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)
Health research capacity development in low and middle income countries: reality or rhetoric?
by The Editorial TeamThere has been steady progress in LMIC health research capacity, but major barriers to research persist and more empirical evidence on development strategies is required.
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).
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.
Global Health Glossary
by The EditorsThis glossary provides definitions of some common terms encountered in clinical research.
ASLM: Reconstructing Laboratory Systems: How to Rebuild in Ebola-Affected Countries
by The Editorial TeamProfessor Lang talks about doing difficult trials in difficult places - including malaria and ebola trials.
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.
Como escribir solicitudes para Fondos o Apoyos (Also available in English)
by The Editorial Team, Elizabeth Allen - Regional Faculty Lead, Jackeline Alger; MD, PhDLas solicitudes para fondos o apoyos difieren substancialmente dependiendo de la organización a la que se esté aplicando, ya que cada una de ellas tiene sus propios objetivos organizacionales, los cuales es importante entender cuando se está considerando a que fondo o apoyo aplicar. En este artículo ofrecemos consejos prácticos e información para escribir solicitudes para fondos o apoyos, los cuales pueden ser aplicados a solicitudes de todo tipo, desde becas hasta solicitudes para financiamientos grandes.
A Guide to Grant Writing (available in English and Spanish)
by The Editorial Team, Elizabeth Allen - Regional Faculty Lead, Jackeline Alger; MD, PhDGrant applications differ substantially depending on the individual funding organisation, and each funding organisation has its own organisational aims, which are important to understand when you are considering which grant to apply to. In this article we provide practical tips and information for writing grant applications, which can be applied to grant applications of all sorts, from fellowships to large funding applications.
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.
Job interviews can be intimidating, but simply preparing well can make the difference between succeeding or failing, regardless of how nervous you are. In this article we pull together advice on how to prepare for job interviews and how to know what questions you’ll be asked.
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.
SPIRIT guidelines for Protocol Writing
by SPIRIT-StatementLinks to the SPIRIT guidelines for protocol development and information about these guidelines - all free and open access.
Research Administration and Grant Management
by Research Administration Tools.orgLinks to resources provided by iRIM (the Initiative on Research and Innovation Management) - free online presentations and tutorials relating to how to manage grants and perform administration of clinical research projects effectively.
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.
Discussing the study protocol part 2
by D. Shamley, N.Kramer, E.Allen, L.Workman, W.Smythe, C.Ovenstone, C.ReddyDiscussing the study protocol
by D. Shamley, C. Heiberg, N. Kramer, B. Wright & C. ReddyEbola 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.
The basic requirements for new sites wanting to take part in clinical research - What sites need to know!
by Caroline SibekoFive 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.
Technology issues for research in remote areas/developing regions
by Mike Workman - Senior ContributorResearchers 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.
A range of downloadable templates and tools for Clinical Research, including monitoring checklists, budget spreadsheets, informed consent forms, SOPs and so on.
Requirements for high impact diagnostics in the developing world
by Mickey Urdea, Laura A. Penny, Stuart S. Olmsted, Maria Y. Giovanni, Peter Kaspar, Andrew Shepherd, Penny Wilson, Carol A. Dahl, Steven Buchsbaum, Gerry Moeller, Deborah C. Hay BurgessTowards a more pragmatic approach to trial regulation
by The EditorsFive seed documents are provided here for use in clinical research, which can be adapted and altered for each study. Here we provide a template concept protocol, a study protocol, a CRF, an informed consent form, and a generic SOP.
It is a recommendation of some IRB/ECs that back translation is included as a necessary step for the translation of some clinical trial documentation, including informed consent documents. This article explains the reasons for back translation, and takes you through how to effectively perform this step, including explaining how to find a suitable translator for the task.
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.
Ethical criteria in clinical research in developing countries: is there a global standard?
by Raffaella RavinettoThis paper, recently published on the Italian Journal of Tropical Medicine(Vol 15, N 1-4, 2010), reports on a debate that took place during the 6thEuropean Conference of Tropical Medicine in 2009, on some topics of greatinterest for GlobalHealthTrials.org: is there a global standard for clinicalresearch? Should standards be adapted in developing countries? How toencourage research while preventing the exploitation of vulnerableindividuals or groups? Five "debate questions" where addressed by ProfessorNick White and by Dr. Lumuli Mbonile, and discussed with the moderator(Raffaella Ravinetto) and the audience.
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.
An overview of different types of clinical trial oversight committees, including steering committees and data safety monitoring committees.
Laboratory data is crucial in ensuring subject safety and determining the effectiveness of an investigational medicinal product. Here are some issues to consider for clinical trial laboratories in resource-poor settings.
Coming soon! A paper series on clinical trial design for tropical diseases. Read more here and get involved!
Project management ensures that the project does not veer off its intended pathway. This begins in planning, all the way through initiation to completion. Read the full article to learn more.
Clinical trial governance encompasses sponsorship, contracts, finance, confidentiality, trial insurance and professional indemnity and scientific and ethical review. You can find guidance and template documents relating to all of these topics throughout GlobalHealthTrials.org or you can contribute your own material to help others.
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.
Ticking the last box: once the trial has ended it is important to ensure correct site closure and archiving of study files.
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.
Community sensitisation is a fundamental aspect of clinical trial operations anywhere in the world but is of particular relevance in the developing world. Share your experiences with other developing country researchers.
Good data management practices are essential to the success of a trial because they help to ensure that the data collected is complete and accurate. This article contains some tips to help you get started with data management.
Clinical trial regulations can be confusing and unwieldy to researchers. The intention of this section is to explain what regulations exist, where they apply and how to work through them in a sensible and pragmatic way to determine what is applicable to any given trial.
The informed consent process is fundamental to ensuring that clinical trials are conducted ethically. This article outlines some issues to consider.