News|Articles|June 1, 2026

Real-World Evidence in Clinical Trials: Where the Industry Stands and Where It's Headed

As the FDA formally recognizes real-world evidence as eligible confirmatory evidence for drug approval, sponsors face a growing imperative to build the data infrastructure, organizational alignment, and analytical capabilities needed to use RWE effectively across the development lifecycle.

Real-world evidence (RWE) has been moving steadily upstream in drug development. With the FDA now explicitly recognizing RWE as eligible confirmatory evidence under its updated single-trial standard, the question is no longer whether RWE belongs in clinical development, but how to build the infrastructure and organizational capabilities to use it effectively.

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September 24th, 2026

When There’s No Registry: Building Rare Disease Evidence That Supports Regulatory Scrutiny

In rare disease drug development where no registry or natural history dataset exists, real-world evidence quality depends on treating evidence engineering as a design-stage decision, defining intended regulatory use and standardizing endpoints, harmonization, and data provenance upfront rather than reconciling gaps after collection.

September 21st, 2026

Moving Beyond Disappointing Pilots: Scaling Adoption of AI-Enablement in Drug Development

Most AI pilots in drug development fail not from poor technology but from lack of strategic prioritization, organizational readiness, integrated data infrastructure, and disciplined governance, making success dependent on business discipline rather than technical capability.

September 14th, 2026

The Execution Gap: Why Clinical Trial Infrastructure Has to Be Built Before AI Can Deliver

Clinical trials have spent decades perfecting data capture, but the execution layer underneath it, including decision workflows, data collection design, and lab connectivity, remains fragmented in ways that limit what AI can realistically deliver and that quietly compromise the scientific validity of the data itself.

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September 22nd, 2026

Is Decentralization Actually Reducing Site Burden, or Just Moving It?

Decentralized trial models have demonstrated real gains in enrollment performance and patient access, but operational switching costs, fragmented technology stacks, and unresolved gaps in the patient-site relationship raise a question the industry has been slow to confront directly.

September 17th, 2026

Lessons from Hundreds of Clinical Trials: AI’s Successes, Gaps, and Opportunities

Why clinical development’s next AI bottleneck is not the model, but the system around it.

September 10th, 2026

Recruitment in the Age of AI: Q&A with John Worden, Javara

In this Q&A, John Worden, chief commercial officer at Javara, discusses why clinical trial recruitment has remained stubbornly one-size-fits-all, how AI can identify patients at scale without displacing the clinician relationships that drive trust, and what care-integrated research engagement needs to look like for health systems, sponsors, and sites.

September 9th, 2026

From Participation to Understanding: Reframing Engagement in Clinical Trials

Participant engagement depends more on clarity and understanding than on gamification or incentives, requiring engagement embedded into trial workflows as a core design component rather than a peripheral consideration

September 24th, 2026

Trust, Technology, and the Patient-Site Relationship: Q&A with Andrea Valente, uMotif

In this Q&A, Andrea Valente, CEO of uMotif, discusses what it takes to build genuine trust between patients and sites, why making technology easier to use isn't the same as making patient-site interaction more effective, and where the industry is still falling short in its push toward patient-centered trial design.