Side effects may include
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Transcript of Side effects may include
Medicine is broken – Ben Goldacre
Side Effects May Include
Gemma Hill
The Problem
Publication Bias/File Drawer Problem
Cochrane module on publication bias
Case Study
Lorcainide, however, is not tolerated well and affords less protection against a sudden death recurrence than is noted in a population on other anti-arrhythmic therapy.(Somberg et al., 1986)
Trial Registration
Trial registration = greater accountability
Date of download: 3/9/2013Copyright © 2012 American Medical Association. All
rights reserved.
From: Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials
JAMA. 2009;302(9):977-984. doi:10.1001/jama.2009.1242
RCT indicates randomized clinical trials.
Figure Legend:
GSK fine
GSK pledges to publish clinical trial data
GSK chief apologises
GSK fined $3bn for misbehaviour
What Has Been Done?
and EudraPharm
Clinicaltrials.gov Only lists results for studies registered since 2008
Does not list results, and only certain study data
EudraCT
What Can Be Done?
References and Further ReadingBourgeois, F.T., Murthy, S., Mandl, K.D., 2010. Outcome Reporting Among Drug
Trials Registered in ClinicalTrials.gov. Annals of Internal Medicine 153, 158–166.
Cameron, H., Waller, P., Ramsay, L., 1988. Drug treatment of intermittent claudication: a critical analysis of the methods and findings of published clinical trials, 1965-1985 [see comments]. British Journal of Clinical Pharmacology 26, 569–576.
Goldacre, B., 2012. Bad Pharma. FOURTH ESTATE LTD, London.
Hopewell, S., Loudon, K., Clarke, M.J., Oxman, A.D., Dickersin, K., 2009. Publication bias in clinical trials due to statistical significance or direction of trial results, in: The Cochrane Collaboration, Hopewell, S. (Eds.), Cochrane Database of Systematic Reviews. John Wiley & Sons, Ltd, Chichester, UK.
Kirkham, J.J., Dwan, K.M., Altman, D.G., Gamble, C., Dodd, S., Smyth, R., Williamson, P.R., 2010. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ 340, c365–c365.
Mathieu S, B.I., 2009. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 302, 977–984.
Somberg, J.C., Laux, B., Wynn, J., Keefe, D., Miura, D.S., 1986. Lorcainide therapy in a cardiac arrest population. Am. Heart J. 111, 648–653.
Gemma Hill @gem_hill
#bracamp @mcrgirlgeeks
@MadLabUK