Practical experiences of adopting assurance as a quantitative framework to support decision making in drug development

Author:

Crisp Adam1,Miller Sam2,Thompson Douglas3,Best Nicky1ORCID

Affiliation:

1. GlaxoSmithKline; Uxbridge Middlesex UK

2. Exploristics; Belfast UK

3. GlaxoSmithKline; Stevenage Hertfordshire UK

Funder

Funding for this research was provided by GlaxoSmithKline plc, Brentford, UK.

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference20 articles.

1. Assurance in clinical trial design;O'Hagan;Pharmaceutical Statistics,2005

2. Sample size and the probability of a successful trial;Chuang-Stein;Pharmaceutical Statistics,2006

3. Some uses of predictive probability of success in clinical drug development;Gasparini;Epidemiology, Biostatistics and Public Health,2013

4. Assurance calculations for planning clinical trials with time-to-event outcomes;Ren;Statistics in Medicine,2014

5. Evaluation of program success for programs with multiple trials in binary outcomes;Wang;Pharmaceutical Statistics,2015

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