Document Detail


The use of external monitoring committees in clinical trials of the National Institute of Allergy and Infectious Diseases.
MedLine Citation:
PMID:  8493424     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Randomized clinical trials are being conducted and/or sponsored by all scientific divisions of the National Institute of Allergy and Infectious Diseases (NIAID). External committees to review the progress of ongoing trials and to make recommendations to the Institute concerning continuation or termination are an integral part of many of these trials. These committees have evolved considerably from the ad hoc committees, called together when a need arose, which were used beginning in the mid 1970s. Currently, there are many monitoring committees operating for NIAID-sponsored trials. They function in a variety of ways, based partially on historical precedent and partially on the specialized requirements of the particular trial; there is no 'standard operating procedure' for the Institute, or even for divisions within the Institute. One of the major issues faced in establishing the data and safety monitoring board for AIDS treatment trials was access to the meetings of this board and to the reports of interim data that the board reviewed. After much discussion, procedures were established that restrict such access to a very limited group of programme and statistical centre staff. These procedures, while remaining controversial, appear necessary to ensure confidentiality and the integrity of the clinical trials process.
Authors:
S S Ellenberg; M W Myers; W C Blackwelder; D F Hoth
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Publication Detail:
Type:  Journal Article    
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:  461-7; discussion 469     Citation Subset:  IM; X    
Affiliation:
Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD 20892.
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MeSH Terms
Descriptor/Qualifier:
Acquired Immunodeficiency Syndrome / drug therapy*,  prevention & control
Clinical Trials as Topic / standards*
Humans
Multicenter Studies as Topic / standards
National Institutes of Health (U.S.)
Professional Staff Committees
Randomized Controlled Trials as Topic / standards
Statistics as Topic
United States

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


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