Three steps to writing adaptive study protocols in the early phase clinical development of new medicines

This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully pe...

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Bibliographic Details
Published in:BMC medical research methodology 2014-06, Vol.14 (1), p.84-84, Article 84
Main Authors: Lorch, Ulrike, O'Kane, Martin, Taubel, Jorg
Format: Article
Language:English
Subjects:
Biomedical Research
Clinical Protocols
Clinical trials
Correspondence
Drug Design
Humans
Medical research
Medicine, Experimental
Methods
Research Design
Writing
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Summary:This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully performed in the UK. During adaptive studies evolving data is used to modify the trial design and conduct within the protocol-defined remit. Adaptations within that remit are documented using non-substantial protocol amendments which do not require regulatory or ethical review. This concept is efficient in gathering relevant data in exploratory early phase studies, ethical and time- and cost-effective.
ISSN:1471-2288
1471-2288
DOI:10.1186/1471-2288-14-84