Winning at the starting point: CDE has focused on the application of biomarkers in the clinical development of anti-tumor drugs

Biomarkers are not only widely used in clinical practice, but their value in the research and development of anti-tumor drugs has also become increasingly prominent.
They have gradually become an extremely important and even indispensable research and development tool in the development of anti-tumor drugs.
June 2021 On July 2, the official website of the Center for Drug Evaluation of the National Medical Products Administration issued the "Technical Guidelines for the Application of Biomarkers in the Clinical Development of Anti-tumor Drugs (Draft for Comment)".
The deadline is July 2, 2021.
This guideline In order to further improve the research level of new anti-tumor drugs in China and rationally use biomarkers to guide the clinical research and development of anti-tumor drugs, currently, China does not have specific technical guidelines for the application of biomarkers in the clinical research and development of anti-tumor drugs.
The value of anti-cancer drug research and development has become increasingly prominent, and it has gradually become an extremely important research and development tool in the process of anti-cancer drug research and development.
This article summarizes the application content of biomarkers in the clinical development of anti-cancer drugs in this guideline and combines them Share your own interpretation with you.
If anything is wrong, I urge everyone to provide valuable comments.

What is a biomarker? Biomarkers usually refer to indicators that can be objectively measured and evaluated, reflecting physiological or pathological processes, and biological effects on exposure or treatment interventions.
Biomarkers have material and quantitative properties: the material properties of biomarkers: In the field of tumors, biomarkers are usually biological substances produced by tumor cells or non-tumor cells that reflect the existence and changes of tumor cells or non-tumor cells in the body.

The quantitative properties of a biomarker: that is, it can be measured.

This change in measurement is closely related to the physiological conditions of the human body, the occurrence and development of diseases, and the state of health.

It can include gene mutations, abnormal expression of protein receptors, or changes in blood components.

According to the different functional characteristics of the biomarkers in the clinical development of common anti-tumor drugs, the biomarkers related to drug development can be divided into the following 6 types.

The application of biomarkers in the clinical application of anticancer drugs.
Chinese anticancer drugs, especially biopharmaceuticals, have entered the fast lane.
In the tide of corporate innovation and internationalization in China, the development focus of innovative drugs has gradually shifted from the laboratory stage to clinical trials.
At this stage, the translational medicine research and development model based on biomarkers will look for opportunities to make innovative drugs with global influence as soon as possible; see the table below for the clinical applications of common biomarkers in anti-tumor drugs.
It should be noted that this guideline Considering the application of biomarkers that are not covered by the principles, it is hoped that applicants will communicate with regulatory authorities in a timely manner to jointly improve the efficiency and success rate of clinical trial research and development.

References 1.
http:// copyright statement welcome personal forwarding and sharing.

Any other media or website that needs to reprint or quote the copyrighted content of this website must be authorized and marked "Reprinted from: Bai Aogu" in a prominent position.