TransCelerate and FDA Collaborate on Streamlined Safety Data Collection to Advance Pragmatic Clinical Trials
核心洞察
TransCelerate BioPharma (搜索) and the FDA's Center for Drug Evaluation and Research (搜索) released a new report on selective safety data collection following a joint tabletop exercise held in late 2025.
The collaboration involved more than 20 pharmaceutical R&D leaders and 15 FDA representatives exploring streamlined safety data collection approaches across four therapeutic areas including obesity (搜索), cardiovascular (搜索), pulmonology, and dermatology.
The initiative aims to scale pragmatic trial elements that enable broader patient participation and generate evidence reflecting real-world clinical practice while maintaining patient safety and data integrity.
TransCelerate BioPharma (搜索) announced the release of a new summary report focused on selective safety data collection (SSDC), capturing key insights from a joint tabletop exercise with the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (搜索) (CDER) Center for Clinical Trial Innovation (C3TI). The collaboration represents a significant step toward scaling pragmatic elements in clinical trials, which are widely recognized as critical to enabling broader participation and generating evidence that better reflects real-world practice.
Joint Exercise Explores Practical Implementation
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. The session built on a previous FDA-TransCelerate tabletop exercise held a year prior, extending ongoing dialogue between regulators and sponsors on scaling pragmatic approaches in clinical trials with particular emphasis on safety reporting.
The exercise explored how SSDC can be applied in practice while maintaining patient safety and data integrity. SSDC represents a risk-based approach reflected in International Council for Harmonization of Technical Requirements for Human Use (ICH) guidance and emerging regulatory frameworks, and is the subject of an FDA white paper.
Case-Based Scenarios Across Multiple Therapeutic Areas
FDA and TransCelerate representatives engaged in structured discussions using simulated trial scenarios developed by TransCelerate leaders across four therapeutic areas: obesity (搜索), cardiovascular (搜索), 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.
"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."
Advancing Embedded Pragmatic Trials Initiative
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. The organization aims to create space for open, practical dialogue across the clinical research ecosystem.
"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."
Expanding Global Regulatory Engagement
The collaboration has generated interest beyond U.S. regulatory authorities, with early indications of interest from other health authorities in participating in similar discussions to scale pragmatic approaches in other regions. This suggests potential for broader international adoption of streamlined safety data collection approaches in clinical trials.
TransCelerate BioPharma (搜索), a nonprofit organization dedicated to improving global health by accelerating and simplifying clinical research, has 18 member companies and maintains a robust portfolio of initiatives focused on transforming connectivity, enabling information sharing and reuse, and driving innovative trial designs.