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Review
. 2005 Sep 10;331(7516):572-4.
doi: 10.1136/bmj.331.7516.572.

Open label extension studies: research or marketing?

G J Taylor  1 , P Wainwright
Affiliations
Review

Open label extension studies: research or marketing?

G J Taylor et al. BMJ. .

Abstract

Open label extension studies allow continued prescribing of unlicensed drugs after a randomised trial, but it is unclear whether patients or drug companies are benefiting the most

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Figures

Figure 1
Figure 1
Participants in open label extension studies need more information Credit: PHOTOS.COM
See this image and copyright information in PMC

References

    1. Micetich KC. The ethical problems of the open label extension study. Camb Q Health Ethics 1996;5: 410-4. - PubMed
    1. Wainwright P. Consent to open label extension studies: some ethical issues. J Med Ethics 2002;28: 373-6. - PMC - PubMed
    1. Council for International Organizations of Medical Sciences. International ethical guidelines for biomedical research involving human subjects. Geneva: World Health Organization, 2002. - PubMed
    1. Blader JC. Can keeping clinical trial participants blind to their study treatment adversely affect subsequent care? Contemp Clin Trials 2005;26: 290-9. - PMC - PubMed