Ann P. White
Austin, TX – 15 AUG 2017 – According to the World Health Organization, prostate cancer is one of the five most common types of cancer to affect men globally. In an effort to improve research for prostate cancer, the Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce the release of a new Therapeutic Area (TA) Standard for Prostate Cancer in the form of a User Guide for data managers, statisticians, programmers and study managers. In announcing the new CDISC Therapeutic Area User Guide, freely available on the CDISC website, President and CEO David R. Bobbitt stated, “CDISC’s community has built this Therapeutic Area Standard to provide research professionals with guidance on how to represent patient data in clinical research to improve quality, efficiency and cost effectiveness, fostering smarter research to discover new treatments. By building data standards for researchers, we give them a more rapid start up and the capacity to share data with collaborators with less effort.”
“I would like to thank each team member for their dedication and help in getting us to this milestone,” commented John Owen, CDISC Project Manager. “We have achieved this through our collaboration with you as volunteers, and always appreciate your help and assistance both in terms of time and knowledge. Well done and congratulations. This project has been of great personal significance to me and my family since my father fought a brave battle against Prostate Cancer for four years and sadly passed away the same week that the user guide was published. It is a great honour to dedicate the Prostate User Guide to my father, with the knowledge that this may help men in a similar situation in the future.”
Team member, Dr. Liz Zhou, MD, Director, Global Medical Evidence Generation, Sanofi added, “As a clinical and scientific lead for the Prostate Cancer DREAM Challenge on behalf of Project Data Sphere, I became interested in participating in this initiative because prostate cancer TA standards are critical to secondary use of prostate cancer clinical trial data especially those hosted in Project Data Sphere. TA Standards help to maximize value of the data on the platform. TA Standards will also enable more researchers to generate valuable insight from these data and ultimately impact prostate cancer patient and treatment. The Prostate Cancer DREAM Challenge is a good example of that - we leveraged CDISC standards to prepare the data for the Challenge and, to date, we have two major publications and continue to impact other researchers in prostate cancer.”
This CDISC Therapeutic Area standard was funded with support in part by grant U24FD005243-01 from the U.S. Food and Drug Administration (FDA) and developed through the Coalition for Accelerating Standards and Therapies (CFAST) initiative, a partnership of CDISC and the Critical Path Institute (C-Path), with participation from the U.S. NIH National Cancer Institute Enterprise Vocabulary Services (NCI-EVS), FDA, TransCelerate, the Japan Pharmaceutical and Medical Devices Agency (PMDA) and additional stakeholders. “The goal of the CFAST initiative is 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,” stated CDISC Chief of Staff Dr. Nicole Harmon, PhD, in making today’s announcement.
CDISC standards have been adopted and used in more than 90 countries, and are required for submissions to the U.S. FDA and Japan PMDA. To date, Therapeutic Area standards have been developed for more than 30 disease areas.
CDISC is a 501(c)(3) global, non-profit organization that develops data standards to foster smarter research and enable connections to healthcare. CDISC standards allow data to speak the same language, by providing common formats for data collection, data sharing and data analyses to make the most of the valuable information offered by patients participating in research studies around the globe, enabling researchers to discover new treatments, find breakthroughs, and unlock cures. CDISC standards are required for regulatory submissions to the U.S. FDA and Japan PMDA, are endorsed by the China CFDA, and are requested for use by the European Innovative Medicines Initiative (IMI). The suite of CDISC standards is freely available on the CDISC website.
CDISC is funded through the generous support of over 430 member organizations from pharmaceutical, biotech, clinical research organizations, regulatory agencies, academia, and healthcare, as well as through grants, authorized CDISC Education courses, events and charitable contributions. To find out more about how to support CDISC and get involved, please visit www.cdisc.org.