Research Papers

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 18 papers

Treatment of Highly Drug-Resistant Pulmonary Tuberculosis

Publication: The New England Journal of Medicine

Author(s): Francesca Conradie, M.B., B.Ch., Andreas H. Diacon, M.D., Nosipho Ngubane, M.B., B.Ch., Pauline Howell, M.B., B.Ch., Daniel Everitt, M.D., Angela M. Crook, Ph.D., Carl M. Mendel, M.D., Erica Egizi, M.P.H., et al., for the Nix-TB Trial Team*

3/2020

Tags: Bedaquiline (TMC-207), BPaL, Clinical Trial Results, Linezolid, MDR-TB, Pretomanid/PA-824, Regimen Change, Trial Design, XDR-TB

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

Author(s): Conor D Tweed, Rodney Dawson, Divan A Burger, Almari Conradie, Angela M Crook, Carl M Mendel, Francesca Conradie, Andreas H Diacon, Nyanda E Ntinginya, Daniel E Everitt, Frederick Haraka, Mengchun Li, Christo H van Niekerk, Alphonse Okwera

11/2019

Tags: Bedaquiline (TMC-207), BPaZ, Clinical Trial Results, MDR-TB, Moxifloxacin, NC-005, PaMZ, Pretomanid/PA-824, Trial Design

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

Author(s): Kathleen M. MacQueen, Natalie T. Eley, Mike Frick, Laia Ruiz Mingote, Alicia Chou, Stephanie S. Seidel, Stacey Hannah, and Carol Hamilton

6/2016

Tags: Advocacy, Clinical Development, Community Engagement, TB-HIV, Trial Design

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

3/2016

Tags: Biomarkers, Clinical Development, Moxifloxacin, ReMoxTB, Trial Design

Drug-resistant tuberculosis clinical trials: proposed core research definitions in adults

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.

3/2016

Tags: Clinical Development, Editorials, MDR-TB, Trial Design, XDR-TB

Towards early inclusion of children in tuberculosis drugs trials: a consensus statement

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.

5/2015

Tags: Advocacy, Childhood TB, Clinical Development, Editorials, Policy, Trial Design

Requirements for the clinical evaluation of new anti-tuberculosis agents in children

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.

6/2013

Tags: Advocacy, Childhood TB, Clinical Development, Editorials, Trial Design

Early bactericidal activity of new drug regimens for tuberculosis - Authors' reply

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.

1/2013

Tags: Clinical Development, Editorials, Moxifloxacin, NC-001, PaMZ, Pretomanid/PA-824, Pyrazinamide, Trial Design

Multidrug-resistant tuberculosis

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.

11/2012

Tags: Advocacy, Clinical Development, Editorials, Trial Design

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.

3/2012

Tags: Advocacy, Childhood TB, Clinical Development, Drug Discovery, Drug-Sensitivity Testing, Editorials, Global Pipeline, MDR-TB, Moxifloxacin, Pharmacodynamics, Pharmacokinetics, Policy, Preclinical Models, Pretomanid/PA-824, Regimen Change, TB Market, TB-HIV, Trial Design

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

6/2010

Tags: Advocacy, Clinical Development, Editorials, MDR-TB, TB Drug Market, TB Market, Trial Design

Global tuberculosis drug development pipeline: the need and the reality

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.

5/2010

Tags: Advocacy, Bedaquiline (TMC-207), Biomarkers, Childhood TB, Clinical Development, Editorials, Global Pipeline, MDR-TB, Moxifloxacin, Policy, Pretomanid/PA-824, Rifapentine, Sutezolid, Trial Design

The ethics of non-inferiority trials

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.

3/2008

Tags: Advocacy, Clinical Development, Clinical Trial Results, Editorials, Policy, Trial Design

Advancing the science in clinical trials for new TB drugs

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.

2/2008

Tags: Biomarkers, Clinical Development, Editorials, Moxifloxacin, Trial Design

Challenges associated with current and future TB treatment

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

Author(s): Laurenzi, M., A. Ginsberg, and M. Spigelman

6/2007

Tags: Advocacy, Clinical Development, Editorials, Global Pipeline, Trial Design

Challenges in tuberculosis drug research and development

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

3/2007

Tags: Clinical Development, Editorials, Global Pipeline, Trial Design

Antimycobacterium Agents

Publication: Ma Z, Ginsberg A, Spigelman M. Antimycobacterium Agents. Elsevier, Philadelphia, PA. 2007 Jan; 700-4, 719-20, 26.

1/2007

Tags: Clinical Development, Drug Discovery, Drug Targets, Global Pipeline, M.tb. Biology, MDR-TB, Moxifloxacin, Preclinical Models, Pretomanid/PA-824, Pyrazinamide, Rifapentine, TB-HIV, Trial Design

Opportunities for overcoming tuberculosis: new treatment regimens

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

1/2006

Tags: Advocacy, Clinical Development, Editorials, Global Pipeline, Policy, Trial Design