PANTHER: A Phase 2 International Platform Trial in ARDS
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In this episode of "In the Interim…" Dr. Scott Berry is joined by Professors Victoria Cornelius, Danny McAuley, and Anthony Gordon, for a technical review of the PANTHER trial—an international, Phase 2 adaptive platform evaluating pharmacologic interventions for ARDS. The trial is open-label and does not employ blinding, as discussed in the episode. The primary endpoint is 28-day organ support-free days (death as -1, survivors 0–28 days), analyzed with a Bayesian proportional odds model. PANTHER uses stratification by hyper- and hypoinflammatory subphenotypes, with fixed, equal randomization within each stratum. Analyses for treatments are separated by stratum, reflecting the potential of differential treatment effects. Quarterly interim analyses allow early stopping by stratum for efficacy or futility. Content includes explicit discussion of infrastructure: rapid device deployment, centralized data for trial and future biological discovery, and governance challenges in multinational collaboration. Funding is provided by NIHR (UK), US Department of Defense, CIHR (Canada), NHMRC and MRFF (Australia), HRB (Ireland), and additional support from Germany and Japan. PANTHER is positioned to streamline Phase 2 critical care drug testing and facilitate graduation to larger platforms such as REMAP-CAP, with potential to expedite pharmaceutical evaluation and accelerate ARDS therapeutic development.
Key Highlights
Real-time phenotyping (Randox device) to stratify ARDS patients.
Separate Bayesian analyses by phenotype stratum.
Open-label, fixed randomization within stratum.
28-day organ support-free days as a composite endpoint.
Quarterly interim analyses enable early dropping or graduation of arms by strata.
Central data resource and biosample collection for future research.
Operational, funding, and device logistics for global trial deployment.
Transition of Phase 2 results to established Phase 3 platforms (e.g., REMAP-CAP).
