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HIV Working Group
September 24 @ 1:00 pm - 1:50 pm
Michael Hughes, Ph.D.
Professor, Department of Biostatistcs, Harvard T.H. Chan School of Public Health
Director, Center for Biostatistics in AIDS Research
Design Considerations in a COVID-19 Platform Trial — Experience from the ACTIV-2 Trial
Abstract: ACTIV-2 is a major international platform trial led by the NIH-funded AIDS Clinical Trials Group. It was designed in response to the COVID-19 pandemic and has evaluated several candidate agents for the treatment of non-hospitalized people with symptomatic COVID-19, with the aim of reducing hospitalizations and deaths. The design incorporates novel design features including the sharing of placebo control groups, potentially with different placebos for each candidate agent, and a seamless transition from phase 2 to phase 3 evaluation. I will discuss the design and implementation of this complex trial.