The Center for Drug Evaluation (CDE) has released a set of Technical Guidelines focused on “Clinical R&D of Anti-tumor Drugs for Children,” which are now in immediate effect. These guidelines were drafted to address the specific needs and considerations in the development of anti-tumor drugs for pediatric patients.
Public Consultation and the Need for Pediatric Anti-tumor Drugs
The draft proposal for these guidelines was released in November of the previous year to solicit public feedback. Pediatric anti-tumor drugs have been relatively neglected compared to adult anti-tumor drugs in research and development. There are significant differences between child and adult tumors in terms of pathogenesis, tissue source, and driving gene changes, which result in different disease types, symptoms, and treatment plans.
Key Considerations in Pediatric Anti-tumor Drug Clinical Plans
When formulating clinical plans for pediatric anti-tumor drugs, the following must be taken into consideration:
- Incorporating pediatric indication development into the overall clinical drug development plan to ensure a comprehensive approach.
- Protecting the rights and interests of children by avoiding unnecessary research among pediatric subjects, ensuring ethical considerations are paramount.
- Generally, following the general rules of drug research and development for children, and gradually promoting research and development according to the age sequence of adults, adolescents, and young children to tailor the approach to different age groups.
- Following the general rules of anti-tumor drug research and development, and gradually promoting research and development according to the disease stage of terminal line/refractory relapse and front-line/initial treatment to address the varying stages of cancer in children.
- Generally, the dose observed to demonstrate controllable risk and anti-tumor activity in adult patients can be used for the pediatric study as a prerequisite, ensuring that the dosage is both safe and effective for pediatric use.-Fineline Info & Tech
