www.fdanews.com/articles/190206-fda-issues-recommendations-for-esophagitis-drug-trials
FDA Issues Recommendations for Esophagitis Drug Trials
February 12, 2019
The FDA released draft guidance on clinical trial designs for treatments of eosinophilic esophagitis (EoE), a chronic inflammatory disease, including recommendations for selecting trial participants.
The randomized, double-blind, placebo-controlled trials should include a prespecified screening period before patients are randomized to confirm their eligibility, the agency said.
Trials conducted to support a drug’s marketing approval should evaluate the drug’s effect on both symptoms and the underlying inflammation of the disease by assessing the coprimary endpoints in Phase 3 trials.