Document Detail

Approaches to data analyses of clinical trials.
MedLine Citation:
PMID:  22225999     Owner:  NLM     Status:  MEDLINE    
There are two types of data analyses of randomized clinical trials (RCTs). The primary analyses are pre-specified in the protocol and the findings form the basis for recommendations and clinical decisions. They typically adhere to the intention-to-treat principle. Secondary analyses are supplemental and of various sorts. Although some may be pre-specified, many are not. We encourage the use of the rich sources of data from large RCTs for these secondary purposes. Depending on the kinds of secondary analyses, whether they are pre-specified, and whether intention-to-treat analysis is used, the results range from being quite conclusive to being hypothesis generating. In this article we answer four questions related to secondary analysis with emphasis on sharing of data primarily from NIH-sponsored trials: Who has access to this information? What questions can be asked? What are the requirements? What are the common challenges?
Curt D Furberg; Lawrence M Friedman
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Progress in cardiovascular diseases     Volume:  54     ISSN:  1873-1740     ISO Abbreviation:  Prog Cardiovasc Dis     Publication Date:    2012 Jan-Feb
Date Detail:
Created Date:  2012-01-09     Completed Date:  2012-02-23     Revised Date:  2013-05-02    
Medline Journal Info:
Nlm Unique ID:  0376442     Medline TA:  Prog Cardiovasc Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  330-4     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012. Published by Elsevier Inc.
Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
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MeSH Terms
Access to Information
Data Interpretation, Statistical*
Randomized Controlled Trials as Topic / standards*

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

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