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 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 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 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.
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 Fourth WHO consultation on the translation of tuberculosis research into global policy guidelines written by World Health Organization and published by World Health Organization. This book was released on 2024-04-17 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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 Developing and Strengthening the Global Supply Chain for Second Line Drugs for Multidrug Resistant Tuberculosis written by Institute of Medicine and published by National Academies Press. This book was released on 2013-02-06 with total page 171 pages. Available in PDF, EPUB and Kindle. Book excerpt: To effectively treat patients diagnosed with drug-resistant (DR) tuberculosis (TB) and protect the population from further transmission of this infectious disease, an uninterrupted supply of quality-assured (QA), second-line anti-TB drugs (SLDs) is necessary. Patients diagnosed with multidrug-resistant tuberculosis (MDR TB)-a disease caused by strains of Mycobacterium tuberculosis (M.tb.) resistant to two primary TB drugs (isoniazid and rifampicin)-face lengthy treatment regimens of 2 years or more with daily, directly observed treatment (DOT) with SLDs that are less potent, more toxic, and more expensive than those used to treat drug-susceptible TB. From 2000 to 2009, only 0.2-0.5 percent of the estimated 5 million MDR TB cases globally were treated with drugs of known quality and in programs capable of delivering appropriate care (Keshavjee, 2012). The vast majority of MDR TB patients either died from lack of treatment or contributed to the spread of MDR TB in their communities. A strengthened global supply chain for SLDs could save lives by consistently delivering high quality medicines to more of the people who need them. This public workshop explored innovative solutions to the problem of how to get the right SLDs for MDR TB to people who critically need them. More specifically, the workshop examined current problems and potential opportunities for coordinated international efforts to ensure that a reliable and affordable supply of high-quality SLDs is available. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary covers the objectives of the workshop, which were to review: -To what extent and in what ways current mechanisms are or are not effectively accomplishing what is needed, including consideration of bottlenecks. -The advantages and disadvantages of centralization in the management of the global drug supply chain, and potential decentralized approaches to improve operations of the supply chain. -What can be learned from case studies and examples from other diseases (e.g., the Affordable Medicines Facility-malaria (AMFm) and the U.S. President's Emergency Plan for AIDS Relief [PEPFAR]) - The current allocation of responsibilities and roles of the private (including industry and nonprofit public health organizations) and public sectors, and examination of opportunities for enhancing and optimizing collaboration -Identification of potential innovative solutions to the problem
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 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.
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 Regulatory Incentives for Innovation written by Amitabh Chandra and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA's Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to innovate around this tradeoff--i.e., whether it improved regulator productivity by allowing products to come to market more quickly without compromising quality. We find that the BTD program shortened clinical development times by 23 percent and did not impact the ex post safety profile of drugs with the designation. In exploring mechanisms, we find that the BTD program had the greatest impact on less experienced firms and was associated with reduced BTD clinical trial design complexity. The results suggest that targeted regulatory innovation can shorten R&D periods without compromising the quality of new products.
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.
Download or read book Guidelines for Treatment of Drug Susceptible Tuberculosis and Patient Care written by World Health Organization and published by . This book was released on 2017-06 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The update of the Guidelines for Treatment of Drug-susceptible Tuberculosis and Patient Care is important in the context of the End TB Strategy, which recommends treatment and patient support for all people with TB. This update aims to use the best available evidence on the treatment of drug-susceptible TB and interventions to ensure adequate patient care and support in order to inform policy decisions made in these technical areas by national TB control program managers, national policy-makers, and medical practitioners in a variety of geographical, economic, and social settings. The objectives of these updated guidelines are to provide updated recommendations based on newly emerged evidence on the treatment of drug-susceptible TB and patient care as well as provide a summary of changes in the new guidelines with all the existing and valid WHO recommendations on the treatment of drug-susceptible TB and TB patient care. The key audience for these guidelines are policy-makers in ministries of health or managers of national TB programs who formulate country-specific TB treatment guidelines or who plan TB treatment programs. In addition, health professionals - including doctors, nurses, and educators working both in government services and nongovernmental organizations, such as technical agencies that are treating patients and organizing treatment services - will find these guidelines to be useful.
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.
Download or read book WHO consolidated guidelines on drug resistant tuberculosis treatment written by World Health Organization and published by World Health Organization. This book was released on 2018-11-07 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tuberculosis (TB) strains with drug resistance (DR-TB) are more difficult to treat than drug-susceptible ones, and threaten global progress towards the targets set by the End TB Strategy of the World Health Organization (WHO). There is thus a critical need for evidence-based policy recommendations on the treatment and care of patients with DR-TB, based on the most recent and comprehensive evidence available. In this regard, the WHO consolidated guidelines on drug-resistant tuberculosis treatment fulfil the mandate of WHO to inform health professionals in Member States on how to improve treatment and care for patients with DR-TB. Between 2011 and 2018, 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 treatment guidelines for multidrug- and rifampicin-resistant tuberculosis, 2018 update, issued by WHO in December 2018. The policy recommendations in each of these guidelines have been developed by WHO-convened Guideline Development Groups (GDGs), using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to summarize the evidence, and formulate policy recommendations and accompanying remarks. The present Consolidated guidelines include a comprehensive set of WHO recommendations for the treatment and care of DR-TB, derived from these WHO guidelines documents. The consolidated guidelines include policy recommendations on treatment regimens for isoniazid-resistant TB (Hr-TB) and MDR/RR-TB, including longer and shorter 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), use of surgery for patients receiving MDR-TB treatment, and optimal models of patient support and care.
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.
