This Guide to Efficient Trial Management, published by the Trial Manager's Network (UK) and available freely online, is a must for all trial managers or coordinators. This link is for the 5th Edition (2016)
This short film shows the impact of the CHAPAS trial on patient health and future possibilities of a small boy from Malawi.
It is time to revise the international Good Clinical Practices guidelines: recommendations from non-commercial North–South collaborative trialsby GHN Editors
The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs).
Professor Sallie Lamb talks about the history of clinical trials, and explains important concepts such as randomisation, masking and minimisation of bias.
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.
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.
Mental Health Innovation Network (MHIN), a global community of mental health innovators, have released a toolkit which will help researchers communicate their findings to stakeholders. The toolkit is aimed at mental health research but can be applied to other types of research
Professor Lang talks about doing difficult trials in difficult places - including malaria and ebola trials.
Difficulties in behaviour and communication are core problems in children with neurodevelopmental disorders, and often cause the most stress to parents and families living in resource poor areas of Africa.
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.
Are you a research scientist working in Global Health? Or an institution looking for partners to run a clinical trial? Site Finder is for you.
In this seminar from January 2014, Dr Jane Crawley talks about clinical standardisation in PERCH (Pneumonia Etiology Research for Child Health), a large case-control study of the causes of and risk factors for severe pneumonia.
Professor Mike English explains how KEMRI-Wellcome are ''working with government to generate patient level data from a network of Kenyan hospitals as a platform for research'.
Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field.
Ebola PPE guidelines - urgent need to revise WHO and CDC guidelines. This video shows an excerpt from keynote address 'The fuss about face masks', Professor Raina MacIntyre from the School of Public Health and Community Medicine, UNSW Australia.
We have recently obtained permission to share some very interesting videos from Global Health Videos by Greg Martin. This video series covers issues relating to research methods and study designs in Global Health.
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.
The last decade has witnessed a substantial increase of multi-centre, public health-oriented clinical trials in poor countries. However, non-commercial research groups have less staff and financial resources than traditional commercial sponsors, so the trial teams have to be creative to comply with Good Clinical Practices (GCP) requirements. This article hopes to feed the reflection on the methodological and ethical aspects of clinical trials carried out in developing countries by North-South collaborative research groups.
A range of downloadable templates and tools for Clinical Research, including monitoring checklists, budget spreadsheets, informed consent forms, SOPs and so on.
This article explains the process of data management operations within clinical trials from start to finish.
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.
During the setting up of our trial in Cameroon we met several operational issues that we needed to overcome. For some of these issues we developed some tools and we have made them available here so that other research groups can use them in their clinical trials.
Regional faculties provide opportunity for increased professional networking and clinical trial skill sharing at a local level. The Global Health Regional Faculties are being set up to facilitate activities that will increase and support clinical research in specific regions this is achieved by sharing skills, knowledge and experience between disease areas, job roles and research sites. Examples are opening up spaces on training courses or for meetings, supporting exchange or observational site visits. This article explains how interested groups could set up a faculty in their region
A set of 4 consent templates for clinical trials, interview studies, observation studies and sampling only studies.
This article explains how an East Africa Research Group have developed and applied a highly pragmatic an effective monitoring system. This group train research staff to monitor or perform QC on studies and then implement a system of reciprocal monitoring between studies. It is cost effective and works well.
The Trial Protocol Tool: a tool to help researchers to write a high quality protocol for a randomised controlled trial AVAILABLE IN SPANISH AND ENGLISH
What is the definition of clinical trial monitoring? Who can be a monitor? What are the monitor's roles and responsibilities? Read on for some answers.
Who should write up the results of the clinical trial? Are there guidelines on what should be included in the paper? This article answers these questions.
Considerations for pharmacovigilance and safety reporting.
Reciprocal or in-house monitoring schemes could be an alternative to expensive out-sourcing. Read on to find out more.
The site initiation process is important as it ensures that all the logistics are organised and the site is ready to begin recruiting subjects.
The effort invested in pre-trial planning and preparation more than pays off in terms of smooth operations, happy staff, happy participants, good recruitment and ultimately high quality data.
Clinical trials don't have to be expensive! Here are some tips for finding funding and drafting a realistic budget for your study.