A Guide to Efficient Trial Managementby The Trial Manager's Network
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 6th Edition (2018)
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.
Interview with Sr Brenda Wright, clinical research nurse-turned book author/editorby GRN coordinator
Scoping available resources and tools - WWARN surveyby Clifford Banda
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.
This short film shows the impact of the CHAPAS trial on patient health and future possibilities of a small boy from Malawi.
Workshop Report: Capacity building for clinical research in the face of disaster and conflict situations in middle and low income countriesby Glory Oluwagbenga Ogunfowokan - Regional Faculty Lead, morenike Ukpong, AUGUSTINE ONYEAGHALA - Senior Contributor, Global Health Trials Nigerian Regional Faculty
The Global Health Trials Nigerian Regional Faculty held a workshop entitled Capacity building for clinical research in the face of disaster and conflict situation in middle and low income countries at the National Hospital, Abuja, on the 28th January 2017. Here we provide the presentations and links discussed during the workshop.
Health research capacity development in low and middle income countries: reality or rhetoric?by The Editorial Team
There has been steady progress in LMIC health research capacity, but major barriers to research persist and more empirical evidence on development strategies is required.
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).
Informed consent is vital in clinical research. Achieving adequate comprehension in low literacy settings however is a significant challenge.
Clinical Trials: One of the most important medical inventions in the last 100 yearsby The Editorial Team
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.
Global Health Glossaryby The Editors
This glossary provides definitions of some common terms encountered in clinical research.
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.
Annual Meeting of the South African Regional Facultyby C.Reddy, E. Allen
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.
Como escribir solicitudes para Fondos o Apoyos (Also available in English)by The Editorial Team, Elizabeth Allen - Regional Faculty Lead, Jackeline Alger; MD, PhD
Las 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, PhD
Grant 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.
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'.
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.
Commentary on the Introduction to Data Management Courseby L.Workman, A.Stewart
SPIRIT guidelines for Protocol Writingby SPIRIT-Statement
Links to the SPIRIT guidelines for protocol development and information about these guidelines - all free and open access.
Research Administration and Grant Managementby Research Administration Tools.org
Links 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 trialsby Barbara Farrell, Sara Kenyon, Haleema Shakur
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.
Data Safety Monitoring Boardsby C.Reddy
Discussing the study protocol part 2by D. Shamley, N.Kramer, E.Allen, L.Workman, W.Smythe, C.Ovenstone, C.Reddy
Discussing the study protocolby D. Shamley, C. Heiberg, N. Kramer, B. Wright & C. Reddy
The Pan African Clinical Trials Registryby Dr Tamara Kredo of the PACTR
Workshop report: 'Recent Trends and Career Development in Clinical Research in India' - 19 Nov 2014by sreedharsmail, Joby George, Jyothsna Tirunagari
A workshop on “Recent Trends and Career Development in Clinical Research –INDIA”, was organized at Bhaskara Auditorium on 19th November 2014 by SAMSKARA, a Non Profit Organization based at Hyderabad and The Global Health Network for the first time in Telangana.
South African Faculty Workshop: Clinical Trial Site Managementby Cordelia Leisegang - Regional Faculty Lead, Elizabeth Allen - Regional Faculty Lead
On the 19th September 2014, Global Health Trials Southern Africa held its Annual Faculty Meeting, themed Clinical Trial Site Project Management. You can download the presentations from the talk and leave feedback here.
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.
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.
Aspectos esenciales en la realización de investigación clínica no patrocinada comercialmente en el Peru - Workshop Reportby Centro de Salud Global - Tumbes, Universidad Peruana Cayetano Heredia
El taller titulado “Aspectos esenciales en la realización de investigación clínica no patrocinada comercialmente en el Perú”, se llevó a cabo en la ciudad de Lima, Perú el miércoles 11 de junio del 2014. La organización del Taller estuvo a cargo de El Centro de Salud Global – Tumbes de la Universidad Peruana Cayetano Heredia – UPCH y el Grupo de Proyectos...
