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

Shadbolt, Cade ; Naufal, Elise ; Bunzli, Samantha ; Price, Veronique ; Rele, Siddharth ; Schilling, Chris ; Thuraisingam, Sharmala ; Lohmander, L Stefan LU orcid ; Balogh, Zsolt J and Clarke, Philip LU , et al. (2023) In JAMA Network Open 6. p.1-10
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... (More)

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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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Humans, Cross-Sectional Studies, Randomized Controlled Trials as Topic, Research Personnel, Research Subjects
in
JAMA Network Open
volume
6
article number
e2250996
pages
1 - 10
publisher
American Medical Association
external identifiers
  • scopus:85146484448
  • pmid:36648945
ISSN
2574-3805
DOI
10.1001/jamanetworkopen.2022.50996
language
English
LU publication?
yes
id
40b0c7c2-78cf-4f28-8c33-1ac7ec369904
date added to LUP
2023-04-14 12:21:03
date last changed
2024-06-15 01:55:16
@article{40b0c7c2-78cf-4f28-8c33-1ac7ec369904,
  abstract     = {{<p>IMPORTANCE: Discontinuation and nonpublication are established sources of avoidable waste among surgical trials, but rates of delayed completion and recruiting shortfalls remain unclear.</p><p>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.</p><p>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.</p><p>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.</p><p>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.</p><p>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.</p>}},
  author       = {{Shadbolt, Cade and Naufal, Elise and Bunzli, Samantha and Price, Veronique and Rele, Siddharth and Schilling, Chris and Thuraisingam, Sharmala and Lohmander, L Stefan and Balogh, Zsolt J and Clarke, Philip and Choong, Peter and Dowsey, Michelle}},
  issn         = {{2574-3805}},
  keywords     = {{Humans; Cross-Sectional Studies; Randomized Controlled Trials as Topic; Research Personnel; Research Subjects}},
  language     = {{eng}},
  month        = {{01}},
  pages        = {{1--10}},
  publisher    = {{American Medical Association}},
  series       = {{JAMA Network Open}},
  title        = {{Analysis of Rates of Completion, Delays, and Participant Recruitment in Randomized Clinical Trials in Surgery}},
  url          = {{http://dx.doi.org/10.1001/jamanetworkopen.2022.50996}},
  doi          = {{10.1001/jamanetworkopen.2022.50996}},
  volume       = {{6}},
  year         = {{2023}},
}