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PubMed · 8834929

Mega-trials: is meta-analysis an alternative?

J Lubsen
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Abstract

Large scale placebo-controlled trials with clinical end-points are not possible when other compounds with proven efficacy are already available. Hence, the question arises whether the available experience from placebo-controlled phase III trials can be analysed jointly to assess whether an effect on clinical end-points exists. This question was answered for the new ACE inhibitor ramipril, with which five exercise capacity trials were done in similar patients with heart failure. Meta-analysis showed that ramipril reduced the occurrence of the combined event death or hospitalisation by 32% (P = 0.05), based on the customary 'intention-to-treat' comparison for large scale trials. From this analysis, the lesson has been learnt that a drug development programme must be carefully planned to allow for this type of meta-analysis.

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Angiotensin-Converting Enzyme InhibitorsHeart FailureHumansMeta-Analysis as TopicRamiprilJournal ArticleResearch Support, Non-U.S. Gov't

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J Lubsen. 1996. Mega-trials: is meta-analysis an alternative?. https://pubmed.ncbi.nlm.nih.gov/8834929/

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