ARTICLE | Regulation

Follow-up rigor

FDA panel expects outcomes trials to meet rigor of Merck's vorapaxar study

January 27, 2014 8:00 AM UTC

A focus on follow-up made the conduct and execution of Merck & Co. Inc.'s CV outcomes trial for Zontivity vorapaxar a model of rigor that FDA's Cardiovascular and Renal Drugs Advisory Committee expects future trials to equal.

Prospective stratification also allowed the company to exclude patients with a prior history of stroke mid-way through the study while the rest of the trial continued unaffected...