Tufts CSDD Report Tracks Growing RWD Use In Drug Development

Key Takeaways:

• In a recent study, RWD and RWE use was reported across trial planning, regulatory submissions, and commercialization activities.
• Participating organizations reported operational gains.
• Adoption was described alongside data-quality challenges and continued reliance on randomized controlled trials.

The study drew on interviews with leaders from 18 pharmaceutical, biotechnology, and contract research organizations spanning oncology, ophthalmology, urology, neurology, and dermatology.

Interviewees described using real-world data to support trial design, feasibility, and study optimization. They also described a focus on patient availability and suitability to inform feasibility assessments and enrollment planning.

Authors noted that participating organizations also linked RWD and RWE to faster decision making, lower trial burden, and quicker handling of regulatory questions. Interviewees further reported market gains tied to generating additional evidence for label expansion for regulatory approvals.

Interviewees identified data quality, completeness, and continuity as key constraints on broader RWD and RWE use. They also emphasized assessing potential suppliers for curation practices and relevant therapeutic expertise before relying on those sources.