How Real-World Evidence Can Help Increase Diversity in Clinical Trials

A common goal exists among clinicians, life sciences companies, and regulatory bodies to bring effective treatments to patients faster and more efficiently through well-designed and executed clinical trials. 

One key factor in doing this is by ensuring a diverse representation of patient populations in clinical trials, where participants often have access to the latest advancements in medicine. The challenge lies in selecting the right patients for the right trials, which can be supported by the use of real-world evidence (RWE).

The Importance of Diversity in Clinical Trials

Diversity in clinical trials is essential to ensure results are generalizable to the broader population. A lack of diversity can lead to results that don’t accurately reflect the efficacy or safety of treatments across different populations. For example, certain glaucoma laser procedures may have varying effects on minority groups. By not including sufficient numbers of patients from these groups in clinical trials, these differences would remain undiscovered.

As our understanding of genomics and disease diversity deepens, we recognize that diseases, such as diabetic retinopathy (DR), are not homogenous. Patients may present differently, progress at different rates, and respond uniquely to treatments. 

In order to understand whether treatments are effective across a variety of patient subgroups, as opposed to observing the effectiveness in real-world studies post-approval of a therapy, it’s vital to evaluate the treatments on diverse patient populations in clinical trials.

Addressing the Lack of Diversity in Clinical Trials with RWE

With secure and advanced technology and clinical expertise, RWE has the ability to provide insights into specific patient populations and the efficacy and safety of treatments.

With secure and advanced technology and clinical expertise, RWE has the ability to provide insights into specific patient populations and the efficacy and safety of treatments. RWE is generated from real-world data (RWD), such as electronic health records (EHRs), medical claims, pharmacy claims, imaging data, and genomics data. Combined, these RWD sources offer a more detailed view of a patient’s healthcare journey to help understand treatment gaps and areas for improvement. 

For example, key variables, such as visual acuity and intraocular pressure, can be extracted from EHR data to reveal details about a patient with glaucoma and their treatment patterns. RWD is also beneficial in helping clinicians and trial sponsors understand patient demographics by practice site, which can allow for better planning of clinical trial site selection and targeted patient cohorts.

RWE is being seen as complementary to clinical trials in monitoring the safety and effectiveness of therapies and medical devices postmarket.

RWE-based approaches are gaining acceptance from the Food and Drug Administration in regulatory decision-making. RWE is being seen as complementary to clinical trials in monitoring the safety and effectiveness of therapies and medical devices postmarket. 

In addition to accelerating the approval of new therapies, there’s also value in using real-world evidence to diversify clinical trials. Recently, the FDA released guidance for sponsors to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations in an effort to increase diversity. 

How Real-World Evidence Widens the Clinical Trial Patient Pool 

By leveraging RWD to generate RWE, we have a greater opportunity to broaden the clinical trial patient pool with more diverse participants. Adopting the following strategies can also help:

• Patient Engagement and Trust: Building trust with patients and clinical teams is essential. Ensuring that patients are engaged and interested in enrolling in trials involves identifying the right patients, making participation feasible, addressing transportation issues, and managing the number of visits required.
• Designing Inclusive Trials: Digital health technology can play a significant role in designing trials that a diverse population can participate in. This includes considering geographic limitations and ensuring that the trials represent the socioeconomic and regional diversity of the patient population that will use the drug or device.
• Site Selection: Collaboration with site investigators can help identify high-volume sites for eligible patients. Real-time assistance can be provided to investigators to determine patient eligibility amid their busy schedules, where they might otherwise overlook potential candidates due to complex criteria.
• Protocol Modification: Careful analysis of trial inclusion and exclusion criteria may reveal overly stringent requirements. For example, a neovascular age-related macular degeneration trial may have treatment history criteria that are overly restrictive. Identifying these issues early allows for protocol modifications or the selection of different sites to enhance patient recruitment early in the process rather than waiting until there is a gap in clinical trial recruitment.

Diverse Clinical Trial Research Solutions with Impactful Results

By leveraging RWD and RWE solutions to ensure more inclusive and effective clinical trials, we can better represent the populations these trials aim to serve. This holistic approach not only improves the acceleration of medical innovations, but the overall quality of patient care.To learn more about the possibilities of unlocking RWD to generate RWE that can help transform patient lives, visit: https://veranahealth.com/.