Open Label Extension Studies: Research or Marketing?
BMJ: British Medical Journal 2005 September 10; 331(7516): 572-574
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Wainwright, P. (2002-12)A frequent feature of pharmaceutical research is the open label extension study, in which patients participating in double blind placebo controlled trials of new medications are invited, on completion of the initial trial, ...
Micetich, Kenneth Craig (1996)In summary, the relationship between RDBS [randomized double-blind study] and OLES [open label extension study] violates the principles of beneficence and autonomy and is not consistent with the sound practice of medicine. ...