Arbitrary Age Parameters Can Limit Clinical Trial Efficacy

Ryan Bailey, MA, Senior Clinical Researcher, Rho

Ryan Bailey, Senior Learning and Performance Specialist, Rho

Turns out age discrimination has spread well beyond the scope of Hollywood actors and hiring in the workplace. “I think there’s been a history of picking an age [range] for trials that is [sometimes] arbitrary,” says Ryan Bailey, a senior clinical researcher at Rho.

It’s difficult to determine if the problem is getting worse, or if there is simply a greater awareness of it now, Bailey says. Regardless, it’s incumbent upon sponsors and contract research organizations (CROs) to stop and think before setting up a trial aimed at a patient population, he adds.

“Is there any justification based on actual health reasons, or is it strictly [because] that’s just the age limit of convenience? Have they actually given thought to what is the most appropriate age for the condition?” Bailey says.

There are a number of factors at work, including a perception that older patients are sometimes more difficult to work with, less independent at handling travel and other trial logistics, and more likely to be taking a different medication that makes them inappropriate for the trial.

“That makes it harder just to kind of tease out who is going to be in the study, and who isn’t,” Bailey says. “It feels like there’s more effort for less return when it comes to trying to get those patients into the trial.”

Another potential factor? In an era where 40 years old is considered the new 30, “maybe we’ve inherited some age limit traditionally that no longer makes sense because [with our current population], people are living longer” and staying healthier longer, Bailey says. “So, 59 as an age limit maybe 20 years ago made more sense, [but] we’re still using it because that’s what we’ve always done…[so now] we need to reexamine some of our basic assumptions about what is an appropriate age for the general study population.”

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CROs can play an important role, according to Bailey. “Maybe we need to be listening to those patients, asking them what their needs are for trial participation,” he suggests. “We need to be engaging patient advocacy groups, and say, ‘Hey, what’s most important to enrolling and working with people in this particular age demographic?’”

CROs should be paying attention to any of the assumptions that are made in the protocol about patient population inclusion/exclusion criteria, Bailey says. “Because our job as a CRO is to help [a sponsor] think about what’s going to be the best design for their product, and that’s going to help them get to” U.S. Food and Drug Administration submission and approval.

Author: Michael Causey