Report Of The Technical Consultation On Innovative Clinical Trial Designs For Development Of New Tb Treatments PDF Download
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Author | : |
Publisher | : World Health Organization |
Total Pages | : 87 |
Release | : 2021-07-28 |
Genre | : Medical |
ISBN | : 9240030867 |
Download Report of the technical consultation on innovative clinical trial designs for development of new TB treatments Book in PDF, ePub and Kindle
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.
Author | : |
Publisher | : World Health Organization |
Total Pages | : 59 |
Release | : 2022-04-19 |
Genre | : Medical |
ISBN | : 9240047158 |
Download Report of the technical consultation on innovative clinical trial designs for evaluating new TB preventive treatments Book in PDF, ePub and Kindle
Author | : |
Publisher | : World Health Organization |
Total Pages | : 14 |
Release | : 2021-07-14 |
Genre | : Medical |
ISBN | : 9240030808 |
Download Position statement on innovative clinical trial design for development of new TB treatments Book in PDF, ePub and Kindle
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.
Author | : |
Publisher | : World Health Organization |
Total Pages | : 44 |
Release | : 2020-08-21 |
Genre | : Medical |
ISBN | : 9240010017 |
Download A global strategy for tuberculosis research and innovation Book in PDF, ePub and Kindle
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.
Author | : Marjorie Zamora Imperial |
Publisher | : |
Total Pages | : |
Release | : 2020 |
Genre | : |
ISBN | : |
Download Model-Based Tools to Improve Treatment of Tuberculosis Patients Book in PDF, ePub and Kindle
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.
Author | : King K. Holmes |
Publisher | : World Bank Publications |
Total Pages | : 1027 |
Release | : 2017-11-06 |
Genre | : Medical |
ISBN | : 1464805253 |
Download Disease Control Priorities, Third Edition (Volume 6) Book in PDF, ePub and Kindle
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.
Author | : World Health Organization |
Publisher | : World Health Organization |
Total Pages | : 16 |
Release | : 2024-04-17 |
Genre | : Medical |
ISBN | : 924009203X |
Download Fourth WHO consultation on the translation of tuberculosis research into global policy guidelines Book in PDF, ePub and Kindle
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.
Author | : World Health Organization |
Publisher | : |
Total Pages | : 294 |
Release | : 2019-08-12 |
Genre | : |
ISBN | : 9789241565714 |
Download Global Tuberculosis Report 2019 Book in PDF, ePub and Kindle
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.
Author | : World Health Organization |
Publisher | : World Health Organization |
Total Pages | : 27 |
Release | : 2023-01-27 |
Genre | : Medical |
ISBN | : 9240064613 |
Download Strategic and Technical Advisory Group for Tuberculosis (STAG-TB) Book in PDF, ePub and Kindle
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.
Author | : World Health Organization |
Publisher | : |
Total Pages | : 0 |
Release | : 2015-04-20 |
Genre | : Evidence-based medicine |
ISBN | : 9789241548960 |
Download WHO Handbook for Guideline Development Book in PDF, ePub and Kindle
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.