2000
DOI: 10.1159/000027168
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On Problems Related to Subgroup Analyses in Clinical Trials

Abstract: Background: The intention of randomized clinical trials is usually the comparison of two or more treatments in a population of patients with a specific disease. Most often, the trial is planned for an overall comparison of the treatment groups. During data analysis of the trial often further questions emerge for treatment differences in certain subgroups of patients defined by prognostic factors. In extreme situations, this may lead to a division into many different subgroups. The treatment groups are then com… Show more

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Cited by 2 publications
(1 citation statement)
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“…The necessity of treatment comparisons within randomized controlled clinical trials has already been highlighted in conjunction with high-dose chemotherapy in breast cancer [22,24]. Additional topics have been the estimation of local recurrence rates [25], problems related with subgroup analyses [26], and the problem arising from the use of 'optimal' cutpoints in the assessment of prognostic factors [27]. In general, the GBSG studies have proven that large-scaled, nationwide breast cancer trials can be successfully conducted in Germany and that the long-term follow-up of the patients enrolled is difficult as compared with other countries, but feasible to a certain extent.…”
Section: Discussionmentioning
confidence: 99%
“…The necessity of treatment comparisons within randomized controlled clinical trials has already been highlighted in conjunction with high-dose chemotherapy in breast cancer [22,24]. Additional topics have been the estimation of local recurrence rates [25], problems related with subgroup analyses [26], and the problem arising from the use of 'optimal' cutpoints in the assessment of prognostic factors [27]. In general, the GBSG studies have proven that large-scaled, nationwide breast cancer trials can be successfully conducted in Germany and that the long-term follow-up of the patients enrolled is difficult as compared with other countries, but feasible to a certain extent.…”
Section: Discussionmentioning
confidence: 99%