3
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Development of new TB regimens: Harmonizing trial design, product registration requirements, and public health guidance

      review-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Christian Lienhardt and colleagues discuss the importance of communication and coordination between regulators, researchers, and policy makers to ensure tuberculosis trials provide high-quality evidence for policy decisions.

          Related collections

          Most cited references14

          • Record: found
          • Abstract: found
          • Article: not found

          Treatment correlates of successful outcomes in pulmonary multidrug-resistant tuberculosis: an individual patient data meta-analysis

          Treatment outcomes for multidrug-resistant tuberculosis remain poor. We aimed to estimate the association of treatment success and death with the use of individual drugs, and the optimal number and duration of treatment with those drugs in patients with multidrug-resistant tuberculosis.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: found

            Tuberculosis: progress and advances in development of new drugs, treatment regimens, and host-directed therapies

              Bookmark
              • Record: found
              • Abstract: not found
              • Article: not found

              Challenges in the Design and Interpretation of Noninferiority Trials

                Bookmark

                Author and article information

                Journal
                PLoS Med
                PLoS Med
                plos
                plosmed
                PLoS Medicine
                Public Library of Science (San Francisco, CA USA )
                1549-1277
                1549-1676
                6 September 2019
                September 2019
                : 16
                : 9
                : e1002915
                Affiliations
                [1 ] Unité Mixte Internationale TransVIHMI, UMI 233 IRD–U1175 INSERM—Université de Montpellier, Institut de Recherche pour le Développement (IRD), Montpellier, France
                [2 ] Division of TB Elimination, National Center for HIV, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America
                [3 ] Office of Anti-infective and Vaccines, Human Medicines Evaluation, European Medicines Agency, Amsterdam, the Netherlands
                [4 ] Division of Anti-Infective Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, United States of America
                [5 ] Division of Pulmonary and Critical Care Medicine, Center for Tuberculosis, University of California, San Francisco, San Francisco, California, United States of America
                Author notes

                I have read the journal's policy and the authors of this manuscript have the following competing interests: At the CDC, AAV serves as part of a research group doing clinical trials in tuberculosis. His group (TBTC) works often in collaboration with pharmaceutical companies, who may provide modest support, such as drug supplies or funding for PK sub-studies. One company, Sanofi, has provided 6 unrestricted grants to the CDC Foundation over the years 2007–2015 totaling ~$2.8 million to facilitate or support TBTC work related to rifapentine. These funds have supported several PK sub-studies, supported 3 contract research staff, have funded travel to TBTC scientific meetings for invited speakers (all in coach class), and have supported expenses related to fulfillment of company requests for data and data formats as part of their efforts to use TBTC data to support regulatory filings. None of these funds have otherwise benefited members of his research group.

                Author information
                http://orcid.org/0000-0003-0233-893X
                http://orcid.org/0000-0003-2811-1311
                Article
                PMEDICINE-D-18-04373
                10.1371/journal.pmed.1002915
                6730844
                31490921
                a947e706-9224-4766-af3c-53f391bace9b
                © 2019 World Health Organization

                Licensee Public Library of Science. This is an open access article distributed under the Creative Commons Attribution IGO License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/3.0/igo/. In any use of this article, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL.

                History
                Page count
                Figures: 0, Tables: 3, Pages: 13
                Funding
                No specific funding was received for this study. No funding bodies had any role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Collection Review
                Medicine and Health Sciences
                Infectious Diseases
                Bacterial Diseases
                Tuberculosis
                Medicine and Health Sciences
                Tropical Diseases
                Tuberculosis
                Medicine and Health Sciences
                Health Care
                Health Care Policy
                Medicine and Health Sciences
                Clinical Medicine
                Clinical Trials
                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
                Clinical Trials
                Research and Analysis Methods
                Clinical Trials
                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
                Medicine and Health Sciences
                Health Care
                Health Care Policy
                Drug Policy
                Medicine and Health Sciences
                Public and Occupational Health
                Drug Policy
                Medicine and Health Sciences
                Pharmaceutics
                Drug Therapy
                Medicine and Health Sciences
                Public and Occupational Health
                Science Policy

                Medicine
                Medicine

                Comments

                Comment on this article