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Refinement of the Clinical Scenario Evaluation Framework for Assessment of Competing Development Strategies with an Application to Multiple Sclerosis

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Abstract

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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Authors and Affiliations

  1. Warwick Medical School, The University of Warwick, Coventry, UK

    Tim Friede PhD, Nigel Stallard PhD & Nicholas Parsons PhD

  2. Imperial College Healthcare NHS Trust, London, UK

    Richard Nicholas PhD, FRCP & Jeremy Chataway PhD, FRCP

  3. Applied Statistics, University of Reading, Reading, UK

    Susan Todd PhD & Elsa Valdés-Márquez PhD

  4. National Hospital for Neurology and Neurosurgery, London, UK

    Jeremy Chataway PhD, FRCP

  5. University Medical Center Göttingen, Department of Medical Statistics, Humboldtallee 32, 37073, Göttingen, Germany

    Tim Friede PhD

Authors
  1. Tim Friede PhD
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  2. Richard Nicholas PhD, FRCP
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  3. Nigel Stallard PhD
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  4. Susan Todd PhD
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  5. Nicholas Parsons PhD
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  6. Elsa Valdés-Márquez PhD
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  7. Jeremy Chataway PhD, FRCP
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Correspondence to Tim Friede PhD.

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Friede, T., Nicholas, R., Stallard, N. et al. Refinement of the Clinical Scenario Evaluation Framework for Assessment of Competing Development Strategies with an Application to Multiple Sclerosis. Ther Innov Regul Sci 44, 713–718 (2010). https://doi.org/10.1177/009286151004400607

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  • DOI: https://doi.org/10.1177/009286151004400607

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