Critical Path Institute (C-Path) and Clinical Data Interchange Standards Consortium (CDISC) Announce Breakthrough in TB Drug Development Tools

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Critical Path Institute and CDISC (Clinical Data Interchange Standards Consortium) announce the availability of a breakthrough tool to help combat tuberculosis (TB)—a persistent disease resulting in 1.7 million deaths globally each year.

Critical Path Institute and CDISC (Clinical Data Interchange Standards Consortium) announce the availability of a breakthrough tool to help combat tuberculosis (TB)—a persistent disease resulting in 1.7 million deaths globally each year.

This new tool—a standardized way to report research data—is critical for advancing new TB drug regimens. For the first time, researchers are able to combine and evaluate data from multiple studies using a common approach. This will help accelerate the development of new TB drugs by enhancing the design of clinical trials and the evaluation of new drugs. The TB data standards will also assist the regulatory review process for new drug development tools, such as clinical trial simulation models and methods to evaluate treatment endpoints.

“The scope of this project was immense and its delivery in nine months was made possible by the smooth collaboration among C-Path, CDISC, FDA, industry partners and the many volunteers who participated in this effort through the Critical Path to TB Drug Regimens initiative,” says Dr. Carolyn Compton, President and CEO of Critical Path Institute.

The Critical Path to TB Drug Regimens (CPTR) initiative is a global collaboration among pharmaceutical companies, academia, patient advocacy groups, and regulatory bodies having the shared goal of accelerating the development of new drug regimens targeting TB.

“A tremendous amount of innovation has enabled an exciting new era of TB drug development,” says Dr. Mel Spigelman, President and CEO, TB Alliance. “To support a regimen-based development approach, the research and regulatory communities need new standards and platforms to help conduct, submit, and review this work. This new standard is an example of such a tool and will benefit both researchers and regulators, ultimately helping to ensure new TB cures reach those who need them as quickly as possible.”

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The U.S. Food and Drug Administration (FDA) has identified TB as one of several disease areas having a critical need for data standards. “CDISC is very pleased to have had the opportunity to collaborate with the FDA, Bill & Melinda Gates Foundation, Global Alliance for TB Drug Development, and C-Path to complete this TB standard work, based in part on preliminary work conducted through a National Institutes of Health ‘Roadmap’ grant and clinical terminology support provided through our partnership with the National Cancer Institute’s Enterprise Vocabulary Services,” says Bron Kisler, VP, Strategic Initiatives and CDISC lead on the project. CDISC standards are vendor-neutral, platform independent, and publically available through the CDISC website at

Future CDISC therapeutic area data standards will be developed under the leadership of CFAST (Coalition For Accelerating Standards and Therapies), a joint endeavor between C-Path and CDISC to accelerate clinical research and medical product development by creating and maintaining data standards, tools, and methods for conducting research in therapeutic areas important to public health.

ABOUT CRITICAL PATH INSTITUTE (C-PATH): Established in 2005 as a non-profit organization, C-Path was formed with public and private philanthropic support from the University of Arizona, the US Food and Drug Administration (FDA), and the Tucson community. Additional funding has been provided by Science Foundation Arizona (SFAz). C-Path is committed to improving human health and well-being by developing new technologies and methods to accelerate the development and review of medical products. An international leader in forming collaborations around this mission, C-Path has established global, public-private partnerships that include more than 1,000 scientists from government regulatory agencies, academia, patient advocacy organizations, and 41 major pharmaceutical companies. C-Path has headquarters in Tucson, AZ and an office in Rockville, MD. For more information, visit and follow us on Facebook.

CDISC is a 501(c)(3) global non-profit charitable organization, with nearly 300 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations can decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.

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