Connecting people with clinical trials is complicated, with factors like geographic incompatibility and financial considerations posing significant hurdles. A recent online survey found that 71% of patients with chronic conditions would be likely to participate in a clinical trial if given the chance, but two-thirds said their healthcare provider had never discussed clinical trials with them.
According to one study, just 9% of adults reported ever being invited to participate in a clinical trial. Clinical trials are essential to developing new medical treatments, but gathering real-world human data can be an arduous task, with up to 86% of clinical trials not meeting their recruitment targets.
Getting people signed up for clinical trials isn’t the only challenge – retention is also a significant issue. Alan Balch, executive board chair at the Patient Advocate Foundation, noted that every touchpoint is an opportunity for access and affordability to be a problem. They see this as a major obstacle to successful trial completion.
The need to improve patient participation in clinical trials is not new, but it’s attracting new interest. In June, the Department of Health and Human Services announced an effort to streamline and enhance clinical research in the United States, including a public request for information about modifying federal rules related to paying clinical trial participants for expenses. This move aims to increase accessibility.
In July, a group of nearly 200 patient advocacy and public health groups sent a letter to the Senate sponsors of the Clinical Trial Modernization Act, urging its passage. The bill would allow trial sponsors to cover trial participants’ medical costs and nonmedical expenses like travel and childcare, making it easier for patients to participate.
Clinical trials can test different drug combinations, medical devices, preventive measures like vaccines, or lifestyle changes. For people with serious illnesses, a clinical trial may offer the best hope for extending their life or improving their quality of life. Mark Fleury, policy principal for emerging science at the American Cancer Society Cancer Action Network, said that clinical trials offer an opportunity to try something that may or may not be better.
Even if patients don’t receive the therapy being tested, they are monitored closely and receive the gold standard of care. Some people participate in trials to aid in advancing science, such as Jim Taylor, whose wife died of Alzheimer’s disease.
Despite interest in clinical trial participation, most patients don’t know how to find one, and can’t necessarily count on their doctors for help. They often have to search for trials on their own.
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Patients can search for trials using online search engines like clinicaltrials.gov, but identifying eligible trials can be a complex task. Some patient advocacy groups have in-person or online navigators to help people find trials, such as the American Cancer Society’s clinical trial matching service.
Organizations like the Arthritis Foundation and the National Multiple Sclerosis Society have information about disease-specific trials on their websites. If a hospital or health facility is part of a clinical trial, patients there are often best positioned to enroll. Alan Balch noted that most recruitment for a trial happens at the site where the trial is happening.
However, much of the clinical research in the U.S. is conducted at large, often urban, academic medical centers, making it tough for patients to enroll in a trial at a site unless they live nearby or are already being treated there. To participate in a trial, people generally have to meet periodically with researchers, get regular blood draws or imaging, or answer questionnaires to monitor their progress.
The number one barrier keeping patients out of trials is a lack of onsite clinical trials, according to Mark Fleury. A 2019 study found that more than half of cancer patients didn’t have an available trial for their type and stage of cancer at the medical facility where they were being treated. If a patient identifies a clinical trial at a viable location, they should contact the trial recruiters directly and ask about eligibility requirements and insurance coverage.
Recently, there’s been interest in decentralized access to clinical trials, allowing patients to do some trial tasks at home or at their local cancer center. While it’s not common yet, decentralization could open up opportunities to more patients and more representative groups of patients, similar to how iron treatments have become more accessible in Australia.
For some patients, incidental expenses like travel, parking, and childcare can put participation in a clinical trial out of financial reach. Trial sponsors may pay for these expenses, but might not make that clear up front to patients. Wendy Selig, founder and CEO of WSCollaborative, said that patients should take the initiative and ask about available help.
There may be assistance available, and patients should take advantage of it if it’s available, she noted. This is particularly important for patients who are interested in participating in trials related to muscle aging or other conditions that require ongoing care.
