Tuberculosis biomarker and surrogate endpoint research roadmap

American Journal of Respiratory and Critical Care Medicine

Volumn 184, Issue 8, 2011, Pages 972-979

  Nahid, Payam ^a   Saukkonen, Jussi ^b   Mac Kenzie, William R ^c   Johnson, John L ^d   Phillips, Patrick P J ^e   Andersen, Janet ^f   Bliven Sizemore, Erin ^c   Belisle, John T ^g   Boom, W Henry ^d   Luetkemeyer, Annie ^h   Campbell, Thomas B ⁱ   Eisenach, Kathleen D ^j   Hafner, Richard ^k   Lennox, Jeffrey L ^l   Makhene, Mamodikoe ^k   Swindells, Susan ^m   Villarino, M Elsa ^c   Weiner, Marc ⁿ   Benson, Constance ^o   Burman, William ^p  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^d CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e MEDICAL RESEARCH COUNCIL   (United Kingdom)

^f CENTER FOR BIOSTATISTICS IN AIDS RESEARCH   (United States)

^g Department of Environmental and Radiological Health Sciences   (United States)

^h UNIVERSITY OF CALIFORNIA   (United States)

ⁱ UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^j UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES   (United States)

^k NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^l EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^m UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

ⁿ UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^o UNIVERSITY OF CALIFORNIA   (United States)

^p DENVER PUBLIC HEALTH   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; DNA; GAMMA INTERFERON; MICRORNA; RNA; TUBERCULOSTATIC AGENT;

BLOOD; CLINICAL DATA REPOSITORY; CLINICAL TRIAL (TOPIC); CONFERENCE PAPER; DEMOGRAPHY; DISEASE MARKER; FOLLOW UP; HUMAN; MICROORGANISM DETECTION; MULTIDRUG RESISTANCE; MYCOBACTERIUM TUBERCULOSIS; PERIPHERAL BLOOD MONONUCLEAR CELL; PLASMA; PRIORITY JOURNAL; RELAPSE; SPUTUM; SPUTUM CULTURE; SPUTUM CYTODIAGNOSIS; SPUTUM SMEAR; TREATMENT DURATION; TREATMENT FAILURE; TREATMENT OUTCOME; TREATMENT RESPONSE; TUBERCULOSIS; CONSENSUS DEVELOPMENT; GENETICS; HEALTH CARE FACILITY; IMMUNOLOGY; LABORATORY DIAGNOSIS; METABOLISM; STANDARD;

ANTITUBERCULAR AGENTS; BIOLOGICAL MARKERS; BIOLOGICAL SPECIMEN BANKS; CLINICAL TRIALS AS TOPIC; HUMANS; SPECIMEN HANDLING; TREATMENT OUTCOME; TUBERCULOSIS;

EID: 80054693304     PISSN: 1073449X     EISSN: 15354970     Source Type: Journal    
DOI: 10.1164/rccm.201105-0827WS     Document Type: Conference Paper

References (33)

