FDA Issues Guidelines for Rhinosinusitis Research
Recommendations are first-ever for clinical trials of treatments for chronic rhinosinusitis
FRIDAY, Nov. 3 (HealthDay News) -- The U.S. Food and Drug Administration has issued the first set of guidelines for researchers conducting clinical trials of chronic rhinosinusitis treatments. "Rhinosinusitis: Developing Guidance for Clinical Trials" will be published in a November supplement of the Journal of Allergy and Clinical Immunology and in Otolaryngology - Head and Neck Surgery.
Some 25 physicians from five medical societies teamed up to create the guidelines, according to an FDA statement. The new guidelines contain recommendations for trials involving allergic fungal rhinosinusitis, chronic rhinosinusitis and acute bacterial rhinosinusitis, the FDA notes.
The recommendations include presenting guidance for clinical studies of symptom relief, anti-inflammatory and antimicrobial rhinosinusitis treatment, and advice on instruments and techniques for assessing infection, inflammation and outcomes, the FDA adds.
"The goal of the Rhinosinusitis Initiative has been to provide researchers with the needed methodologies, which will promote better clinical studies that can lead to improved patient care," Eli O. Meltzer, M.D., of the Allergy and Asthma Medical Group and Research Center in San Diego, said in a statement.