FDA Encourages Inclusion of Older Patients in Cancer Trials

Regulatory NewsRegulatory News | 09 March 2020 |  By 

The US Food and Drug Administration (FDA) is looking to encourage drugmakers to include more elderly patients in cancer clinical trials to ensure that the patient population in those studies better reflects the real-world patient population.
"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 US population, it's particularly important now more than ever to ensure that older adults are also enrolling in cancer clinical trials,” said Richard Pazdur, director of FDA’s Oncology Center of Excellence.
Specifically, the guidance calls on sponsors to try to enroll patients ages 65 and older in clinical trials for cancer treatments, from early-stage studies to pivotal trials.
“Older adults, including those with frailty, should be enrolled in all phases of clinical trials, when they can be safely and ethically enrolled,” FDA writes, noting that sponsors should consider the age demographics of the target patient population early on.
The guidance follows other recent guidance from FDA aimed at ensuring underrepresented populations are enrolled in clinical trials, including five guidances aimed at broadening cancer clinical trial eligibility issued last March and a draft guidance on enhancing clinical trial diversity issued in June.
One of those guidances, on enrolling patients with organ dysfunction or prior or concurrent malignancies, “Is particularly relevant to older adults,” FDA says, as the issues discussed in the guidance tend to increase with age.
FDA’s recommendations in the six-page draft guidance are broken up by development stage, with the agency giving specific recommendations for early clinical development, clinical trials and for gathering information about older patients in the postmarket setting.
During early clinical development, FDA says older patients should be enrolled “to obtain information on safety, exposure, and response to better inform the study design and dose selection of later phase studies.”
FDA also says sponsors should evaluate drug-drug interactions early on so that fewer patients are excluded in later studies due to concomitant medication use.
For clinical trials, FDA offers some potential approaches to facilitate enrollment of older patients, including stratification based on age and enrolling elderly patients in a separate parallel arm of an open-label safety study.
In some cases, FDA says it would be appropriate for study arms with older patients to be actively accruing at the time of a new drug application (NDA) or biologics license application (BLA) submission.
FDA also says that sponsors should consider the perspectives of older patients and their caregivers, as well as clinician and advocacy groups, to facilitate enrollment and to help identify meaningful endpoints.
Sponsors are also instructed to develop recruitment strategies aimed at enrolling older patients, especially those 75 and older, such as including trial sites in community-based settings.
FDA says that sponsors should consider gathering additional information for older adults, such as functional status and frailty measures, as well as a “comprehensive assessment of comorbidities.” The guidance also suggests that sponsors consider additional adverse event monitoring and management measures for older patients.
Sponsors should also consider reporting data for more discrete age groups, FDA says, such as subgroups for patients ages 65-74 and 75 and older.
While FDA says it would be ideal to gather adequate information on older patients in the premarket setting, the agency acknowledges that this is not always the case. As such, FDA says sponsors should develop a plan to collect data on older patients in the postmarket setting, including through postmarketing studies or real-world data collection.


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