Document Detail

Using provisional diagnoses in monitoring a clinical trial.
MedLine Citation:
PMID:  1925165     Owner:  NLM     Status:  MEDLINE    
In clinical trials there is delay between the occurrence of an event and the recording of that event as an end point in the trial data base. Delays are especially likely if events are reviewed carefully to determine whether diagnostic criteria for end points are satisfied. As a result, the value of a statistic used to evaluate efficacy during a trial may differ from the value of that statistic based on the true end point status of all events which have already occurred. Simulating the process causing delays can be useful in evaluating interim efficacy data by providing a quantitative estimate of the uncertainty in a monitoring statistic. These ideas are illustrated using data from the Lipid Research Clinics Coronary Primary Prevention Trial.
J M Karon
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Publication Detail:
Type:  Journal Article; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Statistics in medicine     Volume:  10     ISSN:  0277-6715     ISO Abbreviation:  Stat Med     Publication Date:  1991 Sep 
Date Detail:
Created Date:  1991-11-21     Completed Date:  1991-11-21     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  1341-8     Citation Subset:  IM    
Division of HIV/AIDS (E-48), Centers for Disease Control, Atlanta, GA 30333.
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MeSH Terms
Cholesterol / blood
Clinical Trials as Topic / methods*
Coronary Disease / blood,  diagnosis,  prevention & control
Data Interpretation, Statistical*
Middle Aged
Monitoring, Physiologic
Multicenter Studies as Topic / methods
Time Factors
Grant Support
Reg. No./Substance:

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