Sensitivity analysis for missing data in regulatory submissions

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Sensitivity analysis for missing data in regulatory submissions1d
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由 Thomas Permutt[url=][/url] 通过 Statistics in Medicine[url=][/url]




The National Research Council Panel on Handling Missing Data in Clinical Trials recommended that sensitivity analyses have to be part of the primary reporting of findings from clinical trials. Their specific recommendations, however, seem not to have been taken up rapidly by sponsors of regulatory submissions. The NRC report's detailed suggestions are along rather different lines than what has been called sensitivity analysis in the regulatory setting up to now. Furthermore, the role of sensitivity analysis in regulatory decision-making, although discussed briefly in the NRC report, remains unclear. This paper will examine previous ideas of sensitivity analysis with a view to explaining how the NRC panel's recommendations are different and possibly better suited to coping with present problems of missing data in the regulatory setting. It will also discuss, in more detail than the NRC report, the relevance of sensitivity analysis to decision-making, both for applicants and for regulators. Published 2015. This article is a U.S. Government work and is in the public domain in the USA

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关键词：Sensitivity Regulatory Submission Regulator missions regulatory reporting clinical specific however

Patients with schizophrenia who initiated SGOA therapy were identified in the MarketScan® Medicaid Multi-State database between July 1, 2004 and December 31, 2007. Patients were stratified by <2 psychiatric-related relapse events and ≥2 psychiatric-related relapse events during the 12-month period following SGOA initiation. All-cause and schizophrenia-related health care utilization and costs were estimated for each cohort in various care settings. Univariate and multivariate regression analyses were conducted to assess the differences in all-cause and schizophrenia-related health care utilization and costs between the 2 cohorts. No adjustments were made for multiple inferential statistical tests.