Consent to Open Label Extension Studies: Some Ethical Issues
Journal of Medical Ethics 2002 December; 28(6): 373-376
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, to take the study drug for some further period. Patients are openly given the active substance at this stage, regardless of their assignment in the initial trial. Investigators are typically reluctant to unblind the patients' assignment at the point of entry into the open label phase, on the grounds that this may introduce ascertainment bias in the main study. It is argued that patients invited to participate in open label extension studies cannot give a proper consent to such research unless they know to which arm of the main trial they were recruited. It is further argued that to recruit certain groups of patients from placebo controlled trials into open label extension studies may also be unethical for clinical reasons.
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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. ...