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 16 papers

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