CDISC and C-Path Develop Therapeutic Domain Standard to Promote More Effective and More Meaningful HIV Research

CDISC and the Critical Path Institute (C-Path) are pleased to announce the publication of a global standard for therapeutic areas that specifies how to structure collected data and outcome measures collected during clinical trials. about HIV. The standard, published in the form of User's Guide for Data Managers, Statisticians, Programmers and Study Directors, covers the areas of prevention, vaccines and treatments and is freely available on the website. CDISC Web.

The CDISC Therapeutic Domain User Guides (TAUG) provide examples and tips on implementing CDISC standards to enhance operational efficiencies within organizations that use them. accelerate 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 problems. According to the Joint United Nations Program on HIV / AIDS (UNAIDS), there were about 36.9 million people living with HIV / AIDS worldwide by the end of 2017, of whom 1.8 million were children ( under the age of 15).

Implementing this standard will allow HIV data to be structured efficiently and easily, giving researchers more time to focus on discoveries that will have a valuable impact on clinical research and global public health. . This standard will also promote data harmonization across a wide range of HIV studies, which will facilitate collaboration and cross-study badysis to ensure the best return on research investments.

We are honored to be part of the great team that is developing and publishing the new Therapeutic User Guide for HIV Clinical Trials, "said Martha Brumfield, Ph.D., President and CEO. Chief Executive Officer of C-Path. The importance of these standards can not be sufficiently emphasized. We encourage the research community to quickly adopt this information in their studies, as structuring data in a common format is essential to support the development of additional tools for drug development and treatment for HIV / AIDS.

Collaboration and inclusion have always been the foundation of CDISC culture. That's why we bring together a global community of experts from all fields of research and facilitate the development of open standards that are accessible to all, enabling data sharing worldwide, "said David R. Bobbitt, President and CEO of CDISC. The development of this important standard has benefited from the contribution of a diverse set of collaborators to tackle a critical public health problem.

This CDISC therapeutic domain standard for HIV was developed as part of the CFAST (Coalition for Standardization and Therapies Coalition) initiative, a partnership between CDISC and the Critical Path Institute (C-Path). the participation of the NIH Business Vocabulary Services (NCI). (EVS), the US Food and Drug Administration (FDA), TransCelerate, the Japan Pharmaceutical and Medical Devices Agency (PMDA), and other stakeholders. The AIDS Division of the National Institute of Allergy and Infectious Diseases (NIAID) (DAIDS) has been a major partner in the development of this user guide. The goal of the CFAST initiative is to accelerate clinical research and development of medical products by creating and maintaining data standards, tools and methods for conducting research in therapeutic areas important to public health. This project was funded in whole or in part by federal funding from the National Institute of Allergy and Infectious Diseases, the National Institutes of Health, the Department of Health and Social Services, under the contract No. HHSN272201700078C and US FDA via grant 1U01FD005876.

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

About C-Path

C-Path (Critical Path Institute) is an independent, non-profit organization created in 2005 as a public and private partnership. The mission of C-Paths is to catalyze the development of new approaches that advance medical innovation and regulatory science, thus accelerating the path to a healthier world. C-Path, an international leader in collaborative development, has established numerous global consortia that currently include more than 1,500 scientists from governments and regulatory agencies, universities, patient organizations, and specialized foundations. in the fight against the disease and dozens of pharmaceutical and biotechnological companies. C-Path is headquartered in Tucson, Arizona, with additional staff at multiple remote sites. For more information, visit www.c-path.org.

About CDISC

CDISC clarifies 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 the Japans Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world's leading research organizations, the CDISC standards allow for accessibility. interoperability and reuse of data. With the help of CDISC standards, the entire research community can maximize the value of data for more effective and meaningful research with an invaluable impact on global health. CDISC is a global non-profit charitable organization 501 (c) (3). Headquartered in Austin, Texas, it has hundreds of employees, volunteers and member organizations around the world. www.cdisc.org.

Ann P. White
+1.512.363.5826
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Kissy Black
+1.615.298.1144
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