Development of new TB regimens: Harmonizing trial design, product registration requirements, and public health guidance

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 consequently, the uptake by national or international public health institutions of such recommendations can be limited.