Using real-world evidence to improve clinical development
Real-world data (RWD) and real-world evidence (RWE) not only support RCTs and health economics research but also play a crucial role in shaping the clinical development lifecycle. Life sciences organizations are leveraging RWE to streamline development, cut costs, and boost the probability of technical and regulatory success (PTRS).
management consulting While RWD is used to support randomized controlled trials (RCTs) health economics and outcome research, RWE helps understand diseases and the relative effectiveness of treatments in a real-world setting. But, an area that’s less explored is the way RWE influences the clinical development life cycle.
Life science leaders have found key impact areas where RWE can help streamline clinical development, reduce costs, and improve the probability of technical and regulatory success (PTRS):
Understanding the study population
With the implementation of clinical trial development, the first step is to have a deep, nuanced understanding of the patient population under study. Specifically, where needs are left unmet. By using electronic health records (EHRs) and working with life sciences solutions companies, life science leaders can examine longitudinal patterns of biomarkers in different groups of patients. These insights help develop a more precise trial plan and help leaders create models for the target population and provide the care they need.
Optimizing trial design with EHR analysis
Real-world evidence can make clinical trials more practical and effective. For instance, life science leaders can use an EHR analytics platform and EHR data to ask the right questions, execute queries on fresh data and retrieve answers in real time. They can also study how certain diagnoses differ between ethnic and racial groups, and use this information to design trials that better fit real-life patterns. With faster data analysis and clear insights, teams can design smarter trials that save time, lower costs, and deliver more meaningful outcomes.
Leveraging RWE to improve patient care
When we talk about aspects that are reshaping the real world evidence pharma landscape, it is helping invest in the right tools and collaborate with the right people. Leaders can leverage RWE to identify patients’ natural frequency of clinical visits (NFCV) and real-world interaction within the healthcare system.
With better understanding of patient experiences, it's easier to develop a system that enables patient-centric trial design. A trial that respects the patient’s experience is more likely to achieve better retention and improved patient experience. In one case, the NFCV metric aligned patient-visit cadence more closely with standard care.
