A Guide to Efficient Trial Management
by The Trial Manager's NetworkThis 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 6th Edition (2018)
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).
Around half of the clinical trials done on medicines we use today are not published; a tragic truth that needs to be changed.
The team interview panel members talking about the Novartis Access Initiative's work on NCDs.
Clinical Trials: One of the most important medical inventions in the last 100 years
by The Editorial TeamProfessor Sallie Lamb talks about the history of clinical trials, and explains important concepts such as randomisation, masking and minimisation of bias.
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.
Professor Lang talks about doing difficult trials in difficult places - including malaria and ebola trials.
An RCT to improve behaviour and communication in Kenyan children with Neurodevelopmental Disorders
by The Editorial TeamDifficulties 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.
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.
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.
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.
Professor Bongani M Mayosi from the Department of Medicine, Groote Schuur Hospital & University of Cape Town describes the transofmation of the science cohort in South Africa.
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.
Bayesian Clinical Trials (Nature Reviews Article)
by Donald A. BerryAn introduction into and overview on the mathematics and practice of Bayesian (adaptive) clinical trials.
Five keys to improving research costing in low- and middle-income countries
by ESSENCE on Health Research InitiativeESSENCE 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.
Good Clinical Practice in Resource-Limited Settings: Translating Theory into Practice
by The Editorial TeamChallenges of non-commercial multi-centre North-South collaborative clinical trials
by Raffaella Ravinetto , on behalf of the 4ABC Study GroupThe 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.
Towards a more pragmatic approach to trial regulation
by The EditorsThis 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.
Templates from an investigator-led trial in Cameroon: the CAMPS trial (also available in French)
by Lawrence MbuagbawDuring 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
Health research: the challenges related to ethical review and informed consent in developing countries
by Raffaella RavinettoAn article about a workshop that assessed ethical review and informed consent in vulnerable populations. This article aims to prompt a debate leading to better guiding principles on health research in constrained settings
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
Clinical trials don't have to be expensive! Here are some tips for finding funding and drafting a realistic budget for your study.