FDA Provides 2020 Rheumatology Drug Update

In response to small COVID-19 drug trials with low-quality evidence, the FDA issued a guidance statement for industry in May.²¹ The agency stressed the need for randomized, placebo-controlled, double-blind trials using a superiority design, defining endpoints to assess clinically meaningful aspects of the disease, and the inclusion of a broad range of participants, including patients from ethnic and racial minorities, Dr. Nikolov said. In research to find effective COVID-19 treatments, “there is a need for a multidisciplinary approach, coordinated global efforts and multi-stakeholder engagement,” he said.

Susan Bernstein is a freelance journalist based in Atlanta.

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