This portfolio supports patient-relevant clinical research and the design, development and execution of clinical trials and registries in rheumatic diseases in adults and children, such as rheumatoid arthritis, lupus, scleroderma, ankylosing spondylitis, psoriatic arthritis, gout, inflammatory myopathies and vasculitis. These studies are intended to test hypotheses and translate early evidence into clinically meaningful, valid information to improve adherence to, and the quality of routine patient care by aiming to treat, cure or prevent these rheumatic diseases.
An important focus is on studies that effectively test the comparative efficacy and safety of new and existing therapies (drugs, biologics, devices), address comorbidities and patient-important outcome measures relating to disease damage, symptoms (e.g., pain) and functional impairment by utilizing creative approaches to trial design and implementation in both common and rare autoimmune diseases of interest to the NIAMS.
The portfolio will also encompass biomarker validation protocols, especially those that will enhance the ability to personalize treatment decisions, particularly at early stages of disease. It also includes scientific leadership of the PEPR initiative as well as ongoing management of the PROMIS and ECHO initiatives.