Colloquia at CDISC International Interchange to Focus on Major Diseases

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“Standards for Patients” is the theme of the coming CDISC International Interchange, which will take place in Baltimore on 10-14 October 2011. This theme will also be the focus of a set of Colloquia to continue development of standards to support the collection of clinical research efficacy data and to facilitate regulatory reviews of clinical research data in eSubmissions for approval of potential new therapeutic products.

According to Dr. Raymond Woosley, MD, PhD, President and CEO of C-Path, "The data standards established by CDISC make it possible for scientists to communicate and share data and knowledge efficiently"

“Standards for Patients” is the theme of the coming CDISC International Interchange, which will take place in Baltimore on 10-14 October 2011. This theme will also be the focus of a set of Colloquia to continue development of standards to support the collection of clinical research efficacy data and to facilitate regulatory reviews of clinical research data in eSubmissions for approval of potential new therapeutic products.

Work has already been initiated on standards development in certain of these areas that will form the basis of the Colloquia themes: TB, Virology (Hep C/Hep B/HIV), Pain, Oncology, Diabetes, Imaging. At the CDISC Interchange, representatives of FDA’s Center for Drug Evaluation and Research (CDER) will be available to discuss their assessment of therapeutic area standards and additional standards that are needed to support upcoming eSubmissions. CDISC has developed standards to support a core set of data that are essential across all clinical research studies. However, standards specific to determinations of efficacy and other specialty areas are still in development. This requires input from those with experience in these disease areas – clinicians and patients.

The Colloquia will be made possible through the support of Critical Path Institute (C-Path), the Association of Clinical Research Professionals (ACRP) and CDISC. C-Path will partner with CDISC to lead the colloquia and provide standards development expertise, and ACRP will invite participation of experienced clinicians. Additional active participation will be sought from the patient and clinical research arenas.

According to Raymond Woosley, MD, PhD, President and CEO of C-Path, “In order to facilitate more efficient development of new therapies, we must establish disease-specific standards for data collected in clinical research, as well as for eSubmission of that data for regulatory review. The data standards established by CDISC make it possible for scientists to communicate and share data and knowledge efficiently, creating an increased likelihood that new therapies will move more quickly and reliably through the regulatory review process and reach the patients who need them.”

“ACRP is excited to be involved in this important endeavor that will directly affect its membership in the future,” said James Thomasell, Executive Director of ACRP. Paula Brown Stafford, Chair-elect for the CDISC Board of Directors, stated “The development of these important standards for efficacy data in clinical research is a key strategic focus area for CDISC from 2012-2015.”

Interested parties can obtain criteria for participation in the Colloquia and further information at: http://www.cdisc.org/stuff/contentmgr/files/0/50a3e79cae14693185274cd49cd9fca9/misc/colloquiainvite_rdkaug2011_final.pdf. The program and registration opportunities for the CDISC Interchange and associated educational events can be found at http://www.cdisc.org/interchange?a=2437#2437.

About CDISC
The Clinical Data Interchange Standards Consortium (CDISC) is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata to streamline clinical research. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website. Additional information on CDISC can be found on the CDISC website at http://www.cdisc.org.

The CDISC Vision: Informing patient care and safety through higher quality medical research

About Critical Path Institute (C-Path)
An independent, non-profit organization established in 2005 with public and private philanthropic support from the Southern Arizona community, Science Foundation Arizona (SFAz), and the U.S. Food and Drug Administration (FDA), C-Path is committed to improving health and saving lives by accelerating the development of safe, effective medicines. An international leader in forming collaborations around this mission, C-Path has established global, public-private partnerships that currently include over 1,000 scientists from government regulatory agencies, academia, patient advocacy organizations, and thirty five major pharmaceutical companies. C-Path is headquartered in Tucson, Arizona, with offices in Phoenix, Arizona, and Rockville, Maryland. For more information, visit http://www.c-path.org. Click here to view a video showing why the work of C-Path is essential.

About ACRP
The Association of Clinical Research Professionals (ACRP) is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. ACRP was founded in 1976 to address the educational and networking needs of research nurses and others who supported the work of clinical investigations. With its own professional society came the recognition of a new distinctive profession — that of the clinical researcher. More than 35 years later, ACRP is a global association comprised of more than 18,000 individuals in over 65 countries dedicated to clinical research and development. Our mission is “To provide global leadership to promote integrity and excellence for the clinical research profession”. The Academy of Pharmaceutical Physicians and Investigators (APPI) is an affiliate of ACRP and is the leading professional organization, exclusive to physicians, that supports and addresses the unique issues and challenges of all physicians involved in clinical research.

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Shirley Williams
CDISC
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