The Medical Device Innovation Consortium (MDIC) has laid out some recommendations for improving medical device clinical trials with increased patient input.
Having observed that clinical trial sponsors seldom refer to patient input — something the FDA issued guidance for in September 2019 — MDIC offered its view on how to increase and utilize patient input to improve clinical trials in the medtech space.
In the report, MDIC cited that FDA guidance, which defined patient engagement as “intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” Effective engagement, according to the administration, could result in faster recruitment, enrollment and completion for studies, greater participant commitment and less follow-up loss, greater compliance, fewer protocol revisions, streamlined data collection and more relevant data on important patient outcomes.
Patient input, according to MDIC, can provide insight into how they would value benefits that can impact the design and development of new technology, something that can contribute to regulators determining whether clinical benefits outweigh risks, as, “ultimately, it is the patients who take the risks to realize the benefits of medical therapies.”
Insights provided by patients and families with deep, personal understanding of what it is like to live with a certain disease, can highlight the ways in which a device could affect their quality of life. Understanding how patients evaluate the benefits and risks of certain medical products has turned into a focal point in regulatory review, according to MDIC.
Another area of clinical trials that can be improved with patient input is outcomes, as the patients can help sponsors better define the outcomes by determining which ones are most important to them. Ultimately, sponsors can then develop data that will demonstrate the impact that matters most for the target population and will be meaningful during regulatory review.
Barriers that exist even after a patient has demonstrated a willingness to enroll in a trial can impact entry, participation in data collection activities and the ability to stay in the trial. Understanding the impact of these barriers on patients can give sponsors avenues through which they can refine trial plans and accrue and retain patients with disabilities and those from diverse demographic groups to ensure a broad range of participants.
Finally, patient insights can impact both regulatory use and post-approval activities, MDIC says. Sponsors can utilize patient views on unmet needs, burdens of living with specific conditions and the level of satisfaction with the standards of care to bolster regulatory submissions, while patient input can offer an opportunity to communicate the impact of a new product while explaining its benefits and risks in the post-approval phase.
“The report encourages sponsors to take the time and make the effort to build relationships with patient groups and individual patients that are based on shared commitment to the effort, clear expectations, regular communications, and a common language about the project,” MDIC wrote. “Avoiding the perception that engagement activities are tokenism and are just being done to ‘check a box’ by ensuring that all parties feel respected and able to contribute within the process is a key component of making this process meaningful.”