title: Sustainable tuberculosis drug development.
abstract: Six new antituberculosis compounds in 4 classes are presently in clinical trials. Although these show substantial promise for drug-resistant (DR) tuberculosis, the presently planned studies of these compounds will not inform their optimal use, as each will be tested singly vs placebo with existing drugs, rather than in new regimens. Each successive regulatory approval will increase the size, cost, and complexity of trials for those that follow, causing delays during which suboptimal use will occur and resistance will emerge. This paper proposes the development of a novel regimen with the potential for use in both drug-sensitive (DS) and DR tuberculosis. Adaptive licensing for DR tuberculosis based on 2-month sputum culture would shorten time to initial approval by several years. A global outcomes registry would confirm safety and effectiveness in both DS and DR tuberculosis, making possible the second transformation of tuberculosis treatment. We should do our utmost to see it succeed.
authors.affiliation: Clinical Research, Specialty Therapeutics, Pfizer Inc., Groton, CT 06340, USA. robert.wallis@pfizer.com
authors.forename: Robert S
authors.initials: RS
authors.lastname: Wallis
mesh_terms: D000818:Animals; D000995:Antitubercular Agents / Q000737:chemistry* / Q000627:therapeutic use*; D015415:Biomarkers; D002986:Clinical Trials as Topic / Q000379:methods*; D055808:Drug Discovery / Q000379:methods*; D014943:Global Health; D006801:Humans; D051379:Mice; D016032:Randomized Controlled Trials as Topic; D012044:Regression Analysis; D013183:Sputum / Q000382:microbiology; D014376:Tuberculosis / Q000188:drug therapy*; D018088:Tuberculosis, Multidrug-Resistant
chemical_list: D000995:Antitubercular Agents; D015415:Biomarkers