In this episode of “In the Interim…,” Dr. Scott Berry talks with Dr. Roger Lewis, Dr. Anna McGlothlin, and Dr. Nick Berry — all co-authors on the CHIPS trial results recently published in JAMA (Spinella et al., August 2026) — about the design, implementation, and results. The conversation covers why room-temperature platelets, which can be stored only five to seven days, leave rural hospitals, low-volume centers, and military and disaster settings without a reliable supply, and how a Bayesian adaptive design was used to find the maximum safe cold-storage duration rather than testing a single fixed duration. Roger, Anna, and Nick walk through the monotonic dose-response model that governed escalation, an unplanned mid-trial complication when the FDA independently authorized fourteen-day cold storage, and how the Data Safety Monitoring Board reviewed results within days of each interim. The trial ultimately demonstrated non-inferiority of cold-stored platelets out to twenty-one days with a Bayesian probability greater than 99.9%, offering a path to expanding platelet access in settings where it was previously very challenging.

Key Highlights

• Cold-stored platelets tested as a potential answer to platelet shortages in rural, low-volume, and military/disaster settings.
• Bayesian adaptive design used to find the maximum safe cold-storage duration, not just test a single fixed duration.
• A monotonic dose-response model constrained escalation to a pre-specified, safety-first ladder across four interim analyses.
• Mid-trial complication: an independent FDA decision allowing 14-day cold storage, absorbed into the design without unblinding.
• Non-inferiority demonstrated out to 21 days of cold storage, with a Bayesian probability greater than 99.9%.
• Interim data turned around by the unblinded implementation team in five business days, versus the six weeks often assumed for adaptive trials.
• Implications for platelet access in disaster, military, and low-volume hospital settings, and for how shelf-life-dependent products are tested going forward.

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