TransCelerate and FDA Advance Collaboration on Streamlined Safety Data Collection to Accelerate Inclusion of Pragmatic Elements in Clinical Trials

New report highlights practical application of selective safety data collection approaches to enable more efficient, real-world clinical research and expand patient access

PHILADELPHIA, May 5, 2026 /PRNewswire/ -- TransCelerate BioPharma (TransCelerate), a nonprofit organization dedicated to improving the health of people around the world by accelerating and simplifying clinical research, today announced the release of a new summary report focused on selective safety data collection (SSDC).

The report captures key insights from a recent joint tabletop exercise convened in collaboration with U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI) – focused on how to streamline collection of safety data – an essential step in scaling the use of pragmatic elements in clinical trials, which are widely recognized as critical to enabling broader participation and generating evidence that better reflects real-world practice. SSDC is a risk-based approach reflected in International Council for Harmonization of Technical Requirements for Human Use (ICH) guidance and emerging regulatory frameworks, and the subject of an FDA white paper. The exercise explored how SSDC can be applied in practice while maintaining patient safety and data integrity.

Held in late 2025, the informal, non-binding exercise convened more than 20 pharmaceutical research and development leaders from TransCelerate and its member companies, alongside more than 15 representatives from the FDA. Building on the FDA-TransCelerate tabletop exercise held a year prior, the session extended ongoing dialogue between regulators and sponsors on how to scale the adoption of pragmatic approaches in clinical trials, with particular emphasis on safety reporting.

Through its Embedded Pragmatic Trials initiative, TransCelerate is working to accelerate the adoption of these trial designs by building awareness, fostering dialogue with regulatory authorities and other stakeholders, and offering practical tools to guide implementation.

"As our collaboration with FDA continues, we are focused on working through specific, concrete trial scenarios, and sharing those findings publicly for the benefit of all R&D stakeholders," said Rob DiCicco, Vice President of Portfolio Management at TransCelerate. "Our intent is to build sponsor confidence in designing trials that include pragmatic elements and engaging FDA in productive, transparent dialogue on the topic."

Case-Based Discussions Informing Trial Design
At the session, FDA and TransCelerate representatives engaged in structured discussions using simulated trial scenarios developed by TransCelerate leaders across four therapeutic areas: obesity, cardiovascular, pulmonology, and dermatology. These scenarios served as a framework for examining trial design, operational, and oversight considerations associated with incorporating pragmatic elements, including the application of SSDC approaches.

"This work is part of a broader effort by TransCelerate to create space for open, practical dialogue across the clinical research ecosystem," said Kevin Bugin, Head of Global Regulatory Policy at Amgen and executive sponsor of TransCelerate's Embedded Pragmatic Trials initiative. "Alongside continued engagement with the FDA, we have seen early indications of interest from other health authorities in participating in similar discussions to scale pragmatic approaches in other regions."

The public summary of the 2025 tabletop exercise is available here.

To learn more about TransCelerate's Embedded Pragmatic Trials initiative, visit: https://www.transceleratebiopharmainc.com/initiatives/embedded-pragmatic-clinical-trials/

About TransCelerate BioPharma Inc.
TransCelerate BioPharma (TransCelerate) is a nonprofit organization that fosters collaboration across the global biopharmaceutical research and development community to simplify clinical trials and help bring new treatments to patients faster, safer, and more efficiently.

Headquartered in the Philadelphia area, TransCelerate has 18 member companies and a robust portfolio of initiatives focused on transforming connectivity, enabling information sharing and reuse, and driving innovative trial designs. For more information, please visit https://www.transceleratebiopharmainc.com/who-we-are/.

SOURCE TransCelerate BioPharma