A new and very inspiring project for developing Therapeutic Area Standards places CDISC in a leading position to achieve patient safety through higher quality medical research around the globe.
Please see below for further details about the Therapeutic Area Standards. And please stay tuned to our most recent updates as well as our Press Releases!
*If your organization is not currently a CDISC member and you would like to gain access to the Members Only Area including the Therapeutic Area Standards, please contact Sheila Leaman*
Standard Cardiovascular End Point Definitions
Parkinson's Disease
**Standard Cardiovascular End Point Definitions Posted for Public Review**
**New** Standard End Point Definitions in Cardiovascular Trials Slides (pdf)
Presented by Karen A. Hicks, M.D. Medical Officer Division of Cardiovascular and Renal Products (DCRP), Center for Drug Evaluation and Research (CDER), Food & Drug Administration on behalf of the Standardized Data Collection for Cardiovascular Trials Initiative for the CDISC Webinar on Friday, November 19, 2010
The Standardized Data Collection for Cardiovascular Trials Initiative is a working group composed of academicians as well as clinicians and representatives from professional societies, Clinical Data Interchange Standards Consortium (CDISC), Health Level Seven (HL7), Clinical Trials Transformation Initiative (CTTI), industry organizations, and the Food and Drug Administration (FDA). The goal of this working group is to improve the quality and efficiency of cardiovascular trials.
Working group members were divided into three teams led by Drs. Kenneth W. Mahaffey of Duke Clinical Research Institute, Roxana Mehran of Mount Sinai School of Medicine, and Steven E. Nissen of Cleveland Clinic Foundation. Each team created definitions for particular cardiovascular end point events based on clinical and research expertise, published guidelines and definitions, and their current understanding of the specific laboratory tests, diagnostic tests, and imaging techniques used in clinical practice to diagnose these events. Each working group member was invited to comment on all definitions, regardless of team assignment. These definitions were discussed at two public meetings (9/11/2009, 3/26/2010) and one internal working group meeting (2/5/2010), as well as via e-mail exchanges and telephone conferences within the individual teams. All cardiovascular end point definitions were compiled into a final draft document.
The purpose of this document is to propose definitions for cardiovascular end points that could be used as a framework to design clinical trials. End point definitions are necessary in clinical trials to ensure that events are clearly characterized by objective criteria and reported uniformly. If uniformly defined, events may be analyzed more easily in drug development programs or across different clinical trials, allowing trends and other safety signals to be identified.
To ensure broad public review and consensus through an established standards development process, the cardiovascular end point definitions are being posted on the CDISC website with feedback being solicited from a broad group of national and international stakeholders. Additionally, web-links to these posted definitions will be provided to key cardiovascular organizations (e.g., American College of Cardiology (ACC)).
**Standard Parkinson’s disease Common Data Elements Posted for Public Review**
The National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), recently assembled an external working group of nearly 70 international experts to develop the PD CDEs (Parkinson’s disease Common Data Elements), and they are now ready for feedback from the larger Parkinson’s disease clinical research community.
The NINDS CDE Web site:
http://www.commondataelements.ninds.nih.gov
fully describes the NINDS CDE Project and its goals. In summary, the CDE Project aims to develop content standards, both generic and disease-specific, to enable clinical investigators to systematically collect, analyze, and share data across the research community. Over the past 10 months, the PD CDE Working Group has identified and defined a catalog of CDEs which investigators can choose from when assembling their clinical study materials. The PD CDE Working Group has not attempted to define the complete universe of variables a clinical study might collect but rather to isolate elements that will be useful across clinical studies.
Cardiovascular and Tuberculosis Data Standards
These materials are being updated. Please check back soon for new information!
