You Want To Join a Clinical Trial. Here’s What To Know About the Hurdles.

Joining a clinical trial can be a challenging endeavor, even for those who have identified a suitable match. Geographic, financial, and time constraints often pose significant hurdles. A recent survey of over 2,000 adults revealed that 71% of chronic condition patients would likely participate in a clinical trial if offered the opportunity, yet two-thirds reported their healthcare provider had never discussed trials with them. In fact, only 9% of adults had ever been invited to join a trial.

Clinical trials are crucial for developing new and effective medical treatments. However, the process of gathering the necessary real-world human data to secure FDA approval for drugs, devices, or interventions is often difficult. Up to 86% of trials fail to meet their recruitment targets within the trial time frame. The challenges don't end with recruitment, as retaining participants also presents difficulties. Each interaction with the trial team can bring up issues of access and affordability.

The need for improved patient participation in clinical trials has been recognized for some time, but recent efforts are gaining momentum. In June, the Department of Health and Human Services announced plans to streamline and enhance clinical research in the United States, seeking feedback on potential modifications to federal rules that discourage trial sponsors from paying expenses like travel and lodging.

A coalition of nearly 200 patient advocacy and public health groups urged the Senate sponsors of the Clinical Trial Modernization Act, which would allow trial sponsors to cover medical and nonmedical expenses for participants and exclude up to $2,000 in financial support from federal taxes.

Clinical trials come in various forms, testing new drugs, therapies, medical devices, preventive measures, or lifestyle changes. For individuals with serious illnesses, trials may offer the best chance for extending life or improving quality of life. In some cases, participants receive the gold standard of care even if they don't receive the therapy being tested. Some patients participate to contribute to scientific advancements and advocate for others facing similar conditions.

Despite the interest in clinical trials, most patients are unaware of how to find one. Primary care physicians play a crucial role, but a survey of over 500 physicians found that while 86% were likely to refer patients to trials, only 37% had done so. When doctors discuss trials, it's often due to patient requests or a lack of response to standard treatment.

However, searching for trials can be a daunting task for both physicians and patients. Community oncologists face the challenge of conducting searches using available clinical trial search engines, and patients may find the process even more challenging on their own. Some patient advocacy groups offer navigators to help identify suitable trials, but overall, the process remains complex and often discourages participation.