OCE Director’s Message
After five years of tremendous growth since its formation in 2017, the Oncology Center of Excellence slowed the launch of new projects in 2022 to allow existing projects to grow in depth and strength.
This year, our work examined several ways the OCE could leverage its resources to modernize evidence generation in oncology drug development. That is, what could the OCE do to encourage the development of clinical trial data that responds to the modern needs of patients and their physicians. With the initiatives we began or strengthened this year, we aim to:
- Ensure that clinical trial participants adequately reflect the demographic representation of patients with cancer for whom the products are intended—FDA’s draft Diversity Plans guidance, led by Project Equity.
- Open and complete clinical trials more quickly, using less complex trial designs seeking answers to clinical questions important to patients and their doctors—Project Pragmatica.
- Explore the potentially more efficient development of drugs for cancers defined by molecular alterations—Tissue Agnostic Drug Development Program and draft guidance document.
- Reform the dose optimization and dose selection paradigm in oncology drug development to maximize not only the efficacy of a drug but the safety and tolerability as well—Project Optimus.
- Address the problem of outdated labeling of older oncology drugs by assessing publicly available information that may support updates to FDA-approved product labeling—Project Renewal.
Please explore our 2022 Annual Report to learn more about the OCE’s work. I hope you will be inspired to take part in our programs and projects to improve the lives of patients with cancer.
Richard Pazdur, M.D.
Director, Oncology Center of Excellence