Testing for baseline differences in clinical trials
نویسندگان
چکیده
منابع مشابه
Testing for baseline balance in clinical trials.
Once the data from a clinical trial are available for analysis it is common practice to carry out 'tests of baseline homogeneity' on prognostic covariates before proceeding to analyse the effects of treatment on outcome variables. It is argued that this practice is philosophically unsound, of no practical value and potentially misleading. Instead it is recommended that prognostic variables be i...
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ALTHOUGH REPORTING BASELINE DATA seems simple, it is crucial information for readers in judging the validity of a trial. Knowing the baseline characteristics of the trial participants allows readers to assess how closely these match patients seen in their own clinical practice, and therefore how generalisable the results of the trial will be (so-called external validity). Baseline characteristi...
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In clinical trials investigating the treatment of chronic, progressive diseases, a common design is to make some physiologic measurement of the disease state at the start of the trial, randomize patients to either the experimental treatment or some control treatment (placebo), follow the patients over some period of time, and then measure once again the physiologic measurement of the disease st...
متن کاملGuideline on adjustment for baseline covariates in clinical trials
Draft Agreed by Biostatistics Working Party (BSWP) March 2013 Adoption by CHMP for release for consultation 30 May 2013 Start of public consultation 28 June 2013 End of consultation (deadline for comments) 31 December 2013 Agreed by BSWP January 2015 Adopted by CHMP 26 February 2015 Date for coming into effect 01 September 2015 This guideline replaces Points to Consider on adjustment for baseli...
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BACKGROUND According to the CONSORT statement, significance testing of baseline differences in randomized controlled trials should not be performed. In fact, this practice has been discouraged by numerous authors throughout the last forty years. During that time span, reporting of baseline differences has substantially decreased in the leading general medical journals. Our own experience in the...
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ژورنال
عنوان ژورنال: International Journal of Clinical Trials
سال: 2020
ISSN: 2349-3259,2349-3240
DOI: 10.18203/2349-3259.ijct20201720