Situation
Hard endpoints are often not evaluated in clinical trials because of limitations due to the number of patients needed, length of the clinical required to have endpoints occur, and significant costs. Among different drug classes, our client would like to understand hard endpoints of mortality and Major Adverse Cardiovascular Events (MACE) via a real-world dataset of Electronic Medical Records (EMR) representing ten times the patient clinical experience and exposure previously represented across the cumulative literature.
Challenge
- The EMR data was unstructured and contained numerous inconsistencies, making it difficult to derive accurate and meaningful insights
- A multitude of risk factors may have been contributing to the analysis results, making it difficult to clearly interpret the data
- Clinicians currently do not have good data to support their understanding of the specific risk factors associated with mortality and cardiovascular morbidity in this therapeutic area and disease population
The Xelay Approach
- Performed comprehensive data cleaning to address inconsistencies, impute missing values, and standardize the dataset, ensuring high-quality and reliable data for analysis
- Conducted both univariable and multivariable analyses to adjust for various factors, enabling a more accurate comparison of the effectiveness and safety of the different drug classes while providing novel insights into hard endpoints like mortality and MACE in the patient population at an unprecedented scale
- Developed visualizations and publications in a clear and clinically meaningful manner, aiding clinicians in understanding the risk factors and making informed treatment decisions
