Article

Optimizing Primary Analyses in Randomized Controlled Trials with Multiple Endpoints: A Simulation Study with Application to Kidney Transplantation

2025-10-07

Abstract excerpt

<title>Abstract</title> <p>Relying on a single primary endpoint in randomized controlled trials (RCTs) is often not feasible, e.g. due to low event rates. We explored three approaches to consider multiple endpoints in the primary analysis of RCTs, as stated in the FDA and EMA guidelines on multiplicity issues: (i) a composite endpoint (CE), (ii) multiple testing and multiplicity correction (MTMC), and (iii) a hie...

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Literature Corpus work: 0f5f8f6e-649e-5b64-b8dc-377749be4aa1
DOI: 10.21203/rs.3.rs-7591828/v1

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