Field Trials of Health Interventions: A Toolbox

This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in `field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a `toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing. Contributors to this volume - Richard Adegbola Global Director, Scientific Affairs and Public Health, GlaxoSmithKline Vaccines, Wavre, Belgium. Kenneth Babigumira Senior Analyst Programmer, Medical Research Council (MRC) Clinical Trials Unit at University College London, UK. Kathy Baisley Lecturer in Epidemiology and Medical Statistics, MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK. David Beckles Data Processing Consultant, Upton, Oxfordshire, UK. Fred Binka Vice-Chancellor, University of Health and Allied Sciences, Ho, Ghana. Clare Chandler Lecturer in Social Science, Department of Global Health and Development , London School of Hygiene and Tropical Medicine, London, UK. Michael Chew Science Portfolio Advisor, Wellcome Trust, London, UK. Aoife Doyle Lecturer in Epidemiology, MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK. Chris Drakeley Professor of Infection and Immunity, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London, UK. Anbrasi Edward Associate Scientist, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. Greg Fegan Head of Statistics, Kenya Medical Research Institute (KEMRI)-Wellcome Trust, Centre for Geographic Medicine Research (Coast), Kilifi, Kenya and Centre for Tropical Medicine, University of Oxford, UK. Susan Foster Professor of International Health, Department of International Health, Boston University School of Public Health, Boston, USA. Richard J. Hayes Professor of Epidemiology and International Health, MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK. Hilary Hunter Planning and Governance Manager, London School of Hygiene and Tropical Medicine, London, UK. Anatoli Kamali Deputy Director, MRC/Uganda Virus Research Institute Uganda Research Unit on AIDS, Entebbe, Uganda. Dorcas M. Kamuya Researcher in Ethics and Community Engagement, The Ethox Centre, University of Oxford, UK; and KEMRI-Wellcome Trust, Centre for Geographic Medicine Research (Coast), Kilifi, Kenya. Juntra Karbwang Laothavorn Professor and Head, Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, Japan. Saidi Kapiga Reader in Epidemiology and International Health, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK. Jane Kengeya-Kayondo Coordinator, Strategic Alliances, Special Programme for Research and Training in Tropical Diseases, World Health Organization, Geneva, Switzerland. Irene Kuepfer Scientist, Health Systems Research, Swiss Tropical and Public Health Institute, Basel, Switzerland. Claudio F. Lanata Senior Researcher, Instituto de Investigacion Nutricional, Lima, Peru and US Naval Medical Research Unit No. 6, Peru. Trudie Lang Head of the Global Health Network, Centre for Tropical Medicine, University of Oxford, UK. Vicki Marsh Senior Researcher, Health Systems and Social Science Group, KEMRI-Wellcome Trust, Centre for Geographic Medicine Research (Coast), Kilifi, Kenya, and Research Lecturer, Centre for Tropical Medicine and Research Associate, Ethox Centre, University of Oxford, UK. Sassy Molyneux Lecturer and Group Head, Centre for Tropical Medicine and Ethox Centre, University of Oxford, UK; and KEMRI-Wellcome Trust, Centre for Geographic Medicine Research (Coast), Kilifi, Kenya. Richard H. Morrow Professor of International Health, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. Lawrence H. Moulton Professor of Biostatistics, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. Seth Owusu-Agyei Director, Kintampo Health Research Centre, Kintampo, Ghana. David A. Ross Professor of Epidemiology and International Public Health, MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK. Donald de Savigny Professor of Epidemiology and Public Health, Swiss Tropical and Public Health Institute, Basel, Switzerland. Joanna Schellenberg Professor of Epidemiology and International Health and Head of Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK. Peter G. Smith Professor of Tropical Epidemiology, MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK. Jim Todd Reader in Applied Biostatistics, Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK. Cesar Victora Emeritus Professor of Epidemiology, Departmento de Medicina Social, Faculdade de Medicina, Universidade Federal de Pelotas, Brazil. Jimmy Volmink Dean, Faculty of Medicine and Health Sciences, Stellenbosch University and Director, South African (SA) Cochrane Centre, SA Medical Research Council, Tygerberg, South Africa. Damian G. Walker Senior Program Officer, Integrated Delivery, Bill and Melinda Gates Foundation, Seattle, USA. Helen Weiss Professor of Epidemiology and Head of the MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK. Peter Winch Director, Social and Behavioural Interventions Program, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. Fabio Zicker Senior Visiting Professor, Center for Technological Development in Health, Oswaldo Cruz Foundation, Fiocruz, Rio de Janeiro, Brazil.