“This was truly a collaborative effort with representatives from across the biopharmaceutical industry, the U.S. FDA and Japan Pharmaceutical and Medical Devices Agency (PMDA). We are thrilled with the content and were excited to have both the FDA and PMD
Austin, TX (PRWEB) November 17, 2016
The Clinical Data Interchange Standards Consortium (CDISC) announced today the open availability of a new clinical research data standard for Rheumatoid Arthritis (RA). The RA data standard and accompanying User Guide describe the most common biomedical concepts gathered from patient data relevant to clinical RA studies and define concepts in a clear, unambiguous way, allowing researchers to effectively collect, manage, share and compare data to advance treatments and find breakthroughs.
An estimated 1.5 million people in the United States suffer from RA, an auto-immune and inflammatory disease that can cause stiffness, pain, swelling and limited joint mobility as well as additional symptoms. Utilizing this standard makes it possible for medical research data on RA to be more easily shared and compared across studies, streamlining research processes and improving analysis capabilities to ensure accelerated learning and better science, and to advance treatments for patients with RA. Furthermore, implementing CDISC standards in clinical research studies has been found to significantly reduce time and costs, while improving data quality and streamlining development of medical products and therapies for patients.
“The Rheumatoid Arthritis Therapeutic Area team is very pleased to announce that version 1.0 of the User Guide has been published,” stated Mikenlette Avent, Senior Standards Manager at UCB and RA Team Co-Lead. “This was truly a collaborative effort with representatives from across the biopharmaceutical industry, the U.S. FDA and Japan Pharmaceutical and Medical Devices Agency (PMDA). We are thrilled with the content and were excited to have both the FDA and PMDA provide a thorough review of the User Guide prior to publication.”
The User Guide was developed through the Coalition for Accelerating Standards and Therapies (CFAST) RA Team, led by Ms. Avent and her colleague, Trisha Simpson, Director, Global Integrated Standards at UCB, and supported by a consortium of medical and technical experts. CFAST is a joint initiative of CDISC and Critical Path Institute, formed to accelerate clinical research and medical product development by creating and maintaining data standards, tools and methods for conducting research in therapeutic areas that are important to public health, with invaluable support and advice from such organizations as the National Cancer Institute, Innovative Medicines Initiative, TransCelerate, and regulatory agencies, including the FDA, PMDA, and the European Medicines Agency.
CDISC is a 501(c)(3) global non-profit charitable organization that streamlines research and enables connections to healthcare through the development of clinical research data standards. CDISC has developed a suite of standards to support clinical research from protocol through analysis and reporting. CDISC standards make it possible for data to speak the same language, empowering simple data collection and private sharing that makes the most of the valuable information offered by patients participating in research studies around the globe. Using CDISC standards from the start of studies enables Smarter Research to Unlock Cures (http://www.unlockcures.org), saving 70-90% time in the start-up of clinical research studies and ~60% overall in terms of time and resources to conduct research. CDISC is the patient’s advocate, creating therapeutic area data standards for over 25 different disease areas that advance medical product development and various types of clinical research.
CDISC is funded through the generous support of over 400 member organizations, as well as through grants, Authorized CDISC Education courses, events and charitable contributions. To find out more about how to support CDISC, please visit http://www.cdisc.org.