On March 20, 2024, Datong Fifth Hospital held a clinical trial project of endocrine specialty drugs: a multicenter, randomized, parallel, active-controlled phase III clinical study project kick-off meeting to evaluate the efficacy and safety of semaglutide injection and Novotech ® in the treatment of type 2 diabetes patients with poor metformin glycemic control.
The kick-off meeting was organized by the Office of Drug Clinical Trial Institutions of our hospital, and attended by the Director of the Department of Endocrinology, Chief Physician Gao Yanhong, Project PI, and the GCP Research Team of the Department of Endocrinology, Su Weiwen, Director of the Institutional Office, Ma Chunming, Deputy Director of the Institutional Office, Secretary of the Institutional Office, Quality Controller, Data Administrator, Drug Administrator, Project CRO Representative, Clinical Monitor (CRA), and Clinical Coordinator (CRC).
Drug clinical trials can improve the scientific research level and academic status of hospitals, promote discipline construction and talent training, and make positive contributions to the high-quality development and social influence of hospitals. Chief Physician Gao Yanhong, PI of the project, asked everyone to be familiar with the trial protocol and process as soon as possible, and to follow the quality management practices and relevant laws and regulations for drug clinical trials during the implementation of the trial, and strictly follow the implementation of the trial protocol to ensure the authenticity, accuracy and reliability of the test data, and at the same time strictly abide by the ethical principles to fully protect the rights and safety of the subjects.
Representatives of the sponsor, CRO and CRA conducted training on the project implementation plan and related content, introduced the test plan and precautions in detail, and answered questions on related issues, and the on-site discussion atmosphere was warm.
In 2024, the Office of Drug Clinical Trial Institutions of our hospital will continue to promote drug clinical trials and help the high-quality development of medical treatment and scientific research in hospitals. The drug clinical trial institutions of our hospital can undertake clinical trials in cardiovascular medicine, rheumatology and immunology, endocrinology, oncology, urology, gynecology, gastroenterology, nephrology, and neurology. Interested sponsors or CROs are welcome to come to investigate and cooperate.
Institutional Contact:
Su Weiwen, Director of the Office of the Agency: 13513677497
Ma Chunming, Deputy Director of the Office of the Agency: 18734215017
Li Su, Secretary of the Office of the Agency: 18636260361
Agency Office Tel: 0352-2389347
Editor-in-charge: Sun Mingyue