Microbicide Trial Design Flexibility Supported At FDA Advisory Panel Meeting
This article was originally published in The Tan Sheet
Executive Summary
Microbicide researchers and health advocates urged FDA to adopt a flexible approach to the design of clinical studies on products for reducing HIV transmission during an August 20 meeting of the agency's Antiviral Drugs Advisory Committee in Bethesda, Md
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A microbicide clinical trial "win" should be based on "compelling" evidence of superior efficacy versus placebo and "supportive" evidence compared with a no-treatment arm, FDA Antiviral Drugs Advisory Committee consultant Richard Haubrich, MD, University of California, San Diego, said at an Aug. 20 meeting of the panel
Microbicide Trial Three-Arm Design May Be Optimal Initially – Panelists
A microbicide clinical trial "win" should be based on "compelling" evidence of superior efficacy versus placebo and "supportive" evidence compared with a no-treatment arm, FDA Antiviral Drugs Advisory Committee consultant Richard Haubrich, MD, University of California, San Diego, said at an Aug. 20 meeting of the panel
Microbicide Trial Three-Arm Design May Be Optimal Initially – Panelists
A microbicide clinical trial "win" should be based on "compelling" evidence of superior efficacy versus placebo and "supportive" evidence compared with a no-treatment arm, FDA Antiviral Drugs Advisory Committee consultant Richard Haubrich, MD, University of California, San Diego, said at an Aug. 20 meeting of the panel