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Volumn 20, Issue 12, 2016, Pages S4-S7

Methodological considerations in clinical trials for new MDR-TB treatment regimens

Author keywords

Clinical trials; Evidence based medicine; MDR TB; Methodology

Indexed keywords

BEDAQUILINE; DELAMANID; ISONIAZID; RIFAMPICIN; TUBERCULOSTATIC AGENT;

EID: 85016126101     PISSN: 10273719     EISSN: 18157920     Source Type: Journal    
DOI: 10.5588/ijtld.16.0061     Document Type: Article
Times cited : (3)

References (23)
  • 2
    • 84907377122 scopus 로고    scopus 로고
    • Multidrug-resistant tuberculosis and culture conversion with bedaquiline
    • Diacon A H, Pym A, Grobusch M P, et al. Multidrug-resistant tuberculosis and culture conversion with bedaquiline. N Engl J Med 2014; 371: 723-732.
    • (2014) N Engl J Med , vol.371 , pp. 723-732
    • Diacon, A.H.1    Pym, A.2    Grobusch, M.P.3
  • 3
    • 84861864703 scopus 로고    scopus 로고
    • Delamanid for multidrug-resistant pulmonary tuberculosis
    • Gler M T, Skripconoka V, Sanchez-Garavito E, et al. Delamanid for multidrug-resistant pulmonary tuberculosis. N Engl J Med 2012; 366: 2151-2160.
    • (2012) N Engl J Med , vol.366 , pp. 2151-2160
    • Gler, M.T.1    Skripconoka, V.2    Sanchez-Garavito, E.3
  • 5
    • 84865541246 scopus 로고    scopus 로고
    • Multidrug resistant pulmonary tuberculosis treatment regimens and patient outcomes: An individual patient data meta-analysis of 9153 patients
    • Ahuja S D, Ashkin D, Avendano M, et al. Multidrug resistant pulmonary tuberculosis treatment regimens and patient outcomes: an individual patient data meta-analysis of 9153 patients. PLOS MED 2012; 9: e1001300.
    • (2012) PLOS MED , vol.9
    • Ahuja, S.D.1    Ashkin, D.2    Avendano, M.3
  • 6
    • 84894198937 scopus 로고    scopus 로고
    • WHO/HTM/TB/2015.22. Geneva, Switzerland: WHO
    • World Health Organization. Global tuberculosis report, 2015. WHO/HTM/TB/2015.22. Geneva, Switzerland: WHO, 2015.
    • (2015) Global Tuberculosis Report, 2015
  • 7
    • 84907033159 scopus 로고    scopus 로고
    • High cure rate with standardised short-course multidrug-resistant tuberculosis treatment in Niger: No relapses
    • Piubello A, Harouna S H, Souleymane M B, et al. High cure rate with standardised short-course multidrug-resistant tuberculosis treatment in Niger: no relapses. Int J Tuberc Lung Dis 2014; 18: 1188-1194.
    • (2014) Int J Tuberc Lung Dis , vol.18 , pp. 1188-1194
    • Piubello, A.1    Harouna, S.H.2    Souleymane, M.B.3
  • 8
    • 77952365008 scopus 로고    scopus 로고
    • Short, highly effective, and inexpensive standardized treatment of multidrug-resistant tuberculosis
    • Van Deun A, Maug A K J Salim M A H, et al. Short, highly effective, and inexpensive standardized treatment of multidrug-resistant tuberculosis. Am J Respir Crit Care Med 2010; 182: 684-692.
    • (2010) Am J Respir Crit Care Med , vol.182 , pp. 684-692
    • Van Deun, A.1    Maug, A.K.J.2    Salim, M.A.H.3
  • 9
    • 84910039155 scopus 로고    scopus 로고
    • Correcting for multiple-testing in multi-arm trials: Is it necessary and is it done?
    • Wason J M, Stecher L, Mander A P. Correcting for multiple-testing in multi-arm trials: is it necessary and is it done? Trials 2014; 15: 364.
    • (2014) Trials , vol.15 , pp. 364
    • Wason, J.M.1    Stecher, L.2    Mander, A.P.3
  • 10
    • 84904793436 scopus 로고    scopus 로고
    • More multiarm randomised trials of superiority are needed
    • Parmar M K, Carpenter J, Sydes M R. More multiarm randomised trials of superiority are needed. Lancet 2014; 384: 283-284.
    • (2014) Lancet , vol.384 , pp. 283-284
    • Parmar, M.K.1    Carpenter, J.2    Sydes, M.R.3
  • 11
    • 84929410434 scopus 로고    scopus 로고
    • Adaptive clinical trials in tuberculosis: Applications, challenges and solutions
    • Davies G R, Phillips P P, Jaki T. Adaptive clinical trials in tuberculosis: applications, challenges and solutions. Int J Tuberc Lung Dis 2015; 19: 626-634.
    • (2015) Int J Tuberc Lung Dis , vol.19 , pp. 626-634
    • Davies, G.R.1    Phillips, P.P.2    Jaki, T.3
  • 12
    • 84929511425 scopus 로고    scopus 로고
    • Towards early inclusion of children in tuberculosis drugs trials: A consensus statement
    • Nachman S, Ahmed A, Amanullah F, et al. Towards early inclusion of children in tuberculosis drugs trials: a consensus statement. Lancet Infect Dis 2015; 15: 711-720.
    • (2015) Lancet Infect Dis , vol.15 , pp. 711-720
    • Nachman, S.1    Ahmed, A.2    Amanullah, F.3
  • 13
    • 84960129843 scopus 로고    scopus 로고
