ACT Brief: DIA Leadership and Infrastructure Priorities, Real-Time Data Review Readiness, and CLL Treatment Expansion

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• At the 2026 DIA Global Annual Meeting, speakers emphasized that real-time regulatory oversight demands quality-by-design thinking from protocol inception, not post-study cleanup, alongside protocol digitization to enable amendment automation and unified data infrastructure. Mixed outsourcing models and explicit patient accountability from development start emerged as critical operational priorities for managing growing trial complexity.
• In a new Q&A, Raj Indupuri, CEO and co-founder of eClinical Solutions, discussed why the FDA's push toward continuous data review is fundamentally an infrastructure challenge, not a technology one. Organizations need unified data pipelines and enterprise-level RBQM moving beyond study-by-study implementation, supported by transparent AI agents that sponsors can inject with their own governance frameworks and protocols.
• The EMA's CHMP issued a positive opinion for Eli Lilly's Jaypirca across all lines of CLL therapy, regardless of prior BTK inhibitor treatment. BRUIN CLL-322 showed 45% reduction in disease progression when pirtobrutinib was added to venetoclax-based regimens in previously treated patients, establishing potential new standard of care for second-line therapy.

That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.