How evidence is generated and published creates gaps between what science knows and what the record reflects. Technology can address this.

2026 is an extraordinary year for medicine. The convergence of real-world data networks, artificial intelligence, blockchain infrastructure, and connected patient devices is creating conditions that make it possible — for the first time — to build a drug evidence ecosystem that is continuous, comprehensive, transparent, and genuinely patient-centered.

Congressional recognition of this moment came with the 21st Century Cures Act of 2016, which directed the FDA to develop frameworks for integrating real-world evidence (RWE) into regulatory decision-making — a mandate whose technical fulfilment is now within reach.

The pharmaceutical industry has built extraordinary science. Regulatory agencies like the FDA have protected public health under enormous complexity and resource constraints. Academic researchers have advanced clinical knowledge.

And yet structural patterns in how evidence is generated, funded, and published — documented across multiple therapeutic areas in the peer-reviewed literature — create gaps between what science knows and what the evidence record reflects. Technology is now uniquely positioned to close those gaps.

There is a concrete, technology-grounded framework for doing so: Evidence 2.0, which is organized around three pillars — holistic real-world evidence generation, end-to-end transparency and traceability, and technology-enabled regulatory modernization, and is grounded in existing FDA programs, published research, and implementable technology standards.

Evidence 2.0 is detailed in longer-form whitepaper by Sonata here.

Greater discussion in the above paper is placed on understanding the current landscape, recognizing where technology can make the greatest difference, providing a look at technology-enabled regulatory evolution for modernizing FDA, presenting a collaborative implementation roadmap, and more.

Ultimately, Evidence 2.0 is about patients. It is about a person with a chronic condition who deserves to know not just that a therapy worked in a trial, but how well it has worked in thousands of people who look like them, live like them, and take the other medications they take.

It is about a clinician who deserves an evidence base comprehensive enough to support genuinely informed prescribing. It is about a regulator who deserves the data infrastructure to identify emerging safety signals before they become clinical crises.

The technology to build this system exists today and is increasingly mandated into place. The ONC’s FHIR requirements, the FDA’s Sentinel expansion, published blockchain clinical trial frameworks, and the FDA’s own RWE program, together constitute a substantial foundation on which Evidence 2.0 can be built.

What is needed now is the coordination, the investment, and the collaborative governance to connect these components into a unified, patient-serving system.

The pharmaceutical industry, academic medicine, and the FDA have a genuine opportunity to build something that will benefit patients for generations.

An evidence system as sophisticated as the science it evaluates, as continuous as the health it monitors, and as transparent as the public trust it must earn.

The tools are here. The framework exists. The opportunity is now.

To learn more about the whitepaper from Sonata, visit here.

Article authored by Raghav Dave, SVP, Business Unit Head, Healthcare and Lifesciences at Sonata Software