92% of Clinical Trial Organizations Plan AI Investment by 2028

A substantial gap exists between current artificial intelligence adoption in clinical trials and planned investment, according to WCG's 2026 Clinical Research Trends and Insights Report. While only about one-third of organizations currently deploy AI across a meaningful portion of their trials, 92% intend to increase investment within the next two years.

The report identifies four operational priorities shaping the industry's near-term trajectory: AI and machine learning integration, site and investigator readiness, participant experience design, and cell and gene therapy logistics. Each represents a domain where execution capability will separate high-performing organizations from those still operating reactively.

Site activation delays persist

Site readiness emerges as a critical bottleneck that technology alone cannot resolve. An ICON survey of more than 100 principal investigators conducted in mid-2025 found that 55% reported site activation taking longer than five months after selection. WCG frames readiness not as a pre-trial checklist but as a continuous organizational capability—a distinction with practical implications for sponsors who typically invest heavily in site identification while underinvesting in the period between selection and first patient enrollment.

This gap is where delays compound into protocol deviations and data variability. The report suggests that tying site readiness scores to contract renewal and payment milestones could convert readiness from recommendation to industry standard.

Regulatory framework takes shape

The FDA issued draft guidance in January 2025 addressing AI supporting regulatory decision-making, signaling an evaluative rather than permissive approach. This means governance and auditability requirements are foundational, not optional. Organizations treating AI governance as infrastructure will hold an advantage when regulators scrutinize AI-generated data at submission.

The global AI in clinical trials market is projected to reach $3.32 billion in 2026, driving vendor proliferation that outpaces most sites' ability to evaluate tools rigorously. The transition from experimental AI pilots to embedded trial operations is underway, making governance frameworks an immediate operational need.

Participant design drives retention

WCG distinguishes between participant-centric design—largely a framing exercise—and participant-driven design, which represents actual structural change. The latter approach improves both retention and data quality, outcomes with direct financial impact. Retention failures reliably predict trial extension costs, making participant experience a material operational concern rather than a secondary consideration.

Why it matters

The 92% investment figure reveals an industry acknowledging that AI adoption is no longer optional, even as most organizations lack meaningful implementation experience. The real test will be whether sponsors and sites can build governance infrastructure and site readiness capabilities fast enough to match their investment timelines. Organizations that treat these as operational fundamentals rather than pilot projects will gain measurable advantages in trial speed, data quality, and regulatory acceptance.

The findings were first reported by WCG in their 2026 Clinical Research Trends and Insights Report.