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  1. FDA In Brief

FDA In Brief: FDA Encourages Inclusion of Older Adult Patients in Cancer Clinical Trials

March 5, 2020

Media Inquiries:  Brittney Manchester  301-796-1026


The following quote is attributed to Richard Pazdur, M.D., 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:

“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. 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.

“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.

  • Today, the U.S. Food and Drug Administration issued a draft guidance document, “Inclusion of Older Adults in Cancer Clinical Trials Guidance for Industry,” to provide recommendations to sponsors and institutional review boards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, aged 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  • The draft guidance recommends enrolling older adults in early phase studies of cancer clinical trials, if appropriate, to obtain information to better inform later phase studies.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.
  • 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 (effectiveness) of either the cancer drug or other drugs they are taking and may also impact the incidence and the severity of adverse events. 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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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