Report of the technical consultation on innovative clinical trial designs for development of new TB treatments

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Publisher : World Health Organization
ISBN 13 : 9240030867
Total Pages : 87 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis Report of the technical consultation on innovative clinical trial designs for development of new TB treatments by :

Download or read book Report of the technical consultation on innovative clinical trial designs for development of new TB treatments written by and published by World Health Organization. This book was released on 2021-07-28 with total page 87 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Global Tuberculosis Programme of the World Health Organization (WHO) convened a virtual technical consultation on “Innovative Clinical Trial Designs for Development of New TB Treatments” on 5 days between 20 August and 13 October 2021. The main objective of the meeting was to establish evidence-based approaches to trial designs and use of data to inform policy guidance of new regimens for the treatment of TB with the view to accelerate future regimen development. The consultation brought together researchers, academics, technical partners, TB drugs and regimens developers including pharmaceutical industry, trialists, regulators, guideline developers, programme managers, nongovernmental organizations and civil society.

Report of the technical consultation on innovative clinical trial designs for evaluating new TB preventive treatments

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Publisher : World Health Organization
ISBN 13 : 9240047158
Total Pages : 59 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis Report of the technical consultation on innovative clinical trial designs for evaluating new TB preventive treatments by :

Download or read book Report of the technical consultation on innovative clinical trial designs for evaluating new TB preventive treatments written by and published by World Health Organization. This book was released on 2022-04-19 with total page 59 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Position statement on innovative clinical trial design for development of new TB treatments

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Publisher : World Health Organization
ISBN 13 : 9240030808
Total Pages : 14 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis Position statement on innovative clinical trial design for development of new TB treatments by :

Download or read book Position statement on innovative clinical trial design for development of new TB treatments written by and published by World Health Organization. This book was released on 2021-07-14 with total page 14 pages. Available in PDF, EPUB and Kindle. Book excerpt: This position statement aims to support TB regimen development by highlighting key clinical trial characteristics to help advance novel therapies. It summarises key innovations in TB clinical trial designs, ranging from pharmacokinetic-pharmacodynamic (PK-PD) modelling and new advances in biomarker development to the value of novel clinical trial design methodologies and post-licensure observational studies. For various stages along the development pathway, outstanding challenges are described alongside possible solutions to help overcome these issues. Beyond a welcome expansion of the TB drug pipeline, innovations in TB drug development and clinical trial design are anticipated to accelerate the development and evaluation as well as facilitate approval of novel regimens to treat all forms of TB.

A global strategy for tuberculosis research and innovation

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Publisher : World Health Organization
ISBN 13 : 9240010017
Total Pages : 44 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis A global strategy for tuberculosis research and innovation by :

Download or read book A global strategy for tuberculosis research and innovation written by and published by World Health Organization. This book was released on 2020-08-21 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tuberculosis (TB) is the leading cause of death from a single infectious agent, and one of the leading causes of death from antimicrobial resistance. To reach the milestones of the End TB Strategy, rapid progress must be made towards universal access to existing TB tools and services in the context of universal health coverage and socioeconomic development. At the same time, new technologies must be developed and introduced to make meaningful progress. The Global Strategy for Tuberculosis Research and Innovation will support the efforts of governments and other stakeholders to accelerate TB research and innovation, and improve equitable access to the benefits of research. This document is aimed primarily at Member States, particularly ministries of health, science and technology, finance and education.

Addressing the Threat of Drug-Resistant Tuberculosis

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Publisher : National Academies Press
ISBN 13 : 0309130441
Total Pages : 252 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Addressing the Threat of Drug-Resistant Tuberculosis by : Institute of Medicine

Download or read book Addressing the Threat of Drug-Resistant Tuberculosis written by Institute of Medicine and published by National Academies Press. This book was released on 2010-01-07 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tuberculosis is one of the leading causes of death in the world today, with 4,500 people dying from the disease every day. Many cases of TB can be cured by available antibiotics, but some TB is resistant to multiple drugs-a major and growing threat worldwide. The Institute of Medicine's Forum on Drug Discovery, Development, and Translation hosted a workshop on November 5, 2008, to address the mounting concern of drug-resistant TB. The session brought together a wide range of international experts to discuss what is known and not known about this growing threat, and to explore possible solutions.

Global Tuberculosis Report 2019

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Publisher :
ISBN 13 : 9789241565714
Total Pages : 294 pages
Book Rating : 4.5/5 (657 download)

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Book Synopsis Global Tuberculosis Report 2019 by : World Health Organization

Download or read book Global Tuberculosis Report 2019 written by World Health Organization and published by . This book was released on 2019-08-12 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: WHO has published a global TB report every year since 1997. The main aim of the report is to provide a comprehensive and up-to-date assessment of the TB epidemic, and of progress in prevention, diagnosis and treatment of the disease, at global, regional and country levels. This is done in the context of recommended global TB strategies and targets endorsed by WHO?s Member States, broader development goals set by the United Nations (UN) and targets set in the political declaration at the first UN high-level meeting on TB (held in September 2018). The 2019 edition of the global TB report was released on 17 October 2019. The data in this report are updated annually. Please note that direct comparisons between estimates of TB disease burden in the latest report and previous reports are not appropriate. The most recent time-series of estimates are published in the 2019 global TB report.

