Article Text

Download PDFPDF
Consent to open label extension studies: some ethical issues
  1. P Wainwright
  1. Correspondence to:
 Dr P Wainwright, Centre for Philosophy and Healthcare, University of Wales Swansea, Singleton Park, Swansea SA2 8PP, UK;


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.

  • Clinical trials
  • consent
  • open label extension studies
  • placebo
  • research ethics

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.


Other content recommended for you