Recently, the National Health Commission, the Ministry of Science and Technology, the National Health Insurance Administration, the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine, and the National Bureau of Disease Control and Prevention jointly issued the "National Emergency Clinical Trial Work Plan for Infectious Diseases" (hereinafter referred to as the "Work Plan").
Policy interpretation of the Work Programme1. Why is it necessary to formulate the "National Work Plan for Emergency Clinical Trials of Infectious Diseases"? Attach great importance to the prevention and control of infectious diseases and scientific research. The general secretary pointed out that science and technology are the most powerful in the fight against diseases for mankind, and we must take scientific research on epidemic prevention and control as a major and urgent task on the scientific and technological front, unify leadership and coordinate scientific research, and provide strong scientific and technological support for winning the people's war, overall war, and resistance war for epidemic prevention and control. In order to implement the decision-making and deployment of the first place, promote the establishment of a public platform for coordinating clinical trials, and improve the overall efficiency of scientific research on epidemic prevention and controlThe National Health Commission, together with the Ministry of Science and Technology, the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine, the National Disease Control and Prevention Administration, and the National Health Insurance AdministrationIn accordance with relevant laws and regulations, the Work Plan was formulated on the basis of summarizing the results of the previous work and conducting in-depth research. II. What are the overall requirements and main objectives of the Programme of Work? The "Work Plan" follows the thought of socialism with Chinese characteristics in the new era, fully implements the spirit of the 20th National Congress of the Communist Party of China, takes people's health as the core, follows the principle of the rule of law and the spirit of science, and advocates coordination, cooperation and high-quality services. Under normal circumstances, the main goal is to establish a database of various clinical trial resources, enhance clinical trial support, and improve the level of clinical trials through the study of major infectious diseases. In the emergency situation, the main goal is to cooperate with multiple parties, coordinate resources, and coordinate and promote the orderly and efficient development of clinical trials. 3. What are the key tasks of the Work Programme? The "Work Plan" clarifies three aspects: building a public platform for coordinating emergency clinical trials, strengthening the capacity building of clinical trials in medical and health institutions, and improving the overall efficiency of clinical trials under emergency conditions, and specifically stipulates eight measures.
4. What are the specific measures in the Work Plan to build a public platform for coordinating emergency clinical trials?
The work plan includes four specific measures in the construction of a public platform for the overall planning of emergency clinical trials: first, establish and improve the management system for the overall coordination of emergency clinical trial resources to ensure the effective coordination of clinical trial resources; The second is to build a clinical trial network and resource library, conduct resource investigations, and explore the establishment of a preclinical evaluation resource library; The third is to build a unified and integrated clinical trial information platform to promote the docking and sharing of clinical trials and infectious disease monitoring information; Fourth, focusing on major infectious diseases, we will continue to improve the management and operation of public platforms, so as to lay the foundation for the orderly implementation of emergency clinical trials.
5. What are the specific measures in the Work Plan to strengthen the capacity building of clinical trials in medical and health institutions? The Work Plan includes two specific measures to strengthen the capacity building of medical and health institutions in clinical trials. The first is to establish and improve the internal management and operation mechanism of medical and health institutions, optimize the management system and standard operating procedures, and carry out emergency drills. The second is to strengthen support for medical and health institutions to carry out high-level clinical trials, carry out clinical trial skills training, and improve clinical trial capabilities.
6. What are the specific measures in the Work Plan to improve the overall effectiveness of clinical trials under emergency conditions? The Work Plan includes two specific measures to improve the overall effectiveness of clinical trials under emergency conditions: first, under the framework of the national public health emergency response command system, the emergency state of clinical trials of infectious diseases will be activated, and the national emergency response to public health emergencies will be activated after evaluation; The second is to support the rapid implementation and transformation of emergency clinical trials for infectious diseases, and promote the inclusion of verified drugs, vaccines and devices in clinical diagnosis and treatment standards and epidemic prevention and control guidelines.
7. How to ensure the implementation of the Work Programme? The first is to strengthen the organization and implementation, and all relevant departments should perform their duties, strengthen coordination and cooperation, and promote the orderly conduct of emergency clinical trials. The second is to improve management and operation, and the National Health Commission shall assume the leading responsibility and establish and improve relevant operation systems. The third is to strengthen support and guarantees, and all relevant departments should strengthen the supervision and management, technical review and support of clinical trials. February** Dynamic Incentive Program