In November 2021, the Drug Review Center of the National Medical Products Administration issued the “Guiding Principles for Clinical Research and Development of Anti-tumor Drugs Guided by Clinical Value” aiming to achieve the goal of Drug development with patient needs as the core and clinical value as the guide. By combining patients' experience, determining which key areas need to treat patients' opinions as reference can improve the quality and efficiency of Drug development and provide more information for drug development and regulatory decisions.

In the guiding principles, guided by patient needs, the main aspects are as follows:

1) Strengthen mechanism research and optimize drug design;

2) Improve precision treatment and actively explore different forms of combination medication plans;

3) Pay attention to the dynamic changes in treatment needs and continuously explore the unmet clinical needs of tumor patients.

4) Continuously improving drug safety, enhancing and improving safety management, testing, prevention and other measures.

5) Improve the treatment experience and convenience, and improve the drug delivery route.

Furthermore, the clinical trial design which reflected the needs of patients can be divided into exploration stage and key research stage. In the early exploration stage and the key research stage of clinical trial design CDE encourages the use of scientific tools such as models to guide drug development, and the use of efficient clinical trial design, presets the threshold of research and development decisions, and makes interim analysis, so as to reduce the ineffective exposure of subjects, protect their rights and interests, and improve research efficiency; In addition, attention should also be paid to the representativeness of the population and the development of medication for special populations, in order to maximize the satisfaction of the safe medication needs of different types of people in clinical practice.