    • Toward earlier inclusion of pregnant and postpartum women in tuberculosis drug trials: Consensus statements from an international expert panel
    • Gupta A, Mathad J S, Abdel-Rahman S M, et al. Toward earlier inclusion of pregnant and postpartum women in tuberculosis drug trials: consensus statements from an international expert panel. Clin Infect Dis 2016; 62: 761-769.
    • (2016) Clin Infect Dis , vol.62 , pp. 761-769
    • Gupta, A.1    Mathad, J.S.2    Abdel-Rahman, S.M.3
  • 14
    • 85048345152 scopus 로고    scopus 로고
    • Choice of control group and related issues in clinical trials
    • International Council on Harmonisation Expert Working Group. Choice of control group and related issues in clinical trials. Geneva, Switzerland: ICH Harmonised Tripartite Guideline Current Step 2000; 4: E10.
    • (2000) Geneva, Switzerland: ICH Harmonised Tripartite Guideline Current Step , vol.4 , Issue.E10
  • 15
    • 84908229272 scopus 로고    scopus 로고
    • Randomised controlled trials for ebola: Practical and ethical issues
    • Adebamowo C, Bah-Sow O, Binka F, et al. Randomised controlled trials for Ebola: practical and ethical issues. Lancet 2014; 384: 1423-1424.
    • (2014) Lancet , vol.384 , pp. 1423-1424
    • Adebamowo, C.1    Bah-Sow, O.2    Binka, F.3
  • 16
    • 84927588597 scopus 로고    scopus 로고
    • Right job, wrong tool: A commentary on designing clinical trials for ebola virus disease
    • Nelson R M, Roth-Cline M, Prohaska K, Cox E, Borio L, Temple R. Right job, wrong tool: a commentary on designing clinical trials for Ebola virus disease. Am J Bioeth 2015; 15: 33-36.
    • (2015) Am J Bioeth , vol.15 , pp. 33-36
    • Nelson, R.M.1    Roth-Cline, M.2    Prohaska, K.3    Cox, E.4    Borio, L.5    Temple, R.6
  • 17
    • 84907020883 scopus 로고    scopus 로고
    • Successful '9-month Bangladesh regimen' for multidrug-resistant tuberculosis among over 500 consecutive patients
    • Aung K J, Van Deun A, Declercq E, et al. Successful '9-month Bangladesh regimen' for multidrug-resistant tuberculosis among over 500 consecutive patients. Int J Tuberc Lung Dis 2014; 18: 1180-1187.
    • (2014) Int J Tuberc Lung Dis , vol.18 , pp. 1180-1187
    • Aung, K.J.1    Van Deun, A.2    Declercq, E.3
  • 18
    • 77049123034 scopus 로고    scopus 로고
    • Timing of relapse in short-course chemotherapy trials for tuberculosis [Short communication]
    • Nunn A J, Phillips P P J Mitchison D A. Timing of relapse in short-course chemotherapy trials for tuberculosis [Short communication]. Int J Tuberc Lung Dis 2010; 14: 241-242.
    • (2010) Int J Tuberc Lung Dis , vol.14 , pp. 241-242
    • Nunn, A.J.1    Phillips, P.P.J.2    Mitchison, D.A.3
  • 19
    • 84865813010 scopus 로고    scopus 로고
    • Time until relapse in tuberculosis treatment trials: Implication for phase 3 trial design
    • Johnson J L, Thiel B A. Time until relapse in tuberculosis treatment trials: implication for Phase 3 trial design. Am J Respir Crit Care Med 2012; 186: 464.
    • (2012) Am J Respir Crit Care Med , vol.186 , pp. 464
    • Johnson, J.L.1    Thiel, B.A.2
  • 20
    • 84908126151 scopus 로고    scopus 로고
    • Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis
    • Gillespie S H, Crook A M, McHugh T D, et al. Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis. N Engl J Med 2014; 371: 1577-1587.
    • (2014) N Engl J Med , vol.371 , pp. 1577-1587
    • Gillespie, S.H.1    Crook, A.M.2    McHugh, T.D.3
  • 21
    • 84908139920 scopus 로고    scopus 로고
    • High-dose rifapentine with moxifloxacin for pulmonary tuberculosis
    • Jindani A, Harrison T S, Nunn A J, et al. High-dose rifapentine with moxifloxacin for pulmonary tuberculosis. N Engl J Med 2014; 371: 1599-1608.
    • (2014) N Engl J Med , vol.371 , pp. 1599-1608
    • Jindani, A.1    Harrison, T.S.2    Nunn, A.J.3
  • 22
    • 84908147456 scopus 로고    scopus 로고
    • A four-month gatifloxacin-containing regimen for treating tuberculosis
    • Merle C S, Fielding K, Sow O B, et al. A four-month gatifloxacin-containing regimen for treating tuberculosis. N Engl J Med 2014; 371: 1588-1598.
    • (2014) N Engl J Med , vol.371 , pp. 1588-1598
    • Merle, C.S.1    Fielding, K.2    Sow, O.B.3
  • 23
    • 84958522574 scopus 로고    scopus 로고
    • Drug-resistant tuberculosis clinical trials: Proposed core research definitions in adults
    • Furin J, Alirol E, Allen E, et al. Drug-resistant tuberculosis clinical trials: proposed core research definitions in adults. Int J Tuberc Lung Dis 2016; 20: 290-294.
    • (2016) Int J Tuberc Lung Dis , vol.20 , pp. 290-294
    • Furin, J.1    Alirol, E.2    Allen, E.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.