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Single-arm clinical trials that supported FDA accelerated approvals have modest effect sizes and were at high risk of bias

Tatiane Bomfim Ribeiro, Luis Enrique Colunga‐Lozano, Ana Paula Vieira Araujo, Charles L. Bennett, Iztok Hozo, Benjamin Djulbegović

2022Journal of Clinical Epidemiology24 citationsDOIOpen Access PDF

Topics & Concepts

MedicineClinical trialPublication biasResearch designMeta-analysisRandomized controlled trialInternal medicineStatisticsMathematicsStatistical Methods in Clinical TrialsAdvanced Causal Inference TechniquesHealth Systems, Economic Evaluations, Quality of Life
Single-arm clinical trials that supported FDA accelerated approvals have modest effect sizes and were at high risk of bias | Litcius