FDA watchers and clinical trialists in oncology may want to pay close attention to the agency’s latest plans to increase representation of traditionally marginalized populations in drug development.
There’s a cultural perception in drug development that enrolling a diverse, heterogeneous patient cohort can be “risky” for detecting drug effects—a perception that needs to go away, said Lola Fashoyin-Aje, associate director of the Science & Policy Program to Address Disparities at the FDA’s Oncology Center of Excellence and a deputy division director in the agency’s Office of Oncologic Diseases.
Drug manufacturers and researchers have a moral obligation to design clinical trials that adequately represent the target population for the investigational agent—and these medical products need to be safe and effective for everyone, leading clinical trial experts in oncology say.
Prof. Elihu (Eli) H. Estey, MD, a pioneering AML researcher, physician and scholar collapsed and died unexpectedly on Oct. 8 at his home in Seattle. He was 75.
Our good friend and colleague Ed Gehan passed away on Sept. 28 at the age of 92. Ed and his contributions to cancer research and to cancer patients are legend.
An argument can be made that only a government research agency like NCI has the capacity to answer questions about monitoring pancreatic cysts—and how some of them turn malignant.
Prevention and early detection trials have been especially vulnerable to being disrupted by the COVID-19 lockdown, and a comparison of two regimens for monitoring pancreatic cysts—EA2185—was more vulnerable than most.
Prevention and early detection studies frequently require engaging physicians from specialties other than oncologists, said Peter O’Dwyer and Mitchell Schnall, co-chairs of ECOG-ACRIN Cancer Research Group.
American cancer patients have collectively gained up to 14 million years of life since 1980 as a result of NCI-funded cancer trials conducted by the National Clinical Trials Network, a study led by SWOG Cancer Research Network found.
Racial and ethnic minorities that are underrepresented in medicine have even lower representation in leadership of NCI-designated cancer centers, a study by Memorial Sloan Kettering Cancer Center researchers found.
