Some Guidelines for Interim Data Review of Clinical Trial Data

This article describes guidelines for interim data review for industry-sponsored clinical trials. Interim data review includes all types of data review during the progress of a clinical trial that do not affect the statistical design (type I error adjustments) or statistical conduct (such as decisio...

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Bibliographic Details
Published in:Drug information journal 2008-09, Vol.42 (5), p.449-453
Main Authors: King, Dennis W., Jokinen, Jeremy D.
Format: Article
Language:English
Subjects:
Biostatistics
Clinical trials
Data entry
Decision making
Drug Safety and Pharmacovigilance
Geographic profiles
Guidelines
Pharmacotherapy
Pharmacy
Product development
Reviews
Sample size
Statistics
Studies
Citations: Items that this one cites
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Description
Summary:This article describes guidelines for interim data review for industry-sponsored clinical trials. Interim data review includes all types of data review during the progress of a clinical trial that do not affect the statistical design (type I error adjustments) or statistical conduct (such as decisions to stop for futility or superiority based on hypothesis tests) of the trial. A set of levels of interim data review are described and procedures are given for documentation of the interim data review by the sponsor. A discussion of sponsor risks related to interim data review is included in the article along with recommendations for sponsor conduct of interim data review.
ISSN:0092-8615
2168-4790
2164-9200
2168-4804
DOI:10.1177/009286150804200505