Tuberculosis (TB) poses a severe global public health problem that is exacerbated by growing drug resistance to current treatments, and co-infection with HIV. Today’s efforts to develop improved TB treatments, which are so urgently needed, are markedly hindered by the long duration and laborious, costly nature of late-stage clinical TB drug trials.
Development of improved TB drugs and treatments is significantly hindered by the lack of validated biomarkers or surrogates to determine efficacy. The availability of qualified biomarkers that could distinguish patients who have responded well to treatment from those who have not would streamline clinical development by allowing a triage of treatments most worthy of evaluation. This strategy is likely to shorten clinical development time by speeding up Phase II and definitive Phase III trials.
The biomarker strategy described here requires the availability of adequate numbers of high-integrity clinical specimens. Therefore, the goal of the TB Biorepository is to establish a robust biorepository to support and expedite the discovery and qualification of biomarkers of TB drug effect. Formed in 2010 to continue building the TB Biorepository begun by the Global Alliance for TB Drug Development, the Consortium for TB Biomarkers (CTB2) agreed on plans to conduct Biostorage Studies as adjuncts to ongoing clinical trials or treatment programs in order to contribute biospecimens to the TB Biorepository as efficiently as possible. The Consortium members agreed:
On standards for collection, processing and storage of a core set of relevant samples, including use of common data standards and elements;
To establish a Biorepository of the agreed upon samples;
To establish a peer review system for making the samples available to qualified scientists throughout the world for TB biomarker development by enabling qualification of biomarkers of TB drug effect, including a marker of stable TB cure vs. relapse as a first priority.
The CTB2 brings together the CDC's TB Trials Consortium (TBTC), NIAID's AIDS Clinical Trials Group (ACTG), and the Global Alliance for TB Drug Development (GATB or TB Alliance), with advice from and outreach to other relevant stakeholders and consultants. The CTB2 has cooperatively tackled a major hurdle to succesful TB drug development by establishing for the first time relevant standards and a high-quality TB Biorepository comprising biospecimens vital to improved TB treatments.