Document Detail

How much data should we collect in a randomized clinical trial?
MedLine Citation:
PMID:  2189185     Owner:  NLM     Status:  MEDLINE    
Multicentre randomized controlled clinical trials are usually designed to answer a specific question. In accomplishing this they often collect a large quantity of data during screening, baseline and follow-up visits. These data are not all necessarily related to the main study question. This collection impacts on the overall recruitment process and the participants' time. During the planning phase of the trial we need to consider the reasons for collecting data and the use of that data for the current study as well as its potential use in future investigations. We discuss briefly some of the possible reasons that data may be collected: screening or determining eligibility; conducting a run-in or dose titration phase; assessing group comparability; aiding patient management; evaluating the natural history of the disease; monitoring the study; testing the study hypotheses; evaluating adherence; estimating side effects and the use of other therapies; analysis of other study questions.
J Verter
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  Statistics in medicine     Volume:  9     ISSN:  0277-6715     ISO Abbreviation:  Stat Med     Publication Date:    1990 Jan-Feb
Date Detail:
Created Date:  1990-06-29     Completed Date:  1990-06-29     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  103-11; discussion 112-3     Citation Subset:  IM    
Biostatistics Research Branch, National Heart, Lung and Blood Institute, Bethesda, Maryland 20892.
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MeSH Terms
Data Collection / methods*
Drug Therapy / adverse effects
Multicenter Studies as Topic
Patient Compliance
Quality Control
Randomized Controlled Trials as Topic / methods*
Time Factors

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

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