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Remote Monitoring A Potential Strategy To Recruit Older Adults Into Oncology Trials

Executive Summary

Final FDA guidance also suggests sponsors recruit representative populations and limit exclusions.

A lesson that helped sustain clinical trials during the worst throws of the COVID-19 pandemic could be used to improve and expand oncology clinical trial enrollment going forward.

In its final guidance on including older adults in cancer clinical trials, the US Food and Drug Administration suggested “where feasible, remote monitoring approaches should be considered” as a recruitment strategy.

The guidance defined “older adults” as those age 65 and above, but also “emphasizes the particular importance of including adults 75 years of age and older in cancer clinical trials.”

The FDA and sponsors were initially hesitant to employ the tactic, which allows patients to participate in trials without regular clinic visits. But when the coronavirus pandemic forced widespread lockdowns and prevented patients from visiting hospitals, remote monitoring was allowed to ensure clinical trials could continue, as well as quickly test potential COVID-19 treatments.

The practice proved widely successful. FDA Principal Deputy Commissioner Janet Woodcock, who at the time was acting commissioner, said in December 2021 that the agency wanted more widespread adoption of it and other new approaches to trials.  (Also see "US FDA’s Woodcock Sees Clinical Trial Reform Coming, But ‘Not Wholly Optimistic’" - Pink Sheet, 13 Dec, 2021.)

The draft guidance on including older people in cancer clinical trials was issued at the beginning of the pandemic, 6 March 2020. FDA seems to have quickly incorporated the lesson into its clinical development policy.  (Also see "COVID-Era Trial Flexibilities, Equity Focus, Could Be Used To Reshape Cancer Study Enrollment" - Pink Sheet, 18 Jun, 2021.)

The FDA wrote in the guidance that sponsors should work with clinical trial cooperative groups to develop strategies that can reflect the proposed treatment’s intended population. The agency said enrollment challenges could be mitigated by including community-based sites that are more accessible than urban academic medical centers, as well as including caregiver support, and offering accommodations for visual, mobility and other impairments, travel and other logistics.

FDA officials released three final guidances pertaining to cancer treatment development. The announcement coincided with President Biden’s 1 March State of the Union address, which included the goal to “end cancer as we know it.” (See sidebar below.)

Biden wants to use his Advanced Research Projects Agency for Health (ARPA-H) idea to fuel the push. Legislation creating ARPA-H is making its way through Congress, although there are disagreements about where the agency should be located.  (Also see "ARPA-H: New Health Research Agency Faces Old Concerns About Disrupting Private Investment" - Pink Sheet, 8 Feb, 2022.)

Note Comorbidities, Limit Exclusions, FDA Recommends

The FDA also made clear in the guidance that during early clinical development stages, sponsors should work to include patients with other conditions. A new bullet point in the final guidance states that “sponsors should document comorbidities and make every effort to safely include these patients as well as those with organ dysfunction and prior/concurrent malignancies.”

The guidance also retained recommendations from the draft that sponsors should enroll older adults in early phase studies when appropriate “to obtain information on safety, exposure and response to better inform study design and dose selection of later phase studies.” In addition, drug interactions should be evaluated early “to allow enrollment of older adults who may otherwise be excluded because of their concomitant medication use.”

The FDA has pushed drug sponsors to avoid unnecessary exclusions in clinical trials for years, including those older than 75.  (Also see "FDA’s Clinical Trial Inclusion Policy Sold As Mild And Gentle" - Pink Sheet, 19 Feb, 2014.)

Parallel Older Adult Trial Arms Could Accrue At NDA/BLA Submission, FDA Says

Alternative clinical trial designs should be proposed if a representative sample of older adults cannot be enrolled, such as open label studies that could include older populations in a parallel arm, the FDA wrote.

“In some cases, the older adult arm(s) can be actively accruing” when the new drug application, biologics license application or supplement is submitted, the agency said in the guidance.

Because outcomes could differ among patients 65 and older, the agency also suggested multiple age subgroups, such as a 65 to 74 and 75 and older age groups may be appropriate.

“Sponsors may consider combining data across trials of similar design to ensure adequate representation of older adults across discrete age subgroups,” the FDA wrote.

FDA Says Patients Should Be Consulted On Recruitment Strategy

And in a nod to the growing role of patients and advocates in clinical development, the FDA changed the draft guidance to encourage sponsors to consult caregivers and others when considering trial design and recruitment.

In addition to discussing enrollment goals with investigators and training clinical sites to enroll older adults, the FDA wrote in the draft to also discuss recruitment with geriatric oncologists and oncologists with expertise treating older adults. The final guidance added several others to the list, including geriatricians, social and behavioral scientists, as well as patient advocates and navigators.

Patients have been involved in trial design and drug development for some time, but the FDA acknowledgement of their place in the process is significant. Stakeholders are pushing the FDA to make patient experience data a larger part of application decisions.  (Also see "PDUFA VII: US FDA Will Offer Additional Meetings To Boost Rare Disease Endpoint Development" - Pink Sheet, 30 Aug, 2021.)

Programs like Patient-Focused Drug Development, which allow patients to offer opinions on unmet needs and potential treatments to FDA staff, also will continue in the coming years.  (Also see "US FDA Should Explain How It Uses Patient Experience Data In Drug Approvals – Report" - Pink Sheet, 26 Oct, 2021.)

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