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 A draft guidance issued by FDA on June 26, 2024 is intended to help medical product sponsors submit Diversity Action Plans to support select clinical studies, and the document,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The US Food and Drug Administration (FDA) published a much-anticipated draft guidance that recommends more diverse patient cohorts in clinical trials and is meant to improve the data the agency receives in support of premarket applications.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 The draft guidance,…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,…
The Clemson University Young Alumni Council annually recognizes 10 outstanding individuals who have graduated within the last 10 years for their impact in business, leadership, community, educational and/or philanthropic endeavors. The honor is given to individuals who exemplify Clemson’s core values of honesty, integrity and respect while also demonstrating the characteristics of a determined spirit. Brandon…
In this second installment of our nine-part deep-dive into the U.S. Food & Drug Administration (“FDA” or “the Agency”) final rule on Laboratory Developed Tests (“LDTs”) – which established a staged plan that will phase out the Agency’s previous policy of enforcement discretion for LDTs – we are taking a closer look at the response to the…
The Association for Molecular Pathology on Thursday published a new set of evidence-based recommendations for the analytical validation and reporting of tumor mutational burden (TMB) testing. TMB is a predictive biomarker for immune checkpoint inhibitor (ICI) therapies, which takes the form of a score derived as a measure of the number of mutations per sequenced…
CHICAGO — Healio once again welcomed the excitement of the Disruptive Innovator Awards, working with new partners and celebrating nine distinct areas of progress in oncology and hematology. Hosted again by Shikha Jain, MD, FACP, joined this year by Mark A. Lewis, MD, as the “understudy” to Edward S. Kim, MD, MBA, FACP, FASCO, who had family celebrations, the ceremony followed a great turnout…
