Analysis of the time consumption of clinical trials contract signing and its influencing factors / 中华医学科研管理杂志

ABSTRACT

Objective:To study the time consumption of clinical trial projects in each link of contract signing in medical institutions and its influencing factors, to provide a reference for further optimizing the clinical trial management process and improving the efficiency of contract signing.Methods:All of the review records of projects that signed clinical trial contracts at Peking Union Medical College Hospital from January 1st, 2018 to December 31st, 2021 were retrospectively analyzed by comparing the time consumption in each link before signing the contracts and the frequency of contract reviews. Multiple linear regressions were applied to multivariate analyze the influence of different factors on contract signing.Results:A total of 761 clinical trial contracts signed at Peking Union Medical College Hospital from 2018 to 2021 were included in this study, and the average time consumption of contract signing was 127.0 days, among which the consumption of contract review by the hospital was 10.5 days and by sponsors was 99.0 days. The time consumption of contract signing has been decreasing in recent 4 years, from 154.0 days in 2018 to 104.0 days in 2021. The phase of clinical trials, category of sponsors, frequency of contract reviews, and different policies of the institutions were the main influencing factors for contract signing time ( P<0.05). Conclusions:Clinical trial institutions should optimize the contract approval progress, provide agreement templates and targeted service, and strengthen propaganda and information system construction, to improve the efficiency of reviewing and signing clinical trial contracts.