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.
ABSTRACT
With the implementation of the national biomedical innovation strategy, new requirements for ethical review of clinical trials have been put forward, and more attention has been paid to the ethical pre-review. Based on the current situation of clinical trials and ethical review of new drugs in China, this paper discussed the concept, advantages and necessity of ethical pre-review, sorted out the problems and challenges in the implementation of ethical pre-review at this stage, and put forward the following suggestions on how to better implement ethical pre-review in clinical trials under the pharmaceutical innovation strategy: the complete definition of "ethical pre-review" should be made clearly; ethical review should be carried out on the basis of necessary reference; the scope of application of ethical pre-review should be clarified; after the ethical pre-review, the statement of the approval document should be standardized and accurate.
ABSTRACT
OBJECTIVE： To explore the ways to improve the efficiency and quality of ethical review in multi-center clinical trial. METHODS： After issuing the policy of Opinions on Deepening the Reform of Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices and Measures for the Administration of Drug Registration （Revised Version）， combined with the practice of our center， the methods to improve the efficiency and quality of ethical review， the possible problems of complete filling system and the way to improve the efficiency and quality of ethical review in multi-center clinical trial were analyzed in our center. RESULTS & CONCLUSIONS： Our center adopted a variety of review methods （conference review， rapid review， filing system， etc.）， implemented hierarchical management and differential review process for research projects， and formulated defined rules of filling system operation and other ways to improve the efficiency and quality of review， doubled the review efficiency， increased the number of follow-up review and field visit. In the process of exploration， the ethics committee of our center believes that the complete implementation of the filing system will lead to problems such as the difficulty to evaluate the quality of the ethical review of the leader unit， different research qualifications and conditions of each center， etc. In order to improve the efficiency and quality of the ethical review of multi-center clinical research， the measures are can be adopted， such as improving the quality of the ethical review of the center， strengthening the communication and mutual recognition of the ethics committees of each center， and establishing the preliminary review system of the secretary of the ethics committee， so as to realize the balance of efficiency and quality.