Ten recommendations for closing the credibility gap in reporting industry-sponsored clinical research: A joint journal and pharmaceutical industry perspective

Mayo Clinic Proceedings

Volumn 87, Issue 5, 2012, Pages 424-429

  Mansi, Bernadette A ^a   Clark, Juli ^b   David, Frank S ^c   Gesell, Thomas M ^d,e,l   Glasser, Susan ^f   Gonzalez, John ^g   Haller, Daniel G ^h,m   Laine, Christine ⁱ   Miller, Charles L ^a   Mooney, Laverne A ^j   Zecevic, Maja ^k  

^a GLAXOSMITHKLINE   (United States)

^b AMGEN INC   (United States)

^c Amaka Consulting and Evaluation Services   (United States)

^d NOVARTIS PHARMA AG   (Switzerland)

^e International Society for Medical Publication Professionals   (United States)

^f JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^g ASTRAZENECA   (United Kingdom)

^h Journal of Clinical Oncology   (United States)

ⁱ Annals of Internal Medicine   (United States)

^j Pfizer Medical   (United States)

^k ELSEVIER MASSON   (France)

^l UNITED BIOSOURCE CORPORATION   (United States)

^m Gastrointestinal Cancer Research   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACCESS TO INFORMATION; ADVERSE OUTCOME; CLINICAL PROTOCOL; CLINICAL RESEARCH; CLINICAL STUDY; DATA ANALYSIS; DRUG INDUSTRY; GOOD CLINICAL PRACTICE; HEALTH CARE POLICY; HUMAN; INFORMATION DISSEMINATION; INFORMATION PROCESSING; INTERPERSONAL COMMUNICATION; MANDATORY REPORTING; MATHEMATICAL ANALYSIS; MEDICAL LITERATURE; NOTE; PROFESSIONAL COMPETENCE; PUBLISHING; QUALITY CONTROL; RESEARCH ETHICS; STUDY DESIGN; WRITING;

EID: 84860683317     PISSN: 00256196     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.mayocp.2012.02.009     Document Type: Short Survey

References (28)

1. Bruyere O, Kanis JA, Ibar-Abadie ME, et al. The need for a transparent, ethical, and successful relationship between academic scientists and the pharmaceutical industry: a view of the Group for the Rest of Ethics and Excellent in Science (GREES). Osteopor Int. 2010;21(5):713-722.
2. Pyke S, Julious SA, Day S, et al. The potential for bias in reporting of industry-sponsored clinical trials. Pharm Stats. 2011;10(1):74-79.
3. Strahlman E, Rockhold F, Freeman A. Public disclosure of clinical research. Lancet. 2009;373(9672):1319-1320.
4. PhRMA Principles on Conduct of Clinical Trials: Communication of Clinical Trial Results. PhRMA Web site. http://www.phrma.org/sites/default/files/105/ 042009-clinical-trial-principles-final.pdf. Accessed January 31, 2012.
5. Amgen. Amgen Guidelines for Publications. Amgen Web site. http://www.amgen. com/about/amgen-guidelines-for-publications.html. Accessed January 31, 2012.
6. AstraZeneca. Transparency of Trial Information. AstraZeneca Web site. http://www.astrazeneca.com/Responsibility/Researchethics/Clinical-trials/ Transparency-of-trial-information. Accessed January 31, 2012.
7. GlaxoSmithKline. Reports and publications, Public policies, Disclosure of Clinical Trial Information. GlaxoSmithKline Web site. http://www.gsk.com/ reportsandpublications-policies.htm. Accessed January 31, 2012.
8. Johnson & Johnson. Transparency in Our Business Activities. Johnson & Johnson Web site. http://www.jnj.com/connect/about-jnj/our-citizenship/ transparency-in-our-business-activities/transparency-in-our-business-activities. Accessed January 31, 2012.
9. Merck. Merck Guidelines for Publication of Clinical Trials and Related Works. Merck Web site. http://www.merck.com/research/discovery-and-development/ clinical-development/Merck-Guidelines-for-Publication-of-Clinical-Trials-and- Related-Works.pdf. Accessed January 31, 2012.
10. Pfizer. Conducting Ethical Research - Registration, Disclosure, and Authorship. Pfizer Web site. http://www.pfizer.com/research/research-clinical- trials/registration-disclosure-authorship. jsp. Accessed January 31, 2012.
11. Angell M. Industry-sponsored clinical research: a broken system. JAMA. 2008;300(9):1069-1071.
12. Clark J, Gonzalez J, Mansi B, et al. Enhancing transparency and efficiency in reporting industry-sponsored clinical research: report from the Medical Publishing Insights and Practices initiative. Int J Clin Pract. 2010;64(8):1028-1033.
13. MPIP Web site. www.mpip-initiative.org. Accessed January 31, 2012.
14. Clark S, Horton R. Putting research into context - revisited. Lancet. 2010;376(9734):10-11.
15. Lehman R, Loder E. Missing clinical trial data. BMJ. 2012;344:d8158.
16. Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ. 2011;344:d7373.
17. Ross JS, Tse T, Zarin DA, et al. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ. 2011;344:d7292.
18. Fighting plagiarism [editorial]. Lancet. 2008:371(9631):2146.
19. ICMJE. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Ethical Considerations in the Conduct and Reporting of Research: Conflicts of Interest. ICMJE Web site. www.icmje.org/ethical-4conflicts.html. Accessed January 31, 2012.
20. Lanier WL. Bidirectional conflicts of interest involving industry and medical journals: who will champion integrity? Mayo Clinic Proc. 2009;84(9):771-775.
21. Steinbrook R. Online disclosure of physician-industry relationships. N Engl J Med. 2009;360(4):325-327.
22. CONSORT. The CONSORT statement. CONSORT Web site. www.consort-statement. org/consort-statement. Accessed January 31, 2012.
23. Chipperfield L, Citrome L, Clark J, et al. Authors' Submission Toolkit: a practical guide to getting your research published. Curr Med Res Opin. 2010;26(8):1967-1982.
24. EQUATOR. Resources for authors of research reports. EQUATOR Network Web site. www.equator-network.org/resource-centre/authors-of-research-reports/ authors-of-researchreports. Accessed January 31, 2012.
25. Norris R, Bowman A, Fagan JM, et al. International Society for Medical Publication Professionals (ISMPP) position statement: the role of the professional medical writer. Curr Med Res Opin. 2007;23(8):1837-1840. (Pubitemid 47300382)
26. Ionnidis JPA, Evans SJW, Gøtzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141(10):781-788. (Pubitemid 39524916)
27. Chan AW. Bias, spin and misreporting: time for full access to trial protocols and results. PLoS Med. 2008;5(11):e230.
28. Fontanarosa PB, Flanagin A, De Angelis CD. Reporting conflicts of interest, financial aspects of research, and role of sponsors in funded studies. JAMA. 2005;294(1):110-111. (Pubitemid 41002847)