臨床試験の透明性の現状：昨年動向と2026年展望

2026 marks the year transparency shifts from a compliance requirement to a core principle of good clinical practice (GCP). As ICH E6(R3) is implemented across major markets, transparency becomes embedded in trial design rather than addressed after the fact. Sponsors are expected to plan for global disclosure, plain‑language communication with participants, and expanded reporting obligations from day one—fundamentally changing how trials are designed, conducted, and reported.

AI’s value in 2026 is practical, targeted, and workflow‑driven, not transformational hype. The most effective uses include:

• Extracting disclosure‑relevant data from protocols and trial documents
• Converting unstructured protocols into structured formats aligned with ICH M11
• Generating first‑draft plain‑language summaries that reduce manual effort
• Supporting multi‑jurisdictional formatting and submission requirements

Rather than replacing disclosure professionals, AI augments existing tools and processes to help teams meet expanding obligations without expanding headcount.

Key priorities include:

• Building disclosure strategy into protocol design from the outset
• Preparing for ICH E6(R3) implementation timelines across regions (including Singapore, Canada, the UK, and EU)
• Ensuring readiness for Europe’s maturing transparency ecosystem, including PASS and EUDAMED requirements
• Developing robust plain‑language summary capabilities
• Rethinking registry strategies in light of uncertainty around ClinicalTrials.gov reliability
• Integrating AI selectively to support data extraction, formatting, and content generation

The organizations that act early will be best positioned to navigate regulatory fragmentation and demonstrate leadership in transparency.