Safety considerations and data sources are crucial to consider when designing studies for rheumatology treatments, according to presenters at the 2022 ACR-FDA Summit.
PsA Trial Design Can Improve Patient Safety, Outcomes
For best safety and efficacy outcomes, trials in psoriatic arthritis should use active comparators and stricter remission criteria, with outcome measures that are important to patients.
Tips for Designing Studies That Actually Reveal Causal Inference
In a randomized, controlled trial, the risk difference between groups is interpreted as a causal effect of the treatment, according to Seoyoung C. Kim, MD, ScD, MSCE, an associate professor of medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics and the Division of Rheumatology, Inflammation and Immunity at Brigham and Women’s Hospital and Harvard Medical…