A number of research sites are looking at ways to increase the number of seniors participating in clinical trials.
According to the National Center for Health Statistics (NCHS), 85% of people over 60 use prescription drugs. But the Food and Drug Administration found that for 59 new drugs, only 15% of the 44,000 patients who participated in drug trials were 65 or older, and it was only 3% for neurology drug trials.
Duke University School of Medicine, San Francisco Coordinating Center, and The National Academies of Sciences, Engineering and Medicine, Health and Medicine Division, are among the research centers focusing on finding ways to increase senior representation in clinical trials, according to an article written by Beth Baker for NextAvenue, a public media national journalism service for America’s older population.
Researchers often find older adults unsuitable for trials for multiple reasons: They may have multiple illnesses — diabetes and hypertension, as well as cancer or Alzheimer’s disease — that could complicate the study’s results, or they may be taking several medications already that could interact with therapies being examined.
But that rationale does not make sense, says Steven Cummings, director of the San Francisco Coordinating Center, a nonprofit academic research organization affiliated with UCSF. “If your drug only works in the small portion of older people who don’t have any other problems or medications, then it will be irrelevant to the vast majority of older people,” Cummings says.
Also, older adults may live alone, and not have someone who can accompany them to the study site for tests and procedures — a significant concern for Alzheimer’s trials, which typically require a caregiver to provide input about the patient’s condition and progress. Or, they can’t get around easily. Or they’re frail. Additionally, technology considerations are a concern. Many seniors are not connected to the internet or using a smart phone.
An effort is underway, however, to make it easier for people to join some clinical trials. Rather than travel to a research center, patients participate from home.
To address these concerns, Cummings is launching a new drug trial for Parkinson’s that would give older patients a way to participate in the research without having to travel. He has found from previous studies that making enrollment easy for patients is crucial to their willingness to participate. With TOPAZ, patients will be identified through their health system, the Parkinson’s Foundation or other trusted sources. Neurologists who are specialists in Parkinson’s disease may conduct a video interview with the patient to confirm the diagnosis.
According to Cummings, “We’re making it really simple,” he says. “They go to a website and if they qualify, a nurse will come to their home and give them an infusion of either the drug or a placebo. That’s it.”Source: Next Avenue