Accelerating Clinical Research and Application Strategies for New Drug Launch

　Pharmaceutical Network, August 11 — Under the encouragement of the national new drug innovation policy, more and more pharmaceutical companies are participating in new drug research and development, with a significant increase in the number of innovative drugs approved. Improving the success rate of new drug clinical trials, accelerating the speed of new drug launch, and ensuring integrated top-level design, operational control, and application for new drug clinical research are particularly important.

　　Integrated Top-Level Design of Clinical Research

　　Based on the key nodes of the entire drug development process, the integrated top-level design of new drug clinical research needs to consider the following aspects:

　　First, overall planning before clinical research, which largely determines the clinical research strategy; second, the connection between various stages, including the connection between preclinical research and clinical research, and between different phases of clinical trials; third, coordination and communication among various disciplines and specialties; fourth, robustness and standardization of management systems; fifth, efficient execution by the team members.

　　Clinical Research Operational Control

　　Clinical research operational control is the means to ensure the implementation of the top-level design.

　　Clinical trials, from project initiation, partner selection, ethical review, start-up enrollment to final submission of registration application materials, are divided into 19 primary stages, 67 secondary stages, and 134 tertiary execution stages. To achieve high-quality and efficient management, detailed project plans need to be developed, and different plan levels should be divided according to the process.

　　The three key elements of clinical research operational control are progress, cost, and quality. Progress refers to the advancement from the start of the clinical trial to final approval; cost refers to the expenses and resources invested; quality refers to the extent to which the results meet scientific, ethical, regulatory, and application requirements. These three are both independent and closely linked, requiring balance and adjustment according to different stages.

　　Progress Control The prerequisite for conducting clinical trials is completing the genetic resource office application and obtaining approval from the genetic resource office. Currently, the genetic resource office application work mainly relies on the Regulations on the Administration of Human Genetic Resources. Domestic innovative drug clinical trials usually involve "collection approval", "international cooperation approval/filing", and "information external provision or open use filing", focusing respectively on whether the number of clinical trial participants exceeds 500, whether partners involve foreign capital, and whether information generated by clinical trials leaves the country. From project initiation, protocol design to clinical trial implementation, the entire process should consider genetic resource aspects. collection approval" international cooperation approval/filing" and "information external provision or open use filing", focusing respectively on whether the number of clinical trial participants exceeds 500, whether partners involve foreign capital, and whether information generated by clinical trials leaves the country. From project initiation, protocol design to clinical trial implementation, the entire process should consider genetic resource aspects.

　　Cost Control Routine cost control generally involves resource allocation planning, preliminary cost estimation, cost budgeting, and cost control stages. The key to cost control is to make a good cost budget, understand resources in advance, plan resources, and achieve optimal resource allocation.

　　Quality Control The goal of quality control is to protect the rights and interests of subjects, comply with ethical and legal requirements, and obtain authentic, standardized, and complete clinical trial data. Corresponding systems and frameworks should be established, and training on these systems, frameworks, and trial-related content should be conducted. Additionally, risk management should be well implemented, including risk identification, prevention, and correction, as well as establishing rapid response and handling mechanisms.

　　Application for Market Approval

　　China's Drug registration policies and application channels continue to improve, reflecting support and encouragement for new drug research and development. Currently, the main support systems for accelerating new drug application and market approval include:

　　First, the meeting system, including Type I, II, and III meetings. Type I meetings refer to those held when major safety issues arise during drug clinical trials or when major technical issues occur during breakthrough therapy drug development. Type II meetings are held at key stages of drug development, mainly including pre-application meetings for new drug clinical trials; meetings before the end of Phase II/ start of Phase III clinical trials; pre-market application meetings; risk assessment and control meetings, etc. Type III meetings refer to other meetings besides Type I and II. Second, there are four procedures, including breakthrough therapy drug procedures, conditional approval procedures, priority review and approval procedures, and special approval procedures.