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Consent to open label extension studies: some ethical issues

By Paul Wainwright

Abstract

A frequent feature of pharmaceutical research is the open label extension study, in which patients participating\ud in double blind placebo controlled trials of new medications are invited, on completion of the\ud initial trial, to take the study drug for some further period. Patients are openly given the active substance\ud at this stage, regardless of their assignment in the initial trial. Investigators are typically reluctant to\ud unblind the patients’ assignment at the point of entry into the open label phase, on the grounds that this\ud may introduce ascertainment bias in the main study.\ud It is argued that patients invited to participate in open label extension studies cannot give a proper consent\ud to such research unless they know to which arm of the main trial they were recruited. It is further\ud argued that to recruit certain groups of patients from placebo controlled trials into open label extension\ud studies may also be unethical for clinical reasons

Topics: nursing
Year: 2002
OAI identifier: oai:eprints.kingston.ac.uk:801

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