The Future of Patient Recruitment: Leveraging Real-World Data for Precision and Scale

The important work of locating and enrolling potential participants is often riddled with inefficiencies and outdated, manual processes that both slow down the momentum of the trial and drive up costs.

Patient recruitment has long been an area of challenge for drug developers. Can the use of comprehensive, real-world data solutions offer a faster, better way to achieve recruitment goals?

The current landscape of patient recruitment

Patient recruitment is the cornerstone of a successful clinical trial: Without enough of the right participants, clinical research cannot move forward. As critical as patient recruitment is, doing it efficiently and successfully has long been a challenge for sponsors. The important work of locating and enrolling potential participants is often riddled with inefficiencies and outdated, manual processes that both slow down the momentum of the trial and drive up costs. In recent years, a new emphasis on including diverse patient pools in clinical trials has improved healthcare for both underrepresented patient groups and the wider patient population. It has also posed a new challenge for clinical trial sponsors, as conventional approaches to patient recruitment do not always include these diverse groups, leaving vital populations out of clinical trial patient cohorts. Persistent and pervasive recruitment issues of all kinds present significant risks for sponsors and can ultimately threaten the viability of a research study.

What is real-world data (RWD)?

An effective solution for combatting the costly challenges of patient recruitment and keeping trials on track is the strategic use of real-world data (RWD). Using the right combination of datasets, sponsors can gain a view of patients within a given therapeutic area to determine disease prevalence as it relates to patient demographics. They can also use RWD to find the physicians who treat individuals within that demographic, as well as pinpoint the clinical trial sites most likely to yield a larger number of enrolling patients. RWD can include:

• Electronic health records (EHRs): Digital records of patient medical information, including medical history, immunizations, medications, and treatment outcomes
• Claims data: Records submitted from healthcare providers to payers (such as insurance companies) that include information like patient demographics, appointments, bills, and more, providing insights into patient care and resource utilization
• Data from patient registries: Information from organized systems that collect data about individuals with specific conditions, diseases, and exposures
• Wearables data: Data from devices like fitness tracker watches that monitor daily activity, caloric intake, sleep, and other health-related information in real time

Leveraging RWD for precision in patient recruitment

To fully capture the potential power of RWD in clinical trial recruitment, RWD should be gathered from across multiple sources and synchronized across multiple relevant and comprehensive health datasets. When gathered and combined in this way, RWD can be used to generate important insights into the patient populations that need to be reached. Those insights can then be used to power effective patient recruitment strategies. Benefits of using RWD as part of a strategic approach to recruitment efforts include:

• Targeted identification: Data-driven tools can extract vast amounts of RWD from a wide array of sources, including demographics, disease profiles, and patient history. These tools can then analyze the RWD according to the needs and protocols of the trial. This segmentation of patient population data allows sponsors to drill down and precisely identify the specific individuals most likely to benefit from a given study or treatment.
• Enhanced matching: RWD can match patients to clinical trials with speed and accuracy. Instead of relying on the traditional trial-and-error approach to recruitment, sponsors can use data-enabled tools to produce detailed patient profiles to quickly and precisely match appropriate patients to clinical trials that are actively recruiting.
• Real-world efficiency: Data gathered from EHRs and wearable health devices can quickly be analyzed by data-powered solutions to pinpoint patients appropriate for clinical trials, down to the specific biomarkers required to be considered for participation. These streamlined patient data searches can help accelerate enrollment and improve trial outcomes.

Scaling recruitment with RWD

Using RWD to power patient recruitment translates into processes that are more efficient, outreach that is more streamlined, and speed that is not possible with traditional recruitment approaches. Data-driven platforms can incorporate advancements like artificial intelligence (AI), natural language processing (NLP), and machine learning (ML) to instantaneously process huge stores of data from disparate sources, identifying potential clinical trial participants in the blink of an eye. Because these tools can seamlessly integrate multiple sources of data, sponsors can expand their patient pools at a greater scale, while still maintaining a focus on the often highly specific needs of their clinical trials.

Future RWD recruitment trends

The use of RWD in patient recruitment and site selection is growing rapidly, aided by technological advances like AI and ML. While challenges such as maintaining data privacy and successfully integrating software, hardware, and data systems still exist, data governance frameworks and new innovations in technology are actively addressing these concerns. These developments are paving the way for a future where RWD fuels novel ways of thinking about patient recruitment, including:

• New innovations: Predictive analytics and advanced digital platforms will be used to forecast patient behavior and predict treatment outcomes, transforming recruitment strategies and enabling proactive planning and agile responses to shifting conditions
• Industry Partnerships: Not only will new technologies arise from collaborations between healthcare providers and tech companies, but new regulatory and operational frameworks will emerge as a result
• Market Impact: Faster and more efficient healthcare delivery will become the norm as the benefits of streamlined clinical trial patient recruitment practices positively impact the development speed and quality of treatments, ultimately leading to improved human healthcare worldwide