Despite strong interest from patients, enrolling in a clinical trial remains difficult for most Americans. A recent online survey of more than 2,000 adults found that 71% of patients with chronic conditions would likely participate if given the chance, but two‑thirds said their health‑care provider had never discussed trials with them. Only 9% of adults reported ever being invited to join a trial, according to a 2020 data set.
Why Trials Matter and Why They’re Hard to Fill
Clinical trials are essential for developing new drugs, devices and other medical interventions that must win Food and Drug Administration approval. Yet up to 86% of trials fail to meet recruitment targets within their planned time frames, making it harder to bring effective treatments to market.
“Recruitment is one thing – retention is another,” said Alan Balch, executive board chair at the Patient Advocate Foundation, which offers a trial‑search tool and educational resources. He warned that each touchpoint in the enrollment process can introduce new affordability and access challenges.
Federal Efforts to Ease the Burden
In June, the Department of Health and Human Services announced a request for information on whether to modify federal rules that currently discourage some sponsors from reimbursing participants for travel, lodging and other expenses. The goal is to reduce financial barriers that deter eligible patients.
Following that, nearly 200 patient‑advocacy and public‑health groups sent a letter to Senate sponsors of the Clinical Trial Modernization Act. The proposed legislation would let sponsors cover participants’ medical costs, such as insurance deductibles and copays, as well as non‑medical expenses like travel and childcare. It also seeks to exclude up to $2,000 in trial‑related support from federal taxes, protecting participants from losing Medicaid or other income‑based benefits.
Finding a Trial Is Not Simple
Many patients rely on their doctors for trial referrals, but a survey of 500 primary‑care physicians in March, sponsored by the Patient Advocate Foundation, revealed a gap: while 86% said they were somewhat or very likely to refer patients, only 37% had ever done so. When physicians did discuss trials, it was usually because the patient asked (67%), standard treatment wasn’t working (65%) or the disease was progressing (55%).
For physicians, identifying suitable trials can be time‑consuming. A community oncologist must search databases like ClinicalTrials.gov, input detailed patient characteristics, review potential studies and contact trial sites to confirm availability. “And if they’re successful, what happens? They lose their patient,” warned Mark Fleury, policy principal for emerging science at the American Cancer Society Cancer Action Network.
Geographic Gaps and Decentralized Options
Most U.S. research occurs at large, often urban, academic medical centers. Patients living far from these sites face a major barrier. A 2019 study of 8,893 cancer patients found that 55.6% did not have an available trial for their cancer type and stage at the facility where they were being treated, and another 21.5% failed to meet eligibility criteria for existing trials.
Decentralized trial models, which allow participants to complete certain procedures at home or at local centers, are gaining interest but remain limited. “It’s not common yet,” said Balch, noting that broader adoption could help bridge the distance gap.
What Patients Can Do
Patients interested in trials should start by asking their doctors or the health facility where they receive care. Hospital‑based trial sites often have the most up‑to‑date information. Organizations such as the American Cancer Society, the Arthritis Foundation and the National Multiple Sclerosis Society also provide disease‑specific matching services.
If a suitable trial is identified, patients need to verify eligibility, confirm insurance coverage and understand any out‑of‑pocket costs. Direct contact with trial recruiters is essential to clarify requirements and discuss potential financial assistance.
Improving enrollment will require coordinated effort from providers, sponsors, policymakers and patient advocates. By reducing financial hurdles, expanding decentralized options and increasing physician awareness, the United States can move closer to meeting the critical demand for clinical research participants.
Original reporting: Texarkana Gazette — read the source article.
