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Analysis of Rates of Completion, Delays, and Participant Recruitment in Randomized Clinical Trials in Surgery

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Key Points Question What are the rates of delays and incomplete enrollment among randomized clinical trials in surgery? Findings In this cross-sectional study of 2542 randomized clinical trials registered on… Click to show full abstract

Key Points Question What are the rates of delays and incomplete enrollment among randomized clinical trials in surgery? Findings In this cross-sectional study of 2542 randomized clinical trials registered on ClinicalTrials.gov between 2010 and 2014, approximately 1 in 5 trials were completed within their planned trial timeframe, with the median delay lasting 12.2 months. Less than half of trials met their prespecified enrollment target upon completion, with the median shortfall accounting for 31.0% of the planned sample size. Meaning These findings suggest that greater efforts are needed to ensure that investigators and funders do not overestimate the feasibility of planned trials.

Keywords: trials surgery; clinical trials; completion delays; analysis rates; randomized clinical; rates completion

Journal Title: JAMA Network Open
Year Published: 2023

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