To follow Laura Schanberg as President of CARRA is a daunting task! Under Laura’s leadership, we successfully enrolled the CARRA Legacy Registry, formed a 501c3 organization replete with a Board of Directors, an External Advisory Council, and new by-laws. We have a new website and a partnership with the Arthritis Foundation. We funded and launched the new CARRA Registry, began the first CTP comparative effectiveness study, and are working with Novartis and Roche on post marketing surveillance. CARRA is a part of PARTNERS, a patient-powered research network and began incorporating patient engagement in research. The 2016 annual meeting was a tremendous success, had a record attendance, and the energy was palpable. That energy continues with work groups pressing ahead on major initiatives. There are roughly 15 publications in progress. Laura’s contributions are too numerous to list, but I am honored to follow her. I look forward to all we can achieve together over the next 2 years. We look forward to the 2017 meeting in Houston, the planning for which is already in progress. Steering Committee members and annual meeting tri-chairs, Stacy Ardoin, Peter Blier, and Adam Huber, are working with Executive Director Kelly Mieszkalski to plan the meeting, which will be in conjunction with PRSYM. Stacy, who heads the abstract committees of both CARRA and PRSYM, has worked with Jason Jones, Sr. Director of Research, and the ACR to develop a jointly managed abstract program.
The Steering Committee members are developing work group and committee planning and project prioritization. In December, the Steering Committee will come together in Philadelphia for a full day of strategic planning, identification and alignment of cross-committee synergies, and problem solving. Pam Weiss has assumed the role of JIA Chair and Sarah Ringold is the new JIA Vice Chair. Theresa Wampler-Muskardin is the new Vice Chair of the Small Centers committee. I am thrilled with the expanded roles many CARRA members are assuming.
The CARRA biosample repository is closer to becoming a reality, and all Steering Committee members and Registry PIs, along with commercial biobanks, received an RFP. This is the culmination of TRTC members’ hard work over many months. The biorepository will be a valuable resource for translational research.
Enrollment in the Registry is approaching 1800 subjects, and the data quality looks outstanding. Sites are doing a terrific job of enrolling the right patients and completing data entry. Mary Beth Son and Sarah Ringold were selected as the inaugural Registry fellows and are each working on several important Registry projects. We are excited that the PCORI-funded STOP-JIA study that Sarah Ringold and I lead has started enrolling patients. STOP-JIA will help answer our question of which treatment strategy for starting biologics results in the best outcomes for patients with new onset polyarticular JIA. We truly appreciate all the enthusiasm and work of all site PIs and coordinators to make these studies successful.
Precision Decisions to STOP-JIA, with funding from the Arthritis Foundation and support from CARRA, will collect biosamples on patients enrolled in STOP-JIA. These will be banked while work is done on existing samples and in silico to initiate the identification of biomarkers of response and diagnosis. PI Rae Yeung is collaborating with Sue Thompson, Mara Becker, Nora Singer, and Betsy Mellins, while Toronto Sick Kids and the University of Cincinnati will serve as biobanks for STOP-JIA samples.
In Q3 2016 with funding from Genentech, we will launch the FROST study, which will address a question of critical importance to patients with systemic JIA: What is the best first-line therapy for patients with new-onset systemic JIA? In FROST, we will compare the effectiveness of sJIA CTPs (biologic vs. non-biologic) in achieving clinical inactive disease off glucocorticoids at 9 months in patients with new-onset sJIA, and we will compare patient/caregiver reported outcomes between the CTPs. More information and training will be forthcoming. In addition, we have funding from a private foundation to collect biosamples in subjects in FROST, which will mirror the Precision Decisions sample collection. The TRTC is developing a process for FROST sample access.
Also in Q3, we will launch electronic collection of Patient Reported Outcomes (PROs) for the Registry, STOP-JIA, and FROST, as well as electronic consenting (eConsenting). To accomplish this, all sites will receive iPADS to use for consenting and collecting PROs. Many of you attended workshops about eConsenting at the annual meeting, and the feedback was very positive. eConsenting will make it easier to enroll patients by answering questions and assuring consistent messaging,. In addition, it will provide data and feedback about the consent process and overall consent management for sites. Training on this will be forthcoming.
In Q4, we expect to launch the enrollment of patients with lupus and scleroderma in the Registry. We are also working on including dermatomyositis next. We are very keen on adding as many diseases to the Registry as possible, but each requires significant work, so must to be done in stages. We are continuing to look for more funding to support the addition of diseases to the Registry.
Last but not least, in round one of our small grant funding we funded 17 grants totaling $269,000, and we have now opened the application process for two large CARRA grants ($50K each), a second round of small grants (up to $25K each) and up to 5 grants (up to $10K each) to pay for analyses that will lead to publications of CARRA data. Please refer to the CARRA website for more details. We are excited to offer these resources to our membership.
In short, we are very busy! Our members now number more than 460, representing 40 of the United States plus Puerto Rico and the District of Columbia, seven Canadian provinces, Germany, Israel, Italy, Kuwait, Turkey and the United Kingdom. Thank you for your continued active engagement. I look forward to all we can achieve together and to the impact I am sure we will make in the outcomes of children with rheumatic diseases.