New research by Tufts Center for the Study of Drug Development (CSDD) documents the growing importance of real-world data (RWD) and real-world evidence (RWE) in clinical trials. The study, “The Use of Real-World Data and Evidence in Clinical Trials,” highlights the increasing value of RWD and RWE in decision-making, trial optimisation, commercialisation, and real-world efficacy.
The research was conducted in October and November of 2025 and sponsored by Verana Health, a digital health company. Researchers interviewed leaders at 18 pharmaceutical, biotechnology, and contract research organisations (CRO) focused on oncology, ophthalmology, urology, neurology, and dermatology therapeutic areas.
Participating companies reported using RWD/RWE to support drug development through rapid access to data to help enable faster decision-making, reduce trial burden, and accelerated response times to address regulatory inquiries. Interviewees also noted that market gains were a result of the ability to produce additional evidence for label expansion for regulatory approvals. Ten of 14 companies anticipated an increase in ROI over the next one to two years.
“Adoption and usage of RWD is having a significant impact on efficiencies and downstream conduct of studies,” said Sujay Jadhav, CEO of Verana Health.
“Stakeholders are increasingly aware that trial design, feasibility, and optimization can be enhanced with RWD focusing on patient availability and suitability. The increasing adoption of RWD in all phases of drug development and growing regulatory recognition is a positive industry trend.”
“The use of real-world data is becoming increasingly important to drug development, patient safety, and commercialization activity,” said Ken Getz, executive director of Tufts CSDD and research professor at Tufts University School of Medicine.
“The results of this study provide valuable insights into avenues for improving study initiation, efficiency and effectiveness, commercialization, and post-marketing surveillance.”
Although randomised controlled trials (RCT) remain the gold standard, the study noted growing acceptance of RWD by regulatory agencies in submissions. Regulators have asked for more RWD to support information on how a particular disease is being managed, standard of care, and are open to conversations and feedback from RWE departments.
With FDA guidance in place, representatives interviewed at several organisations noted the responsibility to bring positive or innovative use cases of RWE successes lies with the industry. This insight indicates a positive development since a prior Tufts CSDD study found a high proportion of companies cited a lack of trust among regulatory agencies as a major challenge to RWD adoption. RWD and RWE challenges identified by interviewees related to quality, completeness, and continuity highlight the importance of high-quality data and vetting potential RWD suppliers for their curation process and relevant therapeutic expertise.