NIH Director Monica Bertagnolli and Rep. for Kentucky’s 2nd congressional district, Brett Guthrie were named recipients of Friends of Cancer Research 2024 Cancer Leadership Award. Bertagnolli and Guthrie will be honored on Sept. 19, 2024, in Washington, DC. Monica Bertagnolli will receive the Ellen V. Sigal Advocacy Leadership Award, recognizing her incredible contributions to the…
Industry and researchers welcomed a set of guidances from the US Food and Drug Administration (FDA) that seek to expand eligibility criteria in oncology clinical trials, but they pushed for clearer examples of how to apply the proposed flexibility, especially in early-stage trials. In April 2024, FDA issued a set of three draft guidance documents…
The Supreme Court last week upended one of the underpinnings of administrative law by weakening the authority of federal health agencies to rely on technical expertise as they regulate medical products, issue coverage decisions, and respond to public health crises. The court’s decision in two cases, Loper Bright Enterprises v. Raimondo and Relentless Inc. v.…
For the 12th consecutive year, OncLive is honored to recognize oncology leaders whose innovations have contributed to immeasurable improvements in outcomes for countless patients with cancer. The 15 winners of the 2024 Giants of Cancer Care awards have made their mark with novel therapies and protocols across the spectrum of care. BREAST CANCER Joseph A.…
New Guidance Seeks to Broaden Cancer Clinical Trials Eligibility Criteria, Expand Participation The Association for Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) are applauding efforts by the U.S. Food and Drug Administration (FDA) to broaden eligibility criteria for cancer clinical trials in order to include more diverse patient populations. In joint comments submitted on June…
Diversity Action Plans are now required to be submitted by medical product sponsors after changes governed by the Food and Drug Omnibus Reform Act. A draft guidance issued by FDA on June 26, 2024 is intended to help medical product sponsors submit Diversity Action Plans to support select clinical studies, and the document, Diversity…
The US Food and Drug Administration (FDA) published a much-anticipated draft guidance that recommends more diverse patient cohorts in clinical trials and is meant to improve the data the agency receives in support of premarket applications. It broadly describes what sponsors should include in their Diversity Action Plans as mandated by Congress. The draft guidance,…
Quick background: FDA’s work to advance clinical trial diversity through prospective planning The FDA has longstanding policy interests focused on research study diversity. The agency first issued guidance on demographic subgroup analyses in the 1980s. In the intervening years, FDA continued to update guidance in line with updates from the Office of Management and Budget (OMB)…
Friends of Cancer Research characterized postmarketing requirements and commitments over the last decade. The perspective article, titled “An evaluation of novel oncology approvals with a PMR/C for assessing data in racial and ethnic populations underrepresented in premarket clinical trials,” provides insights into FDA’s expectations for representation of race and ethnicity in oncology clinical trials. “This…
In a session at the 2024 DIA Global Annual meeting in San Diego, CA, Jane Myles, program director, Decentralized Trials and Research Alliance (DTRA); Joseph Unger, PhD, MS, associate professor, Fred Hutchinson Cancer Center; Ramya Thota, associate professor, Intermountain Medical Oncology – IMC; and Suanna Bruinooge, chief and division director, Research Strategy and Operations Center,…
