Document Detail

Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations.
MedLine Citation:
PMID:  8493425     Owner:  NLM     Status:  MEDLINE    
The characteristics of data monitoring and the need for the use of data monitoring committees in clinical trials sponsored by the pharmaceutical industry differ from those of trials sponsored by government. Data monitoring is a continuous process in industry trials due to the regulatory requirements and the need to more thoroughly evaluate safety of new compounds. As part of this process, interim analyses are employed to make decisions about treatment effects. In some cases, such analyses may require the use of an external data monitoring committee to assist in the data review, analysis and decision making. A number of examples of interim analyses, with and without data monitoring committees, are discussed. Issues surrounding the need for external data monitoring committees and recommendations are presented. In particular the issues of sponsor participation in the data monitoring committee and controls of the decision making process are considered.
F W Rockhold; G G Enas
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Statistics in medicine     Volume:  12     ISSN:  0277-6715     ISO Abbreviation:  Stat Med     Publication Date:  1993 Mar 
Date Detail:
Created Date:  1993-06-17     Completed Date:  1993-06-17     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  471-9     Citation Subset:  E; IM    
SmithKline Beecham Pharmaceuticals, Four Falls Corporate Center, King of Prussia, PA 19406.
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MeSH Terms
Clinical Trials Data Monitoring Committees*
Clinical Trials as Topic / standards*
Drug Industry*
Government Regulation
Research Design / standards
Research Subjects
Risk Assessment
United States
United States Food and Drug Administration

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