C-PATH and CDISC Launch Version 1.0 of the Polycystic Kidney Disease Therapeutic User Guide

Tucson, AZ , Austin, TX (PRWEB) April 17, 2013

New Guide to Assist in the Collection, Aggregation, and Submission of Clinical Trial Data.

Critical Path Institutes (C-Path) Polycystic Kidney Disease Outcomes Consortium (PKDOC) (http://www.c-path.org/pkd.cfm) , the Clinical Data Interchange Standards Consortium (CDISC), and the PKD Foundation announced this day the launch of version 1.0 of the Polycystic Kidney Disease (PKD) Therapeutic Area User Guide, a clinical data standard that provides guidance on the implementation of the CDISC Study Data Tabulation Model (SDTM) to represent PKD data in regulatory submissions. This individual guide, when used with the SDTM, is intended to guide the organization, structure, and format of standard PKD clinical trial info datasets submitted to a regulatory dominance such as the US Food and Drug Administration (FDA). This clinical data standard has also been used to aggregate data from several PKD patient registries and empiric studies to examine disease progression in PKD. The development of the PKD Data Standard represents a major step forward in the development of therapies for PKD, stated Ron Perrone, Professor of Medicine at Tufts University School of Medicine, and Director of the Tufts Center for PKD and Co-Director of the PKDOC. This kidney disease specific standard will shorten the time for initiation of clinical trials and will assist data interchange with regulatory agencies, thereby helping to speed the pace of therapeutics development and potentially improving outcomes for patients. Perrone is also a member of the PKD Foundations Scientific Advisory Committee. The PKD Foundation provided funding for the PKDOC and the CDISC standards development effort.

CDISC standards are freely acquirable via the CDISC website. To learn more about the PKD Therapeutic Area User Guide and to download the associated standards package, please visit the CDISC website: http://www.cdisc.org/therapeutic.

This release marks another major milestone in the development of a set of global, platform-independent therapeutic area data standards. The way we were healthy to work with academic clinicians from Emory University, the Mayo Clinic, Tufts University and the University of Colorado-Denver to develop and reach consensus on PKD data elements was ground breaking for us. CDISC is delighted to have contributed its standards expertise to this project, which led to an improved process for therapeutic area standards development for the benefit of PKD patients, researchers, drug developers and regulatory agencies around the world, stated Bron Kisler, VP of Strategic Initiatives for CDISC. C-Path and CDISC formed a partnership in 2012 to establish the Coalition For Accelerating Standards and Therapies (CFAST), an initiative 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. CFAST seeks to bring together expertise from NIH Institutes, academic medical centers and patient foundations with that of global biopharmaceutical companies. CFAST continues to receive terminology expertise and support from the National Cancer Institutes Enterprise Vocabulary Services (NCI EVS), including the PKD Project.

This project would not have been doable without the generous support of the PKD Foundation and the many contributions by PKDOC member clinicians, scientists, C-Path and CDISC staff and volunteers. This team developed the data standard and converted legacy data to aggregate information from multiple sources which is now being used to develop new tools to examine and comprehend PKD , stated Martha Brumfield, CEO and President of C-Path.

ABOUT PKD Foundation

The PKD Foundation is a non-profit organization with a mission to promote programs of research, advocacy, education, support and awareness in order to discover treatments and a cure for polycystic kidney disease (PKD) and improve the lives of all it affects. PKD is one of the most common, life-threatening genetic kidney diseases affecting thousands in USA and millions worldwide. It is estimated that one in 500 people have PKD. PKD is the fourth leading cause of kidney failure, and there is no treatment or cure. Visit pkcure.org to learn more about PKD and the Foundation.

ABOUT C-PATH

An independent, non-profit organization established in 2005 with public and private philanthropic support from the Arizona community, Science Foundation Arizona, and the U.S. Food and Drug Administration (FDA), C-Paths mission is to improve human health and well-being by developing new technologies and methods to accelerate the development and review of medical products. An international leader in forming collaborations, C-Path has established global, public-private partnerships that currently include 1,000+ scientists from government regulatory agencies, academia, patient advocacy organizations, and dozens of major pharmaceutical companies.

