The Center for Drug Evaluation and Research at the FDA recently released its Drug Trials Snapshot Summary Report. This report is released annually, and details representation in clinical trials of certain subgroups, such as women, people of racial and ethnic minority groups, and people 65 and over. On one level, the report tells a story of success: 59 new drugs, treating a broad variety of conditions, were approved last year. On another level, it spotlights a disturbing lack of older participants in clinical trials.
The snapshot report shows that only 15 percent of clinical trial participants for drugs approved in 2018 were 65 and older. The three main therapeutic areas were oncology, infectious diseases, and neurology. In oncology trials, 50 percent of participants were 65 and older. In infectious diseases trials, of the more than twelve thousand participants, only 11 percent were 65 and older. And in neurology trials, among the more than seven thousand participants, a mere three percent were 65 and older.
What causes this underrepresentation of older adults, and does it matter?
First, it matters a great deal. Clinicians, when prescribing for older adults, routinely deal with medications that have been tested on a much younger population. The body of a 70-year old will no doubt respond differently from that of a 50-year-old. But without data from clinical trials that include people over 65, doctors are essentially being asked to guess about dosing, side effects, and interactions with other drugs that the older patient is most likely taking.
Admittedly, there are hurdles to overcome if individuals 65 and over are to be adequately represented in clinical trials. For instance, older people are at greater risk of side effects, and may have to drop out of a trial, creating a problem for research teams. Patients may be taking a variety of drugs, making it more difficult to interpret study results and work with “clean science”. Older individuals may be living alone, and may need help to interpret and comply with the trial requirements.
While these are real challenges, there are available options which could help with recruitment of older adults. The National Institute on Aging has recently updated its Project ROAR (Recruiting Older Adults into Research) toolkit, which provides guidance on how to expand older adults’ knowledge of research, and give them easier ways to participate. Some researchers have suggested that regulatory action may be needed to ensure that clinical trials include appropriate numbers of the patients a drug is designed to treat. Polling shows that many patients, including older adults, would willingly participate in clinical trials if a trusted health care provider asked. It may take a combination of high-level action, and improved one-on-one communication to increase the number of people over 65 in clinical trials. But with the right combination of effort and tactics, future Drug Trials Snapshot summaries could deliver more encouraging reports.
Jim Scott serves as the chair of the Alliance for Aging Research’s Board of Directors. He is also the president and CEO at Applied Policy in Washington, D.C.