Advancing Pediatric Drug Development

Comparison of Pediatric and Adult Oncology Safety and Efficacy Within Similar Indications

Briefly describe your research question :

Pediatric oncology clinical trials often begin after the development or approval of a drug for adults. By pooling available pediatric clinical trials and related adult clinical trials, can we assess the safety and efficacy profiles of the drug in the two populations to identify similarity and differences? An analysis could explore the dosing regimens—both the level and frequency of administration—between adults and pediatric patients and the correlation with patient outcomes and the number and severity of adverse events in the clinical trial setting. This work could inform discussion surrounding dose optimization in both the pediatric and adult oncology clinical trial settings as well as optimal timing and considerations for initiating pediatric clinical studies.

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Idea No. 183