On July 2, CDE (the Center for Drug Evaluation of the National Medical Products Administration) released the "Clinical Value-Oriented Anti-tumor Drug Clinical Research and Development Guidelines (Draft for Comment)", which caused heated discussions in the industry . At this CSCO-CDE special session, Tang Ling, the reviewer of CDE Chemical Medicine Clinic I, shared on the "Clinical Value-Oriented Anti-tumor Drug Development" and related policies.
value-oriented clinical anti-tumor drug development
NMPA CDE
CSCO2021 Tangling
The basis of clinical research:
is patient-centric and clinical value-oriented
br9 Kind of problem,For example:
· There are multiple the same standard treatment, who should I choose as the control group?
·I want to make an oral drug against the target of PD-1 . How should clinical trials be designed? Should it be compared with anti-PD-1 monoclonal antibody injection?
·Domestic innovative drug A has been on the market in China for many years, and our imported drug is to be listed in China. Should we choose A for comparison?
· Drug A was approved for marketing last month. I am now doing refractory relapse XX. Should I choose the population after drug A treatment?
· 10 patients have been admitted to the first phase of the product, and the ORR has reached 60%. Can one arm be done?
These problems are complicated, but they are all clinical problems. The foundation of clinical research and development is to take the patient as the core and clinical value as the orientation. In the clinical research and development process, first understand the needs of patients, and solve and meet the needs of patients through the development of new drugs. Finally, the patients participate in the clinical trial, and the clinical trial submits the answer sheet to prove that the drug solves the patient's problem.
The highest goal of new drug development should be "providing patients with better treatment". The concept of "better" may be more effective, safer, or more convenient, or the launch of a drug Make the patient's medicine more accessible. It is based on this consideration that CDE issued the "Clinical Value-Oriented Clinical Research and Development Guidelines for Anti-tumor Drugs (Draft for Comment)" on July 2.
As a guiding principle, it is forward-looking, it is also a review of the review scale based on the accumulation of past review experience, and a summary of thoughts: The previous "Technical Guiding Principles" of aimed to introduce technical requirements and propose standards-"How to do it". returns to the patient group and listens to the voice of patients The following points can be considered: strengthening mechanism research
li122 is the fundamental driving force for the research and development of drugs and the basic mechanism of drug development.
improves precision treatment
- Different patient populations may be suitable for different programs. The appropriate treatment plan/combination plan should be selected according to the biological characteristics of the disease and the mechanism of action of the drug.
- to reduce "accompany running" patients.
- is a highly tolerable adverse reaction to multiple malignant diseases, but is a more lethal tumor .
- malignant tumors gradually show the characteristics of chronic diseases,The safety of long-term medication is easily overlooked.
- can affect patients' treatment compliance, increase the treatment burden of patients, and affect the quality of life of patients.
- eventually leads to treatment reduction or termination, which affects the patient's ultimate curative effect.
- Common improved methods: route of administration, frequency of administration.
- Regardless of the modified method, the safety of the patient's medication should be ensured, and the general treatment habits of the patient should be conformed to the convenience of the patient. It features
- target indications population
- medication special populations
- Drug Interactions
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- With a very high remission rate, there are still patients who have not benefited, and these patients have higher treatment needs.
- Choosing to conduct research in an enriched population does not mean that other patient populations will not benefit from treatment.
- Once drug resistance develops, the patient may fall into a situation where there is no cure.
- The development and administration of drugs for cancer patients ranges from "drug-free (drug-resistant)" to "medicine to be treated", "medicine to be available" and "better treatment".
- may not be convenient to travel.
- may increase the risk of infection in cancer patients with poor immune function.
- Child subjects face the dilemma of not being able to participate in study and work, and may also bring additional socio-economic burdens such as missed work and loss of income to the guardian.
- reasonable planning.
- should not only meet the necessary information collection, but also minimize the burden on the subjects and the family.
- Encourage patient interviews to understand patient needs.
- The most important thing is that drug development must be closely related to the problem and not forget the original intention.
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Continuously improve drug safety
to improve the treatment experience and convenience
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attention to the needs of different groups of treatment
Focus on the dynamic changes of treatment needs
to reduce the burden on subjects
Therefore, we emphasize that we should pay attention to the following in our clinical trials:
Return to the patient group and listen to the voice of the patients
In fact, clinical value-oriented drug research and development is not a new concept. The State Council’s Opinions on Reforming the Review and Approval System for Drugs and Medical Devices issued in 2015 clearly pointed out that it is encouraged Drug innovation oriented by clinical value.
In recent years, my country's anti-tumor drug research and development has ushered in rapid development, and patients have higher expectations for drug safety, treatment experience and quality of life. Therefore, it is necessary for us to carry out scientific and orderly research and development of oncology drugs with the needs of patients as the core and clinical value as the orientation.
Reference source of this article:
2021 CSCO CDE special session: Tang Ling is clinical value-oriented,Scientifically advance the research and development of new anti-tumor drugs
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