Standards for clinical trials for treating TB

Author:

du Cros P.1,Greig J.2,Alffenaar J.-W. C.3,Cross G. B.4,Cousins C.5,Berry C.6,Khan U.7,Phillips P. P. J.8,Velásquez G. E.9,Furin J.10,Spigelman M.11,Denholm J. T.12,Thi S. S.13,Tiberi S.14,Huang G. K. L.15,Marks G. B.16,Turkova A.17,Guglielmetti L.18,Chew K. L.19,Nguyen H. T.20,Ong C. W. M.21,Brigden G.22,Singh K. P.23,Motta I.24,Lange C.25,Seddon J. A.26,Nyang’wa B-T.27,Maug A. K. J.28,Gler M. T.29,Dooley K. E.30,Quelapio M.31,Tsogt B.32,Menzies D.33,Cox V.34,Upton C. M.35,Skrahina A.36,McKenna L.37,Horsburgh C. R.38,Dheda K.39,Marais B. J.40

Affiliation:

1. Burnet Institute, Melbourne, VIC, Monash Infectious Diseases, Monash Health, Melbourne, VIC, Australia

2. Burnet Institute, Melbourne, VIC, Médecins Sans Frontières (MSF), Manson Unit, London, UK

3. Sydney Infectious Diseases Institute (Sydney ID), and, School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Westmead Hospital, Sydney, NSW

4. Burnet Institute, Melbourne, VIC, Kirby Institute, University of New South Wales, Sydney, NSW, Australia

5. Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, Institute of Clinical Trials and Methodology, University College London, London, UK

6. Médecins Sans Frontières (MSF), Manson Unit, London, UK

7. Interactive Research and Development Global, Singapore City, Singapore

8. UCSF Center for Tuberculosis, Division of Pulmonary and Critical Care Medicine, and

9. UCSF Center for Tuberculosis, Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San Francisco, CA

10. Harvard Medical School, Department of Global Health and Social Medicine, Boston, MA

11. Global Alliance for TB Drug Development, New York, NY, USA

12. Victorian Tuberculosis Program, Melbourne Health, Melbourne, VIC, Department of Infectious Diseases, Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, VIC, Australia

13. Eswatini National TB Control Program, Mbabane, Kingdom of Eswatini

14. Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, GlaxoSmithKline, London, UK

15. Burnet Institute, Melbourne, VIC, Northern Health Infectious Diseases, Northern Health, Melbourne, VIC

16. School of Clinical Medicine, University of New South Wales, Sydney, NSW, Australia

17. Medical Research Council Clinical Trials Unit at University College London, London, UK

18. Médecins Sans Frontières (MSF), Paris, Sorbonne Université, Institut national de la santé et de la recherche médicale, Unité 1135, Centre d’Immunologie et des Maladies Infectieuses, Paris, Assistance Publique Hôpitaux de Paris (APHP), Groupe Hospitalier Universitaire Sorbonne Université, Hôpital Pitié-Salpêtrière, Centre National de Référence des Mycobactéries et de la Résistance des Mycobactéries, Paris, France

19. Department of Laboratory Medicine, National University Hospital, Singapore City, Singapore

20. Research Department, Friends for International TB Relief, Ha Noi, Vietnam

21. Infectious Diseases Translational Research Programme, Department of Medicine, National University of Singapore, Singapore City, Division of Infectious Diseases, Department of Medicine, National University Hospital, Singapore City, Institute of Healthcare Innovation & Technology, National University of Singapore, Singapore City, Singapore

22. The Global Fund, Geneva, Switzerland

23. Department of Infectious Diseases, Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, VIC, Australia, Victorian Infectious Disease Unit, Royal Melbourne Hospital, Melbourne, VIC, Australia

24. MSF, Geneva, Switzerland

25. Division of Clinical Infectious Diseases, Research Center Borstel, Borstel, German Center for Infection Research (DZIF), TTU-TB, Borstel, Respiratory Medicine & International Health, University of Lübeck, Lübeck, Germany, Baylor College of Medicine and Texas Children’s Hospital, Houston, TX, USA

26. Department of Infectious Disease, Imperial College London, London, UK, Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg, South Africa

27. Public Health Department, Operational Center Amsterdam (OCA), MSF, Amsterdam, The Netherlands

28. Damien Foundation Bangladesh, Dhaka, Bangladesh

29. De La Salle Medical and Health Sciences Institute, Dasmariñas, the Philippines

30. Division of Infectious Diseases, Vanderbilt University Medical Center, Nashville, TN, USA

31. Tropical Disease Foundation, Makati City, Manila, the Philippines, KNCV Tuberculosis Foundation, The Hague, The Netherlands

32. Mongolian Anti-TB Coalition, Ulaanbaatar, Mongolia

33. Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute & McGill International TB Centre, Montreal, QC, Canada

34. Centre for Infectious Disease Epidemiology and Research, School of Public Health and Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town

35. TASK Applied Science, Cape Town, South Africa

36. The Republican Scientific and Practical Center for Pulmonology and TB, Minsk, Belarus

37. Treatment Action Group, New York, NY

38. Departments of Global Health, Epidemiology, Biostatistics and Medicine, Schools of Public Health and Medicine, Boston University, Boston MA, USA

39. Centre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and UCT Lung Institute & South African MRC/UCT Centre for the Study of Antimicrobial Resistance, University of Cape Town, Cape Town, South Africa, Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, UK

40. Sydney Infectious Diseases Institute (Sydney ID), and, The Children’s Hospital at Westmead, Sydney, NSW, WHO Collaborating Centre in Tuberculosis, The University of Sydney, Sydney, NSW, Australia

Abstract

BACKGROUND: The value, speed of completion and robustness of the evidence generated by TB treatment trials could be improved by implementing standards for best practice.METHODS: A global panel of experts participated in a Delphi process, using a 7-point Likert scale to score and revise draft standards until consensus was reached.RESULTS: Eleven standards were defined: Standard 1, high quality data on TB regimens are essential to inform clinical and programmatic management; Standard 2, the research questions addressed by TB trials should be relevant to affected communities, who should be included in all trial stages; Standard 3, trials should make every effort to be as inclusive as possible; Standard 4, the most efficient trial designs should be considered to improve the evidence base as quickly and cost effectively as possible, without compromising quality; Standard 5, trial governance should be in line with accepted good clinical practice; Standard 6, trials should investigate and report strategies that promote optimal engagement in care; Standard 7, where possible, TB trials should include pharmacokinetic and pharmacodynamic components; Standard 8, outcomes should include frequency of disease recurrence and post-treatment sequelae; Standard 9, TB trials should aim to harmonise key outcomes and data structures across studies; Standard 10, TB trials should include biobanking; Standard 11, treatment trials should invest in capacity strengthening of local trial and TB programme staff.CONCLUSION: These standards should improve the efficiency and effectiveness of evidence generation, as well as the translation of research into policy and practice.

Publisher

International Union Against Tuberculosis and Lung Disease

Subject

Infectious Diseases,Pulmonary and Respiratory Medicine

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