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From participants to partners: Rethinking clinical trial design

Robert Den, MD
Physician
July 27, 2025
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Clinical trials are the cornerstone of progress in cancer treatment. Yet, paradoxically, the very patients these trials are designed to help often face the greatest obstacles to participation. While the concept of “patient-centered” clinical trials has been around for years, more than 20 percent of U.S. clinical trials fail to accrue a sufficient number of participants, forcing them to fold.

Why aren’t patients enrolling in clinical trials?

While there have been significant strides in oncology research and treatment, there is still room to grow. Currently, only about 7.1 percent of adult cancer patients participate in treatment trials, and just 21.9 percent participate in any form of cancer research. While multiple factors can limit participation, and not every barrier can be addressed simultaneously, understanding what prevents patients from enrolling is the first step toward reducing or eliminating those obstacles.

One of the most fundamental and persistent barriers to trial enrollment is a lack of awareness. Many patients are simply not aware that clinical trials are an option, let alone that there may be ones suited to their specific condition and that they might qualify. Partnering with advocacy organizations and trusted community clinicians can help close this information gap, raising awareness and building trust when it matters most.

Once patients become aware of the trial and confirm they meet the eligibility criteria, they can still face barriers, including travel requirements, coordinating time away from work, arranging childcare, and the financial burden associated with these disruptions. While some trials offer financial compensation, the cost of time and coordination remains a significant hurdle.

Tackling barriers to trial enrollment

When patients are offered the opportunity to participate in clinical trials, only about 50 percent choose to enroll, citing concerns that include cost, logistical challenges, and side effects. The good news is that clinical trial participation has evolved significantly, offering participants more flexibility, options, and opportunities than ever before.

The rise of wearable devices, remote patient monitoring, and telehealth all enable more decentralized trials: Therefore removing geographic barriers. What is more, wearable devices that transmit data directly to clinicians can reduce the need for in-person visits, improving both trial participation and retention.

Newer trials are increasingly designed around patient convenience. In some cases, cancer therapies can be delivered in a single session, with just an initial and follow-up visit required. These ultra-localized treatments are administered directly into the tumor, where they continue to work after the patient leaves. By minimizing systemic exposure, they avoid many of the side effects associated with traditional therapies.

Moving from participation to partnership

For sponsors and clinicians, patient-centered trial design is not just a recruitment tactic but an opportunity to align with patients’ daily lives. Flexible schedules, reduced treatment burdens, and side effect minimization offer a recipe for increased participation without decreasing data collection. And it is effective. Research shows that trials incorporating patient feedback see higher enrollment and better retention. We know clinical trials are the gateway to life-saving therapies. By designing around patient needs and priorities, the industry can reach more people and ultimately improve more lives.

Robert Den is a physician executive.

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  • Most Popular

  • Past Week

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