Abstract
With the passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA), greater emphasis has been given to evaluating Risk Evaluation and Mitigation Strategies (REMS) and the tools used to mitigate risks. The FDAAA requires tool evaluation as part of even a minimal REMS, to be repeated at 1.5, 3, and 7 years after program implementation. Sponsors and FDA have become more concerned that the studies used to evaluate REMS interventions be sufficient in size and scope and fairly pose questions to people who prescribe, dispense, and use the drug and biological products evaluated. This article discusses several important issues in the design of survey evaluations such as: (1) identifying the survey sample and administrating the survey, (2) determining and justifying the sample size, (3) focusing survey questions on topics of need and of interest, and (4) how to design questionnaires to minimize bias and provide useful and actionable information.
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