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The following persons had a major role in the production of this book, in contributing drafts of chapters and in subsequent revisions.

xxx CONTRIBUTORS

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

Saidi Kapiga

Reader in Epidemiology and International Health, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK

Juntra Karbwang Laothavorn

Professor and Head, Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, Japan

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 & 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

xxxi CONTRIBUTORS School of Hygiene & Tropical Medicine,

London, UK

Peter G. Smith

Professor of Tropical Epidemiology, MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK

Jim Todd

Reader in Applied Biostatistics, Department of Population Health, London School of Hygiene & 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 & 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,

# number

ABC activity-based costing ACT artimisinen combination

treatment AE adverse event ASRH adolescent sexual and

reproductive health BCG bacille Calmette–Guérin BMI body mass index

CAB Community Advisory Board CAG Community Advisory Group CBA cost–benefit analysis CEA cost-effectiveness analysis CI confidence interval CIOMS Council for International

Organizations of Medical Sciences

CONSORT Consolidated Standards of Reporting Trials

CRO clinical research organization CSF cerebrospinal fluid

CT Chlamydia trachomatis CUA cost-utility analysis CVD cardiovascular disease DALY disability-adjusted life-year DDI Data Documentation Initiative DDT dichlorodiphenyltrichloroethane df degree of freedom

DFID Department for International Development

DHMT district health management team DHS Demographic and Health Surveys DMB Data Monitoring Board DMC Data Monitoring Committee DNA deoxyribonucleic acid DSMB Data and Safety Monitoring

Board

DSMC Data and Safety Monitoring Committee

ELISA enzyme-linked immunosorbent assay

EPI Expanded Programme on Immunisation

ERC ethics review committee ESR erythrocyte sedimentation rate ESRC Economic and Social Research

Council

GCP Good Clinical Practice

GCLP Good Clinical Laboratory Practice GDP gross domestic product

GIS geographical information system GPS global positioning system GRADE Grading of Recommendations

Assessment, Development, and Evaluation

HBV hepatitis B virus HDSS health and demographic

surveillance system HIC high-income country

HIV human immunodeficiency virus HLA human leucocyte antigen HSV 2 herpes simplex virus type 2 IATA International Air Transport

Association

ICER incremental cost-effectiveness ratio

ICH International Conference on Harmonisation

ICMJE International Committee of Medical Journal Editors IDMC Independent Data Monitoring

Committee

IEC information, education, and communication

IMCI Integrated Management Of Childhood Illness

INDEPTH International Network for the Demographic Evaluation of Populations and Their Health

ACRONYMS xxxiii

INESS INDEPTH Effectiveness And Safety Studies

INSERM Institut National de la Santé et de la Recherche Médicale

IPT intermittent preventive therapy for malaria

IPTc intermittent preventive treatment for malaria in children

IPTi intermittent preventive treatment for malaria in infants

IPTi-SP intermittent preventive treatment for malaria in infants using sulfadoxine–pyrimethamine IPTp intermittent preventive treatment

for malaria in pregnancy IRB Institutional Review Board ITN insecticide-treated bed-net IU international unit kg kilogram LAN local area network

LDMS Laboratory Data Management System

LIMS Laboratory Information Management System

LMIC low- and middle-income country Mango Management Accounting

for Non-governmental Organisations

MeSH medical subject heading MkV MEMA kwa Vijana MOH Ministry of Health

MTA Material Transfer Agreement NGO non-governmental organization ODK Open Data Kit

OHRP Office for Human Research Protections

OR odds ratio PCV packed cell volume PDA personal digital assistant PI principal investigator PICOS Population; Interventions

(or Exposure); Comparison; Outcomes; Study design PLA participatory learning and action POC point of care

PRA participatory rural appraisal

PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses

QA quality assurance QALY quality-adjusted life-year QC quality control

RCT randomized controlled trial RDT rapid diagnostic test

RR relative risk or risk ratio or rate ratio

SAE serious adverse event SAP statistical analysis plan SMC seasonal malaria

chemoprevention

SOP standard operating procedure SP sulfadoxine–pyrimethamine SPIRIT Standard Protocol Items:

Recommendations for Intervention Trials

SRH sexual and reproductive health STD sexually transmitted disease STI sexually transmitted infection TB tuberculosis

UK United Kingdom

UMPC ultra-mobile personal computer UN United Nations

UNAIDS Joint United Nations Programme on HIV/AIDS

UNESCO United Nations Educational, Scientific, and Cultural Organization

UNFPA United Nations Population Fund

UNICEF United Nations Children’s Fund USA United States of America USAID United States Agency for International Development vs versus

WHO World Health Organization WHO ERC World Health Organization

Research Ethics Review Committee

XML extensible markup language YLD years of life lived with disability YLL years of life lost

Chapter 1

Introduction to field trials

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