Analysis of the time consumption of clinical trials contract signing and its influencing factors
10.3760/cma.j.cn113565-20221101-00207
- VernacularTitle:临床试验合同签署耗时及其影响因素分析
- Author:
Yang ZHANG
1
;
Xutong TAN
;
Yingxin TANG
;
Shuxia GUAN
;
Chi ZHANG
;
Xiaohong HAN
Author Information
1. 中国医学科学院北京协和医院临床药理研究中心 疑难重症及罕见病国家重点实验室 国家药监局药物临床研究与评价重点实验室 创新药物临床PK/PD北京市重点实验室 100730
- Keywords:
Clinical trials;
Review efficiency;
Contract signing;
Time consumption
- From:
Chinese Journal of Medical Science Research Management
2023;36(2):110-116
- CountryChina
- Language:Chinese
-
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.
