CDISC Releases Therapeutic Area User Guide to Assist in Discovery of New Treatments for Prostate Cancer.
M2 PHARMA-August 15, 2017-CDISC Releases Therapeutic Area User Guide to Assist in Discovery of New Treatments for Prostate Cancer
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- US-based non-profit standards development organisation The Clinical Data Interchange Standards Consortium (CDISC) has released of a new Therapeutic Area Standard for Prostate Cancer in the form of a User Guide for data managers, statisticians, programmers and study managers, the group said.
In announcing the new CDISC Therapeutic Area User Guide, freely available on the CDISC website, president and CEO David R. Bobbitt said, "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," he said.
This CDISC Therapeutic Area standard was funded with support in part by grant U24FD005243-01 from the US Food and Drug Administration 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 US NIH National Cancer Institute Enterprise Vocabulary Services (NCI-EVS), FDA, TransCelerate, the Japan Pharmaceutical and Medical Devices Agency 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," said CDISC Chief of Staff Dr. Nicole Harmon, PhD, in making the announcement.
CDISC standards have been adopted and used in more than 90 countries, and are required for submissions to the US FDA and Japan PMDA. To date, Therapeutic Area standards have been developed for more than 30 disease areas.
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|Date:||Aug 15, 2017|
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