The online version of this article (doi:10.1186/1471-2288-14-84) contains supplementary material, which is available to authorized users.
The authors declare that they have no financial competing interests.
MO declares that the views presented in this publication are those of the author and should not be understood or quoted as being made on behalf of the MHRA and/or its scientific committees. Views are presented solely to aid the discussion and should not be interpreted as adopted guidance.
UL prepared the current manuscript. MO provided a regulatory review. JT supervised the process of writing and revised the manuscript critically for important intellectual content. All authors read and approved the final manuscript.
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.
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- Three steps to writing adaptive study protocols in the early phase clinical development of new medicines
- BioMed Central
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