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A High-throughput Compatible Assay to Evaluate Drug Efficacy against Macrophage Passaged Mycobacterium tuberculosis
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Accelerating clinical drug development for children with tuberculosis

S Murray1, L McKenna2, E Pelfrene3

  • 1The Global Alliance for TB Drug Development, New York, New York.

The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease
|November 14, 2015
PubMed

Insights

Pediatric tuberculosis (TB) drug development needs acceleration. Strategies include earlier pediatric study initiation, concomitant enrollment of children, and leveraging adult development pathways for child-friendly TB treatments.

Area of Science:

  • Pediatric pharmacology
  • Infectious disease research
  • Drug development

Background:

  • Childhood tuberculosis (TB) treatment lags adult options.
  • Children are often excluded from TB drug development research.

Purpose of the Study:

  • To propose strategies for accelerating pediatric TB drug development.
  • To integrate pediatric drug development into adult pathways.

Main Methods:

  • Initiating pediatric studies post-adult Phase II efficacy data.
  • Implementing concomitant enrollment across pediatric age groups.
  • Utilizing the Unified Pathway and regimen development concepts.

Main Results:

  • The proposed strategies aim to expedite the availability of child-friendly TB drugs.
  • Integration into adult pathways can streamline development.

Conclusions:

  • Accelerated development of pediatric TB drugs is crucial.
  • Adopting new enrollment and pathway strategies can improve child access to TB treatments.

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