In a discussion with Peers & Perspectives in Oncology, Jeff Allen, PhD, explains the important work of Friends of Cancer Research in crafting policy to better optimize care for patients with cancer. Targeted Oncology: Please describe how Friends of Cancer Research fits into the wider oncology space. ALLEN: We are highly interested in doing what we…
For the third year in a row, more than 250 leaders in cancer care, including cancer center directors, physicians, scientists, ethicists, journalists, public officials, and patient advocates, gathered at the Richard Nixon Presidential Library and Museum in Yorba Linda, California, to attend the Nixon National Cancer Conference, held January 17–18, 2024. Launched in December 2021 to…
The withdrawal of Pepaxto, the first to use a new streamlined pathway, was much less agonizing than prior efforts to remove products that had received accelerated approval over the objections of the sponsor, according to Peter Marks, director of the US Food and Drug Administration Center for Biologics Evaluation and Research. Marks, who was the…
US Food and Drug Administration advisory committees are heading back in person to the agency’s White Oak headquarters this fall after an absence of more than four years. “First of all, we’re coming back,” Oncology Center of Excellence Director Richard Pazdur said on 26 February. “I think that’s very important to get back in person.”…
A lack of harmonized terminologies could be impeding the global uptake of real-world data (RWD) and real-world evidence (RWE), Mark McClellan, founding director of the Duke-Margolis Center for Health Policy at Duke University, said at a 20 February meeting on the use of RWD/RWE to support oncology applications. The meeting was sponsored by the Duke-Margolis…
Importance of Diversity in Clinical Trials The importance of diversity in clinical trials cannot be overstated. A diverse cohort of clinical trial participants enables researchers to develop treatments that are effective across a wide spectrum of patients. This inclusivity in research not only ensures equity but also helps in identifying unique responses to treatments among…
Quick background: FDA’s work to advance clinical trial diversity FDA has demonstrated interest in racial and ethnic diversity in research studies for decades. The agency first issued guidance on demographic subgroup analyses in the 1980s. In the intervening years, FDA continued to update guidance in line with Office of Management and Budget (OMB) updates and Congressional directives.…
In a world where medical advancements promise better health for all, the path to achieving this goal is fraught with challenges, not least of which is the issue of diversity in clinical trials. At a recent Friends of Cancer Research virtual meeting, Representative Anna Eshoo (D-CA) spotlighted a critical shortfall in the pursuit of equitable…
The US Food and Drug Administration (FDA) is several weeks late in issuing guidance on how and when drug and device companies must submit diversity action plans for clinical trial research. The Food and Drug Omnibus Reform Act (FDORA), passed by Congress in late December 2022, requires drug and device manufacturers to submit diversity action plans to…
Rep. Anna Eshoo (D-CA) called out the FDA for having yet to publish guidance for industry on drafting diversity action plans for clinical trials during a Friends of Cancer Research virtual meeting Thursday. In opening remarks, Eshoo, who chairs the House Energy and Commerce health subcommittee and is retiring at the end of this term,…
