CDISC Blog

The Critical Path to TB Drug Regimens (CPTR) is a recently formed collaboration of global pharmaceutical companies; government and regulatory agencies; foundations and donors; academia; and patient advocacy groups. The CPTR initiative was created and is managed by a partnership of the Bill & Melinda Gates Foundation, the Global Alliance for TB Drug Development (Global TB Alliance) and the Critical Path Institute (C-Path). CPTR seeks to test promising TB drug candidates in combination and identify new regulatory pathways to speed approval of novel TB therapies. This will be achieved through a new development paradigm that seeks to significantly accelerate the registration of new TB combinations around the world. Global standards for Tuberculosis are seen as a critical component of this work. CDISC was recently invited to participate in the CPTR launch working meeting held in Washington DC. This meeting included 2 breakout sessions - Regulatory Science and Research Resources. In the Regulatory Science sessions, Data Standards were a primary topic of discussion in addition to Biomarkers and Clinical Disease Progression Modeling.

In 2008 as part of a US National Institutes of Health Grant awarded to Duke University, CDISC and HL7 released an initial set of TB data standards focused on Pulmonary Tuberculosis. The initial set of TB data standards is being implemented in new TB clinical trials by global pharmaceutical companies and biotechnology companies. Working with dedicated industry volunteers, the Centers for Disease Control (CDC) is currently aligning a large TB dataset to the TB data standard as well as CDISC SDTM for evaluation by US FDA. The CPTR initiative seeks to extend existing TB data standards to cover other important areas such as: Extrapulmonary TB, Pediatric TB as well as TB-HIV Co-Infection. The scope and project plan(s) for future TB data standards development will be determined in the next couple of months with the goal of launching the first new project in early fall.

Additionally, CDISC has been invited to participate and possibly present at an upcoming TB meeting in Ethiopia entitled Open Forum 4 - Key Issues in TB Drug Development. This meeting is being sponsored by Bill & Melinda Gates Foundation, The Global TB Alliance, Treatment Action Group and the Stop TB Working Group on New Drugs. This will be the fourth meeting of its kind dedicated to regulatory issues surrounding the development of new TB drugs. The meeting in Ethiopia will focus on regulatory challenges specifically relevant to the African region and be one of the first platforms available to discuss the regulatory implications of the CPTR new TB drug development paradigm.

CDISC is proud to be participating in CPTR activities and looking forward to leading development of new data standards for TB. This is seen as an opportunity to achieve significant and tangible results in the global fight against  Tuberculosis in the developing world.

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