Drug and Medical Device Clinical Trial Institution

The Institutional Office is responsible for the initiation, organization, coordination, supervision, and management of clinical trials for the registration of drugs, medical devices, and in vitro diagnostic reagents throughout the hospital.

In 9/2013, it passed, for the first time, the on-site inspection for the review of institutional qualification accreditation by the China Food and Drug Administration (CFDA), with accredited specialties of cardiovascular medicine and cardiac and great-vessel surgery; in 5/2017, it again passed the on-site inspection for the review of CFDA institutional qualification accreditation, with accredited specialties of cardiovascular medicine, cardiac and great-vessel surgery, and the newly added specialty of endocrinology; in 6/2018, it completed the filing of the medical device clinical trial institution on the official website of the National Medical Products Administration (filing number: 械临机构备201800154), with 20 specialties filed in total, including cardiovascular medicine, cardiac and great-vessel surgery, and endocrinology; in 12/2019, it completed the filing of the drug clinical trial institution on the official website of the National Medical Products Administration (filing number: 药临床机构备字2019000081), with 4 specialties filed: cardiovascular medicine, cardiac and great-vessel surgery, endocrinology, and the Phase 1 Clinical Trial Research Unit.

The hospital has 39 personnel qualified as principal investigators for medical device clinical trials and 23 personnel qualified as principal investigators for drug clinical trials. The clinical trial research team participated in drafting the CFDA "Guiding Principles for the Management of Phase 1 Clinical Trials of Drugs" and "Provisions for the Administration of Biological Sample Analysis Laboratories for Drug Clinical Trials," drafting the CFDA "Guidance for First-in-Human Clinical Trials," and participating in discussions of the CFDA "Guidance on QTc Studies in Early Clinical Trials."

The clinical trial institution has successively undertaken nearly 200 drug clinical trials in Phases 1-4, medical device clinical trials, and in vitro diagnostic reagent clinical trials, including more than 20 Class 1 innovative drugs. It has undergone various project audits and monitoring conducted by dozens of domestic and international pharmaceutical companies, as well as reviews and inspections by drug regulatory authorities. Among these, in 2014 it completed the first cardiotoxicity clinical evaluation in China compliant with the international standard (E14) (TQT trial); in 2020, as the lead institution, with President Liu Xiaocheng serving as the principal investigator, it led, for the first time in China, a multicenter clinical trial evaluating the safety and efficacy of an implantable magnetically levitated ventricular assist device for the treatment of end-stage heart failure, becoming the first ventricular assist product in China to successfully complete a clinical trial strictly according to the clinical trial protocol; the product was approved for marketing by the National Medical Products Administration on 7/13/2022.

The hospital places great emphasis on the standardized development of the institution, continuously optimizes internal operational management, and conducts trials in strict accordance with GCP and relevant laws and regulations; at the same time, it safeguards the rights and interests of subjects to the greatest extent possible, strives to fulfill the duties that the institution and investigators are expected to perform, and, together with all parties involved in clinical trials, ensures trial quality and jointly promotes the development of clinical trials.

Organizational Structure Chart of the Drug and Medical Device Clinical Trial Institution