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

By Lindsay Clarke

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, 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 under-enrollment. 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 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 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 im­ pact reporting and informed consent, mobility issues or supportive care needs, and they may be tak­ ing multiple medications that can confound research results.

Even when eligibility is not a barrier, people are not volunteering—only 10 percent of Ameri­ cans have participated in a clinical trial. A 2003 study in the Journal of Clinical Oncology 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. Americans also do not appreciate the individual and societal value of clinical trials. A 2006 survey from the Center for Information & Study on Clinical Research Participation asked the public who made a greater contribution to society—40 percent said organ donors, 29 percent said blood donors, 10 percent said people who raise money for charity by run­ning a race and only 9 percent said clinical trial participants.

Stakeholders Plan Public Awareness Campaign

Recognizing the challenges to enrollment, the Alliance for Aging Research has joined forces with other national stakeholders through the Coalition for Clinical Trials Awareness (CCTA), which advocates for the creation of a federally spon­sored public awareness campaign to increase the public’s understanding of the benefits of clinical trials. The CCTA believes such a national awareness campaign could see success similar to the Donate Life campaign—one of the most successful public awareness initiatives that focused on the need for and value of organ donations. That campaign saw an increase in organ donors in the United States from 28 percent to nearly 50 percent.

The CCTA campaign would:

Support patients navigating the clinical trials landscape. This means combatting misperceptions and misunderstandings and helping patients find the right trials if they choose to participate.

Empower physicians to talk about clinical trials with their patients. Discussions about available clinical trials need to be a standard part of patient care, and physicians need to be able to better navigate available trials and stay current on the research. Also, the financial disincentives that may deter physicians from sending patients to someone outside of their practice for a clinical trial need to be addressed.

Engage diverse stakeholders. Public–private partnerships could lead to a sustained, more ef­fective campaign.

Frame clinical trials as a way to benefit society. A 2015 survey from CISCRP ( FDRSUP) found that altruistic reasons—helping to advance science and medical treatments (28 percent) and helping others (26 percent)—are the top perceived benefits of participation in clin­ical trials. We should also help people understand that clinical trials offer the potential benefits of access to a cutting-edge treatment, first-class care, reimbursement of costs, payment for time and participation and more.

Medical research is suffering from under-enrollment, and the access to care that Americans ex­pect and deserve is in jeopardy. “Paying it forward” through participation in clinical trials should be a conversation everyone has with their healthcare professionals, their families and themselves.

Lindsay Clarke is vice president of Health Programs at the Alliance for Aging Research in Wash­ington, D.C. In an effort to raise awareness about clinical trial under-enrollment and the value of participation, the Alliance for Aging Research recently released a short video on clinical trials—“Pay it Forward: Volunteering for Clinical Trials”  that describes clinical trials, why they are important, how to enroll and what to expect when volunteering.

Editor’s Note: This article appears in the September/October, 2017, issue of Aging Today, ASA’s bi-monthly newspaper covering issues in aging research, practice and policy nationwide. ASA members receive Aging Today as a member benefit; non-members may purchase subscriptions at our online store.