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)
Pragmatism in practice: lessons learned during screening and enrollment for a randomised controlled trial in rural northern Ethiopia
by Meseret Molla, Henok Negussie, Moses Ngari, Esther Kivaya, Patricia Njuguna, Fikre Enqueselassie, James A. Berkley, Gail DaveyWe 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/editor
by GRN coordinatorScoping available resources and tools - WWARN survey
by Clifford BandaScoping 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.
Strategies for developing sustainable health research capacity in Low and Middle Income Countries
by Sam Franzen, ClareChandler, Sisira Siribaddana, Julius Atashili, Brian Angus, Trudie LangA prospective, qualitative, multi-site study investigating the barriers and enablers to locally-led clinical trial conduct in Ethiopia, Cameroon, and Sri Lanka; here the protocol, methods and instroduction are available for readers.
Workshop Report: Capacity building for clinical research in the face of disaster and conflict situations in middle and low income countries
by Glory Oluwagbenga Ogunfowokan - Regional Faculty Lead, morenike Ukpong, AUGUSTINE ONYEAGHALA - Senior Contributor, Global Health Trials Nigerian Regional FacultyThe 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.
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.
Informed consent is vital in clinical research. Achieving adequate comprehension in low literacy settings however is a significant challenge.
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.
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.
Global Health Glossary
by The EditorsThis glossary provides definitions of some common terms encountered in clinical research.
Sponsorship in non-commercial clinical trials
by Raffaella Ravinetto , Katelijne De Nys, Marleen Boelaert, Ermias Diro, Graeme Meintjes, Yeka Adoke, Harry Tagbor, Minne CasteelsNon-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.
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.
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.
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.
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.
Research Nurse Jerome Ackeneck discusses what's involved in his role on a Cameroonian HIV Study
In this video, Professor Theonest Mutabingwa discusses the two key challenges that face developing countries to progress their malaria research.
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.
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 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.
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.
Data Safety Monitoring Boards
by C.ReddyDiscussing 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. ReddyThe Pan African Clinical Trials Registry
by Dr Tamara Kredo of the PACTRSouth African Faculty Workshop: Clinical Trial Site Management
by Cordelia Leisegang - Regional Faculty Lead, Elizabeth Allen - Regional Faculty LeadOn 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.
Improving the capacity for quality clinical research in selected South African public health and/or academic intuitions through an enhanced Global Health Trials
by Elizabeth Allen - Regional Faculty Lead, Cordelia Leisegang - Regional Faculty Lead, Trudie LangThe 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 MolyneuxIn 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. 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.
Monitoring - A Gradual Process
by ogundokun Olusegun - Senior Contributor, Regional Faculty Committee MemberNew 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.
Good Clinical Practice in Resource-Limited Settings: Translating Theory into Practice
by The Editorial TeamResearch 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.
Challenges 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.
Report from the sixth EDCTP forum in Ethiopia - Clinical trials in practice: how to achieve the best protection of the study subjects?
by Raffaella RavinettoThe 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.
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 Research
by 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 SiribaddanaThese 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.
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
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.
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
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.
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
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.
Clinical trials don't have to be expensive! Here are some tips for finding funding and drafting a realistic budget for your study.