A first-of-its-kind cross-industry initiative, the Aetion CARE Initiative brings together leaders in healthcare to facilitate multiple trial emulations using various data sources to understand where real-world evidence is appropriate and where it is not, beginning with a focus on oncology. Together with our partners, we are seeking to answer these questions and set a new precedent for the use of RWE to complement RCTs to better inform regulatory decision-making. The findings from CARE will be published in a series of peer-reviewed publications to ensure transparency and the greatest impact on the field.
Study Overview
This study piloted the use of real-world electronic health record (EHR) data to emulate the KEYNOTE-189 clinical trial, which examined the effectiveness of pembrolizumab and chemotherapy in non-small cell lung cancer patients. The aim was to see if real-world data could replicate the clinical trial’s results. However, the study found notable differences, with less pronounced survival benefits in the EHR-based cohort compared to the trial. These discrepancies were likely due to variations in patient treatment, data capture methods, and potential biases that are harder to control in nonrandomized, real-world settings.
The findings highlight the challenges of using EHR data to emulate clinical trial outcomes, particularly in oncology. The complexity of real-world data, such as treatment variability and diagnosis accuracy, played a significant role in the differences observed. This study emphasizes the need for high-quality oncology-specific data and improved study design to better align real-world research with clinical trial results, ensuring more reliable insights into treatment effectiveness.