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

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.”