When the Supreme Court changes a legal standard, the system adjusts. When the FDA changes a regulatory default, the drug development ecosystem recalibrates.
Last week’s FDA decision to make one adequate and well-controlled trial the default, supported by confirmatory evidence and ongoing validation, marks a structural shift in how we establish credibility.
This shift was not inevitable. The two-trial norm emerged when biologic insight was limited and data infrastructure immature. Today we operate in a world of multiomics, AI-driven analytics, and real-world data delivered at scale in near real time.
This moment builds on the FDA’s December action removing barriers to the use of real-world evidence in regulatory review. December signaled institutional confidence that regulatory-grade data can strengthen application review. The one-trial default is the logical next step. It formalizes real-world evidence not as supplemental, but as integral to credibility itself.
This is not theoretical for Truveta. We already support evidence generation across every therapeutic area—from oncology and cardiometabolic disease including GLP-1 therapies, to cardiovascular medicine, vaccines, rare conditions, and more—where real-world validation strengthens clinical insight. The infrastructure required for intelligent evidence is not aspirational. It is operational.
Credibility is no longer defined by counting trials. It is defined by the strength, coherence, and integration of evidence. This is not a lowering of standards. It is a recalibration of rigor itself.
The rise of intelligent evidence
In programs where a second large trial would previously have been required, a one-trial default will remove years from development timelines.
Life sciences organizations will invest more in designing that first trial and in rigorous safety and effectiveness monitoring once complete. Capital, time, and scientific effort move from duplication to integration.
A one-trial framework signals the transition from episodic studies to integrated intelligence. Regulators and life sciences will increasingly rely on:
- Representative, complete, and timely patient data
- High-fidelity outcome capture
- Rigorous scientific methodology backed by transparent, reproducible analytics
- Strong governance and auditability
Truveta was built for this moment
As the one-trial default takes hold, confirmatory evidence must be credible, scalable, and intelligent. That requires regulatory-grade, complete, and timely data, rigorous quality processes, and reproducible analytics at national scale.
The line between development and care will narrow as trials increasingly sit within continuously learning systems, where health systems, life sciences, and regulators learn from the same data, evidence, and intelligence.
This is a defining shift in how medicine advances.
In medicine, time saved becomes lives saved.
This is how we Save Lives with Data.
