Advancing Pediatric Drug Development

External Control Arms from Historical Clinical Trial Data for Pediatric Oncology

Briefly describe your research question :

Many pediatric oncology clinical trials fail due to lack of patient enrollment. With a low disease prevalence and ethical considerations to treat all patients, efforts should be made to minimize patients assigned to a control arm. Pooled historical control arm data from randomized clinical trials (RCTs) could be utilized to create a regulatory-grade external control arm. Using the pooled pediatric clinical trials available, can we evaluate differences in baseline characteristics and other factors of the control arms to determine the feasibility of pooling RCT data to form SCAs for future use in pediatric oncology studies?




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Idea No. 184