A Call to Action: Older Patients and Clinical Trials

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A 2013 poll conducted by Research!America shows that while 76 percent of Americans feel that clinical research is important, only 16 percent of Americans report that they or another member of their family have participated in a clinical trial. While clinical trial enrollment is a challenge across all demographics, many clinical trial investigators struggle with one particular age group: seniors. Let’s take a closer look at the issue, along with what can be done to remedy the problem.

Why Do Clinical Trials Need Seniors?

In order to produce results that benefit everyone, clinical trials require a diverse group of participants. The National Institutes of Health (NIH) reinforces the importance of participation by older people in clinical trials, citing reasons such as age-associated differences in drug reactions, side effects, and dosage requirements. Enrolling seniors helps scientists determine the right treatments — from drugs and therapies to medical devices and survival procedures — for both the old and the young.

Additionally, we can expect to see a rise in age-related diseases as the massive “Baby Boom” generation continue to enter their senior years, making the need for seniors in clinical trials even more critical. Perhaps no other area manifests this so clearly as the Alzheimer’s “epidemic.” And while the 2012 National Plan to Address Alzheimer’s Disease is ambitious in its goal to eradicate the illness, it’s significantly impeded by a lack of volunteers.

Understanding the Barriers

The decision to participate in a clinical trial is far from a simple matter, and this uncertainty compounds with age. Everything from chronic health conditions to the inability to drive can interfere with an older adult’s ability to participate.

Age-bias from physicians is also a concern. According to Cancer Control: 11 percent of doctors cite age as the reason for not enrolling patients, while one New York Times article concluded that 20 percent of studies excluded patients based on age alone.

From a patient perspective, fears about loss of control, patient opposition, and the feeling that their involvement lacks the potential to have a real impact also contribute to the clinical trial age gap.

Taking Action

A 2014 study published in Health Affairs evaluated these barriers and proposed solutions to help connect patients, caregivers and providers toward greater clinical trial enrollment among seniors. Alzheimer’s Disease Centers (ADC) Program Assistant Director Nina Silverberg identifies the following priorities for increasing older patient recruitment:

  • closing the chasm between clinical care and research
  • linking participant registries
  • acknowledging and addressing the needs of participants and their families
  • enhancing community awareness and trust through the most effective channels

Additionally, the National Institute on Aging, the Administration for Community Living, and the Centers for Disease Control and Prevention have joined forces with “ROAR — Recruiting Older Adults into Research.” This project is designed to help seniors and their loved ones understand why clinical research is important, and the steps they can take to become involved. While Alzheimer’s is their initial area of focus, the initiative is expected to grow.

While the obstacles to enrolling more seniors in clinical trials may be large, the need is very real — particularly with baby boomers turning 65 at a rate of 8,000 every day. As the healthcare system readies to care for them, the data collected from clinical trials can play a valuable role in their health and treatment…but only if that data exists.

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