CC Community News Digest (May 3-9)

Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee, May 11-12.  On May 11, 2021, the subcommittee will discuss the development and successful implementation of the Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) as a tool for eliciting the patient’s voice in oncology clinical trials to more accurately determine tolerability and toxicity of drugs under investigation.  On May 12, 2021, the subcommittee will discuss real-world evidence (RWE) for regulatory use in pediatrics, real-world data (RWD) resources, and RWD and RWE to advance pediatric safety assessments of oncology drug products in children within the context of the FDA Framework for RWE. Potential data sources and publicly available platforms including those made possible through the development and implementation of the National Cancer Institute’s Childhood Cancer Data Initiative will be discussed. Link to join will be here two days before the meeting commences: https://www.fda.gov/advisory-committees/oncologic-drugs-advisory-committee/2021-meeting-materials-oncologic-drugs-advisory-committee.

CureSearch is pleased to continue the 2021 CureSearch Virtual Summit Series with the second session:  Blurred Lines: Therapeutic vs Research-only Biopsies on May 14, 11:00-2:00 ET.  This session will explore the concepts of “direct benefit” and “minimal risk” as they apply to biopsies and examine how new technologies and biomarkers are increasing the potential for therapeutic benefit with decreasing risk.