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A pragmatic approach to prospective evidence generation in clinical trials


June 2024

A pragmatic approach to prospective evidence generation in clinical trials

Clinical trials have been fraught with challenges for many years, including cumbersome data collection processes, longer-than-desired timelines, and struggles for diversity in participating patients. The need for more efficient and inclusive trials is pressing, as Sponsors seek to accelerate trial timelines while considering site bandwidth and ensuring patient safety.

There are inspiring examples of clinical trials that have overcome some of these long-lasting challenges through the use of technology and a more pragmatic design. Trials like the Prospective Clinico-Genomic Study—which saw 100% of surveyed sites saying they’d run a similar study again—was designed as a real-world study with a goal of reducing the burden of participation on sites and patients. Additionally encouraging is the push from organizations like Regan-Udall and the FDA regarding pragmatic evidence generation in the post-marketing setting and initiatives like Project Pragmatica, which hope to explore and introduce feasible, pragmatic elements into future oncology trials. The combination of regulatory support and the success of prior, pragmatically-designed trials indicate a shift in how our industry can and should approach evidence generation.

To enact significant change in how we conduct clinical trials in the near-term, we can look to advancements in how we approach post-marketing trials.   Post-marketing requirements, especially in fields like oncology, are becoming increasingly stringent. As sites continue to experience constrained resources, they will be unable to meet these imminent demands, leaving us to confront the widening gap between evidence needs and site capacity.

In this episode of ‘Wait, but why?’ produced by Research Revolution, a Florence Healthcare brand, Flatiron’s Director of Clinical Operations, Josh Buddle, offers valuable insights into how the industry can prepare for upcoming evidence demands, including guidance on:

  1. Simplifying Post-marketing Studies: Streamlining processes and reducing unnecessary data collection is crucial to make post-marketing studies more efficient and feasible.

  2. Embedding Clinical Trials at the Point-of-Care: Integrating trial activities seamlessly into existing healthcare workflows can improve the efficiency of trial data collection and make trials more appealing for sites to participate. 

  3. Incentivizing Participation: Finding novel ways to motivate sites and patients to participate in post-marketing studies is essential for success.

  4. Embracing a Pragmatic Approach: Moving beyond traditional approaches requires  engaging with a broader range of stakeholders to foster confidence in pragmatic study designs.

Looking ahead, the next five years will likely see a continued push for innovation and collaboration in post-marketing evidence generation. As the industry adapts to evolving regulatory frameworks and embraces new methodologies, we can anticipate a more streamlined and patient-centric approach to post-marketing trials.

While the challenges in post-marketing evidence generation are significant, they are not insurmountable. With strategic planning, cross-functional collaboration, and a commitment to innovation, we can pave the way for a more efficient and impactful post-marketing trial landscape, ultimately advancing patient care and safety.