Discovery of Biomarkers (CTB2)
The TB Alliance is working with the U.S. CDC TB Trials Consortium and the AIDS Clinical Trials Group of the U.S. NIAID, NIH, to identify biomarkers for TB, which can dramatically speed the time and decrease the cost of clinical trials for new TB drugs.
In 2010, the TB Alliance received a grant from the United States Food and Drug Administration to establish a Consortium for Tuberculosis Biomarkers (CTB2), comprised of the TB Alliance, CDC's TB Trials Consortium (TBTC), and NIAID's AIDS Clinical Trials Group (ACTG). By collecting high-quality patient specimens in late-stage TB drug clinical trials where they are linked to detailed (anonymized) clinical documentation, CTB2 will enable discovery and qualification of biomarkers to speed clinical development of improved TB treatments for both drug-sensitive and multidrug resistant-TB.
Biomarkers of drug effect are biological features or substances that can be used as indicators of treatment effectiveness. For example, HIV/AIDS drug development was revolutionized by the validation of biomarkers like viral load and CD4 counts, which reliably predict success of treatment and allowed for a dramatic reduction in the duration of clinical trials.
Biomarkers will help streamline the discovery of new TB cures.
Biomarkers will help streamline clinical development of new TB cures. TB drug clinical development programs take a minimum of six years to complete -- far longer than most trials for other infectious diseases. New drugs and drug combinations must prove safe for human use, and they must demonstrate their efficacy against Mycobacterium tuberculosis, which requires months of treatment. Following the completion of treatment in Phase III trials, patients are followed for one to two years so that they can be monitored for relapse rates. Trial costs are high, and each additional month of testing delays the introduction of new medicines that could save lives.
Once potential markers are identified, they are rigorously tested and must be approved for use by regulatory authorities before they can be used as surrogate endpoints in pivotal registration trials. The process is complex, but the potential rewards are enormous. Successful identification of relevant biomarkers would revolutionize TB drug development by accelerating its pace and decreasing its cost.