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TitleBiomarkers of treatment response in clinical trials of novel antituberculosis agents.
Linkhttp://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6W8X-4NT250B-1&_user=910131&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000047819&_version=1&_urlVersion=0&_userid=910131&md5=53a3a9bffd66fe097cab9a2b9063a060
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Author(s)Perrin FM; Lipman MC; McHugh TD; Gillespie SH.
AbstractGlobal initiatives have been launched to develop improved tuberculosis chemotherapy. New drugs and potential treatment-shortening regimens require careful assessment in clinical trials, but existing markers of treatment outcome—clinical cure and relapse—require prolonged follow-up of patients. There is, therefore, a need to find alternative biomarkers or surrogate endpoints predictive of response. Effective treatment requires drugs with sterilising activity to produce clinical cure without relapse, and thus a useful biomarker for a drug under trial must predict the likelihood of relapse. We explore the strengths and weaknesses of existing biomarkers, which assess either host response or mycobacterial load. Change in mycobacterial burden is likely to be the best indicator of treatment outcome, but the optimum study techniques remain undefined. Finally, we propose methods to assess candidate markers, and how these candidate markers could be implemented in future clinical trials.
Peer Reviewer
PublisherElsevier
SourceLancet Infectious Diseases
Publication TypeJournal article, Research study
CategoryInvestigation, Treatment
Level of EvidenceEvidence cited
CoverageNational
FormatPdf
LanguageEnglish
Access RightsSite-specific password
Date of publishing07/01/2007
Date of last review by us03/04/2008

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