July 27th, 2017

FDA Spearheading New Efforts to Improve Patient Enrollment in Clinical Trials


The FDA is recognizing the importance of patient engagement in the clinical trial enrollment process – it’s time the industry followed suit.

It’s no secret that in the clinical research world, patient enrollment remains one of the biggest roadblocks to success. Approximately 29% of a given clinical trial’s total expenses can be attributed to the enrollment process. Moreover, each day that a drug development program is delayed can cost sponsors as much as $37,000 and represent between $600,000 and $8 million in lost sales opportunities.

To make matters more complicated, the FDA is increasing its emphasis on participant diversity – in terms of age, gender, and ethnicity – in order to maximize the safety and efficacy of a new drug or device. That means that going forward, clinical trials will need source more participants across more demographics in order to secure approvals in a timely and cost-effective manner.

Improving Patient Participation

Right now, “patient engagement” and “patient centricity” are top-of-mind for the industry at large – two related concepts that everyone agrees will play an integral role in our ability to improve clinical recruitment and retention going forward. The FDA has recognized this as well and is spearheading a number of initiatives to help improve the clinical trial experience, outcomes, and ultimately, lower the cost of care for patients.

As Jill Wechsler, writing for Applied Clinical Trials, points out, the FDA’s Center for Devices and Radiological Health (CDRH) just launched a new Patient Engagement Advisory Committee (PEAC), which will be examining “factors that may deter patient participation in clinical trials.” It will also host a panel of “experienced patient advocates and disease group leaders” at its inaugural meeting, October 11 to 12, 2017, to discuss clinical trial design and medical device conduct from a patient perspective.

Last year, she reminds us, the FDA launched an awareness campaign intended to educate “Hispanics and other minority groups about the importance of biomedical research and need for broad participation in clinical studies.” One of the campaign’s primary aims is to “encourage physician and health centers to steer patients to appropriate trials or resources on clinical research.”

The organization is also looking into the cause of the current lack of older clinical trial participants, which is seriously hampering the industry’s ability to bring new treatments to market for conditions that typically affect the elderly, like cancer and alzheimer’s.

What the Industry Can Do

Pharmaceutical and medical device companies need to recognize the direction the FDA is headed in and follow suit – that means adopting a patient-centric approach to trial design and execution, and making patient engagement and awareness a top priority.

If the industry wants its message to be heard, it needs to start embracing tactics and processes that are aligned with participant expectations and preferences. With patients increasingly relying on digital media and technologies to take control of their health, clinical trials need to ensure they’re providing enough information to position themselves as viable treatment options — and that they’re doing so via the proper channels.

For example, now that 77% of Americans own smartphones, mobile represents a massive opportunity to connect with a more diverse array of prospective clinical trial participants, more cost-effectively than ever before. Sponsors can leverage digital advertising platforms like Facebook and Google to identify qualified patients, then provide them with the resources they need to get the treatment they deserve.