A “breakthrough” tool that standardises reporting of research data in the development of drug regimens to combat tuberculosis (TB) has been launched by the US-based Critical Path Institute (C-Path) and Clinical Data Interchange Standards Consortium (CDISC).

The tool enables researchers for the first time to combine and evaluate data from multiple studies using a common approach, explained C-Path and CDISC, which said the standard was “critical” for advancing new TB drug regimens.

It will also help with the regulatory review process for new drug-development tools, such as clinical-trial simulation models and methods of evaluating treatment endpoints, they noted.

Smooth collaboration

That the “immense” project was delivered in just nine months is a testament to the “smooth collaboration” between C-Path, CDISC, the US Food and Drug Administration (FDA) and others through the Critical Path to TB Drug Regimens initiative, said C-Path president and chief executive officer Dr Carolyn Compton.

The global initiative brings together pharmaceutical companies, academia, patient advocacy groups and regulatory bodies with the shared goal of accelerating the development of new drug regimens for TB.

The FDA has identified tuberculosis as one of a several disease areas with a critical need for data standards.

Partners in the TB standards project included the FDA, the Bill & Melinda Gates Foundation and the Global Alliance for TB Drug Development.

The completed standard drew on preliminary work conducted through a National Institutes of Health ‘Roadmap’ grant, with clinical terminology support provided through CDISC’s partnership with the National Cancer Institute’s Enterprise Vocabulary Services.

More standards

Further CDISC therapeutic-area data standards will be developed under the leadership of the Coalition For Accelerating Standards and Therapies (CFAST).

This is a joint effort by 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.