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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.
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.
The Global Tuberculosis Programme of the World Health Organization has the mandate to develop and disseminate evidence-based policy for tuberculosis prevention, diagnosis, treatment, and care. Regular review of evidence, and assessment of country needs for policy across the cascade of care is part of its core function. In this regard, GTB organized a fourth consultation assembling scientists, public health experts, partners, civil society, and countries to exchange views on emerging areas of need for evidence and for global TB policy guidance to achieve the goals and targets of the WHO End TB Strategy. The present report summarizes the outcome of this meeting.
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.
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.
"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.
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.
This handbook provides detailed instructions for guideline developers on the following topics: application of high quality methodology for guideline development using systematic search strategies, synthesis and quality assessment of the best available evidence to support the recommendations; appropriate collection and management of experts' declared conflict of interest; expert group composition including content experts, methodologists, target users, policy makers, with gender and geographical balance; instructions for the management of group process to achieve consensus among experts; standards for a transparent decision-making process, taking into consideration potential harms and benefits, end users values and preferences; developing plans for implementing and adapting guidelines; and minimum standards for reporting.--Publisher description.
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.