Disparate databases containing spontaneous safety reports vary in quality, quantity and format, making it difficult to leverage these databases to identify and investigate safety signals. CLÆRITY standardizes the coding of drugs, conditions and procedures, allowing for rapid signal detection and investigation of spontaneously reported adverse events.
As the drug safety landscape shifts, so do the methods for AE reporting. Traditional sources of adverse event reporting include clinical trial investigator site and post marketing medical information call center. However, potential adverse event reporting can occur in any patient interaction program, such as specialty pharmacies, patient assistance programs, and patient adherence services. Because capturing drug safety information is paramount, I chose this topic for my presentation at last week’s HNC U.S.
A study, designed and undertaken by medical and industry experts including Krista Payne and Noreen Lordan of UBC, assesses the health-related quality of life (HRQoL) of 154 patients with multiple myeloma (MM). This cross-sectional, bi-national, multicenter study enrolled patients with MM presenting for routine care visits at five United Kingdom and six German sites.