Overcoming Real-World Data Capture Challenges In Phase IV Trials

By Melissa Newara, VP of Subject Matter Expertise, and Tina Caruana, eClinical Solutions (Digital & Decentralized Trials) Subject Matter Expert

Real-world data (RWD) and real-world evidence (RWE) hold significant research implications and substantial financial potential, prompting sponsors to explore diverse sources such as electronic health records (EHRs), questionnaires, claims, genomics, and wearable technologies to amass comprehensive real-world data for novel insights. The period from 2004 to 2022 witnessed an impressive 2,000% increase in studies utilizing RWD. However, as sponsors endeavor to integrate more RWD and RWE into research studies, particularly in Phase 4 trials, they encounter a spectrum of challenges and opportunities.

In this context, industry experts Tina Caruana, eClinical Solutions Subject Matter Expert, and Melissa Newara, VP of Subject Matter Expertise at Medrio, provide valuable insights. Their blog delves into the distinctions between RWD and RWE elucidates the challenges associated with capturing RWD in Phase 4 trials, and highlights the advantages of implementing front-end digital processes in this evolving landscape. As the demand for real-world insights continues to grow, navigating these challenges and leveraging emerging opportunities becomes crucial for advancing clinical research in the real-world setting.