ASCO commends the U.S. Food and Drug Administration (FDA) for releasing draft guidance that encourages inclusion of older adults in clinical trials of drugs for the treatment of cancer. The guidance emphasizes the importance of including adults aged 75 or older in clinical trials to better enable evaluation of the benefit-risk profile of cancer drugs in this population.
Howard A. “Skip” Burris, III, MD, FACP, FASCO
“This draft guidance signals to researchers and sponsors that clinical trials should include older adults with cancer when they can be safely and ethically enrolled,” said ASCO President Howard A. “Skip” Burris, III, MD, FACP, FASCO. “In particular, the guidance recommends sponsors include older adults in early-phase studies; design trials that allow for participation of older adults; develop recruitment strategies targeted [at] older adults; report results for discrete age subgroups; and develop plans for capturing postmarket data, along with other recommendations.”
ASCO published a set of recommendations, which were led by the late Arti Hurria, MD, FASCO, a leader in geriatric oncology, that are focused on ensuring clinicians and patients have the information they need to develop treatment plans for this population. In 2017, ASCO partnered with the FDA to hold a Geriatric Oncology Workshop, which convened members of the oncology community—including clinicians, health-care providers, patient advocacy groups, pharmaceutical representatives, academicians, and scientists—to discuss approaches to improve the evidence base for treating older patients with cancer.
ASCO will provide more detailed comments about the proposal to the FDA and will continue to collaborate with stakeholders to improve the quality of clinical research and access to care for people with cancer.
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