By Clinical Research News Staff 

May 19, 2026 | Earlier this month, TransCelerate BioPharma released a summary report focused on selective safety data collection (SSDC) gathered during a joint tabletop exercise convened in late 2025 in collaboration with U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI).  

The 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. 

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 conversation between FDA and sponsors explored how SSDC can be applied in pragmatic clinical trials, which are widely recognized as critical to enabling broader participation and generating evidence that better reflects real-world practice while maintaining patient safety and data integrity. 

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 in a statement. “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 hypothetical trials served as a framework for examining trial design, operational, and oversight considerations associated with incorporating pragmatic elements, including the application of SSDC approaches. 

The takeaway messages from the session are not FDA guidance, but they can inform sponsor thinkings as they consider using SSDC approaches.  

FDA encouraged sponsors to propose SSDC for late-stage pre- or post-marketing trials for a drug where the safety profile is well-understood and documented. In fact, the agency expressed openness toward “dynamic” safety reporting, in which trials are designed to adapt between comprehensive and selective safety data collection as evidence evolves, though sponsors should plan the adaptation clearly and explicitly describe it.  

Global trials, however, present a challenge. While FDA supports SSDC implementation, it might not be equally welcomed by other regulatory bodies. FDA is open to facilitating international discussions with other health authorities to align regulatory positions, the agency indicated.  

For any data acquisition method, FDA emphasized, there must be a pre-planned approach to data quality in terms of personnel, operational workflows, and technical systems, and the agency distinguished between SSDC and EHR as data collection methods, noting that they could be used independently.  

Full notes from the exercise are available online.