CDISC, C-Path Develop Therapeutic Area Standard to Foster More Efficient and Meaningful Research for HIV

AUSTIN, Texas & TUCSON, Ariz.–(BUSINESS WIRE)–CDISC and the Critical Path Institute (C-Path) are pleased to announce
the release of a global Therapeutic Area Standard that specifies how to
structure commonly collected data and outcome measurements in clinical
trials for HIV. The standard, released in the form of User Guide for
data managers, statisticians, programmers and study managers, covers the
areas of prevention, vaccines and treatment and is freely available on
the CDISC
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.

HIV, the virus that causes AIDS, is one of the world’s most serious
health and development challenges. According to the Joint United Nations
Programme on HIV/AIDS (UNAIDS), there were approximately 36.9 million
people worldwide living with HIV/AIDS at the end of 2017. Of these, 1.8
million were children (<15 years old).

Implementing this standard will allow HIV data to be structured
effectively and easily analyzed, leaving more time for researchers to
focus on discoveries that will have invaluable impact on clinical
research and global public health. This standard will also promote data
harmonization across a wide range of studies in HIV, which will
facilitate collaboration and cross-study analyses to ensure the highest
return on research investments.

“We were honored to be a part of the amazing team working on the
development and publication of the new Therapeutic Area User Guide for
HIV clinical trials,” said C-Path President and CEO Martha Brumfield,
Ph.D. “The importance of these standards cannot be underscored enough.
We encourage the research community to rapidly adopt this information in
their studies, as structuring data in a common format is key to
supporting the development of additional drug development tools and
therapies for HIV/AIDS.”

“Collaboration and inclusivity have always been bedrocks of CDISC’s
culture. It’s why we convene a global community of experts from across
the research spectrum and facilitate the development of standards that
are open and available to all, enabling data sharing around the world,”
said David R. Bobbitt, CDISC President and CEO. “The development of this
important standard has benefitted from the input of a diverse set of
collaborators to tackle a critical public health issue.”

This CDISC Therapeutic Area standard for HIV was 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 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 National Institute of
Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) was a
major partner in the development of this User Guide. 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. This project has been funded in whole or in part with
Federal funds from the National Institute of Allergy and Infectious
Diseases, National Institutes of Health, Department of Health and Human
Services, under Contract No. HHSN272201700078C and the US FDA through
grant 1U01FD005876.

CDISC standards have been adopted and used in more than 90 countries. To
date, TA standards have been developed for over 30 disease areas.

About C-Path

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,
visit www.c-path.org.

ABOUT CDISC

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
world. www.cdisc.org.

Contacts

Ann P. White
+1.512.363.5826
[email protected]

Kissy Black
+1.615.298.1144
[email protected]