Journal
DRUG INFORMATION JOURNAL
Volume 44, Issue 6, Pages 713-718Publisher
DRUG INFORMATION ASSOC
DOI: 10.1177/009286151004400607
Keywords
Clinical scenario evaluation; Drug development program; Clinical development; Adaptive seamless design; Multiple sclerosis
Funding
- NIHR Biomedical Research Centre
- MS Society of Great Britain and Northern Ireland [878/08, 913/09]
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When competing strategies for development programs, clinical trial designs, or data analysis methods exist, the alternatives need to be evaluated in a systematic way to facilitate informed decision making. Here we describe a refinement of the recently proposed clinical scenario evaluation framework for the assessment of competing strategies. The refinement is achieved by subdividing key elements previously proposed into new categories, distinguishing between quantities that can be estimated from preexisting data and those that cannot and between aspects under the control of the decision maker from those that are determined by external constraints. The refined framework is illustrated by an application to a design project for an adaptive seamless design for a clinical trial in progressive multiple sclerosis.
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