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Adaptive clinical trials incorporating treatment selection and evaluation: methodology and application in progressive multiple sclerosis

By R. (Richard) Nicholas, Jeremy Chataway, S. C. (Susan C.) Todd, Nigel Stallard, Elsa Valdés-Márquez, Nicholas R. Parsons and Tim Friede


In progressive multiple sclerosis (MS) irreversible disability often takes many years to accumulate as a result prolonged trials are required to assess the benefits of therapies. There is a need to understand the relationship between short-term outcome measures such as MRI endpoints and long-term clinical outcomes in progression to determine the evolution of the disease early on. Thus, the common phase I-II-III paradigm for clinical trial design with separate trials for each phase may not be appropriate

Topics: R1, RC0321
Year: 2009
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