Bridging the Gap Between Clinical Trials and Real-World Evidence

Clinical trials have long been the gold standard for evaluating the safety and efficacy of new treatments and therapies. However, these trials often involve controlled environments, strict eligibility criteria, and specific patient populations, which may not fully represent the broader population that will ultimately use the treatments. 

On the other hand, real-world evidence (RWE) provides insights derived from data collected outside of traditional clinical trial settings, capturing the experiences of individuals in real-life scenarios. Bridging the gap between clinical trials and real-world evidence is a crucial step in making healthcare more personalized, efficient, and aligned with actual patient outcomes.

Let’s take a look at bridging the gap between trials and evidence.

What Is Real-World Evidence?

Real-world evidence refers to the clinical evidence derived from real-world data (RWD), which includes information on patient health status and outcomes obtained from sources such as electronic health records (EHRs), insurance claims, patient registries, and wearable health devices. 

Unlike the tightly controlled conditions of clinical trials, RWE reflects how treatments perform in broader, diverse patient populations over a longer duration. It provides valuable insights into treatment effectiveness, safety, and patient experiences across various demographics, including those who may have been excluded from clinical trials due to comorbidities, age, or other factors.

Why Bridging the Gap Is Important

The gap between clinical trials and real-world evidence exists because clinical trials typically involve highly controlled settings, strict eligibility criteria, and closely monitored conditions. While this ensures robust data collection, it may not fully represent the diversity of the broader patient population. 

Real-world evidence, by contrast, reflects how treatments work outside the controlled trial environment, where factors like comorbidities, socioeconomic status, and different treatment regimens come into play. Integrating RWE with clinical trial data allows for a more comprehensive understanding of treatment effectiveness, safety, and long-term outcomes.

Enhancing the Generalizability of Research

Clinical trials often involve a limited and specific patient population, which may not fully reflect the diversity of individuals who will eventually use the treatment. For example, older adults, people with multiple chronic conditions, or those from different ethnic backgrounds may be underrepresented in clinical trials. Integrating real-world evidence helps provide a clearer picture of how treatments perform across various subgroups, enhancing the generalizability of the findings. 

This broader perspective allows healthcare providers to make better-informed decisions tailored to the unique needs of individual patients.

Improving Post-Marketing Surveillance

Once a treatment is approved, it is used by a much larger, more diverse group of patients in real-world settings. Post-marketing surveillance powered by real-world evidence helps track the safety and effectiveness of treatments over time, identifying potential adverse events or long-term outcomes that may not have been observed during clinical trials. This ongoing monitoring is critical for ensuring that the benefits of a treatment continue to outweigh the risks once it is made available to the public.

Personalizing Treatment Plans

The integration of RWE with clinical trial data can significantly enhance the personalization of treatment plans. By analyzing data from a broader patient population, healthcare providers can gain a better understanding of how different individuals respond to treatments based on factors like age, gender, comorbidities, and lifestyle. This information can help clinicians select the most appropriate treatment for each patient, ensuring better outcomes and minimizing the risk of adverse effects.

Overcoming Challenges in Integrating RWE with Clinical Trials

While the integration of real-world evidence and clinical trial data offers numerous benefits, it also comes with challenges. One of the main barriers is the quality and consistency of real-world data. Unlike clinical trial data, which is collected in a controlled environment with standardized protocols, RWD can vary significantly depending on the source and context. Ensuring that RWE is accurate, reliable, and representative of the broader patient population is essential for its successful integration into clinical decision-making.

Furthermore, regulatory frameworks for the use of RWE in clinical trials are still evolving, and there is a need for clearer guidelines to ensure that both clinical trial data and RWE are used effectively and ethically.

Research at Biofortis

Biofortis is dedicated to protecting consumer health throughout the world by delivering a wide range of testing and consultancy services to the food, supplement, and nutrition industries. Biofortis supports this mission in two ways—through clinical trials and sensory and consumer insights testing. We specialize in clinical research targeting foods, ingredients, and dietary supplements that affect body structures, function, and overall health. Contact us with any clinical trial or scientific consulting needs.