This database includes peer-reviewed publications authored by TB Alliance staff. Use the tags on the left to filter by subject, or search for a particular author or term using the search bar.
Tag: Trial Design
Displaying 17 papers
Bedaquiline, moxifloxacin, pretomanid, and pyrazinamide during the first 8 weeks of treatment of patients with drug-susceptible or drug-resistant pulmonary tuberculosis: a multicentre, open-label, partially randomised, phase 2b trial
Publication: The Lancet Respiratory Medicine
Developing a Framework for Evaluating Ethical Outcomes of Good Participatory Practices in TB Clinical Drug Trials
Publication: Journal of Empirical Research on Human Research Ethics 1556264616657452, first published on June 30, 2016 doi:10.1177/1556264616657452
Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials
Publication: Phillips PPJ, Mendel CM, Burger DA, et al. Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials. BMC Medicine. 2016 Mar.14:19. doi: 10.1186/s12916-016-0565-y
Publication: Furin J., Alirol E, Allen E, et. al. Drug-resistant tuberculosis clinical trials: proposed core research definitions in adults. Int J Tuberc Lung Dis. 20161 Mar; 20(3): 290-294.
Publication: Nachman S, Ahmed A, Amanullah, et. al. Towards early inclusion of children in tuberculosis drugs trials: a consensus statement. Lancet Infect Dis. 2015 Jun;15(6):711-20. doi: 10.1016/S1473-3099(15)00007-9.
Publication: Donald PR, Ahmed A, Burman WJ, et. al. Requirements for the clinical evaluation of new anti-tuberculosis agents in children. Int J Tuberc Lung Dis. 2013 Jun;17(6):794-9. doi: 10.5588/ijtld.12.0567.
Publication: Diacon AH, Donald PR, Mendel CM. Early bactericidal activity of new drug regimens for tuberculosis - Authors' reply. Lancet. 2013 Jan 12;381(9861):112-3. doi: 10.1016/S0140-6736(13)60042-2.
Publication: D'Ambrosio L, Centis R, Migliori GB. Multidrug-resistant tuberculosis. N Engl J Med. 2012 Nov 29;367(22):2154; author reply 2155-6. doi: 10.1056/NEJMc1210001#SA1.
New Drugs for the Treatment of Tuberculosis: Needs, Challenges, Promise, and Prospects for the Future
Publication: Lienhardt C, Raviglione M, Spigelman M, et. al. New drugs for the treatment of tuberculosis: needs, challenges, promise, and prospects for the future. J Infect Dis. 2012 May 15;205 Suppl 2:S241-9. doi: 10.1093/infdis/jis034.
New initiative speeds tuberculosis drug development: novel drug regimens become possible in years, not decades
Publication: Spigelman M, Woosley R, Gheuens J. New initiative speeds tuberculosis drug development: novel drug regimens become possible in years, not decades. Int J Tuberc Lung Dis. 2010 Jun;14(6):663-4. http://www.ingentaconnect.com/content/iuatld/ijtld/2010/0000001
Publication: Ma Z, Lienhardt C, McIlleron H, Nunn AJ, Wang X. Global tuberculosis drug development pipeline: the need and the reality. Lancet. 2010 Jun 12;375(9731):2100-9. doi: 10.1016/S0140-6736(10)60359-9.
Publication: Nunn AJ, Meredith SK, Spigelman MK, Ginsberg AM, Gillespie SH. The ethics of non-inferiority trials. Lancet. 2008 Mar 15;371(9616):895; author reply 896-7. doi: 10.1016/S0140-6736(08)60404-3.
Publication: Wells WA, Brooks A. Adoption of new health products in low and middle income settings: how product development partnerships can support country decision making. Health Res Policy Syst. 2011 Mar 31;9:15. doi: 10.1186/1478-4505-9-15.
Publication: Laurenzi M, Ginsberg AM, Spigelman M. Challenges associated with current and future TB treatment. Infect Disord Drug Targets. 2007 Jun;7(2):105-19. http://www.ingentaconnect.com/content/ben/iddt/2007/00000007/00000002/art00004?token=004e1567d370e7e442f206
Publication: Ginsberg AM, Spigelman M. Challenges in tuberculosis drug research and development. Nat Med. 2007 Mar;13(3):290-4. http://www.nature.com/nm/journal/v13/n3/full/nm0307-290.html. Accessed March 7, 2016
Publication: Ma Z, Ginsberg A, Spigelman M. Antimycobacterium Agents. Elsevier, Philadelphia, PA. 2007 Jan; 700-4, 719-20, 26.
Publication: Freire MC. Opportunities for overcoming tuberculosis: new treatment regimens. World Hosp Health Serv. 2006;42(1):34-7. http://www.ncbi.nlm.nih.gov/pubmed/16669375. Accessed March 7, 2016