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CDISC Hosts Strategy Session Moderated by FDA Commissioner, Dr. Robert Califf, on the Future of Medical Research and Role of Standards



CDISC Contact:

Andrea Vadakin




Thought leaders from across the medical research and healthcare arenas are participating today in an interactive session to explore how collaboration, global CDISC standards and related enablers can catalyze more efficient and innovative medical research 


Austin, TX – 02 August 2016 – The Clinical Data Interchange Standards Consortium (CDISC) is hosting today a special Strategy Session moderated by FDA Commissioner, Robert Califf, MD, at the National Academy of Sciences in Washington, DC. The Session will address “The Future of Medical Research and the Role of Standards: ‘Forming Connections Towards Complementary Systems.’”

This unique meeting brings together sixty senior thought leaders from the United States, Europe and Japan, representing the U.S. National Institutes of Health, FDA, Japan’s PMDA and Translational Research Institute, biopharmaceutical companies, academic research organizations, clinical research organizations, technology service providers and patient-focused foundations. During this interactive session, participants will explore how to achieve four desired outcomes: building consensus around a minimum core research dataset standard that aligns with comparable healthcare data; harmonizing research protocol templates and required elements; launching and documenting metrics for electronic health record (EHR)-enabled research studies; and ensuring maintenance and support of CDISC standards and the sustainability of the CDISC electronic standards library (SHARE).

“We are very pleased that such distinguished leaders have agreed to convene today to progress actionable solutions towards the desired outcomes for this Strategy Session,” said Rebecca Kush, PhD, President and CEO, CDISC. “Smarter Research to Unlock Cures will depend upon widespread use of standard data formats from the start of each and every research study, while leveraging electronic health records and other new technologies for measuring patient data. CDISC has worked with thousands of volunteers from around the world for two decades now to build consensus around global standards to streamline processes and pave the way forward to improve patient health and safety through higher quality research.”

CDISC will hold its flagship Interchange 26-30 September 2016 in Bethesda, Maryland, where more information about “Smarter Research to Unlock Cures” will be given. To find out more about the 2016 CDISC International Interchange, please visit the CDISC website



CDISC is a 501(c)(3) global non-profit charitable organization that streamlines research and enables connections to healthcare through the development of clinical research data standards. CDISC has developed a suite of standards to support clinical research from protocol through analysis and reporting. CDISC standards make it possible for data to speak the same language, empowering simple data collection and private sharing that makes the most of the valuable information offered by patients participating in research studies around the globe. Using CDISC standards from the start of studies enables Smarter Research to Unlock Cures (www.unlockcures.org), saving 70-90% time in the start-up of clinical research studies and ~60% overall in terms of time and resources to conduct research. CDISC is the patient’s advocate, creating therapeutic area data standards for over 25 different disease areas that advance medical product development and various types of clinical research.


CDISC is funded through the generous support of over 400 member organizations, as well as through grants, Authorized CDISC Education courses, events and charitable contributions. To find out more about how to support CDISC, please visit www.cdisc.org.