Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
10484622 | Value in Health | 2014 | 5 Pages |
Abstract
The steps are as follows: 1) identification of a specific disease, including appropriate genetic definition; 2) identification of clinically relevant outcomes to evaluate efficacy; 3) establishment of the inherent variability of measurements of clinically relevant outcomes; 4) calculation of the sample size required to assess the efficacy of a new treatment with acceptable statistical power; and 5) estimation of the difficulty of recruiting an adequate sample size given the estimated prevalence or incidence of the disorder in the population and the inclusion criteria to be used.
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Authors
Joe T.R. MD, PhD, Doug PhD, Gerald MD, Janet PharmD, Eric MD, MSc,