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.”
Final ENLIVEN Trial Results Confirm Long-Term Benefit of Turalio in Tenosynovial Giant Cell Tumor
July 9th 2025In final data from the Phase III ENLIVEN study, Turalio (pexidartinib) demonstrated durable tumor responses and a consistent safety profile in patients with symptomatic TGCT not amenable to surgery.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
Effect of AI/ML, Real World Evidence and Master Protocols on Trial Success
July 7th 2025How the application of artificial intelligence, broader use of real-world evidence, decentralized clinical trials, master protocols, and risk-based quality monitoring, together with strong ethical oversight and increased collaboration, are contributing to better healthcare delivery and strengthening the role of clinical research in driving global health progress.