Clinical Trials Still Often Exclude Older Adults

Despite having higher rates of many diseases, older adults are often excluded from clinical trials of new therapies that could benefit them. Their underrepresentation makes it more difficult to evaluate the safety, efficacy, and dosage of drugs across all age groups, according to researchers who spoke with STAT.

In January 2019, the NIH rolled out the Inclusion Across the Lifespan Policy, which requires researchers applying for NIH funding to enroll participants of all ages in their studies or provide ethical or scientific reasoning for not doing so. However, a recent paper published in JAMA Internal Medicine found that among 97 cardiovascular trials on ClinicalTrials.gov, one-third had age limits the year after the policy went into effect – the same proportion as the year before.

Given how far in advance studies are designed and funding is allocated, “it’s going to be a few years before we know the effects of the policy … because they only looked at the first year, so time is going to tell us more,” said Kenneth Covinsky, MD, MPH, a clinician and researcher specializing in geriatrics at University of California San Francisco.

In addition to age limits, other exclusion criteria such as preexisting conditions and technology requirements can leave out older adults, and most studies’ endpoints don’t focus on the treatment’s effects on older adults, such as whether they are likely to experience problems with mobility or have trouble adhering to the regimen.

“It’s imperative that we let patients across all ages have the opportunity to participate in trials and use thoughtful decision-making in who we include and exclude,” Ethan Ludmir, MD, a clinician-researcher at MD Anderson Cancer Center, said.

Sources: STAT, September 30, 2020; Nanna MG, Chen ST, Nelson AJ, et al. Representation of Older Adults in Cardiovascular Disease Trials Since the Inclusion Across the Lifespan Policy. JAMA Intern Med. September 8, 2020. doi:10.1001/jamainternmed.2020.2750.