How Can Real-World Evidence Inform Clinical Trial Design in Drug Development?
Author:
Ashley Daigneau
Head of Clinical Trials
Clinical trials are essential to drug development—they are also notoriously resource-intensive. From recruiting the right participants to managing the logistics of multiple trial sites, the process is often lengthy, costly, and fraught with challenges. Among the chief goals of clinical trial development is to streamline costs and de-risk strategy to get innovative treatments to patients more quickly. Real-world evidence (RWE), generated from real-world data (RWD), can help achieve these goals across the drug development lifecycle.
By leveraging RWE for clinical trial design insights, researchers can build more effective, efficient, and patient-centric trials.
RWD is disorganized patient healthcare data gathered from real-world data sources such as electronic health records (EHRs) and claims. To transform it into RWE, the data is curated and analyzed to generate both broad and deep insights into diverse patient populations. By leveraging RWE for clinical trial design insights, researchers can build more effective, efficient, and patient-centric trials.
Connect with the right patients
RWE can help identify patients most likely to benefit from a drug in development across the full range of individuals seeing a clinician for a target condition.
A successful clinical trial connects patients who are good matches for a treatment. RWE can help identify patients most likely to benefit from a drug in development across the full range of individuals seeing a clinician for a target condition. By aggregating data from multiple clinicians treating a certain condition, researchers can better understand the impacted populations, including historically underrepresented groups.
The benefits of RWE go beyond identifying ideal patient personas to help researchers connect with actual people. Traditional methods of patient recruitment are often time-consuming and inefficient. RWD-aggregating applications, such as Verana Trial Connect (VTC), streamline recruiting for clinical trials to save time and resources. VTC’s HIPAA-compliant platform rapidly cross-references EHR data against inclusion and exclusion criteria to deliver high-match patient lists to participating clinicians, accelerating the recruitment process. VTC also assesses other patient characteristics that may make them a better candidate for the trial such as their distance to the trial site, past or current clinical trial participation, comorbidities, etc.
Choose strategic trial sites
The wrong clinical trial site can be a major resource drain, leading to poor recruitment numbers and high patient dropout when distance is a barrier to participation. Despite this, clinical trial sites have historically been selected based on existing relationships and patient volumes that have not been validated using RWD. RWD completely shifts the site selection paradigm by helping researchers identify facilities that align with the ideal patient populations for the study. By locating suitable trial sites with a high density of potentially eligible patients, clinical trial site selection becomes a data-driven decision.
Applications, such as Site Explorer, use RWD data to pinpoint locations with a higher concentration of eligible potential patients, reducing geographic and logistical barriers to participation. Site Explorer assesses a site’s suitability based on necessary resources and experience and then narrows down which suitable sites are near the most ideal patients. By choosing sites that are more convenient and accessible for patients, travel costs decrease and retention rates improve.
Predict patient pain points
Understanding participant behavior is essential for designing effective, disruption-free trials, and RWE is extremely effective at predicting what comes next.
With the right patients and the right clinical sites, trials already face less risk of patient dropout. RWE can help take clinical trial development even further by identifying likely dropout scenarios that can be proactively mitigated. Understanding participant behavior is essential for designing effective, disruption-free trials, and RWE is extremely effective at predicting what comes next. By analyzing data from past trials and real-world patient experiences, researchers can identify high-risk dropout points and implement additional support measures to build trials that are more resistant to disruption.
Plan for plans to change
De-risking a trial before it starts is fundamental to good clinical trial design, but some scenarios are easier to plan for than others. By predicting the many paths a trial could take, researchers can build flexibility into trial design, ensuring trial efforts are not wasted if the unexpected occurs.
Adaptive trial designs allow for modifications to the trial procedures based on interim results. RWE can play a crucial role in these designs by helping predict likely scenarios so that contingency plans are in place. RWE also drives flexibility during trials by delivering real-time insights that can offer an early alert when plans may need to change. Whether it’s shifting focus to a subgroup or the need to recruit additional patients, RWE gives researchers the information needed to adapt without starting from scratch.
Take your trials to the next level with RWE
From discovery to market, RWE can provide critical insights that drive innovation, improve patient outcomes, and extend product applications.
RWE and drug development are natural partners before, during, and after clinical trials. From discovery to market, RWE can provide critical insights that drive innovation, improve patient outcomes, and extend product applications.
For example, RWE can bring together unique data sources to help predict biomarkers involved with a condition, leading to drug development insights for more targeted and effective treatments. It can identify earlier and better risk factors for disease, uncover indicators of disease progression, and illuminate social determinants of health that may impact patient outcomes. Further, RWE can uncover common off-label uses for existing drugs, offering new treatment options for patients and extending the life cycle of existing products. This comprehensive understanding helps clinicians deliver more personalized and effective treatments, benefiting patients, clinicians, and life sciences companies.
Incorporate the power of RWE into your next trial design
Bringing together the power of real-world evidence and clinical trials helps researchers develop therapies that can transform the future of health and improve a patient’s quality of life. RWE empowers researchers to streamline patient recruitment, choose data-driven trial sites, engage in adaptive trial design, and uncover new treatment possibilities. Verana Health is at the forefront of RWD and RWE, with applications that offer real-time insights into patient experiences and outcomes through highly curated datasets from hundreds of partner practices.
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