TransCelerate and FDA Advance Work on Streamlined Safety Data Collection for Pragmatic Clinical Trials

TransCelerate BioPharma has released a summary report from a joint tabletop exercise conducted with the FDA's Center for Drug Evaluation and Research, focused on how selective safety data collection can be applied in real-world clinical trial settings.¹

The report captures findings from a session held in late 2025 that brought together more than 20 pharmaceutical research and development leaders from TransCelerate and its member companies alongside more than 15 FDA representatives.

Selective safety data collection (SSDC) is a risk-based approach reflected in ICH guidance and emerging regulatory frameworks, and the subject of a prior FDA white paper. The exercise used simulated trial scenarios across four therapeutic areas—obesity, cardiovascular, pulmonology, and dermatology—to examine how SSDC can be incorporated into trial design while maintaining patient safety and data integrity.

The session built on a similar tabletop exercise held a year prior, extending an ongoing dialogue between regulators and sponsors on scaling pragmatic approaches in clinical research.

Pragmatic trial elements are broadly recognized as critical to enabling wider patient participation and generating evidence that better reflects real-world clinical practice.

A key barrier to their adoption has been uncertainty around how to handle safety reporting in less controlled, more naturalistic study environments. The exercise was designed to work through that uncertainty using concrete scenarios rather than abstract principles.

"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, in a press release. "Our intent is to build sponsor confidence in designing trials that include pragmatic elements and engaging FDA in productive, transparent dialogue on the topic."

The work sits within TransCelerate's broader Embedded Pragmatic Trials initiative, which aims to accelerate adoption of these designs by building awareness, fostering regulatory dialogue, and offering practical implementation tools.

Interest from health authorities outside the US in participating in similar discussions has also been noted, suggesting the conversation may extend beyond domestic regulatory frameworks.

"This work is part of a broader effort by TransCelerate to create space for open, practical dialogue across the clinical research ecosystem," added Kevin Bugin, head of global regulatory policy at Amgen and executive sponsor of the initiative, in the press release.

A pattern of industry-regulator collaboration

The release adds to a growing body of work TransCelerate has pursued in recent years to align industry and regulators around evolving clinical research standards.

In late 2025, the Applied Clinical Trials Podcast featured Jeneen Donadeo, executive director of portfolio management at TransCelerate, and Laura Galuchie, senior director and TransCelerate program lead at Merck, to discuss findings from a joint TransCelerate and Tufts Center for the Study of Drug Development study revealing that nearly one-third of data collected in Phase III trials is non-essential.²

The conversation explored why trial complexity continues to grow despite industry efficiency efforts, and what sponsors, CROs, and sites can do to better collaborate on smarter data strategies that reduce burden without compromising compliance.

Earlier in 2025, David Nickerson, head of clinical quality management at EMD Serono, and Arlene Lee, director of product management for data quality and risk management solutions at Medidata, were also featured on the ACT Podcast to discuss how TransCelerate and ACRO have partnered to help the industry navigate the newest ICH E6(R3) Good Clinical Practice (GCP) guidelines.³

Nickerson, who serves as executive sponsor of TransCelerate's ICH E6(R3) Initiative and as PhRMA topic lead on the ICH E6(R3) Expert Working Group, and Lee, an ACRO member participating in the initiative, addressed how the updated GCP guidelines are reshaping risk management and data governance practices across clinical operations.

This discussion covered practical tools developed to help stakeholders understand and implement the new standards, as well as recommendations for organizations working to align internal practices with the revised framework.

References

1. TransCelerate and FDA Advance Collaboration on Streamlined Safety Data Collection to Accelerate Inclusion of Pragmatic Elements in Clinical Trials. News release. TransCelerate. May 5, 2026. Accessed May 8, 2026. https://www.prnewswire.com/news-releases/transcelerate-and-fda-advance-collaboration-on-streamlined-safety-data-collection-to-accelerate-inclusion-of-pragmatic-elements-in-clinical-trials-302762139.html?tc=eml_cleartime

2. Unifying Industry to Better Understand GCP Guidance. Applied Clinical Trials. May 7, 2025. Accessed May 8, 2026. https://www.appliedclinicaltrialsonline.com/view/unifying-industry-better-understand-gcp-guidance

3. Streamlining Clinical Data to Reduce Site and Participant Burden. Applied Clinical Trials. November 4, 2025. Accessed May 8, 2026. https://www.appliedclinicaltrialsonline.com/view/streamlining-clinical-data-reduce-site-participant-burden