Check the current status of clinical trials of domestic children's anti-tumor drugs!

Article source: Med

Author: Ala Lei

Regarding the "dimness" of children's anti-tumor drug research and development, we simply carried out an inventory, hoping to give everyone a more intuitive feeling

Development of clinical trials of children's anti-tumor drugs in China

1.

As of November 1, 2021, search with "children", a total of 616 clinical trials were retrieved, 6 of which were indicated as "tumor", and only 2 were related to new anti-tumor drugs (entratinib, larotrectinib) )

2.

As of November 1, 2021, search with "pediatric cancer", a total of 702 clinical trials were retrieved, and the keyword "China" was added.

Sorting out 15 clinical trials in mainland China, only 3 are related to new anti-tumor drugs (sintilimab, rituximab, famitinib, carrelizumab), and 1 is still withdrawn

Children's drug clinical trials-difficult!

As a special group, children are different from adults in physiology, pathology, and drug metabolism, and they have greater risks than adults during medication

The main difficulties of children's drug clinical trials are as follows: 1.

For child subjects themselves, there are also many difficulties, especially ethical considerations: 1.

Can the FDA's RACE Act effectively promote the development of children's anti-tumor drugs?

In 2003, the U.

In 2017, the FDA issued the "Accelerated Child Treatment and Equity Act" [Research to Accelerate Cures and Equity (RACE) for Children Act]

Children's anti-tumor drugs approved by the U.

Favorable domestic policies frequently provide opportunities for children's anti-tumor drug research and development

Domestic research and development of anti-tumor drugs is in full swing, but children's anti-tumor drugs are almost blank

In China, there are no clear regulations requiring new or marketed drugs to carry out children's research

NMPA's published guidelines/draft for comments on children's drug development [6]

Written at the end: It is urgent to promote the research and development of children's anti-tumor drugs, and it is an issue that R&D companies, researchers, and regulatory agencies need to pay attention to

Note: The original text has been deleted

references

1.

3.
He Long, et al.
Discussion and practice of ethical issues in clinical trials of anticancer drugs for children.
Chinese Medical Ethics.
2020; 33(2): 175-179.

4.
Min Xiaoqing, et al.
An Analysis of the Legislative Guarantee of Children's Drug Use in the United States and Its Enlightenment to my country.
Chinese Pharmacy.
2017; 28(13): 1740-1743.

5.
Jennifer LW Fink.
Will the RACE for Children Act lead to new treatments for pediatric cancer? Cancer.
2017; 123(2): 189.

6.
Tang Ling, et al.
Current status and thinking on the development of anti-tumor drugs for children.
Chinese Journal of Clinical Pharmacology.
2021; 37(10): 1296-1300.