Strategic and Technical Advisory Group for Tuberculosis (STAG-TB)

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Publisher : World Health Organization
ISBN 13 : 9240064613
Total Pages : 27 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis Strategic and Technical Advisory Group for Tuberculosis (STAG-TB) by : World Health Organization

Download or read book Strategic and Technical Advisory Group for Tuberculosis (STAG-TB) written by World Health Organization and published by World Health Organization. This book was released on 2023-01-27 with total page 27 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report provides the conclusions and recommendations of the 22nd meeting of WHO Strategic and Technical Advisory Group for Tuberculosis (STAG-TB), held in June 2022. In its work on TB, the World Health Organization (WHO) aims for a world free of TB and, as part of the Sustainable Development Goals, to end the global TB epidemic by 2030. It seeks to enable universal access to TB prevention and care, guide the global response to threats, and promote innovation. The WHO Secretariat, at all its levels, requires regular scientific, technical and strategic advice from the STAG-TB, the most recent of which is outlined in this report.

Global Tuberculosis Report 2012

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Publisher :
ISBN 13 : 9789241564502
Total Pages : 0 pages
Book Rating : 4.5/5 (645 download)

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Book Synopsis Global Tuberculosis Report 2012 by : World Health Organization

Download or read book Global Tuberculosis Report 2012 written by World Health Organization and published by . This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The World Health Organization (WHO) Global Tuberculosis Report 2012 provides the latest information and analysis about the tuberculosis (TB) epidemic and progress in TB care and control at global, regional and country levels. It is based primarily on data reported by WHO's Member States in annual rounds of global TB data collection. In 2012, 182 Member States and a total of 204 countries and territories that collectively have more than 99% of the world's TB cases reported data."--Executive summary, p. 1

The Future of Public Health

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Publisher : National Academies Press
ISBN 13 : 0309581907
Total Pages : 240 pages
Book Rating : 4.3/5 (95 download)

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Book Synopsis The Future of Public Health by : Committee for the Study of the Future of Public Health

Download or read book The Future of Public Health written by Committee for the Study of the Future of Public Health and published by National Academies Press. This book was released on 1988-01-15 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The Nation has lost sight of its public health goals and has allowed the system of public health to fall into 'disarray'," from The Future of Public Health. This startling book contains proposals for ensuring that public health service programs are efficient and effective enough to deal not only with the topics of today, but also with those of tomorrow. In addition, the authors make recommendations for core functions in public health assessment, policy development, and service assurances, and identify the level of government--federal, state, and local--at which these functions would best be handled.

Reassessing Twenty Years of Vaccine Development Against Tuberculosis

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Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (136 download)

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Book Synopsis Reassessing Twenty Years of Vaccine Development Against Tuberculosis by :

Download or read book Reassessing Twenty Years of Vaccine Development Against Tuberculosis written by and published by . This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tuberculosis (TB) remains the prime bacterial infection worldwide with 10.4 million infections and a death toll of 1.7 million people in 2016 according to WHO statistics. Tuberculosis is caused by members of the Mycobacterium tuberculosis complex, facultative intracellular bacteria able to thrive within otherwise potent innate defense cells, the macrophages. In a world of increasing numbers of infections with drug resistant M. tuberculosis strains, the daunting race between developing new therapeutics and emerging resistant strains will hardly produce a winner. This cycle can only be broken by enhancing population wide immune control through a better vaccine as the only one currently in use, M. bovis Bacillus Calmette Guerin (BCG). The protective efficacy of BCG against pulmonary tuberculosis in all age groups is dissatisfying and geographically highly diverse with the tropical areas showing the lowest efficacy rates. Despite worldwide vaccination coverage, the impact of BCG on the steep decrease of tuberculosis incidence rates in the developed world seems therefore questionable and can rather be attributed to improved social, housing and nutritional conditions, better health care, surveillance and treatment systems. The last 15 years saw tremendous efforts to improve vaccination strategies against tuberculosis. Different paths of vaccine approaches were followed including genetically improved BCG strains, attenuated M. tuberculosis variants, recombinant viral vectors and subunit vaccine candidates combined with novel more potent adjuvants. With the first novel vaccine candidates being evaluated in clinical phases II and III and initial results chastening the expectations, a critical reassessment of all candidates is inevitable. Here, we assembled experts to review and assess the current status of novel anti-tuberculosis vaccine candidates, their efficacy and prospects for implementation as well as the pitfalls and possible measures for improvement.

