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. 2023 Jan 3;6(1):e2250996.
doi: 10.1001/jamanetworkopen.2022.50996.

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

Cade Shadbolt  1 , Elise Naufal  1 , Samantha Bunzli  2   3 , Veronique Price  4 , Siddharth Rele  1 , Chris Schilling  1 , Sharmala Thuraisingam  1 , L Stefan Lohmander  5 , Zsolt J Balogh  6 , Philip Clarke  7 , Peter Choong  1 , Michelle Dowsey  1
Affiliations

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

Cade Shadbolt et al. JAMA Netw Open. .

Abstract

Importance: Discontinuation and nonpublication are established sources of avoidable waste among surgical trials, but rates of delayed completion and recruiting shortfalls remain unclear.

Objectives: To examine the rate of delayed completion, incomplete enrollment, and discontinuation among randomized clinical trials in surgical populations and the duration of delays and extent of recruiting shortfalls among these trials.

Design, setting, and participants: This cross-sectional study examined randomized clinical trials in surgical populations registered on ClinicalTrials.gov between January 1, 2010, and December 31, 2014. Analysis was conducted between October 27, 2021, and June 30, 2022.

Main outcomes and measures: The main outcomes were the percentages of trials completed on time or with full enrollment. Delays and recruiting shortfalls were identified by comparing projected enrollment and study timeframes prespecified at the time of registration with the actual study duration and enrollment reported on completion or discontinuation. Absolute and relative differences between planned and actual trial conduct were presented for discontinued trials and those completed with delays or recruiting shortfalls.

Results: In total, 2542 randomized clinical trials in surgical populations were included in the study sample, of which 370 (14.6%; 95% CI, 13.2%-15.9%) were completed both on time and with full enrollment. Approximately 1 in 5 trials (20.4%; 95% CI, 18.9%-22.0%) were completed within their planned timeframe, and 1166 trials (45.9%; 95% CI, 43.9%-47.8%) met their prespecified enrollment target. The median delay among completed trials was 12.2 months (IQR, 5.1-24.3 months) or 66.7% (IQR, 30.1%-135.8%) longer than planned. Among completed trials that did not meet their prespecified enrollment target, the median recruiting shortfall was equivalent to 31.0% (IQR, 12.7%-55.5%) of the planned study sample. A total of 546 trials (21.5%; 95% CI, 19.9%-23.1%) were discontinued. The median time to discontinuation was 26.4 months (IQR, 15.2-45.7 months), and the median recruiting shortfall among discontinued trials was equivalent to 92.7% (IQR, 65.0%-100.0%) of the trial's prespecified enrollment target.

Conclusions and relevance: This cross-sectional study found that delayed completion, recruiting shortfalls, and untimely discontinuation were common among surgical trials. These findings highlight the importance of ensuring that investigators and funders do not overestimate the feasibility of planned trials.

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Conflict of interest statement

Conflict of Interest Disclosures: Mr Shadbolt reported receiving a Research Training Scheme Scholarship and Stipend from the Australian government outside the submitted work. Dr Choong reported receiving consultancy fees and royalties from Johnson & Johnson, consultancy fees from Stryker, royalties from Kluwer, and grants from National Health & Medical Research Council outside the submitted work. Dr Dowsey reported receiving grants from National Health & Medical Research Council during the conduct of the study and grants from Medibank P/L and the HCF Foundation outside the submitted work. No other disclosures were reported.

References

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