Magazine article Aging Today

Clinical Trials, Key to the Future of Medicine, Face Low Enrollment

Magazine article Aging Today

Clinical Trials, Key to the Future of Medicine, Face Low Enrollment

Article excerpt

Stories about cutting-edge discoveries in biomedical research with the potential to change and save lives crop up almost daily in the news. And the public expects that such breakthrough treatments will be available and accessible when it needs them.

But there is a disconnect between the desire for access to treatments and volunteer participation in the clinical trials needed to get breakthrough treatments to patients. According to a 2013 study from the Tufts Center for the Study of Drug Development (goo.gl/AuxPu6), 37 percent of clinical trials did not meet their enrollment goals, and 11 percent failed to enroll a single patient.

Trials that fail to enroll any patients will not proceed, while those with low enrollment may be cancelled or unable to report results due to a too small sample size to reach meaningful conclusions. Imagine if the pharmaceutical company that developed insulin was never able to enroll volunteers to test it-how different would the quality of life for people with diabetes be today?

Factors Driving Low to No Enrollment

Various factors lead to clinical trial underenrollment. Many trials arbitrarily include an age limit-shutting out older adults who are disproportionately affected by chronic diseases and most likely to need and use the new treatments. A 2017 study in the Journal of the American Geriatrics Society (goo.gl/yjxYHd) looked at 839 trials for ischemic heart disease and found that 53 percent explicitly excluded adults older than ages 75, 80 and 85, depending upon the study. Similarly, a 2003 study in the Journal of Clinical Oncology (goo.gl/SasBRe) found that only 25 percent of enrollees in cancer-focused trials were older adults.

Older adults often are excluded because researchers feel they are too difficult to include. They may have comorbidities that complicate assessment of trial outcomes, challenges with cognition that impact reporting and informed consent, mobility issues or supportive care needs, and they may be taking multiple medications that can confound research results.

Even when eligibility is not a barrier, people are not volunteering-only 10 percent of Americans have participated in a clinical trial. A 2003 study in the Journal of Clinical Oncology (goo.gl/ byK6xY) found that 40 percent of adults did not understand clinical trials. However, after they had a better understanding, 32 percent said they would consider participating.

One serious misconception is that clinical trials are reserved for those who have exhausted all other options. With treatment options rapidly changing, many times getting access to cutting-edge treatment means enrolling in a clinical trial.

Additional barriers such as distrust of the science, fear of risk factors and side effects, transportation and financial difficulties, or simply not knowing how to find a trial all can keep people from volunteering. …

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