Navigation Links
CDISC Announces New Standard for Rheumatoid Arthritis
Date:11/17/2016

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.

About CDISC
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.

Read the full story at http://www.prweb.com/releases/2016/11/prweb13855033.htm.


'/>"/>
Source: PRWeb
Copyright©2016 Vocus, Inc.
All rights reserved


Related medicine news :

1. CDISC to Host 2016 Japan Interchange in Tokyo
2. CDISC and TransCelerate Announce New Standard for Breast Cancer to Support Data Sharing for Oncology Research
3. CDISC Announces Groundbreaking Clinical Trial Registry XML Standard
4. CDISC to Host 2016 Europe Interchange in Vienna to Enable “Smarter Research to Unlock Cures”
5. CDISC, C-Path and TransCelerate Announce Availability of New and Updated Standards for COPD, Virology and Diabetes
6. CDISC Welcomes New Vice President, Standards, Terminology and Technical Services
7. CDISC & One Mind Host Benefit Supporting Post-Traumatic Stress CDISC & One Mind Host Benefit Supporting Post-Traumatic Stress and Mental Health Research
8. Cowboy Up! CDISC & One Mind Event for PTS and Mental Health Research
9. CDISC & One Mind Event for PTS and Mental Health Research
10. CDISC & One Mind Event for PTS and Mental Health Research
11. CDISC and One Mind Announce Availability of Research Data Standard for Traumatic Brain Injury
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/21/2017)... ... , ... Japanese Zen artist couple, Fumie and Kentaro Mune, have announced to ... at Miranda Kuo Gallery on Lower East Side, NYC. This exhibition will feature some ... Wanderlust , one of the largest US yoga online media outlets in the world, ...
(Date:9/21/2017)... ... 2017 , ... FlipBelt, the fitness brand that specializes in problem solving fitness ... market with the launch of their FlipBelt Crops. , The new fitness bottoms feature ... fingertips while at the gym, on the trail, or on-the-go. , “We always thought ...
(Date:9/21/2017)... , ... September 21, 2017 , ... ... offices serving communities in northern Alabama and Georgia, is embarking on an extended ... by utilizing modern early detection methods. , US Breast Cancer statistics show ...
(Date:9/20/2017)... ... 20, 2017 , ... Reflections Recovery Center, a men-only drug ... Joint Commission for chemical dependency and behavioral health services. , The Joint Commission ... that meet the commission’s rigorous standards. Accreditation by The Joint Commission is the ...
(Date:9/20/2017)... ... September 20, 2017 , ... ... Plus Coating System for clients that rely on safety and cleanliness. This unique ... microorganisms. , Silver has been used for centuries for its antimicrobial properties. Unlike ...
Breaking Medicine News(10 mins):
(Date:9/6/2017)... , Sept. 6, 2017   PDI , a leader ... will host an educational session focused on the role ... (CLABSI) prevention at the 2017 Annual Scientific Meeting of ... take place at the Phoenix ... from Sept. 16-19, will also feature PDI,s Prevantics® ...
(Date:9/6/2017)... Eli Lilly and Company (NYSE: LLY ) ... and lasmiditan, two investigational treatments for migraine, at the ... place Sept. 7-10 in Vancouver . ... from an open-label study evaluating the safety and effectiveness ... mg) for the prevention of migraine. Galcanezumab is a ...
(Date:9/5/2017)... , Sept. 5, 2017  Xyntek Inc. has announced another milestone in their ... Midwest office to meet the growing demands of customer engagements regionally.  ... Xyntek's new Midwest office is located at 318 West Adams ... ... engagements regionally. ...
Breaking Medicine Technology: