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Developing biomarker assays to accelerate tuberculosis drug development: defining target product profiles.
Gillespie, Stephen H; DiNardo, Andrew R; Georghiou, Sophia B; Sabiiti, Wilber; Kohli, Mikashmi; Panzner, Ursula; Kontsevaya, Irina; Hittel, Norbert; Stuyver, Lieven J; Tan, Jia Bin; van Crevel, Reinout; Lange, Christoph; Thuong, Thuong Nguyen Thuy; Heyckendorf, Jan; Ruhwald, Morten; Heinrich, Norbert.
Afiliación
  • Gillespie SH; Division of Infection and Global Health, School of Medicine, University of St Andrews, St Andrews, UK. Electronic address: shg3@st-andrews.ac.uk.
  • DiNardo AR; Global TB Program, Texas Children's Hospital and Baylor College of Medicine, Houston, TX, USA; Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, GA Nijmegen, Netherlands.
  • Georghiou SB; FIND, Campus Biotech, Geneva, Switzerland.
  • Sabiiti W; Division of Infection and Global Health, School of Medicine, University of St Andrews, St Andrews, UK.
  • Kohli M; FIND, Campus Biotech, Geneva, Switzerland.
  • Panzner U; Division of Infectious Diseases and Tropical Medicine, University Hospital, Ludwig-Maximilians-Universität München (LMU), Munich, Germany; German Center for Infection Research (DZIF), Partner Site Munich, Munich, Germany.
  • Kontsevaya I; German Center for Infection Research (DZIF), Partner Site Hamburg-Lübeck-Borstel-Riems, Borstel, Germany; Department of Infectious Disease, Faculty of Medicine, Imperial College London, London, UK.
  • Hittel N; Janssen Global Public Health R&D, Janssen Pharmaceutica NV, Beerse, Belgium.
  • Stuyver LJ; Otsuka Novel Products, Munich, Germany.
  • Tan JB; FIND, Campus Biotech, Geneva, Switzerland.
  • van Crevel R; Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, GA Nijmegen, Netherlands; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Lange C; Global TB Program, Texas Children's Hospital and Baylor College of Medicine, Houston, TX, USA; Division of Clinical Infectious Diseases, Research Center Borstel, Borstel, Germany; German Center for Infection Research (DZIF), Clinical Tuberculosis Unit, Borstel, Germany; Respiratory Medicine & In
  • Thuong TNT; Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam.
  • Heyckendorf J; Respiratory Medicine & International Health, University of Lübeck, Lübeck, Germany; Clinic for Internal Medicine I, University Hospital Schleswig-Holstein (UKSH) Campus Kiel, Kiel, Germany.
  • Ruhwald M; FIND, Campus Biotech, Geneva, Switzerland.
  • Heinrich N; Division of Infectious Diseases and Tropical Medicine, University Hospital, Ludwig-Maximilians-Universität München (LMU), Munich, Germany; German Center for Infection Research (DZIF), Partner Site Munich, Munich, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunol
Lancet Microbe ; 5(9): 100869, 2024 Sep.
Article en En | MEDLINE | ID: mdl-38735303
ABSTRACT
Drug development for tuberculosis is hindered by the methodological limitations in the definitions of patient outcomes, particularly the slow organism growth and difficulty in obtaining suitable and representative samples throughout the treatment. We developed target product profiles for biomarker assays suitable for early-phase and late-phase clinical drug trials by consulting subject-matter experts on the desirable performance and operational characteristics of such assays for monitoring of tuberculosis treatment in drug trials. Minimal and optimal criteria were defined for scope, intended use, pricing, performance, and operational characteristics of the biomarkers. Early-stage trial assays should accurately quantify the number of viable bacilli, whereas late-stage trial assays should match the number, predict relapse-free cure, and replace culture conversion endpoints. The operational criteria reflect the infrastructure and resources available for drug trials. The effective tools should define the sterilising activity of the drug and lower the probability of treatment failure or relapse in people with tuberculosis. The target product profiles outlined in this Review should guide and de-risk the development of biomarker-based assays suitable for phase 2 and 3 clinical drug trials.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tuberculosis / Biomarcadores / Desarrollo de Medicamentos / Antituberculosos Límite: Humans Idioma: En Revista: Lancet Microbe Año: 2024 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tuberculosis / Biomarcadores / Desarrollo de Medicamentos / Antituberculosos Límite: Humans Idioma: En Revista: Lancet Microbe Año: 2024 Tipo del documento: Article Pais de publicación: Reino Unido