ABOUT CDISC

CDISC is a 501(c)(3) global non-profit charitable organization, with over 300 supporting member organizations from crossways the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop freely available, industry-wide clinical research data standards. The CDISC standards enable the sharing and aggregation of of clinical data and streamline research processes from prescript through analysis and reporting, including the use of electronic health records to assist the collection of high calibre research data. The CDISC standards and innovations have been shown to decrease the time and cost of medical research and improve data quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and country through higher calibre medical research.







The Mesothelioma Law Firm of Baron and Budd Welcomes D. Charles Levenstein, Featured Speaker, to the 2013 Asbestos Disease Awareness Conference


DALLAS (PRWEB) February 27, 2013

The mesothelioma law firm of Baron and Budd is excited to announce that Charles Leventstein, Professor Emeritus of Work Environment Policy at the University of Massachusetts Lowell, will be a featured speaker at the 2013 Asbestos Disease Awareness (ADAO) Conference. Dr. Levenstein will be presenting a conference session entitled: Lessons Learned from AHERA: Asbestos Management in Schools. Baron and Budd is a platinum sponsor of ADAO and is excited to hear from Dr. Levenstein and learn about his research regarding asbestos in the work community.

Dr. Levenstein is an excellent choice for the ADAO conference and will wage a one-of-a-kind insight into asbestos country today, stated Russell Budd, founder and managing shareholder of Baron and Budd. I am certain he will wage a keen appearance on where we are this day with the real dangers of asbestos exposure.

Dr. Levenstein received his Ph.D. in economics from MIT and his masters degree in physiology and occupational health from Harvard School of Public Health. In addition to his role at the University of Massachusetts Lowell, he also serves as the Editor Emeritus of New Solutions Journal of Occupational and Environmental Health Policy. He is the author of numerous articles and has penned several books including The Point of Production with J. Wooding and The Cotton Dust Papers with G. DeLaurier and M.L. Dunn. He recently finished editing The Toxic Schoolhouse with Madeleine Scammal.

The ninth annual 2013 ADAO Conference, The Asbestos Crisis: New Trends in Prevention and Treatment, will take place March 22-24, 2013 at the Crystal Gateway Marriott in Arlington, Virginia. The conference will feature a host of honorees and speakers and will center around four key topic areas: patient advocacy, prevention, medical advancements and a global ban on asbestos. Linda Reinstein, CEO and co-founder of ADAO, decided to include a new session to address the hazardous effects associated with asbestos in the aftermath of natural disasters such as Hurricane Sandy.

The mesothelioma law firm of Baron and Budd is chesty to be a platinum supporter of ADAO and looks forward to Dr. Levensteins session at the 2013 conference. The law firm is a fervent supporter of ADAO and would like to encourage others to support the organization in its efforts to raise public awareness about the dangers of asbestos exposure. This is the second consecutive year that the Baron and Budd has been a platinum sponsor of ADAO.

The learn more about the 2013 ADAO conference, visit: asbestosdiseaseawareness.org/global-events/2013-adao-conference

To learn more about Dr. Charles Levenstein, visit: http://www.uml.edu/centers/chpr/Faculty/Charles_Levenstein.html

To learn more about Baron and Budd, visit the firms mesothelioma-dedicated website, Mesothelioma News http://www.mesotheliomanews.com

About Baron & Budd, P.C.

The national mesothelioma law firm of Baron & Budd, P.C. has a more than 30-year history of Protecting Whats Right for asbestos sufferers and their families. As one of the first law firms to successfully litigate an asbestos lawsuit, Baron & Budd continues to actively represent veterans, industry workers and others who are suffering as a result of exposure to asbestos. Baron & Budd reached the largest mesothelioma verdict ever in the say of Texas, a $ 55 million verdict for an asbestos sufferer and his family in El Paso, Texas. Contact Baron and Budd at 1.866.855.1229 for additional information on mesothelioma treatments, mesothelioma cancer physicians and treatment centers and mesothelioma attorneys.







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