Medidata, a global provider of cloud-based solutions for clinical research in life sciences, has been selected to support the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry, a 10-year project to collect comprehensive data on pediatric rheumatic diseases and their treatments.
CARRA is a North American nonprofit research organization of more than 400 pediatric rheumatologists, researchers and research coordinators at more than 100 sites (95% of all pediatric rheumatologists/sites in North America) who are working together to find treatments for juvenile idiopathic arthritis and other pediatric rheumatic diseases in children.
"While we’ve made huge progress in the last decade, 300,000 children and families in the U.S. alone are affected by rheumatic diseases," said Laura Schanberg, M.D., professor of pediatrics at Duke University and CARRA president, and the Principal Investigator for the CARRA Registry, an observational study of children and adolescents with major rheumatic diseases. By powering data capture for the scalable informatics infrastructure of the CARRA Registry, the Medidata Clinical Cloud will help CARRA develop a resource for patients, physicians and researchers seeking to learn more about pediatric rheumatic diseases and, ultimately, drive better diagnostic and treatment approaches.
In support of its long-term research efforts, the registry is leveraging Medidata’s cloud-based technology for electronic data capture and management (Medidata Rave) and mobile solution for patient-direct data capture (Medidata Patient Cloud). A mobile app unified with Medidata’s platform, Patient Cloud brings new efficiencies to the administration of electronic patient-reported outcomes (ePROs) in clinical trials and registries. The mobile app provides electronic patient questionnaires and diaries in a model that simplifies the process for both patients and researchers.
"Using Medidata’s platform in combination with the open-source, i2b2 federated clinical research data warehouse platform already in use for the CARRA Registry, this post-marketing surveillance network will collect at least 10 years of comprehensive information, including detailed safety and treatment data, on pediatric rheumatic disorders in the U.S. and Canada," said Marc Natter, M.D., the CARRA Registry’s director of informatics development and instructor in the Boston Children's Hospital Informatics Program. “This is a critical next step in understanding how to best apply available therapies and improve the systems for studying the safety and efficacy of treatment options for childhood-onset arthritis."
Dedicated to advancing the health and quality of life of children living with rheumatic disease and arthritis, CARRA was formed by pediatric rheumatologists seeking to answer critical clinical research questions. "Juvenile idiopathic arthritis and other pediatric inflammatory disorders result in persistent joint pain, swelling and stiffness of joints, decreased activity and potentially growth and eye problems," Schanberg said. "Children lose days from school, parents lose days from work and quality of life suffers greatly. We believe that simplifying data capture and patient participation processes will catapult the field of pediatric rheumatology research to the level of performance necessary to realize dramatic improvements in outcomes and quality-of-life for all children with rheumatic disease."