Guidance for Managing Ethical Issues in Infectious Disease Outbreaks

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Publisher :
ISBN 13 : 9789241549837
Total Pages : 0 pages
Book Rating : 4.5/5 (498 download)

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Book Synopsis Guidance for Managing Ethical Issues in Infectious Disease Outbreaks by : World Health Organization

Download or read book Guidance for Managing Ethical Issues in Infectious Disease Outbreaks written by World Health Organization and published by . This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Infectious disease outbreaks are frequently characterized by scientific uncertainty, social and institutional disruption, and an overall climate of fear and distrust. Policy makers and public health professionals may be forced to weigh and prioritize potentially competing ethical values in the face of severe time and resource constraints. This document seeks to assist policy-makers, health care providers, researchers, and others prepare for outbreak situations by anticipating and preparing for the critical ethical issues likely to arise."--Publisher.

WHO consolidated guidelines on tuberculosis. Module 4

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Publisher : World Health Organization
ISBN 13 : 924004812X
Total Pages : 72 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis WHO consolidated guidelines on tuberculosis. Module 4 by : World Health Organization

Download or read book WHO consolidated guidelines on tuberculosis. Module 4 written by World Health Organization and published by World Health Organization. This book was released on 2022-04-30 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 2011 and 2019, WHO has developed and issued evidence-based policy recommendations on the treatment and care of patients with DR-TB. These policy recommendations have been presented in several WHO documents and their associated annexes, including the WHO Consolidated Guidelines on Drug Resistant Tuberculosis Treatment, issued by WHO in March 2019. The policy recommendations in each of these guidelines have been developed by WHO-convened Guideline Development Groups, using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to summarize the evidence, and formulate policy recommendations and accompanying remarks. The present WHO Consolidated Guidelines on Tuberculosis, Module 4: Treatment - Drug-Resistant Tuberculosis Treatment includes a comprehensive set of WHO recommendations for the treatment and care of DR-TB. The document includes two new recommendations, one on the composition of shorter regimens and one on the use of the BPaL regimen (i.e. bedaquiline, pretomanid and linezolid). In addition, the consolidated guidelines include existing recommendations on treatment regimens for isoniazid-resistant TB and MDR/RR-TB, including longer regimens, culture monitoring of patients on treatment, the timing of antiretroviral therapy (ART) in MDR/RR-TB patients infected with the human immunodeficiency virus (HIV), the use of surgery for patients receiving MDR-TB treatment, and optimal models of patient support and care. The guidelines are to be used primarily in national TB programmes, or their equivalents in Ministries of Health, and for other policy-makers and technical organizations working on TB and infectious diseases in public and private sectors and in the community.

Guidelines for the Programmatic Management of Drug-resistant Tuberculosis

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Publisher : World Health Organization
ISBN 13 : 9241547588
Total Pages : 271 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Guidelines for the Programmatic Management of Drug-resistant Tuberculosis by : World Health Organization

Download or read book Guidelines for the Programmatic Management of Drug-resistant Tuberculosis written by World Health Organization and published by World Health Organization. This book was released on 2008 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: The emergence of extensively drug-resistant strains of tuberculosis, especially in countries with a high prevalence of human immunodeficiency virus, is a serious threat to global public health and jeopardizes efforts to effectively control the disease. This publication offers updated recommendations for the diagnosis and management of drug-resistant tuberculosis in a variety of geographical, economic and social settings, and the recording of data that enables the monitoring and evaluation of programs.--Publisher's description.

Sharing Clinical Trial Data

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Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 304 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Ending Neglect

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Publisher : National Academies Press
ISBN 13 : 0309171946
Total Pages : 288 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ending Neglect by : Institute of Medicine

Download or read book Ending Neglect written by Institute of Medicine and published by National Academies Press. This book was released on 2000-08-31 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tuberculosis emerged as an epidemic in the 1600s, began to decline as sanitation improved in the 19th century, and retreated further when effective therapy was developed in the 1950s. TB was virtually forgotten until a recent resurgence in the U.S. and around the worldâ€"ominously, in forms resistant to commonly used medicines. What must the nation do to eliminate TB? The distinguished committee from the Institute of Medicine offers recommendations in the key areas of epidemiology and prevention, diagnosis and treatment, funding and organization of public initiatives, and the U.S. role worldwide. The panel also focuses on how to mobilize policy makers and the public to effective action. The book provides important background on the pathology of tuberculosis, its history and status in the U.S., and the public and private response. The committee explains how the U.S. can act with both self-interest and humanitarianism in addressing the worldwide incidence of TB.

Federal Register

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Publisher :
ISBN 13 :
Total Pages : 844 pages
Book Rating : 4.:/5 (31 download)

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Book Synopsis Federal Register by :

Download or read book Federal Register written by and published by . This book was released on 1998-05-19 with total page 844 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Oxford Handbook of the Economics of the Biopharmaceutical Industry

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Author :
Publisher : OUP USA
ISBN 13 : 0199742995
Total Pages : 618 pages
Book Rating : 4.1/5 (997 download)

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Book Synopsis The Oxford Handbook of the Economics of the Biopharmaceutical Industry by : Patricia M. Danzon

Download or read book The Oxford Handbook of the Economics of the Biopharmaceutical Industry written by Patricia M. Danzon and published by OUP USA. This book was released on 2012-04-24 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume examines the economics of the biopharmaceutical industry, with eighteen chapters by health economists.