This webcast is part of the Global Strategies for Clinical Research Information Series sponsored by CDISC and AMIA.
Abstract:
The Clinical Data Interchange Standards Consortium (CDISC) is exploring the means to provide ready access to standards for clinical research and related areas of healthcare via a global, accessible electronic library called CDISC SHARE (Shared Health and Clinical Research Electronic Library). SHARE will enable access to precise and standardised data element definitions that can be used in applications and studies to improve data quality and interoperability for biomedical research and its link with healthcare.
CDISC is presently completing the ‘Inception Phase’ of this project, which entails conducting a pilot and developing a Scope and Vision document that includes risks, benefits and a stakeholder analysis among other sections. The CDISC SHARE pilot uses a semantic wiki hosted by Mayo Clinic and the National Cancer Institute.
The CDISC tagline “strength through collaboration” will be at the core of this project and key stakeholders have provided invaluable input and a willingness to participate in SHARE, which is essential to its success.
This webinar will include:
- An Introduction, including comments on how SHARE can benefit clinical research, by CDISC Board Chair, Edward Helton, PhD, of the National Cancer Institute
- An overview of SHARE and early results of the Pilot by CDISC VP, Technical Strategy, Dave Iberson-Hurst
- Stakeholder Analysis summary by CDISC CEO, Rebecca Kush, PhD
- Potential business models and the next steps for SHARE by CDISC COO, Frank Newby
Take Away Messages:
- The market needs and benefits of precisely defined and standardized data element definitions and concepts to support semantic interoperability
- Requirements, goals, content governance processes, stakeholder input and other technical and non-technical aspects necessary for the success of SHARE.
- Related activities around the globe, with potential for productive collaboration to achieve success in supporting data sharing for clinical research and related areas of healthcare.
- How to get involved in and/or support the SHARE project.
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With a strong commitment to the development and implementation of data standards in life sciences, SAS has been a member and ardent supporter of CDISC since 2000. In addition to helping define CDISC standards, SAS is making certain that their products and solutions support the implementation of CDISC data standards. Learn more. |
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About CDISC Panel of Experts
Presenters:
Ed Helton, PhD, is currently an Associate Director in the NIH/NCI Center for Biomedical Informatics and Information Technology. He is the NCI Facilitator in the caBIG Clinical Imaging Workspace. Previously he was the Chief Scientist, Regulatory and Biomedical Affairs in the SAS Institute Health, Life Sciences Global Practice. He is on the Clinical Data Interchange Standards Consortium, Board of Directors since 2002 and is the current BOD Chair and Co-Chair of Health Level Seven (HL7) Regulated Clinical Research Information Management Technical Committee (RCRIM) and the Chair of the Outreach Committee for Clinical Research. He is also a member of the HITSP BOD for 2008 and 2009.
Dr. Helton has worked in the pharmaceutical industry, academia (associate professor -- UVA and Albany Medical schools and New Mexico State U.) and served in the US Army Medical Service Corp in the Vietnam War, FDA (career research safety scientist) and in healthcare in drug safety and efficacy. He has a BA in chemistry from Texas Tech University, a MA in biology (endocrinology) from the College of William and Mary and a Ph.D. in biology (endocrinology) from the University of California, Santa Barbara. He was a National Institutes of Health Fellow and World Health Organization Post Doctoral Scientist in Steroid Biochemistry. Member of the Endocrine Society, Society of Toxicology, American Assoc. of Clinical Chemist and the American Chemical Society. He has 55 or so peer reviewed publications.
Margaret Haber, RN, is a biomedical informatics specialist with the Center for Biomedical Informatics and Information Technology, Office of the Director, U.S. National Cancer Institute, and Associate Director of NCI’s Enterprise Vocabulary Services, a set of services and resources that meet NCI and its partner’s needs for controlled terminology. She has more than a decade of experience as an informaticist and medical terminology specialist for both the NCI and the U.S. National Library of Medicine. Haber represents NCI to national and international organizations, including as Project Officer in charge of Interagency Memoranda with both the U.S. FDA and Veteran’s Health Administrations; as NCI Institutional Voting Member to HL7; Vocabulary Facilitator to HL7’s Regulated Clinical Research Information Management Technical Committee (RCRIM); and NCI Liaison to the International Health Terminology Standards Development Organisation (IHTSDO). She serves as NCI liaison to CDISC, responsible for the partnership between NCI EVS and CDISC for the development and publication of CDISC clinical trial and health care related terminology standards. Haber also has a background as an acute care oncology, bone marrow, and organ transplant nurse; as a linguist; and as a historian.
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David Iberson-Hurst, is VP Technical Strategy for CDISC, where he provides technical direction and vision. He is committed to the adoption of global data standards for medical research and has been working within the pharmaceutical industry as both a consultant and trusted advisor for the past 10 years. Iberson-Hurst is Vice Chair of the European CDISC Coordinating Committee (E3C), co-leads the CDISC Technical Advisory Committee (TAC), is a member of the Joint Initiative Council (JIC) a joint ISO, CEN, HL7, CDISC and IHTSDO standards initiative and was a co-lead of the CDISC electronic Source Data Interchange (eSDI) group that worked with the Food and Drug Administration (FDA), examining the difficult topic of electronic source documents and data. In January 2009, he was elected as a co-chair of the Health Level 7 (HL7) Regulated Clinical Research Integrated Management (RCRIM) Technical Committee. His regular contributions to articles and publications worldwide have ensured that he is often quoted and seen as a thought leader in the data standards arena. He has worked closely with the FDA, HL7, ISO, IHE and other organizations that promote better electronic processes for medical research.
Iberson-Hurst is also founder of Assero Limited which develops products and solutions to bring global standards adoption closer to reality. Graduating from Bath University in 1982 with a degree in Mathematics and Computing, he has 25 years experience of computer system development primarily on the development of high reliability, real-time information technology systems.
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Rebecca D. Kush, PhD, is a Founder and the current President and CEO of the Clinical Data Interchange Standards Consortium (CDISC), a non-profit organization with a mission to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. Dr. Kush has over 25 years of experience in the area of clinical research. She has worked for the U.S. National Institutes of Health, academia, a global contract research organization and pharmaceutical companies in the U.S. and Japan. Among numerous publications, Dr. Kush is lead author of the book, eClinical Trials: Planning and Implementation. Dr. Kush has given invited presentations (including keynotes) and tutorials at industry conferences, FDA and other venues in the U.S., Europe, and Japan for over 20 years. She earned a Ph.D. in Physiology and Pharmacology from the University of California (UCSD) School of Medicine in La Jolla, CA and has a B.S. in Chemistry and Biology from the University of New Mexico.
Frank Newby is the COO for CDISC – the Clinical Data Interchange Standards Consortium. He holds degrees in both Biology and Education from East Stroudsburg University and has more than 28 years experience in the pharmaceutical industry. Prior to joining CDISC he held the positions of Vice President, Information Technology and Data Management at SCIREX Corporation; Director, Information Technology and Data Management at Cell Pathways, Inc.; Director, Worldwide Clinical Systems Development for GlaxoSmithKline; and held a number of other positions in the areas of Clinical Information Management for GSK, Aventis, Merck and J&J. In addition, he has been a Middle School teacher in Biology and General Science.
