Statistics in medicine
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Statistics in medicine · Jun 1996
ReviewMeta-analysis and meta-analytic monitoring of clinical trials.
Randomized trials are effective and usually unbiased for showing the average results in a selected outcome variable for treatment A versus treatment B, and meta-analyses produce an average of these averages. The results of both the trials and meta-analyses are often pragmatically unsatisfactory, however, because they do not reflect cogent distinctions desired by practising clinicians in the heterogeneous subgroups formed by diverse components in the patients' baseline states, in proficiency of therapy, and in additional outcome phenomena. If the inadequacies of previous trials have led to performance of a suitable new trial, it should not be stopped by the numbers emerging from meta-analyses of prior non-pertinent results.
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Statistics in medicine · Jun 1996
ReviewThe role of external evidence in data monitoring of a clinical trial.
Data monitoring of interim results from a randomized clinical trial should take into consideration evidence from other trials. This article presents both scientific and practical issues regarding the pros and cons of formally incorporating such external evidence into the decision making process for the current trial. Guidelines on how to use other trials' data are presented, along with cautiously sceptical comments on the impracticality of using formal meta-analyses in data monitoring. The arguments are illustrated by recent examples from specific trials, and the article concludes with some general recommendations.
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Results from external studies often play an important role in many aspects of a clinical trial. Their incorporation into the decision making process of a trial, however, is rarely conducted in a formal manner. This conference will address what formal role, if any, meta-analytic summaries of external results should have in the design and monitoring of an ongoing trial. This introductory presentation describes in detail the example from obstetric research which motivated the conference topic, and, in a Bayesian framework, summarizes the general implications of formally incorporating meta-analytic results into the design and analysis of a new trial.