BMJ  2005;331 (10 September), doi:10.1136/bmj.331.7516.0-c

Extension studies need tighter ethical scrutiny

Open label extension studies, which enable physicians to continue prescribing unlicensed drugs to trial participants after a randomised trial is over, should provide information on long term safety and tolerability of potential new drugs. However, they seem particularly prone to the pressures of marketing rather than good research methods and research ethics, say Taylor and Wainwright (p 572). The authors argue that it is unclear who benefits most from these studies—patients or drug companies. Patients should be better informed when deciding whether to participate, and tighter ethical criteria need to be applied, say the authors.

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Relevant Article

Open label extension studies: research or marketing?

G J Taylor and P Wainwright
BMJ 2005 331: 572-574. [Extract] [Full Text] [PDF]