Report Of The Technical Consultation On Innovative Clinical Trial Designs For Development Of New Tb Treatments

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.

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.

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.

Recent years have witnessed key developments in the diagnosis and treatment of tuberculosis. Alongside this, and running in direct opposition to this progress, was the COVID-19 pandemic, which had an unprecedented detrimental effect on tuberculosis control and the achievement of targets set by the End TB Strategy. This timely and important Monograph provides a crucial update on recent changes, developments and setbacks in the field, and calls for a re-commitment to the achievement of the End TB Strategy and Sustainable Development Goals. Written by authors from across the world, the Monograph covers: diagnosis; advances in treatment; prevention; and tuberculosis control challenges in different populations and contexts.

Tuberculosis is one of the leading causes of death in the world today, with 4,500 people dying from the disease every day. Many cases of TB can be cured by available antibiotics, but some TB is resistant to multiple drugs-a major and growing threat worldwide. The Institute of Medicine's Forum on Drug Discovery, Development, and Translation hosted a workshop on November 5, 2008, to address the mounting concern of drug-resistant TB. The session brought together a wide range of international experts to discuss what is known and not known about this growing threat, and to explore possible solutions.

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.