How Real-World Data Can Help Tackle the Biggest Challenges in Clinical Trial Operations

During Verana Health’s recent webinar, Unlocking Innovation: Tackling the Biggest Challenges in Clinical Trial Operations, we explored major hurdles in planning and executing clinical trials, including the complexities of trial design, site recruitment obstacles and needs, and participant diversity challenges. 

Joining me in this discussion were expert panelists Durga Borkar, MD, MMCi, associate professor of ophthalmology at Duke University School of Medicine and a Verana Health medical advisor and Michelle Rimes, clinical research coordinator and certified ophthalmic assistant at Great Lakes Eye Care.

Together, we addressed barriers to patient recruitment, flaws in site selection strategies, and real world challenges with operational feasibility for sites—critical factors that must be navigated to drive success in this highly competitive field. We also shared key insights and discussed innovative, data-driven strategies to overcome these challenges, with the ultimate goal of accelerating trials and enhancing outcomes for diverse patient populations.

Navigating Complex Trial Operations

Clinical trials today are increasingly complex and, in many cases, with this increased complexity comes increased trial duration and cost. From the growing emphasis on precision medicine to intricate study designs and regulatory demands, these shifts in the clinical trials landscape add to the operational burden on trial sites and research coordinators. 

Polls during our webinar echo this sentiment. We asked attendees if they believe clinical trials have become more challenging to operationalize in the last decade. About 86% stated, ‘yes.’ 

Complex inclusion and exclusion criteria can often make patient identification challenging, especially in rare diseases or underrepresented populations. Dr. Borkar, a retinal surgeon, highlighted that these nuances are essential to ensure trials are relevant to real-world populations. However, balancing precision with feasibility is key. In many instances, overly detailed protocols can overwhelm sites, extend trial timelines, and lead to higher costs and greater screen fail rates.

In response, adopting real-world data (RWD) in trial design and feasibility assessments has shown promise. Leveraging RWD enables sponsors to optimize trial parameters by aligning more closely with typical clinical care patterns, reducing the operational and logistical burden on both patients and sites while still prioritizing quality data. For instance, using data from electronic health records (EHRs) can ensure more accurate recruitment projections and more effective protocol design for target patient populations, decreasing the risk of delays.

Effective Recruitment Strategies in a Competitive Landscape

Recruitment remains one of the most cited challenges in clinical research, especially for trials in specialized or competitive areas. In fact, in a follow-up poll, 71% of webinar attendees identified ‘recruitment and retention’ as primary factors that make modern clinical trials so challenging.

Clinical Research Coordinator, Michelle Rimes, spoke to the recruitment pressures faced by site staff, emphasizing the importance of site support in overcoming obstacles.

Data-driven digital marketing has also become a valuable tool for expanding recruitment reach, allowing sponsors to tap into new populations. However, the potential for high false positives—when non-eligible patients express interest—highlights the need for careful planning and efficient filtering of leads to minimize strain on sites.

One effective approach for recruitment is utilizing technology and EHR data to identify potential candidates based on specific criteria. This reduces the time and labor-intensive nature of traditional prescreening and improves accuracy in patient identification. Additionally, broader awareness campaigns, especially in diverse communities, can help ensure that trials reflect the demographic composition of the disease population.

Real-World Data Solutions to Improve Design, Site Selection, and Patient Recruitment 

Real-world examples underscore the value of data-driven strategies in improving trial success. For instance, a recent Verana Health project involved utilizing its exclusive access to RWD from the American Academy of Ophthalmology IRIS^® Registry (Intelligent Research in Sight) to identify suitable sites for a Phase III trial in nAMD that was struggling with slow recruitment. By recommending sites that had the necessary patient population, we helped reduce enrollment time by over a month, demonstrating how precise data applications, such as Verana Health’s Site Explorer, can accelerate timelines and reduce costs.

Similarly, in trials with narrow inclusion criteria, leveraging unstructured data within EHRs, such as clinician free-text notes, can reveal specific attributes (e.g., tumor size for NMIBC) that are often essential for rare disease studies, but not coded within standard datasets. This method helps sites ensure they are equipped to find the right patients quickly, enhancing recruitment efficiency and minimizing screen fails.

Lastly, aligning trial design with standard clinical workflows is critical to trial success. In one case that we featured during the webinar, protocol rigidity in a glaucoma study led to confusion and protocol deviations. If the site needs had been considered in the study design phase, the resulting complications could have been avoided. For trials to be operationally feasible, they must incorporate site and clinician feedback, balancing scientific rigor with practical, on-the-ground requirements.

The Path Forward: Building a More Efficient, Inclusive Trial Ecosystem

While clinical trial complexity continues to grow, so too does Verana Health’s toolkit for managing obstacles. By adopting data-driven approaches, we can design smarter trials, optimize site selection, and support efficient patient recruitment. Real-world data, especially when used to drive trial design, recruitment, and site selection, can improve patient diversity, reduce protocol amendments, and ultimately accelerate study completion so innovative therapies can reach patients sooner.

Our aim at Verana Health is to enable a more streamlined, patient-centered approach to clinical trials, bridging the gap between clinical innovation and operational feasibility. By tackling these challenges head-on, we can ensure that the trials of tomorrow are not only scientifically robust, but also efficient, inclusive, and accessible to all patients. Together, we can unlock the full potential of clinical research and bring life-changing therapies to patients faster and more effectively than ever before.

To learn more about Verana Health’s clinical research and real-world evidence offerings, visit: veranahealth.com.