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Open Access 01-12-2014 | Correspondence

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

Authors: Ulrike Lorch, Martin O’Kane, Jorg Taubel

Published in: BMC Medical Research Methodology | Issue 1/2014

Abstract

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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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2288/14/84/prepub

Title: Three steps to writing adaptive study protocols in the early phase clinical development of new medicines
Authors: Ulrike Lorch
Martin O’Kane
Jorg Taubel
Publication date: 01-12-2014
Publisher: BioMed Central
Published in: BMC Medical Research Methodology / Issue 1/2014
Electronic ISSN: 1471-2288
DOI: https://doi.org/10.1186/1471-2288-14-84

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

Abstract

Keynote webinar | Spotlight on medication adherence

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