Description of Collaborative Activity: |
This Quarterly meeting to enhance communication between NCI DCTD/CTEP and FDA, thereby expediting the development of new anti-cancer agents. General topics discussed include patient safety, clinical efficacy, and regulatory pathways to licensure, as well as an understanding of the operations of the sister agencies. Since NCI DCTD/CTEP acts as the official regulatory sponsor of IND studies performed in the ETCTN, and selected studies in the NCTN, PBTC, and PEP-CTN, these quarterly meetings are important to ensure NCI DCTD/CTEP is performing its regulatory responsibilities in compliance with regulations and the dialogue with the FDA also helps in exploring new ways to enhance patient safety and clinical trial monitoring in a risk-based approach. The Quarterly meeting dates each year are discussed and scheduled in consultation with the FDA depending on the availability of appropriate FDA staff for the particular issue that will be discussed. NCI and FDA staff have a meeting usually 1 month prior to the next anticipated Quarterly Meeting in order to decide on topics that will be discussed. |
