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Design, Objectives, Execution and Reporting of Published Open‐label Extension Studies by Bowers Megan; Ruth M. Pickering; Mark Weatherall is a Health Professions article available to read on EtoBox.

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## Abstract **Rationale, aims and objectives** Open‐label extension (OLE) studies following blinded randomized controlled trials (RCTs) of pharmaceuticals are increasingly being carried out but do not conform to regulatory standards and questions surround the validity of their evidence. OLE studies are usually discussed as a homogenous group, yet substantial differences in study design still meet the definition of an OLE. We describe published papers reporting OLE studies focussing on stated objectives, design, conduct and reporting. **Method** A search of Embase and Medline databases for 1996 to July 2008 revealed 268 papers reporting OLE studies that met our eligibility criteria. A random sample of 50 was selected for detailed review. **Results** Over 80% of the studies had efficacy stated as an objective. The most common methods of allocation at the start of the OLE were for all RCT participants to switch to one active treatment or for only participants on the new drug to continue, but in three studies all participants were re‐randomized at the start of the OLE. Eligibility criteria and other selection factors resulted in on average of 74% of participants in the preceding RCT(s)

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Author

Bowers Megan; Ruth M. Pickering; Mark Weatherall

Publisher

Wiley

Published

2010

Language

EN

Field

Health Professions (Health Sciences)