Clinical Research and Application Strategy for Accelerating the Listing of New Drugs

On August 11, under the encouragement of the national new drug innovation policy, more and more pharmaceutical enterprises participated in the research and development of new drugs, and the number of approved innovative drugs increased significantly. It is particularly important to improve the success rate of clinical trials of new drugs, speed up the marketing of new drugs, and do a good job in the top-level design of clinical research integration of new drugs, operation control and application for listing.
Top level design of clinical research integration
According to the key nodes of the whole process of drug research and development, the top-level design of clinical research integration of new drugs needs to be considered from the following aspects:
First, the overall planning before clinical research, which largely determines the clinical research strategy; The second is the connection of various links, including the connection between preclinical research and clinical research, and the connection between clinical trials; Third, coordination and communication among disciplines and specialties; Fourth, the stability and standardization of the management system; Fifth, efficient execution of team members.
Clinical research operation control
Clinical research operation control is a means to ensure the implementation of top-level design.
The clinical trial is divided into 19 first level links, 67 second level links and 134 third level implementation links from the opening, partner screening, ethical review, initiation and enrollment to the final submission of registration application materials. To achieve high-quality and efficient management, it is necessary to formulate a detailed project plan and divide different levels of plans according to the process.
The three elements of clinical research operation control are progress, cost and quality. Progress refers to the progress of clinical trials from the beginning to the final approval; Cost refers to the cost and resources invested; Quality refers to the degree to which the completed results meet the scientific, ethical, normative and declaration requirements. The three are both independent and closely linked, and need to be balanced and adjusted according to different stages.
Progress control The precondition for conducting clinical trials is to complete the declaration of the Genetic Office and obtain the approval from the Genetic Office. At present, the application work of the Genetic Office is mainly based on the Regulations on the Administration of Human Genetic Resources. Clinical trials of domestic innovative drugs usually involve "collection and approval", "international cooperation approval/filing", "information provision or open use filing". The focus is on whether the number of clinical trials exceeds 500, whether the partners are involved in foreign capital, whether the information generated from clinical trials is exported, etc. From project initiation, scheme design to specific implementation of clinical trials, the whole process should consider the content of genetic resources.
Cost control Conventional cost control generally involves resource allocation plan, preliminary cost estimation, cost budget, cost control, etc. The key to cost control is to do a good job in cost budget, understand resources in advance, plan resources and achieve the best allocation of resources.
Quality control The goal of quality control is to protect the rights and interests of the subjects, comply with ethical and legal requirements, and obtain true, standardized and complete clinical trial data. Corresponding systems and systems shall be established, and training shall be provided for relevant systems, systems and tests. In addition, risk management should also be done well, including risk identification, prevention and correction, and a rapid response and handling mechanism should be developed.
Application for listing
The continuous improvement of China's drug registration policies and application channels reflects the support and encouragement for new drug research and development. At present, in terms of accelerating the application and listing of new drugs, there are mainly the following support systems:
First, meeting system, including Class I, II and III meetings. Class I meeting refers to the meeting held when major safety problems are encountered in the process of drug clinical trials and major technical problems are encountered in the process of breakthrough therapeutic drug research and development. Class II meeting refers to the meeting held at the key stage of drug research and development, mainly including the pre application meeting for clinical trials of new drugs; End of phase II clinical trial of new drugs/pre launch meeting of phase III clinical trial; Pre marketing application meeting of new drugs; Risk assessment and control meeting, etc. Class III meetings are other meetings except Class I and Class II meetings. The second is four procedures, including breakthrough therapeutic drug procedures, conditional approval procedures, priority review and approval procedures and special approval procedures.