Selective clinical trial reporting: Betraying trial participants, harming patients

BMJ (Online)

Volumn 350, Issue , 2015, Pages

  Wolfe, Sidney M ^a  

^a Public Citizen   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALKYLATING AGENT; ANTINEOPLASTIC AGENT; PREDNISONE;

CANCER REGISTRY; CANCER SURVIVAL; DRUG SAFETY; EDITORIAL; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL LITERATURE; MULTIPLE MYELOMA; OVARY CANCER; PATIENT CARE; PATIENT HARM; PRIORITY JOURNAL; PUBLIC HEALTH; PUBLICATION; WELFARE; DEVICE APPROVAL; HEART ASSIST DEVICE;

DEVICE APPROVAL; HEART-ASSIST DEVICES; HUMANS;

EID: 84936977016     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.h2753     Document Type: Editorial

References (12)

1. Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin Oncol 1986;4:1529-41.
2. US Department of Health and Human Services: compilation of experimental cancer therapy protocol summaries. NIH publication, Government Printing Office, 1977-1983.
3. Stern JM, Simes RJ. Publication bias: evidence of delayed publication in a cohort study of clinical research projects. BMJ 1997;315:640.
4. Lundh A, Sismondo S, Lexchin J, Busuioc OA, Bero L. Industry sponsorship and research outcome. Cochrane Database Syst Rev 2012;12:MR000033.
5. Chang L, Dhruva SS, Chu J, Bero LA, Redberg RF. Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports. BMJ 2105:350;h2613.
6. Doshi P, Zito J, dosReis S.Digging for data on harms in duloxetine trials. It's time for policy makers to get serious about drug related harms. BMJ 2014;348:g3578.
7. Office of Public Affairs. GlaxoSmithKline to plead guilty and pay $3 billion to resolve fraud allegations and failure to report safety data. US Department of Justice, 2012. www.justice.gov/opa/pr/2012/July/12-civ-842.html.
8. European Medicines Agency. Workshop on access to clinical-trial data and transparency kicks off process towards proactive publication of data. EMA, 2012. www.ema.europa.eu/ema/index.jsp?curl=pages/news-and-events/news/2012/11/news-detail-001662.jsp&mid=WC0b01ac058004d5c1.
9. Torjesin I. European Ombudsman ramps up action against European Medicines Agency over data transparency plans. BMJ 2014;348:g3733.
10. World Medical Association. Declaration of Helsinki - ethical principles for medical research involving human subjects. WMA, October 2013. www.wma.net/en/30publications/10policies/b3/.
11. PhRMA. www.plos.org/wp-content/uploads/2014/05/PhRMA-Comments-to-USTR-on-TTIP.pdf.
12. Goldacre B, Godlee F, Heneghan C, et al. Letter. AllTrials campaign, 2104. www.alltrials.net/news/phrma-claims-transparency-risks-damaging-public-health/.