Improving the capacity for quality clinical research in selected South African public health and/or academic intuitions through an enhanced Global Health Trialsby Elizabeth Allen - Regional Faculty Lead, Cordelia Leisegang - Regional Faculty Lead, Trudie Lang
The Global Health Trials South Africa Regional Faculty is currently running the following study, to improve the capacity for clinical research in South Africa by running an enhanced professional membership scheme and eLearning for study staff.
This article explains how to write a cover letter for a research job, tailored for each job and to maximise your chances of securing an interview. Examples and templates are given.
This article describes how to seek research jobs which will suiit you, and how to work out from the job description the best ways to apply and secure an interview.
This article gives practical advice about how to create an excellent research CV, and has links to many templates and advice articles from around the world, as well as information about how to use the Professional Membership Scheme to create a free, formatted GCP-standard CV for you which can be used for site files and job applications.
Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya (Trials Article)by Vibian Angwenyi, Dorcas Kamuya - Expert Committee, Dorothy Mwachiro, Betty Kalama, vicki marsh, Patricia Njuguna, Sassy Molyneux
In this Trials paper, the authors share experiences of formal CE for a paediatric randomized controlled malaria vaccine trial conducted in three sites within Kilifi County, Kenya.
Bayesian Clinical Trials (Nature Reviews Article)by Donald A. Berry
An 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 countriesby ESSENCE on Health Research Initiative
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.
Monitoring - A Gradual Processby ogundokun Olusegun - Senior Contributor, Regional Faculty Committee Member
New to monitoring clinical research trials? Ogundokun Olusegun outlines some of the responsibilities and tasks that the role involves, from revieiwing sites and managing research centers to the lifestyle pressures on the road.
This guide, developed by the WHO and released in December 2013, aims to facilitate implementation research in LMICs.
Technology issues for research in remote areas/developing regionsby Mike Workman - Senior Contributor
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.
Challenges of non-commercial multi-centre North-South collaborative clinical trialsby Raffaella Ravinetto , on behalf of the 4ABC Study Group
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.
Towards a more pragmatic approach to trial regulationby The Editors
Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participantsby Editors
This article explains the process of data management operations within clinical trials from start to finish.
Report from the sixth EDCTP forum in Ethiopia - Clinical trials in practice: how to achieve the best protection of the study subjects?by Raffaella Ravinetto
The report from the Satellite Event at the Sixth EDCTP1 Forum, Addis Ababa, Ethiopia United Nations Conference Centre, 11th October 2011: Clinical trials in practice: how to achieve the best protection of the study subjects?
Article and slide sets about Global Health Trials, which can be used by anyone who may be interested in running seminars in their local institutions, or even organising workshops to further expand on the concept of sharing methods and knowledge to support clinical trials across disease areas.
This editorial describes the work of the WOMAN trial about post partum bleeding, and invites the participation of obstetricians, midwives and nurses from around the world to join an international collaborative effort to identify safe and effective treatments for post partum haemorrhage.
The Critical Path to TB Drug Regimens (CPTR) Initiative is seeking new trial sites for collaboration in planned phase I and II trials. Also available in French - click on the link and scroll down for French version.
The Draft Statement/Guidelines for Disaster Researchby Arthula Sumathipala, Aamir Jafarey, Leonardo de Castro, Aasim Ahmad, Darryl Marcer, Sandya Srinivasan, Nandini K. Kumar, Slemen Sutaryo, Anant Bhan, Dananyaja Wadeyaratne, Sriyakanthi Beneragama, Chandrani Jayasekera, Sarath Edirisingha, Chesmal Siriwardhana, Sisira Siribaddana
These guidelines were developed following a Working Group on Disaster Research and Ethics (WGDRE) meeting in 2007 with the aim of developing ethical guidelines which would be applicable to post-disaster research, partiuclarly that performed in the developing world. We welcome any feedback from members.
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.
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 Mbuagbaw
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
Ethical criteria in clinical research in developing countries: is there a global standard?by Raffaella Ravinetto
This 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.