These guidance articles are peer reviewed and provided to give research teams high quality and trustworthy information on how to conduct a task or resolve an issue in the design, conduct or reporting of a clinical trial. Articles are accompanied by resources, such as a template or example documents. These are free for you to download and adapt for your study. Please acknowledge www.globalhealthtrials.org if you use these.
Pragmatism in practice: lessons learned during screening and enrollment for a randomised controlled trial in rural northern Ethiopiaby Meseret Molla, Henok Negussie, Moses Ngari, Esther Kivaya, Patricia Njuguna, Fikre Enqueselassie, James A. Berkley, Gail Davey
We use the example of the Gojjam Lymphoedema Best Practice Trial (GoLBeT), a pragmatic trial in a remote rural setting in northern Ethiopia, to extract lessons relevant to other investigators balancing the demands of practicality and community acceptability with internal and external validity in clinical trials.
Conducting good, ethical global health research is now more important than ever. Increased global mobility and connectivity mean that in today’s world there is no such thing as ‘local health’. As a collection, these stories offer a flexible resource for training across a variety of contexts, such as medical research organizations, universities, collaborative sites, and NGOs.
Scoping available resources and tools used by investigators to set up and conduct malaria clinical trials in low and middle income countries within malaria endemic settings. Participate in the survey.
Sarah Drew shares her research diary about conducting ethnographic fieldwork in Malawi as part of a Clubfoot study.
Epidemic curves are an important component of the public health and global health toolbox. Learn more about creating and interpretting them.
Professor Sallie Lamb talks about the history of clinical trials, and explains important concepts such as randomisation, masking and minimisation of bias.
Join us in Oxford on the 25th of April to mark World Malaria Day 2016 at a series of talks and a panel discussion. The speakers will present their latest projects and help us to understand the unique and interconnected findings of their research.
Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopiaby Henok Negussie, Thomas Addissie, Adamu Addissie, Gail Davey
This study highlights the utility of rapid ethical assessment prior to clinical trials involving complex procedures and concepts.
Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period.
Could scientists make history and change the way we deal with outbreaks?
Building on the concept of rapid learning health systems, Dr. Peek’s seminar focuses on the use of health information technology to address epidemiological and public health questions and to accelerate the translation of research findings to clinical practice.
Video of Professor Peter Horby, the University of Oxford, on how he and his team set up clinical trials in the heart of the Ebola outbreak.
Guidance for non-economist audience to understand economic evaluations of health care interventions from the ACT consortium.
This article provides a helpful introduction to statistics as it relates to clinical research, explaining common terms and theories with examples and case studies. Powerpoint presentation also attached for further explanation.
Healthcare associated infections (HAI) are of important concern in patient care. This talk discusses Visual Analytics techniques which have been developed to help detect, monitor, analyse and understand trends, clusters and outbreaks of HAI.
The SWAT and SWAR programme is identifying issues about the methods of trials and systematic reviews about which there is sufficient uncertainty to justify research to support well-informed decision making about future designs and choices.
New guidelines help researchers undertaking systematic reviews and IPD meta-analyses to report their findings in a full and transparent manner.
Field trials of interventions against disease in low and middle income countries (LMICs) may be complex and expensive undertakings. This 3rd edition of the Field Trials Toolbox has been compiled by over 30 contributors with extensive direct experience in the design, conduct, and analysis of field trials in LMICs, and it attempts to document their accumulated experience for the guidance of those who might undertake field trials of health interventions. It can be read in its entirety as an introduction to the field and/or can serve as a reference volume during each of the different stages of planning, conducting, and analysing a field trial.
In this video of a seminar delivered at the University of Oxford in June 2014, Professor Nicholas White talks about the challenge of antimalarial resistance.
In celebration of Global Health Trials' fifth birthday (May 11th 2015) Professor Trudie Lang, Principal Investigator of the programme, talks to us about why Global Health Trials was started, why people should share their experience, and what the future holds.
