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

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,

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

Contacts

Ann P. White

+1.512.363.5826

Kissy Black

+1.615.298.1144