I will discuss a project begun during the COVID-19 pandemic, Continuous Monitoring of Pooled International Trials of Convalescent Plasma for COVID-19 Hospitalized Patients (COMPILE). COMPILE consisted of a secure central repository for pooled data from eight randomized trials of convalescent plasma for the treatment of COVID-19 in hospitalized patients who were not yet on mechanical ventilation; these trials originated from four continents around the globe. A data sharing agreement governed publications and other aspects of the pooling. A secure central data repository hosted deidentified individual patient data and a collective data and safety monitoring board (cDSMB) regularly monitored the accumulating evidence. The pooled dataset was continuously updated with new data at two-week intervals. Unblinded biostatisticians conducted the interim analyses and reported to the cDSMB. I will discuss the details of both the statistical models for the primary outcomes and the decision rules that the collective DSMB used to make recommendations. I will also describe a treatment benefit index developed to predict which patients might benefit most from convalescent plasma therapy.
I | Attachment | Action | Size | Date | Who | Comment |
---|---|---|---|---|---|---|
png | A._Troxel__Headshot.png | manage | 278 K | 12 Feb 2024 - 15:42 | CierraStreeter |