Document Detail

Monitoring of clinical trials and interim analyses from a drug sponsor's point of view.
MedLine Citation:
PMID:  8493426     Owner:  NLM     Status:  MEDLINE    
This paper illustrates aspects of data monitoring of clinical trials in the pharmaceutical industry. Formal interim analyses are performed at least in part to address the question of whether the trial should proceed or whether there should be an early termination of the trial. For formal interim analyses, frequently independent data and safety monitoring committees are utilized for monitoring clinical trials, and adjustments to nominal significance levels for test statistics are required. Various statistical methods developed during the last fifteen years are utilized. Administrative interim analyses are those analyses that are performed without any intention to stop the trial as a consequence of those analyses. For administrative interim analyses, adjustments to significance levels may not be required, but results must still be carefully interpreted. Regardless of the interim analyses performed, it is critical that the plans for interim analyses be identified in the study protocol, and the dissemination of interim results be carefully restricted. The following clinical trials sponsored by Merck Sharp and Dohme Research Laboratories (MSDRL) will illustrate these points: CONSENSUS; CONSENSUS II; 4S; Haemophilus influenza type b efficacy trial; famotidine in upper gastrointestinal haemorrhage, and a phase II analgesic study. It is anticipated that data monitoring and interim analysis activities will increase for future clinical trials due to the availability of appropriate statistical methods and improved data management systems.
G W Williams; R L Davis; A J Getson; A L Gould; I K Hwang; H Matthews; W J Shih; S M Snapinn; K L Walton-Bowen
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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:  481-92     Citation Subset:  IM    
Biostatistics and Research Data Systems, Merck Sharp and Dohme Research Laboratories, West Point, Pa 19486.
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MeSH Terms
Clinical Trials as Topic / standards*
Drug Industry*
Professional Staff Committees
Statistics as Topic

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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