CDISC 2014 Business Case Highlights Significant Time and Cost Savings through Use of CDISC Standards in Medical Research Studies

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CDISC is pleased to announce an extensive update to the CDISC Business Case for the use of global, consensus-based standards for clinical research data and related areas of healthcare.CDISC standards at project initiation can save 70 - 90% of time and resources spent prior to first patient enrolled and approximately 75% of the non-patient participation time during the Study Conduct and Analysis stages.

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The use of CDISC standards at project initiation can save 70 - 90% of time and resources spent prior to first patient enrolled and approximately 75% of the non-patient participation time during the Study Conduct and Analysis stages.

The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce an extensive update to the CDISC Business Case for the use of global, consensus-based standards for clinical research data and related areas of healthcare. One key message, re-emphasized from the previous Gartner business case, is that the use of CDISC standards at project initiation can save 70 - 90% of time and resources spent prior to first patient enrolled and approximately 75% of the non-patient participation time during the Study Conduct and Analysis stages. CDISC standards reap substantial benefits, qualitative and quantitative, during the entire research process for all types of research studies including academic, nutritional, device, outcomes and regulated research. These will be topics of discussion at the 2014 CDISC International Interchange, where speakers will share tangible implementation experiences.

“In a culture of big data, increasing use of electronic health records and complex research designs, the importance of using CDISC data standards for research studies has been reinforced by those gathering metrics on such value opportunities,” said Dr. Rebecca Kush, CDISC President. “As regulators begin to require these standards, they are also encouraging the use of the CDISC data acquisition standard, CDASH, to build quality in from the start. CDISC is becoming the global language for data sharing in medical research. As patients, we should be encouraging all researchers and clinicians to use data standards at the point of care to more rapidly gain trustworthy information and to translate this into learning and more effective and efficient healthcare.”

The CDISC Business Case details the complete, harmonized suite of global standards that facilitate clinical research from end-to-end, from protocol and data collection through analysis and reporting for a core set of research data common to all research studies. Also included is information on a set of standards developed with Integrating the Healthcare Enterprise (IHE) that facilitate workflow from clinical care (electronic health records) to research data that will readily flow downstream to produce tables and analysis datasets. The return on investment for these standards has been established in a safety reporting study citing a time savings from 34 minutes to less than a minute to report an adverse event. The Business Case also describes how CDISC’s recently developed Shared Health and Research Electronic Library (SHARE) now makes CDISC standards electronically accessible to transform the way we do data management and accelerate the speed at which therapeutic area-specific (TA) standards can be developed, thereby expediting the availability of new therapies for patients.

The CDISC International Interchange theme is “Embracing a Changing Landscape: Standards to Connect Research and Patient Care.” This event will feature presentations by General Peter Chiarelli of One Mind for Research on CDISC data standards in relationship to traumatic brain injury, by Dr. Laura Esserman on the use of CDISC with electronic health records in the I-SPY initiative for breast cancer patients, by leaders from the Critical Path Institute working with patient advocacy groups and the Translational Research Informatics Institute working with academic institutions. There will also be talks by regulators from the US and Japan on CDISC standards requirements.

CDISC is grateful to all those who have contributed in making the CDISC Interchanges possible, notably Accenture, for their continuing diamond sponsorship of our global CDISC Interchanges. CDISC authorized Education Courses will be provided on 10-11 and 14 November and the Main Conference days will be held 12-13 November. To join the 2014 CDISC International Interchange, please visit the International Interchange page on the CDISC website.

ABOUT CDISC
CDISC is a 501(c)(3) global non-profit charitable organization, with over 350 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations can significantly decrease the time and cost of medical research and improve 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 safety through higher quality medical research.

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Andrea Vadakin
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