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Consideration of factors of low accrual and methods for setting appropriate accrual periods: Japan Clinical Oncology Group study. | LitMetric

AI Article Synopsis

  • Poor patient accrual in clinical trials affects the timely development of new treatments, with only about 23.6% of trials finishing within their planned periods.
  • Factors leading to trial extensions include having planned accrual periods longer than three years and using stratified trial designs, particularly in randomized trials.
  • Estimating accrual pace based on previous clinical trial data effectively improves the chances of completing trials on schedule, while other estimation methods, such as surveys, do not show the same benefit.

Article Abstract

Background: Poor patient accrual can delay reporting of clinical trials and, consequently, the development of new treatments. For reducing the risk of additional resource requirements, a method for setting planned accrual periods with minimal deviation from the actual accrual periods is desirable. Risk factors for poor patient accrual and the appropriate method of estimating the required accrual period for timely completion of clinical trials were evaluated using the data of trials conducted by the Japan Clinical Oncology Group.

Methods: The study included 199 trials that started patient accrual between January 1, 1990, and June 30, 2021. The explanatory variables included factors that could be evaluated prior to trial commencement. We also evaluated whether the estimation methods for accrual pace could lead to completion within the planned accrual period.

Results: Approximately 23.6% of trials were completed within the planned accrual period. The risk factors for trial extension included planned accrual periods > 3 years (reference group: ≤ 3 years, odds ratio [OR] 0.37, 95% confidence interval [CI]: 0.15-0.92, P = 0.033) and stratified trial design (reference group: nonrandomized phase II trials, nonrandomized phase III trial [OR: 3.28, 95% CI: 0.99-10.9, P = 0.051], randomized phase II trial [OR: 3.91, 95% CI: 0.75-20.30, P = 0.105], and randomized phase III trial [OR: 9.29, 95% CI: 3.39-25.40, P < 0.001]). The method of estimating the accrual pace based on past clinical trials facilitated timely completion of the trial (OR: 3.51; 95% CI: 1.73-7.10, P < 0.001), unlike the estimation method based on survey evaluation of the accrual pace for participating institutions (OR: 1.12, 95% CI: 0.56-2.26, P = 0.751). Furthermore, the discrepancy between planned and actual accrual periods was minimal when using the methods of considering the accrual pace of past clinical trials.

Conclusions: Considering the accrual pace of past clinical trials is useful for estimating the required accrual period if data from past trials are available. When conducting a survey, it is necessary to be cautious of overestimating the cases at each facility.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11459883PMC
http://dx.doi.org/10.1186/s13063-024-08508-9DOI Listing

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