The potential for bias in reporting of industry-sponsored clinical trials

Pharmaceutical Statistics

Volumn 10, Issue 1, 2011, Pages 74-79

  Pyke, Stephen ^a   Julious, Steven A ^b   Day, Simon ^c   O'Kelly, Michael ^d   Todd, Susan ^e   Matcham, James ^f   Seldrup, Jorgen ^d  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^b UNIVERSITY OF SHEFFIELD   (United Kingdom)

^c ROCHE PRODUCTS LTD   (United Kingdom)

^d IQVIA   (United States)

^e UNIVERSITY OF READING   (United Kingdom)

^f AMGEN LTD   (United Kingdom)

Author keywords

avoidance of bias; clinical trials; trial reporting

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); DRUG INDUSTRY; HEALTH CARE PERSONNEL; HUMAN; PUBLICATION; REGISTER; STATISTICAL ANALYSIS; WRITING;

BIAS (EPIDEMIOLOGY); CLINICAL TRIALS AS TOPIC; CONFLICT OF INTEREST; DRUG INDUSTRY; HUMANS; PUBLISHING; STATISTICS AS TOPIC;

EID: 79551525783     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.429     Document Type: Article

References (27)

1. Fontanarosa PB, Flanagin A, DeAngelis CD,. Reporting conflicts of interest, financial aspects of research, and role of sponsors in funded studies. Journal of the American Medical Association 2005; 294: 110-111.
2. DeAngelis CD, Fontanarosa PB, Flanagin A,. Reporting financial conflicts of interest and relationships between investigators and research sponsors. Journal of the American Medical Association 2001; 286: 89-91.
3. Davidoff F, DeAngelis CD, Drazen JM, et al,. Sponsorship, Authorship and Accountability. Journal of the American Medical Association 2001; 286: 1232-1234.
4. Tramér MR, Reynolds DJM, Moore RA, McQuay HJ,. Impact of covert duplicate publication on meta-analysis: a case study. British Medical Journal 1997; 315: 635-640.
5. Stern JM, Simes, RJ,. Publication bias: evidence of delayed publication in a cohort study of clinical research projects. British Medical Journal 1997; 315: 640-645.
6. Fontanarosa PB, DeAngelis CD,. JAMA's policy on industry sponsored studies. British Medical Journal 2006; 332: 177.
7. Lies, damn lies and statistics: can we trust scientists or are they puppets of the drugs industry? [Editorial]; New Scientist, 15 Sep 2001.
8. Rennie D,. Fair conduct and fair reporting of clinical trials. Journal of the American Medical Association 1999; 282: 1766-1768.
9. Rothman KJ, Evans S,. Extra scrutiny for industry funded trials. British Medical Journal 2005; 331: 1350-1351.
10. Rockhold FW,. Requiring 'independent' analyses for industry sponsored trials? Pharmaceutical Statistics 2006; 5: 5-6.
11. Senn S,. Sharp tongues and bitter pills. Significance 2006; September: 123-125.
12. Lindner MD,. Clinical attrition due to biased preclinical assessments of potential efficacy. Pharmacology and Therapeutics 2007; 115: 148-175.
13. Ioannidis J,. Contradicted and initially stronger effects in highly cited linical research. Journal of the American Medical Association 2005; 294: 218-228.
14. Al-Marzouki S, Evans S, Marshall T, Roberts I,. Statistical methods for the detection of data fabrication in clinical trials. British Medical Journal 2005; 331: 267-270.
15. Pfizer press release: 'Pfizer to Publicly Disclose Payments to U.S. Physicians, Healthcare Professionals and Clinical Investigators'. 9th February 2009.
16. O'Kelly M, et al,. Making available information from studies sponsored by the pharmaceutical industry: some current practices. Pharmaceutical Statistics, DOI: 10.1002/pst.430.
17. The Lancet: Information for Authors. Updated October 2008.
18. Al-Marzouki S, Roberts I, Evans S, Marshall T,. Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet. Lancet 2008; 372: 201.
19. GÃ?tzche PC, Hrõbjartsson A, Johansen HK, Haahr MT, Altman DG,. Ghost authorship in industry-initiated randomised trials. PLoS Med 4 (1): e19. DOI: 10.1371/journal.pmed.0040019.
20. ICH E9: Statistical Principles for Clinical Trials: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1998.
21. JAMA Instructions for authors. Available at: http://jama.ama-assn.org/ misc/ifora.dtl. 2010.
22. Begg CB, Cho MK, Eastwood S, et al,. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. Journal of the American Medical Association 1996; 276: 637-639.
23. Moher D, Schulz KF, Altman DG,. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Annals of Internal Medicine 2001; 134: 657-662. (Pubitemid 32322244)
24. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, GÃ?tzsche PC, Lang T,. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Annals of Internal Medicine 2001; 134: 663-694. (Pubitemid 32322245)
25. Thomas O, Thabane L, Douketis J, Chu R, Westfall AO, Allison DB,. Industry funding and the reporting quality of large long-term weight loss trials. International Journal of Obesity 2008; 32: 1531-1536.
26. Rising K, Bacchetti P, Bero L,. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med 5 (11): e217. DOI: 10.1371/journal.pmed.0050217.
27. Matcham J, et al,. Proposed Best Practice for Statisticians in the Reporting and Publication of Pharmaceutical Industry Sponsored Clinical Trials. Pharmaceutical Statistics, DOI: 10.1002/pst.427.