Joint GPH & NYU Grossman Biostatistics Seminar: Andrea B. Troxel, ScD

December 03


This event is hosted by the Department of Biostatistics.

TITLE: "Pooling Data from Individual Clinical Trials in the COVID-19 Era"

PRESENTER: Andrea B. Troxel, ScD Director, Division of Biostatistics Professor, Department of Population Health NYU Grossman School of Medicine

ABSTRACT: I will discuss a novel ongoing project, Continuous Monitoring of Pooled International Trials of Convalescent Plasma for COVID-19 Hospitalized Patients (COMPILE). COMPILE consists of a secure central repository for pooled data from at least eight ongoing or completed randomized trials of convalescent plasma for the treatment of COVID-19 in hospitalized patients who are not yet on mechanical ventilation; these trials originate from four continents around the globe. A data sharing agreement governs publications and other aspects of the pooling. A secure central data repository hosts deidentified individual patient data and a collective data and safety monitoring board (cDSMB) regularly monitors the accumulating evidence. The pooled dataset is continuously updated with new data at two-week intervals. Unblinded biostatisticians conduct the interim analyses and report to the cDSMB. When evidence with a high degree of confidence emerges, the cDSMB will make a joint recommendation to the leadership of all trials. I will discuss the details of both the statistical models for the primary outcomes and the decision rules that the collective DSMB will use to make recommendations.