Real World Evidence

In this Q&A, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, discusses the collaborative work underway with FDA and CTTI to explore selective safety data collection as a model for de-risking trial design, reducing site and patient burden, and scaling pragmatic trial approaches across the industry.

The FDA's launch of real-time clinical trial proof-of-concept studies signals a fundamental shift in regulatory oversight, one that most sponsors are not yet equipped to meet and that demands urgent investment in unified data infrastructure, quality-by-design practices, and protocol digitization.

As the FDA formally recognizes real-world evidence as eligible confirmatory evidence for drug approval, sponsors face a growing imperative to build the data infrastructure, organizational alignment, and analytical capabilities needed to use RWE effectively across the development lifecycle.

Real-world evidence is shifting from a post-market footnote to a concurrent validation layer running alongside trial data, requiring organizations to build unified data environments that integrate EHRs, claims, and patient-reported outcomes on an ongoing basis rather than retrospectively.

Real-world data is increasingly used to optimize trial design, reduce recruitment burden, and support regulatory decisions, but adoption remains uneven due to challenges around data quality, integration, and internal alignment across functional areas.

In this episode of the Applied Clinical Trials Podcast, C.K. Wang, MD, chief medical officer at COTA; and Sujay Jadhav, CEO of Verana Health, discuss how their organizations’ merger is advancing the use of real-world data to inform trial design, patient recruitment, and regulatory decision-making.

Individual-level attribution modeling reveals that real-world semaglutide effectiveness is not a fixed property of the molecule, but an interaction between pharmacological exposure and modifiable care and support conditions, carrying implications for real-world evidence interpretation and clinical development.

Uncover how improving data accuracy and leveraging synthetic control arms can optimize trial efficiency, reduce costs, and generate stronger real-world insights.

In today’s high-cost R&D environment, pharma success depends less on cost-cutting and more on evidence-based portfolio decisions, niche-buster strategies, and real-world data-driven indication expansion to maximize both ROI and patient outcomes.

A 2025 survey highlights growing momentum for multi-indication drug development, with opportunities in innovative trial design, targeted patient selection, and real-world evidence to speed label expansion.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, shares practical ways clinical teams can strengthen trial protocols for expedited programs—such as incorporating control groups where possible, leveraging synthetic and real-world data, and adopting adaptive trial designs to reduce regulatory risk.

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world evidence is helping refine patient targeting and improve safety monitoring in obesity and endocrinology clinical trials.

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.

A new global report finds that clinical research teams are making progress but still lack the skills and tools needed to keep pace with growing trial complexity and emerging technologies.

How the application of artificial intelligence, broader use of real-world evidence, decentralized clinical trials, master protocols, and risk-based quality monitoring, together with strong ethical oversight and increased collaboration, are contributing to better healthcare delivery and strengthening the role of clinical research in driving global health progress.

How clinical operations teams can close the gap between controlled trial results and real-world adoption by generating evidence in broader, more representative patient populations.

As clinical research increasingly relies on RWD to enhance trial design and patient insights, tokenization has emerged as a critical solution for securely linking disparate datasets while protecting patient privacy.

In this video interview, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), explores how emerging technologies such as wearable devices, real-world data analysis, and decentralized trial designs can improve the identification and engagement of potential cancer clinical trial participants.

In this video interview, C.K. Wang, MD, chief medical officer, COTA, touches on how he would like to see greater industry collaboration in connecting cancer patients with RWD.

In this video interview, C.K. Wang, MD, chief medical officer, COTA, discusses how real-world data and real-world evidence have helped expedite cancer research.

In this video interview, C.K. Wang, MD, chief medical officer, COTA, shares his key takeaways from a recent study he led on data reporting in oncology and highlights how stakeholders should be closely analyzing the accuracy of data they work with.

In this video interview, C.K. Wang, MD, chief medical officer, COTA, discusses a recent study he led on the validity of using real-world data for reporting mortality.

The ongoing evolution of real-world evidence from a novel concept to a cornerstone of modern medical research signifies its growing importance and vast potential to improve personalized medicine, overall healthcare outcomes, and eventually democratization of scientific facts by general accessibility.