CDISC and The Critical Path Institute (C-Path) are pleased to announce
the release of a global Therapeutic Area Standard, which describes how
to use CDISC standards to represent data in research studies pertaining
to Clostridium difficile associated diarrhea (CDAD).
This press release features multimedia. View the full release here:
The standard, released in the form of a User Guide for data managers,
statisticians, programmers and study managers, is freely available on
website. CDISC Therapeutic Area User Guides (TAUG) provide examples
and guidance on implementing CDISC standards to drive operational
efficiencies within the organizations that use them, expedite the
regulatory review process and reduce time to market.
Caused by infection with the bacterial pathogen C. difficile,
CDAD, also referred to as Clostridium difficile infection, is a
major medical and infection control problem. It is particularly common
among the elderly in long-term care or hospital facilities. A 2015 study
from the US Centers for Disease Control and Prevention found that CDAD
alone caused almost half a million infections among patients in a single
year in the United States.
“CDAD is a serious public health issue, yet many are unaware of its
existence, let alone its gravity,” said David R. Bobbitt, CDISC
President and CEO. “This Therapeutic Area Standard will allow data that
is critical to driving forward clinical research and improving public
health become more accessible and reusable for research today and
This CDISC Therapeutic Area standard for CDAD was developed through the
Coalition for Accelerating Standards and Therapies (CFAST) initiative, a
partnership of CDISC and C-Path, with participation from the NIH
National Cancer Institute Enterprise Vocabulary Services (NCI-EVS), the
U.S. Food and Drug Administration (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.
“The CFAST initiative continues to drive progress in developing
therapeutic area standards for some of the world’s most pressing health
concerns,” said C-Path President and CEO Joseph Scheeren, Pharm. D.
“These standards are crucial to the clinical research and development
community and we hope that this readily available information for CDAD
can quickly be utilized to accelerate the development of treatments and
tools that could improve outcomes for patients.”
This project has been funded in whole or in part with Federal funds from
the FDA through grant 5U01FD005855-02.
CDISC standards have been adopted and used in more than 90 countries. To
date, TA standards have been developed for over 30 disease areas.
CDISC creates clarity in clinical research by convening a global
community to develop and advance data standards of the highest quality.
Required by the United States Food and Drug Administration (FDA) and
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by
the world’s leading research organizations, CDISC standards enable the
accessibility, interoperability, and reusability of data. With the help
of CDISC standards, the entire research community can maximize the value
of data for more efficient and meaningful research that has invaluable
impact on global health. CDISC is a 501(c)(3) global nonprofit
charitable organization and is headquartered in Austin, Texas, with
hundreds of employees, volunteers, and member organizations around the
C-Path (Critical Path Institute) is an independent, nonprofit
organization established in 2005 as a public and private partnership.
C-Path’s mission is to catalyze the development of new approaches that
advance medical innovation and regulatory science, accelerating the path
to a healthier world. An international leader in forming collaborations,
C-Path has established numerous global consortia that currently include
over 1,500 scientists from government and regulatory agencies, academia,
patient organizations, disease foundations, and dozens of pharmaceutical
and biotech companies. C-Path is headquartered in Tucson, Arizona, with
additional staff in multiple remote locations. For more information,