ACR Poster 2018: Adverse Event Reporting Rates and Placebo/Standard-of-Care-Arm ACR Responses Vary by Region in Rheumatoid Arthritis Trials
Clinical trials are increasingly globalized; lower regulatory barriers in Eastern Europe result in disproportionately high early enrollment and the geographic distribution of patients in the interim analysis may be disproportionately represented by the Russian Federation and Eastern Europe. Standard of care, patient populations, and AE reporting rates may differ by region/economic development. Confidence is needed that results of the interim analysis are representative of those of the final analysis. This presentation presents findings of an examination of existing data from placebo/standard of care treatment arms among seven clinical trials in the TransCelerate initiative.