Refinement of the Clinical Scenario Evaluation Framework for Assessment of Competing Development Strategies with an Appl
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Refinement of the Clinical Scenario Evaluation Framework for Assessment of Competing Development Strategies with an Application to Multiple Sclerosis Tim Friede, Richard Nicholas, Nigel Stallard, Susan Todd, Nicholas Parsons, Elsa Valdés-Márquez and Jeremy Chataway Drug Information Journal 2010 44: 713 DOI: 10.1177/009286151004400607 The online version of this article can be found at: http://dij.sagepub.com/content/44/6/713
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REGULATORY AFFAIRS
Tin Frirdr, PhD Wanvick Medical School, The University of Wanvick, Coventry. UK Richard Nicholas, PhD, FRCP Imperial College Healthcare N H S Trust, London, UK Nigrl Stallard, PhD Wanvick Medical School, The University of Wanvick. Coventry, UK Susan Todd, PhD Applied Statistics, University of Reading. Reading, UK Nicholas Parsons, PhD Wanvick Medical School, The University of Wanvick, Coventry. UK Elsa Valdis-Mbrqurz, PhD Applied Statistics, University of Reading, Reading. UK
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Refinement of the Clinical Scenario Evaluation Framework for Assessment of Competing Development Strategies With an Application to Multiple Sclerosis 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 previous-
ij 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 makerfrom 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.
Jrrrmy Chataway, PhD, FRCP Imperial College Healthcare N H S Trust. London, UK; National Hospital for Neurology and Neurosurgery, London, UK
Key Words Clinical scenario evaluation: Drug development program; Clinical development; Adaptive seamless design; Multiple sclerosis Corrrspondrncr Addrrss Dr. Tim Friede, University Medical Center Gottingen. Department of Medical Statistics. Humboldtallee 32,37073 Gottingen, Germany (email: tim. [email protected]. de). Presented at the DIA Third Annual Clinical Forum held in Nice, France, October 19-2I.2009,as part of the prese
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