A Message from the Co-Chairs of the FDA-Duke Global Regulatory Workshop

Welcome to this workshop!Cancer remains a serious global health threat. Oncology drug development has continued to lead other therapeutic areas in addressing the highly unmet medical needs of the cancer patients and their treatment, attested by ever-increasing numbers of global oncology clinical trials. Therefore, speeding up the development and making Read more…

Challenges with Novel Clinical Trial Designs: Master Protocols.

As seen on https://www.ncbi.nlm.nih.gov/pubmed/30696689 Cecchini M1, Rubin EH2, Blumenthal GM3, Ayalew K4, Burris HA5, Russell-Einhorn M6, Dillon H7, Lyerly HK8, Reaman GH9, Boerner S10, LoRusso PM10. The 2018 Accelerating Anticancer Agent Development (AAADV) Workshop assembled a panel of experts for an in-depth discussion session to present Challenges with Novel Clinical Trial Designs. This panel offered assessments of the challenges faced Read more…