Links to the SPIRIT guidelines for protocol development and information about these guidelines - all free and open access.
Pragmatic and ethical research in disease outbreak settings: A one-day skills sharing workshop in Ghanaby Abena Konadu Yawson, Dr. Daniel Ansong, Kwaku Poku Asante
Global Health Trials and Kintampo Health Research Centre collaborated to run the workshop 'Pragmatic and ethical research in disease outbreaks' in November 2014. Here we provide a summary of the workshop and the presentations from the day.
Professor Peter Piot, LSHTM, talks about Ebola and implications for Africa and understanding future epidemics at the Martin School, University of Oxford, 16th October 2014.
These logs from a trial in India, are comprised of essential checklists based on ICH-GCP guidelines enlisting all the important steps required for clinical trials. These checklists will serve as tools for clinical research professionals for executing clinical trials in time and effective manner.
Methods for Specifying the Target Difference in a Randomised Controlled Trial: The Difference ELicitation in TriAls (DELTA) Systematic Reviewby Jai K Das
Randomised controlled trials (RCTs) are widely accepted as the preferred study design for evaluating healthcare interventions. When the sample size is determined, a (target) difference is typically specified that the RCT is designed to detect. This provides reassurance that the study will be informative, i.e., should such a difference exist, it is likely to be detected with the required statistical precision. The aim of this review was to identify potential methods for specifying the target difference in an RCT sample size calculation.
An introduction into and overview on the mathematics and practice of Bayesian (adaptive) clinical trials.
ESSENCE on Health Research have created a good practice document on research costing. It includes a review of the funding practices related to the definition and funding of direct and indirect costs.
This guide, developed by the WHO and released in December 2013, aims to facilitate implementation research in LMICs.
Quality assurance of qualitative research: a suggested approach for assessing and strengthening qualitative research within global health trialsby Joanna Reynolds, Susan Naiga, Lilian Taaka, Clare I. R. Chandler
The ACT consortium have developed and piloted an approach through which qualitative research activities can be assessed and strengthened: the ‘quality assessment and strengthening’ (QAS) approach. This article explains the QAS approach and gives an example protocol.
Researchers can often be tripped up by issues they encounter in developing regions and remote areas. Although no definitive answers are provided (there are just too many options and unknowns), the following issues should be considered when planning such a trial.
Research misconduct is a global problem as research is a global activity. Wherever there is human activity there is misconduct, but we lack reliable data on the extent and distribution of research misconduct. This PLoS paper seeks to illustrate some examples of researsch misconduct in LMICs.
Participant retention refers to keeping enrolled participants in a trial for the duration of the study. This article explains the concept of participant retention, and provides a template retention plan.
Research reporting guidelines are standard statements that provide guidance on how to report research methodology and findings. These are in the form of checklists, flow diagrams or texts. Most of the biomedical journals require authors to comply with these guidelines. Guidelines are available for reporting various study designs:
- CONSORT Statement (reporting of randomized controlled trials)
- STARD (reporting of diagnostic accuracy studies)
- STROBE (reporting of observational studies in epidemiology)
- PRISMA (reporting of systematic reviews)
- MOOSE (reporting of meta-analyses of observational studies)
A range of downloadable templates and tools for Clinical Research, including monitoring checklists, budget spreadsheets, informed consent forms, SOPs and so on.
This article is an introduction to cluster randomised trials.
We present this clinical trial as a gold standard example. This study addressed a key question in the management of severely ill children. It was conducted to a very high standard across 3 African countries. This article links to a short film that explains how this trial can be an example to all researchers in resource-limited settings and shows that research can and should be done.
This article was written by a researcher from Sri Lanka and presents a very helpful overview on Biomedical Ethics. This article will be helpful to all levels of research staff and others who might want an accessible overview
An example of a academic research centre resolving the issue of clinical trial data management Peer reviewed by members of the data management expert committee for this programme.