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Building clinical trial capacity to develop a new treatment for multidrug-resistant tuberculosis
New drugs for infectious diseases often need to be evaluated in low-resource settings. While people working in such settings often provide high-quality care and perform operational research activities, they generally have less experience in conducting clinical trials designed for drug approval by stringent regulatory authorities.
We carried out a capacity-building programme during a multi-centre randomized controlled trial of delamanid, a new drug for the treatment of multidrug-resistant tuberculosis. The programme included: (i) site identification and needs assessment; (ii) achieving International Conference on Harmonization - Good Clinical Practice (ICH-GCP) standards; (iii) establishing trial management; and (iv) increasing knowledge of global and local regulatory issues.
Trials were conducted at 17 sites in nine countries (China, Egypt, Estonia, Japan, Latvia, Peru, the Philippines, the Republic of Korea and the United States of America). Eight of the 10 sites in low-resource settings had no experience in conducting the requisite clinical trials.
Extensive capacity-building was done in all 10 sites. The programme resulted in improved local capacity in key areas such as trial design, data safety and monitoring, trial conduct and laboratory services.
Clinical trials designed to generate data for regulatory approval require additional efforts beyond traditional research-capacity strengthening. Such capacity-building approaches provide an opportunity for product development partnerships to improve health systems beyond the direct conduct of the specific trial.
Journal Article
Architectural graphic standards
The gold-standard design and documentation reference for students Architectural Graphic Standards, Student Edition condenses key information from the definitive industry reference to provide students with a powerful learning resource. Covering design and documentation for a variety of projects, this book offers extensive visuals backed by expert discussion to prepare students for work in a modern professional practice. This new 12th edition has been significantly updated to provide the latest information on important architectural developments and movements, with detailed coverage of sustainability, economy, technology, and more alongside current building standards and best practices. The companion website features sample curricula, student exercises, and classroom projects to aid the understanding of developing designers, and links to additional resources include professional associations, manufacturers' websites, and architectural articles to help students stay up-to-date as the field continues to evolve. Architectural Graphic Standards is the gold-standard reference for practicing architects, engineers, and builders; this Student Edition introduces key elements in a way that's relevant to the budding designer, along with ancillary materials that facilitate internalization. Delve into the design and documentation process for building materials and elements, as used in today's real-world practice Discover the latest advances in sustainability, digital fabrication, building information modeling, and more Learn the building standards and best practices for a wide variety of architectural details Examine thousands of illustrations, richly detailed graphics, PowerPoint slides, and links to additional resources Simply \"knowing\" graphic and documentation standards is not enough; future architects and engineers must develop an instinctual understanding and reflexive use of much of this material. Architectural Graphic Standards, Student Edition provides the depth and breadth of coverage they need, and the expert guidance that will help them succeed.
eBook
Building Codes for Existing and Historic Buildings
MELVYN GREEN, S.E., a licensed engineer in several states, is a structural engineer specializing in historic structures. President of the consulting firm Melvyn Green and Associates, Inc., for over thirty-five years, and a previous building official, he is active in building code development and education. He served on the drafting committee of the International Existing Building Code.
eBook
PHPP illustrated : a designer's companion to the Passive House Planning Package
Concise, user-friendly and illustrated, this step-by-step book is ideal for practitioners and students looking to utilise the Passive House Planning Package (PHPP) as a design tool. Readers will be empowered as they better understand the essential criteria for all low energy building schemes, including: the impact of orientation, envelop to treated-floor ratios, and shading effects on the energy balance.
Book
Mainstreaming building energy efficiency codes in developing countries : global experiences and lessons from early adopters
This report summarizes the findings of an extensive literature survey of the experiences of implementing BEECs in developed countries. It also includes case studies of four developing countries- China, Egypt, India, and Mexico and the state of California in the United States of America. It aims to inform both the World Bank Group and its client countries about global best practices and emerging lessons from developing countries in the design and implementation of BEECs. The report also serves as a primer on the basic features of BEECs and the commonly adopted compliance and enforcement approaches. The key challenges to improving compliance enforcement in developing countries include the level of government commitment to energy efficiency, the effectiveness of government oversight of the construction sector, the compliance capacity of domestic/local building supply chain, and the financing constraints. These challenges are surmountable in countries where economic growth is sustained and energy efficiency is pursued as a key element of national energy strategy.
eBook
Monkeypox — A Sobering Sentinel for Pandemic Preparedness and Sexual Health System Capacity
The monkeypox pandemic has highlighted lessons learned — and sometimes ignored — from Covid-19 and has illustrated the inadequacy of sexual health infrastructure and pandemic preparedness in the United States.
Journal Article