Document Detail


Monitoring clinical trials: experience of, and proposals under consideration by, the Cancer Therapy Committee of the British Medical Research Council.
MedLine Citation:
PMID:  8493427     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The accumulating data from all randomized trials conducted by the Cancer Therapy Committee (CTC) of the British Medical Research Council are monitored on a regular basis. However, for important practical reasons the form of this data monitoring may vary from trial to trial. Thus a trial addressing what is considered a major question in the treatment of cancer patients, (a 'pivotal' or 'high profile' trial), has a formal data monitoring committee (DMC). This is usually made up of two clinicians and one statistician who are completely independent of the trial organization and do not enter patients into the trial. Other trials, which constitute the majority, are monitored by a less formal trial progress group made up of the clinical co-ordinator and trial statistician, sometimes supplemented by a trial participant. Experience with this dual system has led to a new proposal: if the trial progress group wish to modify or stop a trial then they are required to set up and consult an ad hoc DMC for independent advice. This proposal has many advantages, including maximizing the use of resources available, while achieving the degree of objectivity in decision-making required for the many different types of cancer trials conducted by the CTC.
Authors:
M K Parmar; D Machin
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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:  497-504     Citation Subset:  IM    
Affiliation:
MRC Cancer Trials Office, Cambridge, U.K.
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MeSH Terms
Descriptor/Qualifier:
Clinical Trials as Topic / standards*
Female
Great Britain
Guidelines as Topic
Humans
Neoplasms / therapy*
Professional Staff Committees
Randomized Controlled Trials as Topic / standards
Statistics as Topic

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


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