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:
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.
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.
Download or read book Model Based Tools to Improve Treatment of Tuberculosis Patients written by Marjorie Zamora Imperial and published by . This book was released on 2020 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Tuberculosis (TB) infects 10 million people each year and kills more than any other infectious disease. All current approaches to TB treatment are based on a one-size-fits-all approach, which leads to undertreatment of patients with severe forms of disease and entails unnecessarily long treatment with potential toxicities for many patients in whom the disease is less severe. Shorter, efficacious, and better-tolerated oral regimens for TB are needed. Unfortunately, all recent Phase 3 clinical trials aimed to shorten treatment duration from 6 months to 4 months for drug susceptible TB failed. The aims of this dissertation were to quantitively characterize treatment response in TB patients and develop model-based tools that provide informed recommendations on optimal treatment regimens and strategies that: i.) maximize durable cure in all patients, ii.) maximize success of late stage regimen development, and iii.) minimize safety concerns associated with a highly potent, but toxic, high-dose linezolid-containing regimen. In a patient-level pooled analysis of all recent Phase 3 clinical trials evaluating shorter treatments for drug susceptible TB , survival analysis identified risk factors of treatment outcomes. Based on these risk factors, a risk stratification algorithm and clinical simulation tool were developed to provide more individualized predictions of optimal treatment regimens to achieve high cure rates in TB patients. TB regimen development is plagued with many challenges, the most serious being the inability to identify optimal regimens early and efficiently. To facilitate decisions on novel TB regimens that move forward through the development process, an integrated model was developed to describe the translational link between Phase 2 intermediate biomarkers, treatment characteristics, and patient risk factors to Phase 3 clinical outcomes. We provide clinical trial simulation tools to design innovative clinical trial designs that permit evidence-based decisions on moving the best regimens forward in late stage clinical development . The TB regimen development process is also challenged by the lack of reliable, quantitative, non-culture-based biomarkers that inform individual level and trial level treatment response. We showed that leveraging longitudinal sputum culture results and drug exposure and applying advanced nonlinear mixed effect modeling with machine learning approaches offer insights into the response dynamics following anti-TB treatment. We identified candidate proteomic signatures that can potentially predict treatment response.Lastly, using modeling and simulation approaches, we quantified the pharmacokinetic-toxicodynamic relationship of a high-dose linezolid-containing regimen for extensively drug resistant TB. We provide practical data-driven recommendations about linezolid dosing adjustments to optimize therapeutic effects and minimize adverse events. The quantitative, model-based tools developed in this dissertation contributes to providing evidence-based recommendations on optimal treatment strategies for current and novel TB regimens.
Download or read book Disease Control Priorities Third Edition Volume 6 written by King K. Holmes and published by World Bank Publications. This book was released on 2017-11-06 with total page 1027 pages. Available in PDF, EPUB and Kindle. Book excerpt: Infectious diseases are the leading cause of death globally, particularly among children and young adults. The spread of new pathogens and the threat of antimicrobial resistance pose particular challenges in combating these diseases. Major Infectious Diseases identifies feasible, cost-effective packages of interventions and strategies across delivery platforms to prevent and treat HIV/AIDS, other sexually transmitted infections, tuberculosis, malaria, adult febrile illness, viral hepatitis, and neglected tropical diseases. The volume emphasizes the need to effectively address emerging antimicrobial resistance, strengthen health systems, and increase access to care. The attainable goals are to reduce incidence, develop innovative approaches, and optimize existing tools in resource-constrained settings.
Download or read book WHO Handbook for Guideline Development written by World Health Organization and published by . This book was released on 2015-04-20 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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.
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.
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.
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.
Download or read book Guidelines on the Management of Latent Tuberculosis Infection written by WHO and published by World Health Organization. This book was released on 2015-01-15 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt: BACKGROUND: Latent tuberculosis infection (LTBI), defined as a state of persistent immune response to prior-acquired Mycobacterium tuberculosis antigens without evidence of clinically manifested active TB, affects about one-third of the world's population. Approximately 10% of people with LTBI will develop active TB disease in their lifetime, with the majority developing it within the first five years after initial infection. Currently available treatments have an efficacy ranging from 60% to 90%. Systematic testing and treatment of LTBI in at-risk populations is a critical component of WHO's eight-point framework adapted from the End TB Strategy to target pre-elimination and, ultimately, elimination in low incidence countries. OVERVIEW: Recognizing the importance of expanding the response to LTBI, in 2014 WHO developed Guidelines on the Management of Latent Tuberculosis Infection. The guidelines are primarily targeted at high-income or upper middle-income countries with an estimated TB incidence rate of less than 100 per 100 000 population, because they are most likely to benefit from it due to their current TB epidemiology and resource availability. The overall objective of the guidelines is to provide public health approach guidance on evidence-based practices for testing, treating and managing LTBI in individuals with the highest risk of progression to active disease. Specific objectives include identifying and prioritizing at-risk population groups for targeted intervention of LTBI testing and treatment, including defining an algorithm, and recommending specific treatment options. The guidelines are expected to provide the basis and rationale for the development of national guidelines for LTBI management based on available resources, epidemiology of TB including intensity of transmission, the health-care delivery system of the country, and other national and local determinants.
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.
Download or read book Treatment of Tuberculosis written by World Health Organization and published by . This book was released on 1993 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.
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 60 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book International Ethical Guidelines for Health Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.
Download or read book Promoting Access to Medical Technologies and Innovation Intersections between Public Health Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.