1. Ma Z, Lienhardt C, McIlleron H, Nunn AJ, Wang X. Global tuberculosis drug development pipeline: the need and the reality. Lancet 2010;375:2100-2109.
2. Spigelman M, Gillespie S. Tuberculosis drug development pipeline: progress and hope. Lancet 2006;367:945-947.
3. Jindani A, Dore CJ, Mitchison DA. Bactericidal and sterilizing activities of antituberculosis drugs during the first 14 days. Am J Respir Crit Care Med 2003;167:1348-1354. (Pubitemid 36609718)
4. Nuermberger E. Using animal models to develop new treatments for tuberculosis. Semin Respir Crit Care Med 2008;29:542-551.
5. Davies GR, Phillips PP, Nunn AJ. Biomarkers and surrogate end points in clinical trials of tuberculosis treatment. J Infect Dis 2007;196:648-649, author reply 649-650.
6. Perrin FM, Lipman MC, McHugh TD, Gillespie SH. Biomarkers of treatment response in clinical trials of novel antituberculosis agents. Lancet Infect Dis 2007;7:481-490. (Pubitemid 46962336)
7. Wallis RS, Pai M, Menzies D, Doherty TM, Walzl G, Perkins MD, Zumla A. Biomarkers and diagnostics for tuberculosis: progress, needs, and translation into practice. Lancet 2010;375:1920-1937.
8. Walzl G, Ronacher K, Djoba Siawaya JF, Dockrell HM. Biomarkers for TB treatment response: challenges and future strategies. J Infect 2008;57:103-109.
9. Davies GR. Early clinical development of anti-tuberculosis drugs: science, statistics and sterilizing activity. Tuberculosis (Edinb) 2010;90:171-176.
10. Walzl G, Ronacher K, Hanekom W, Scriba TJ, Zumla A. Immunological biomarkers of tuberculosis. Nat Rev Immunol 2011;11:343-354.
11. Doherty TM, Wallis RS, Zumla A. Biomarkers of disease activity, cure, and relapse in tuberculosis. Clin Chest Med 2009;30:783-796. (x.).
12. Wallis RS, Doherty TM, Onyebujoh P, Vahedi M, Laang H, Olesen O, Parida S, Zumla A. Biomarkers for tuberculosis disease activity, cure, and relapse. Lancet Infect Dis 2009;9:162-172.
13. Mitchison DA. Assessment of new sterilizing drugs for treating pulmonary tuberculosis by culture at 2months. Am Rev Respir Dis 1993;147:1062-1063. (Pubitemid 23093839)
14. Markowitz M, Nguyen BY, Gotuzzo E, Mendo F, Ratanasuwan W, Kovacs C, Prada G, Morales-Ramirez JO, Crumpacker CS, Isaacs RD, et al. Rapid and durable antiretroviral effect of the HIV-1 integrase inhibitor raltegravir as part of combination therapy in treatment-naive patients with HIV-1 infection: results of a 48-week controlled study. J Acquir Immune Defic Syndr 2007;46:125-133. (Pubitemid 47482607)
15. De Gruttola VG, Clax P, DeMets DL, Downing GJ, Ellenberg SS, Friedman L, Gail MH, Prentice R, Wittes J, Zeger SL. Considerations in the evaluation of surrogate endpoints in clinical trials. Summary of a National Institutes of Health workshop. Control Clin Trials 2001;22:485-502. (Pubitemid 32907433)
16. Molenberghs G, Buyse ME, Burzykowski T. The evaluation of surrogate endpoints. New York: Springer; 2005.
17. Freedman LS, Graubard BI, Schatzkin A. Statistical validation of intermediate endpoints for chronic diseases. Stat Med 1992;11:167-178.
18. Fleming TR, Prentice RL, Pepe MS, Glidden D. Surrogate and auxiliary endpoints in clinical trials, with potential applications in cancer and aids research. Stat Med 1994;13:955-968. (Pubitemid 24141115)
19. Temple R. Are surrogate markers adequate to assess cardiovascular disease drugs? JAMA 1999;282:790-795. (Pubitemid 29404390)
20. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med 1996;125:605-613. (Pubitemid 126450094)
21. Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 1989;8:431-440. (Pubitemid 19105891)
22. Prentice RL. Surrogate and mediating endpoints: current status and future directions. J Natl Cancer Inst 2009;101:216-217.
23. Blumberg HM, Burman WJ, Chaisson RE, Daley CL, Etkind SC, Friedman LN, Fujiwara P, Grzemska M, Hopewell PC, Iseman MD, et al. American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America: treatment of tuberculosis. Am J Respir Crit Care Med 2003;167:603-662.
24. Jasmer RM, Bozeman L, Schwartzman K, Cave MD, Saukkonen JJ, Metchock B, Khan A, Burman WJ. Recurrent tuberculosis in the United States and Canada: relapse or reinfection? Am J Respir Crit Care Med 2004;170:1360-1366. (Pubitemid 39657201)
25. Nunn AJ, Phillips PP, Mitchison DA. Timing of relapse in short-course chemotherapy trials for tuberculosis. Int J Tuberc Lung Dis 2010;14:241-242.
26. Fox W, Ellard GA, Mitchison DA. Studies on the treatment of tuberculosis undertaken by the British Medical Research Council tuberculosis units, 1946-1986, with relevant subsequent publications. Int J Tuberc Lung Dis 1999;3:S231-279. (Pubitemid 29481843)
27. Brunner N, Schrohl AS, Wurtz S, Kohn E, Banks RE, Nielsen HJ, Sweep FCGJ. Banking of biological fluids for studies of disease-associated protein biomarkers. Mol Cell Proteomics 2008;7:2061-2066.
28. Mac Kenzie WR, Heilig CM, Bozeman L, Johnson JL, Muzanye G, Dunbar D, Jost KC Jr, Diem L, Metchock B, Eisenach K, et al. Geographic differences in time to culture conversion in liquid media: tuberculosis trials consortium study 28. Culture conversion is delayed in Africa. PLoS ONE 2011;6:e18358.
29. Walzl G, Ronacher K, Hanekom W, Scriba TJ, Zumla A. Immunological biomarkers of tuberculosis. Nat Rev Immunol 2011;11:343-354.
30. Lawn SD, Edwards DJ, Kranzer K, Vogt M, Bekker LG, Wood R. Urine lipoarabinomannan assay for tuberculosis screening before antiretroviral therapy diagnostic yield and association with immune reconstitution disease. AIDS 2009;23:1875-1880.
31. Green C, Huggett JF, Talbot E, Mwaba P, Reither K, Zumla AI. Rapid diagnosis of tuberculosis through the detection of mycobacterial DNA in urine by nucleic acid amplification methods. Lancet Infect Dis 2009;9:505-511.
32. The Food and Drug Administration. Guidance for industry: pharmacogenomic data submissions. Rockville, Maryland: Food and Drug Administration; 2005.
33. The Food and Drug Administration. Draft guidance for industry, qualification process for drug development tools. Rockville, Maryland: Food and Drug Administration; 2010.