Children's healthcare crisis, multi-sector protection of research and development of children's medi
Medical institutions are constantly improving their service capacity and clinical level, and the treatment of childhood cancer is an important manifestation of its high-quality development. Compared to the market for adult cancer drugs and research such as cranberries, the market for children's cancer drugs is cool. As of the end of March this year, the number of NMPA-approved drugs on the market in the ATC class of anti-cancer drugs (L01) was 2039 and the number of varieties 471.
However, there is a more urgent need for clinical practice in the field of childhood cancer diagnosis. A. Multi-sectoral childhood drug development safeguards: Currently, the majority of clinical trials in the global population of adult patients with a reasonable use of anti-cancer medicines are considered to be the first and only after successful research and development to extend adaptation to the field of children with a reasonable use of medicines, mainly due to: Relatively rare: the relatively small number of children with tumors, the relatively low rate of return on investment in the development of children's tumors, thus limiting the dynamics, scale and depth of research and clinical practice trials.
However, only 69 medicines and 11 varieties are explicitly available for the treatment of children's tumors, representing 3. 3% and 2. 3%, respectively, indicating that the majority of approved anti-tumor medicines are not available for standard uses for the treatment of children's tumors.
2. Diversity: There are many types and subtypes of childhood tumors, and each subtype has different biological and pathological characteristics, requiring the development of drugs for different types and subtypes, which greatly increases the difficulty and time of research and development. Therefore, children's anti-tumor medicines need to be strictly monitored and evaluated for pharmacokinetics, pharmacokinetics, and toxic side effects, while also assessing the role of medicines in children's growth and development, which requires a significant amount of time and resources.
All relevant departments in China pay great attention to the unmet needs of children in the field of rational use of medicines. The document notes that the development of oncological drugs may consider inclusion of children's adaptations in the overall clinical practice development plan. On March 24, the National Drug Enforcement Administration's Drug Evaluation Center (NDAE) released a guideline on the principles of clinical practice research and development of oncological drugs for children to provide clear pathways for the development of oncological drugs for children.
Randomized clinical practice trials or single-arm clinical practice trials can be used for child-specific tumors. In the case of adult children with concomitant tumors, a simplified small-scale verifiable clinical practice trial can be promoted in child subjects if the drug has been approved for adult adaptation and a clearly recommended dose has been obtained in child subjects, and clinical practice trials may be considered for single-arm design. However, for children with childhood tumors, a key factor in their clinical effects is the adequacy of medicines.
Improvements in the R&D capabilities of domestic enterprises have also led to a high level of simulation of some of the anti-tumor drugs that have not been introduced domestically. Therefore, in today's difficult market for children, exploration of the feasibility or advisability of existing adult medicines for the treatment of children's tumors can address some of the clinical practice needs. For children with childhood tumors who require long-term reasonable use, the dosage, specifications and timing of use of medicines can directly influence the adequacy of medicines.
Pharmaceutical Net shows that among the currently marketed anti-tumor drugs, pills, injectable liquids and tablets are in the top three of all doses, but these three doses are not suitable for children's patients. In addition to the consideration of clinical practice indicators such as pharmacology, pharmacodynamics, and other considerations for adults, consideration should be given to the acceptance of children's patients. In case of doubt, please verify with the relevant parties, the views of the article are not on the Internet and are for readers only.
Statement: This article was posted on the Internet to provide readers with more information, the content of which does not constitute investment and consumption advice. What are the ways to spread the word? Doctors remind these people to focus on promoting the ageing care system to realize the benefits of life-saving care packages from families to families.
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