Overview
I have been involved in both hypothesis driven clinical research as well as clinical trials, both of which are described below.
I have worked with health psychologists, medical fellows, and graduate students in clinical psychology. Most broadly, our research team has studied stress and coping processes in children with chronic disease and their families. Particular interests include describing the pain experience of children with chronic arthritis and the role of parental processes in child adjustment to chronic disease. We investigated the daily pain of children with arthritis in real time and their responses to pain, including activity and school function, as well as emotional regulation. In addition, we have examined the responses of parents to their child's pain in real time recorded using an electronic device. More recently, I have been studying the use of PROMIS patient reported outcomes in pediatric rheumatic disease populations.
I have also been active in the several clinic trials in pediatric rheumatology. I was the Principal Investigator for an NIH funded 21 center interventional trial entitled Prevention of Cardiovascular Complications of SLE: Atherosclerosis Prevention in Pediatric Lupus (APPLE) in conjunction with the Duke Clinical Research Institute (DCRI) and the Childhood Arthritis and Rheumatology Research Association (CARRA). This trial enrolled 221 children and adolescents with SLE and studied the efficacy and safety of statin therapy in children with SLE. I have also led trials studying the use of anakinra to treat Stills Disease and am currently leading a trial to see if abatacept can prevent extension of JIA. Most recently I have been awarded funding from PCORI to use an innovative SMART trial design to determine optimal therapy strategies for children with JIA who have failed treatment with a first biologic (anti-TNF) agent. This trial is leveraging the infrastructure of Duke Clinical Research Institute (DCRI), CARRA and our international partners the Paediatric Rheumatology European Society (PRES) and the Paediatric Rheumatology INternational Trials Organisation (PRINTO).
I am actively engaged with the CARRA network strengthening and broadening research infrastructure to make more pediatric rheumatology sites able to participate in clinical research, including testing consensus treatment plans developed by CARRA members for pediatric rheumatic diseases and a national registry of rheumatic disease to study medication safety and comparative effectiveness. This effort was jump started by a grant from the NIH as part of the American Recovery Act but is now supported by industry and the Arthritis Foundation. The CARRA registry includes 72 CARRA sites and has enrolled over 10,000 children with rheumatic disease (JIA, SLE, JDM) since reopening in July 2015. From this information, we hope to learn more about the outcomes of childhood rheumatic disease and establish best treatment practices.
Finally, I am working on making patient engagement in all aspects of clinical trials standard for CARRA and the pediatric rheumatology community. Patients and parents now participate in helping plan studies and conduct them, as well as bringing the results to the community. Patients and parents develop the patient facing materials for studies and assist in trial design.