ACT Brief: Organizational Barriers to Programmatic Recruitment, Scaling Selective Safety Data Collection, and Subcutaneous Alzheimer's Treatment

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

• In part four of her interview, Gaynor Anders, chief delivery officer at Trialbee, identified organizational silos, siloed budgets, and a study-centric mindset as the biggest barriers to shifting from study-by-study to programmatic recruitment. Mapping a program that sponsors might not initially see requires breaking down these structural obstacles and rethinking how recruitment functions across therapeutic areas.
• In a new Q&A, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, discussed FDA and CTTI collaboration developing four regulatory scenarios for selective safety data collection that reduce visits and assessments by 50-75% without compromising quality. The real opportunity lies in scaling these approaches systematically rather than running pragmatic trials as one-off efforts, which requires regulatory alignment and engagement across sponsors, investigators, and patient communities.
• FDA approved Leqembi Iqlik as the first at-home subcutaneous initiation dose for early Alzheimer's disease, delivered via once-weekly autoinjector. An acceptability study found 94% of patients and caregivers found the device easy to use, with the approval reducing clinic visits and infusion infrastructure burden while maintaining safety comparable to IV administration.

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