CONFIDENTIALITY; CONFLICT OF INTEREST; ELECTRONIC MAIL; EVIDENCE-BASED MEDICINE; GUIDELINE ADHERENCE; GUIDELINES AS TOPIC; HEALTH CARE SECTOR; HUMANS; QUESTIONNAIRES; REGISTRIES; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; RESEARCH SUPPORT AS TOPIC; TRUTH DISCLOSURE;

EID: 78651240650     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-12-9     Document Type: Article

References (34)

1. Sim I, Detmer DE. Beyond trial registration: a global trial bank for clinical trial reporting. PLoS Med 2005, 2(11):e365. 10.1371/journal.pmed.0020365, 1255763, 16220999.
2. Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet 2005, 365(9465):1159-62. 10.1016/S0140-6736(05)71879-1, 15794971.
3. CIHR, Tri-council policy statement: ethical conduct for research involving humans, 1998 (with 2000, 2002, 2005 amendments). 2005, Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada.
4. 42 CFR 50 (f) Code of Federal Regulations. 2000, 42 CFR 50 (f)., http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm
5. 21 CFR 54 Financial Disclosure by Clinical Investigators. Code of Federal Regulations. 21 CFR 54., http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54
6. Department of Health and Human Services Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection. 2004, Department of Health and Human Services., http://www.hhs.gov/ohrp/policy/fguid.pdf
7. Department of Health and Human Services Guidance on Engagement of Institutions in Human Subjects Research. 2008, Department of Health and Human Services., http://www.hhs.gov/ohrp/policy/engage08.html
8. AAMC, Protecting Subjects, Preserving Trust, Promoting Progress II Principles and Recommendations for Oversight of an Institution's Financial Interests in Human Subjects Research: Task Force on Financial Conflicts of Interest in Clinical Research. 2002, AAMC, AAMC, Protecting Subjects, Preserving Trust, Promoting Progress II.
9. AAMC, Protecting Patients, Preserving Integrity, Advancing Health Accelerating the Implementation of COI Policies in Human Subjects Research. A Report of the AAMC-AAU Advisory Committee on Financial Conflicts of Interest in Human Subjects Research. 2008, 87. AAMC: Washington, D. C., AAMC, Protecting Patients, Preserving Integrity, Advancing Health.
10. U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or FDAAA), Title VIII, Section 801. 2007,
11. International Committee of Medical Journal Editors Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication. 2004, International Committee of Medical Journal Editors., http://www.icmje.org/2004_urm.pdf
12. International Committee of Medical Journal Editors Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication. 2008, International Committee of Medical Journal Editors., http://www.icmje.org/2008_urm.pdf
13. De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB. 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. 10.1056/NEJMe058127, 15911780.
14. metaRegister of Controlled Trials (mRCT) - active registers. , http://www.controlled-trials.com/mrct
15. Policy Statements: Authorship. 2007, http://www.wame.org/resources/policies#authorship
16. Schulz KF, Moher D, Altman DG, . CONSORT Group CONSORT 2010 Statement: Updated guidelines for reporting parallel-group randomized trials. Trials 2010, 11(1):32. 10.1186/1745-6215-11-32, 2857832, 20334632, CONSORT Group.
17. Mello MM, Clarridge BR, Studdert DM. Academic Medical Centers' Standards for Clinical-Trial Agreements with Industry. N Engl J Med 2005, 352:2202-10. 10.1056/NEJMsa044115, 15917385.
18. Schulman KA, Seils DM, Timbie JW, Sugarman J, Dame LA, Weinfurt KP, Mark DB, Califf RM. A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med 2002, 347(17):1335-41. 10.1056/NEJMsa020349, 12397192.
19. Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA 2008, 299(15):1800-12. 10.1001/jama.299.15.1800, 18413874.
20. Steinman MA, Bero LA, Chren MM, Landefeld CS. Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Annals of Internal Medicine 2006, 145(4):284-93.
21. Gotzsche PC, Hrobjartsson A, Johansen HK, Haahr MT, Altman DG, Chan AW. Constraints on publication rights in industry-initiated clinical trials. JAMA 2006, 295(14):1645-6. 10.1001/jama.295.14.1645, 16609085.
22. Gotzsche PC, Hrobjartsson A, Johansen HK, Haahr MT, Altman DG, Chan AW. Ghost authorship in industry-initiated randomised trials. PLoS Medicine/Public Library of Science 2007, 4(1):e19.
23. Flanagin A, Carey LA, Fontanarosa PB, Phillips SG, Pace BP, Lundberg GD, Rennie D. Prevalence of articles with honorary authors and ghost authors in peer-reviewed medical journals. JAMA 1998, 280(3):222-4. 10.1001/jama.280.3.222, 9676661.
24. Weissman JS, Koski G, Vogeli C, Thiessen C, Campbell EG. Opinions of IRB Members and Chairs Regarding Investigators' Relationships with Industry. J Empir Res Hum Res Ethics 2008, 3(1):3-13. 10.1525/jer.2008.3.1.3, 19385778.
25. Declaration of Helsinki. 2008, http://www.wma.net/en/30publications/10policies/b3/index.html
26. Rochon PA, Hoey J, Chan AW, Ferris LE, Lexchin J, Kalkar SR, Sekeres M, Wu W, Van Laethem M, Gruneir A, Maskalyk J, Streiner DL, Gold J, Taback N, Moher D. Financial Conflicts of Interest Checklist 2010 for clinical research studies. Open Medicine 2010, 4(1):69-91.
27. Rehnquist J. The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects. 2001, Department of Health and Human Services, Office of Inspector General Report., http://oig.hhs.gov/oei/reports/oei-01-00-00190.pdf
28. Hopewell S, Clarke M, Stewart L, Tierney J. Time to publication for results of clinical trials. Cochrane Database Syst Rev 2007, 2:MR000011.
29. Naylor CD. Early Toronto experience with new standards for industry-sponsored clinical research: a progress report. CMAJ 2002, 166:453-6. 99356, 11873924.
30. International Clinical Trials Registry Platform (ICTRP) International Clinical Trials Registry Platform (ICTRP)., http://www.who.int/ictrp/network/en/
31. Laine C, Horton R, DeAngelis CD, Drazen JM, Frizelle FA, Godlee F, Haug C, Hebert PC, Kotzin S, Marusic A, Sahni P, Schroeder TV, Sox HC, Van der Weyden MB, Verheugt FW. Clinical trial registration--looking back and moving ahead. New England Journal of Medicine 2007, 356(26):2734-6. 10.1056/NEJMe078110, 17548427.
32. Moher D, Bernstein A. Registering CIHR-funded randomized controlled trials: a global public good. CMAJ 2004, 171(7):750-1. 517861, 15451838.
33. Access to and Retention of Research Data: Rights and Responsibilities. 2006, http://206.151.87.67/docs/CompleteDRBooklet.htm
34. Ghost Writing Initiated by Commercial Companies. Policy Statements: Prepared by the WAME Editorial Policy Committee. , http://www.wame.org/resources/policies#ghost