All Times EDT
The FDA’s Oncology Center of Excellence (OCE) was formed out of the 21st Century Cures Act to facilitate the development and clinical review of oncology products. OCE has overseen multiple oncology clinical trial innovations which will be discussed. These include regulatory and statistical innovations such as seamless trial design, master protocols, real-time oncology review, optimization of assessment of contribution of effect and dose, international collaborations, and utilization of real-world evidence. In addition, with the COVID-19 pandemic, oncology has moved the field forward with respect to decentralized trials. And oncology continues to focus on enrollment of a diverse patient population into clinical trials through efforts increasing eligibility and creation of diversity plans. The OCE works with centers and offices across the FDA and helps expedite development of medical products for oncologic and hematologic malignancies and supports an integrated approach to their clinical evaluation.