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Results from the Phase III ARTISTRY-2 study show that a fixed-dose combination of bictegravir and lenacapavir achieved non-inferior efficacy to Biktarvy in adults with HIV who switched therapy, supporting Gilead’s plans to advance the regimen toward regulatory submission alongside data from ARTISTRY-1.

In today’s ACT Brief, we look at new evidence showing how targeted training can build research readiness at community cancer centers, explore McKinsey’s view on how digital tools can make trials more patient-centric and geographically inclusive, and review new Phase III results that could reshape obesity and osteoarthritis treatment.

Discover how remote assessments, wearables, and digital technologies can decentralize data collection, reduce patient burden, and enable trials to reach more diverse and representative populations.

This pilot project evaluated whether targeted training could strengthen clinical research capacity at community cancer centers, improve readiness to conduct oncology trials, and support more inclusive patient enrollment by addressing barriers, building foundational skills, and increasing staff confidence in trial implementation.

In today’s ACT Brief, we examine new data on how AI is improving the accuracy and speed of COA localization, break down McKinsey’s perspective on why trials must expand beyond AMCs and into routine care settings, and highlight the FDA’s latest approval of a targeted biologic for generalized myasthenia gravis.

Explore how expanding clinical trials into community and nontraditional sites, simplifying protocols, and leveraging AI can broaden patient access and bridge the gap between real-world care and research.

New data show that applying AI to the migration of translated COAs into eCOA platforms can meaningfully reduce errors, accelerate localization workflows, and support broader global patient participation—while still relying on human reviewers to ensure linguistic precision and clinical integrity.

In today’s ACT Brief, we highlight new insights from McKinsey on where AI can meaningfully accelerate clinical development, break down the emerging design and regulatory forces reshaping obesity drug development, and examine why human-centered clinical guidance is becoming essential within an increasingly fragmented pharmacy system.

See how combining human oversight with AI insights improves protocol authorship, site selection, and monitoring strategies, delivering better decisions than AI-only or human-only approaches.

Explore how AI can optimize study design, speed patient recruitment, and streamline operational workflows to shorten development timelines and enhance trial efficiency.

In today’s ACT Brief, we break down FDA’s new superiority requirement reshaping CAR-T development, examine Pfizer’s global move into oral small-molecule GLP-1 therapy, and highlight new MONALEESA findings that reinforce long-term disease control with Kisqali.

New FDA guidance signals a major shift for CAR-T development, calling for randomized trials with standard-of-care control groups and clear evidence of superiority over existing therapies, while simultaneously easing REMS requirements to reduce logistical burdens for treatment centers and patients.

In today’s ACT Brief, we explore how stronger vendor–sponsor governance is speeding eCOA study startup, hear from AMR Clinical on the biggest opportunities to advance site operations and collaboration, and highlight new long-term data supporting earlier use of Carvykti in relapsed or refractory multiple myeloma.