Document Detail

The hope and the hazards of using compliance data in randomized controlled trials.
MedLine Citation:
PMID:  9493256     Owner:  NLM     Status:  MEDLINE    
This paper aims to elucidate both the advantages and limitations of using compliance data in the reporting of treatment differences in clinical trials, illustrating the issues with some recent examples. While analysis by intention-to-treat should remain the principal reporting approach for most major clinical trials, arguments are put forward as to why supplementary analyses taking account of compliance can be of value. However, continued recognition of the potential biases inherent in all such selective analysis is of key importance. Some of the possible analytical approaches are presented along with suggestions on interpretation. Particular emphasis is on one case study, a large European trial in obesity incorporating repeated measures of weight loss, drug plasma level and pill count data. In working on compliance data in clinical trials, the statistician's main responsibilities may be to undertake a cohesive analysis strategy not influenced by data dredging, to achieve clarity of exposition without undue complexity or oversimplification, and to provide appropriately cautious interpretations which take account of selection biases and data limitations.
S J Pocock; M Abdalla
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Publication Detail:
Type:  Comparative Study; Journal Article    
Journal Detail:
Title:  Statistics in medicine     Volume:  17     ISSN:  0277-6715     ISO Abbreviation:  Stat Med     Publication Date:  1998 Feb 
Date Detail:
Created Date:  1998-04-13     Completed Date:  1998-04-13     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  303-17     Citation Subset:  IM    
Medical Statistics Unit, London School of Hygiene & Tropical Medicine, U.K. S.
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MeSH Terms
Appetite Depressants / therapeutic use
Data Interpretation, Statistical*
Double-Blind Method
Fenfluramine / blood,  therapeutic use
Follow-Up Studies
Obesity / drug therapy,  therapy
Patient Compliance*
Randomized Controlled Trials as Topic*
Regression Analysis
Time Factors
Weight Loss
Reg. No./Substance:
0/Appetite Depressants; 0/Placebos; 458-24-2/Fenfluramine

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

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