Challenges in the clinical assessment of novel tuberculosis drugs

Kelly E. Dooley, Patrick P.J. Phillips, Payam Nahid, Michael Hoelscher

Research output: Contribution to journalReview articlepeer-review

13 Scopus citations


To tackle the global TB epidemic effectively, novel treatment strategies are critically needed to shorten the duration of TB therapy and treat drug-resistant TB. Drug development for TB, stymied for decades, has enjoyed a renaissance over the past several years. However, the development of new TB regimens is hindered by the limitations in our understanding and use of preclinical models; the paucity of accurate, early surrogate markers of cure, and challenges in untangling the individual contributions of drugs to multidrug regimens in a complex, multi-compartment disease. Lack of profit motive, advocacy, and imagination has contributed mightily to the dearth of drugs we have on the shelf to treat this ancient disease. Areas that will speed the development of new regimens for TB include novel murine and in vitro pharmacodynamics models, clinical endpoints that are not culture-based, innovative clinical trial designs, and an infusion of much-needed funding.

Original languageEnglish (US)
Pages (from-to)116-122
Number of pages7
JournalAdvanced Drug Delivery Reviews
StatePublished - Jul 1 2016


  • Hollow fiber model
  • Mouse model
  • Pharmacokinetic/pharmacodynamic
  • Translational science
  • Trial design
  • Tuberculosis

ASJC Scopus subject areas

  • Pharmaceutical Science


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