FDA issued a draft guidance document, “Inclusion of Older Adults in Cancer Clinical Trials Guidance for Industry,” to provide recommendations to sponsors and institutional review boards for the inclusion of older adult patients, ages 65 years and older, in the clinical trials of drugs for the treatment of cancer.
The draft guidance recommends enrolling older adults in early phase studies of cancer clinical trials, if appropriate, to obtain information to better inform later phase studies. It also includes additional recommendations intended to facilitate a better understanding of the benefit-risk profile of cancer drugs in older adult patients regarding trial design, recruitment strategies, information collection and developing and reporting more discrete age groups.
“Enrolling a broad representation of patients in clinical trials is an important tenet of clinical research as it facilitates a better understanding of the drug’s benefits and risks across the patient population likely to take the drug,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement. “However, because cancer incidence increases with age, and given the aging U.S. population, it’s particularly important now more than ever to ensure that older adults are also enrolling in cancer clinical trials.”
It is important to have older adult patients in clinical trials because differences may exist between younger and older patients in drug response and toxicity. Older adults often have other diseases or conditions and may be taking medications that could impact the efficacy of either the cancer drug or other drugs they are taking and may also impact the incidence and the severity of adverse events.
“Unfortunately, adults aged 65 years and older, and especially those over 75 years old, are currently underrepresented in cancer clinical trials despite accounting for a growing segment of the cancer patient population.
“This has been a persistent issue in oncology and the FDA is engaged with stakeholders to improve the representation of older adults in cancer clinical trials. That is why today, we are providing recommendations on increasing the enrollment of older adults in cancer clinical trials, when appropriate,” Pazdur said.
Furthermore, there may be important differences in efficacy in older adult patients compared to the younger or general population, and information describing such differences should be conveyed to patients and health care providers where appropriate.
