Title |
Three steps to writing adaptive study protocols in the early phase clinical development of new medicines
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Published in |
BMC Medical Research Methodology, June 2014
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DOI | 10.1186/1471-2288-14-84 |
Pubmed ID | |
Authors |
Ulrike Lorch, Martin O’Kane, Jorg Taubel |
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. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 1 | 3% |
Unknown | 36 | 97% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 13 | 35% |
Other | 7 | 19% |
Student > Ph. D. Student | 6 | 16% |
Student > Master | 2 | 5% |
Librarian | 1 | 3% |
Other | 0 | 0% |
Unknown | 8 | 22% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 12 | 32% |
Mathematics | 4 | 11% |
Pharmacology, Toxicology and Pharmaceutical Science | 4 | 11% |
Agricultural and Biological Sciences | 3 | 8% |
Psychology | 2 | 5% |
Other | 4 | 11% |
Unknown | 8 | 22% |