Abstract
Christian Lienhardt and colleagues discuss the importance of communication and coordination between regulators, researchers, and policy makers to ensure tuberculosis trials provide high-quality evidence for policy decisions.
Highlights
Summary pointsRegulatory approval of new tuberculosis (TB) drugs can be based on data from trial(s) using a surrogate endpoint of treatment efficacy under an accelerated or conditional procedure
Under the paradigm of adding a new drug to a regimen or substituting single drugs in a regimen one at a time, it would take 15–20 years to develop an entirely new tuberculosis (TB) regimen comprising three to four new drugs [1]
Data sharing in the domain of TB is a matter of global public good, and funders, donors, and implementers of trials should mandate such expectations for their clinical trials and allocate funding to support the careful curation of data accessible to the public and to policy makers for future analyses
Summary
Regulatory approval of new tuberculosis (TB) drugs can be based on data from trial(s) using a surrogate endpoint of treatment efficacy under an accelerated or conditional procedure. In such circumstances, policy makers and TB programs can be hampered in their ability to make recommendations on the optimal use of the drug(s), and the uptake by national or international public health institutions of such recommendations can be limited. Established mechanisms for communication between drug developers and regulators already exist; equal engagement with policy makers is essential for the optimal selection of trial designs, endpoints, and markers of treatment outcome and for giving consideration to public health and program aspects.
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