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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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Detalles Bibliográficos
Autores principales:	Lorch, Ulrike, O’Kane, Martin, Taubel, Jorg
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2014
Materias:	Correspondence
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4096541/ https://www.ncbi.nlm.nih.gov/pubmed/24980283 http://dx.doi.org/10.1186/1471-2288-14-84

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