Clinical Trials: Will Older Patients Finally Be Adequately Represented?

Would you want your doctor to prescribe a drug even though she did not know how it would affect you?

Of course not. But this is exactly what happens all too often with older patients, given that many drugs and other therapies have not been tested on people beyond a certain age. In fact, one study found that 72% of clinical trials excluded patients due to age.

With older adults being so underrepresented in clinical trials, clinicians often don’t know the potential impact of a treatment on their older patients. The result is a no-win situation: in some cases, clinicians withhold treatments that might have beneficial effects; in other cases, they prescribe therapies that can have unexpected adverse effects on their older patients.

The issue is not a new one, and in fact AARP has been working on it for some time. Several years ago, AARP’s Public Policy Institute proposed a set of policy solutions to address the issue. Finally, things are moving forward and improvements are now taking place.

FDA Recommendations Apply to Cancer Drugs

Recently the Food and Drug Administration (FDA) issued recommendations for expanding clinical trials for cancer therapies to include older adults. The FDA’s recommendations track closely with policy options AARP proposed several years ago, and in fact the implications go well beyond cancer drugs. Some of the notable recommendations from both the FDA and AARP include:

• Regulatory agencies, funders of clinical trials, and researchers should include older patients unless they have a clear rationale for excluding them

• Researchers should be required to report the age distribution of their study population

• The National Institutes of Health and other funders should encourage and incentivize research involving older adults

Limited Scope—with Broader Impact

While related only to cancer therapies, the FDA’s recommendations are likely to substantially increase participation of older adults in clinical trials. Beyond cancer trials, they provide a template that can be applied more broadly to clinical trials in other areas of medical research.

Broader application of these guidelines would expand the range of clinical research that includes older adults. This would make the research results more relevant to clinical practice in real-world settings—where many patients are older and sicker than those currently enrolled in most clinical trials.

We look forward to watching how the FDA’s potentially bellwether recommendations impact clinical trial policy and older adults.

Keith D. Lind is a senior strategic policy advisor at the AARP Public Policy Institute. His areas of expertise include Medicare, hospital observation, medical devices, and fraud and abuse.