The Ethics Committee of Drug Clinical Trials of PUMCH has been dedicating itself to strictly and independently reviewing the scientific nature and ethical rationality of clinical trial projects, and standardizing the review process The work of the Ethics Committee aims to protect the dignity, safety, and rights and interests of subjects, promote the development of clinical trials, and enhance the public’s trust in and support for drug clinical trials. In recent years, the Ethics Committee has reviewed more than 200 new clinical trial cases annually on average, which involve nearly 10,000 documents during the follow-up and review.

To speed up the approval process for clinical trials of innovative drugs, the Ethics Committee has taken the lead in moving forward the ethical review in China since 2007, which has greatly shortened the project initiation time, significantly enhanced clinical trial management, and brought the ethnical review in line with ICH-GCP. Since 2013, the Ethics Committee has explored the mode of mutual recognition of ethical review results for multi-center projects, and adopted an expedited review process instead of review through meetings for projects that have passed the team review, On December 1, 2020, the Alliance for Mutual Recognition of Medical Ethics Review was established in Beijing, and PUMCH is among the first that joined this alliance. In 2019, with the support of the Beijing Municipal Health Commission, the Ethics Committee, considering the needs of all parties, institutionalized and formalized the service of “consultation, mutual help and mutual learning in ethics”. After that, PUMCH, if commissioned, will provide free ethical review services. Up to now, the hospital has been commissioned to take on 9 ethical review projects.

On June 14, 2021, PUMCH made the breakthrough for compassionate usage for the first time in China, and approved the application of the new drug Lptacopan on a patient with a lethal paroxysmal nocturnal hemoglobinuria (PNH) whose condition was not improved by any of the existing therapies. The Ethics Committee collaborated with all parties involved and informed consent and conducted ethical review. With the most rigorous attitude and professional judgment, the Ethics Committee weighed the benefit and risk of the new treatment, and worked for the best result during compassionate drug usage for patients with rare diseases.

After moving into the Translational Medicine Complex, the Ethics Committee will continuously optimize information-based platform. With the support of Medical Research Center, the Biological Sample Center, and the Phase I Laboratory, the Ethics Committee will constantly make its best effort on enhancing the quality and efficiency of medical research.

Written by: The Clinical Pharmacology Center and the Publicity Department

Translator: Liu Haiyan

Editor: Zhang Yang and Wang Yao