These guidance articles are peer reviewed and provided to give research teams high quality and trustworthy information on how to conduct a task or resolve an issue in the design, conduct or reporting of a clinical trial. Articles are accompanied by resources, such as a template or example documents. These are free for you to download and adapt for your study. Please acknowledge www.globalhealthtrials.org if you use these.
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.
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.
The Epidemiological evauation of vaccines course: efficacy, safety and policy
Epidemic curves are an important component of the public health and global health toolbox. Learn more about creating and interpretting them.
Experiences conducting ethnographic fieldwork in Malawi: challenges in navigating a new culture and participant perceptionsby Sarah Drew
During ethnographic fieldwork a researcher works alongside participants to try to understand experiences and knowledge within a particular context. Ethnographers often spend long periods of time conducting fieldwork in order to achieve an insiders’ perspective. However, achieving this takes time and is not necessarily straightforward. This article focuses on some of the challenges I encountered of working within a new context, including personal interaction and mutual understanding of roles. It is hoped that future researchers will be encouraged to consider the impact of their own positionality on findings.
AREF is calling for researcher applications to participate in its 2nd Essential Grant Writing Skills Workshop, to be held in Dakar, Senegal, in May 2017.
This useful article in Grounded Theory Review is a useful read for anyone engaging in coding, whatever approach you're using.
Choosing your theoretical approach and methodology can be intimidating and confusing. Here we share useful articles which seek to overcome some of the common confusions.
This article addresses the global burden of musculoskeletal trauma in particular in low and middle income countries.
The TDR Global Competency Framework for Clinical Research: a set of tools to help develop clinical researchersby TDR, The Global Health Network
The TDR Global Competency Framework for Clinical Research is a flexible framework which lists all the competencies that should be demonstrated by a research team to carry out a successful clinical study. It can be used for any research study, regardless of the size of the team and of the study itself. It can help to plan the staffing requirements for a study, to help carry out appraisals of staff, to help individuals plan their career development, and to help to develop educational curricula for research staff.
If you want to find a job in global health, this is for you.
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.
This framework describes key components of capacity development, indicators for their success and ways to verify capacity development.
If you're interested in Global Health then keep an eye on This Week in Global Health (TWiGH). TWiGH is a live, interactive, weekly global health news update. With Dr Greg Martin.
Travel Medicine and Infectious Diseases have evolved rapidly in recent decades as outbreaks such as SARS, Avian Influenza, Ebola, MERS, Chikungunya, and Zika virus have demonstrated how quickly infections can cross international borders.
Public Health Degrees.org is a comprehensive search engine designed for students who are interested in learning more about Public Health and Health Sciences programs around the United States.
Global Research Nurses is proud to announce skills sharing workshops at Mumbai and Gujarat, India in March 2016
This glossary provides definitions of some common terms encountered in clinical research.
Greg Martin talks about four areas of competencies needed to be effective in public health and global health. He places particular importance on management, leadership and governance.
Looking for a job in global health? A 4 part series that takes a look at what you need to do to get your career in global health off to a good start.
eSeminar: Research papers that make a difference: discussing research waste, reproducibility and impactby Iveta Simera, the EQUATOR Network
Dr Iveta Seimer, Deputy Director of the UK EQUATOR Centre, discusses research waste, reproducibility, and how to use reporting guidelines to make an impact. Poor reporting seriously affects the integrity of health research literature and critically limits the use and impact of published studies.
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
New INTERGROWTH-21st International Postnatal Growth Standards for Preterm Infants - Charts availableby INTERGROWTH-21st
New INTERGROWTH-21st Postnatal Growth Standards charts for individual measurements of length, weight, head circumference, as well as a combined standards chart for length, weight and head circumference are now available for download here.
The CONSORT (CONsolidated Standards of Reporting Trials) 2010 guideline is intended to improve the reporting of parallel-group randomized controlled trial (RCT), enabling readers to understand a trial's design, conduct, analysis and interpretation, and to assess the validity of its results. This can only be achieved through complete adherence and transparency by authors. This series explores how an abstract can be improved through use of the CONSORT guidelines.
Postnatal growth standards for preterm infants: the Preterm Postnatal Follow-up Study of the INTERGROWTH-21st Projectby INTERGROWTH-21st
The first international stnadards for monitroing the growth of preterm babies have now been published in the Lancet Global Health (October 2015).
Evidence shows that in many African regions, including Ghana, malaria is massively over-diagnosed. This means that patients who are not diagnosed with malaria by tests that identify malaria parasites in the blood are still considered to have the disease and therefore receive anti-malarial treatment.
Training manuals from REACT study in Cameroon. REACT Cameroon designed six training modules to support the introduction of malaria rapid diagnostic tests (RDTs). The manuals were used to train health workers at government and mission hospitals and health centres. The six modules are presented in two manuals
Trainer and Learner handbooks for workshops aimed at improving health centre management and patient centred services.
The TACT training manuals and patient leaflet were designed to support the use of malaria rapid diagnostic tests (RDTs). Here we provide Trainer/Trainee manuals in English and French, and visual patient information sheets in English, French and Swahili.
Guidance for non-economist audience on the importance of household costs related to seeking health care from the ACT Consortium.
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.
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.
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.
Fetal Growth Standards for ultrasound measurements of head circumference (HC), bi-parietal diameter (BPD), occipito-frontal diameter (OFD), femur length (FL) and abdominal circumference (AC) are now available for download. For information about how to perform these measurements, or for other information on standards in ultrasound imaging, please see the ultrasound training toolkit.
Joby George discusses his role as a research nurse based in India; what is involved, educational oprtions available, and what's important to him.
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 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.
Notes on How to Survive a GCP Audit forum discussion based on the GCP Inspection Course (Global Health Network eLearning course)by A. Nair, C. Ovenstone, B. Wright, E. Allen, C. Reddy
Links to the SPIRIT guidelines for protocol development and information about these guidelines - all free and open access.
UK EQUATOR Centre Publication School: Writing research articles fit for purpose - Learn the secrets of success in writing, publishing, and disseminating your research. 6th Julay 2015, University of Oxford.
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 4th Edition (2014)
Pragmatic and ethical research in disease outbreak settings: A one-day skills sharing workshop in Ghanaby Abena Konadu Yawson, Dr. Daniel Ansong, Kwaku Poku Asante
Global Health Trials and Kintampo Health Research Centre collaborated to run the workshop 'Pragmatic and ethical research in disease outbreaks' in November 2014. Here we provide a summary of the workshop and the presentations from the day.
In this video, Dr Greg Martin takes a look at the question, "what is public heath?" and considers what it is that public health professionals do.
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.
Is Your Ethics Committee Efficient? Using “IRB Metrics” as a Self-Assessment Tool for Continuous Improvement at the Faculty of Tropical Medicine, Mahidol University, Thailandby Pornpimon Adams et al
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.
In this video, Greg Martin interviews Gelise McCullough and asks her about how her art is being used in the area of global health. Gelise sells her art and uses the proceeds to help pay for HIV positive girls in Africa to get an education.
This extensive toolkit was developed by TDR, and explains how to conduct implementation research. This toolkit was designed to help people learn a standard process that would lead to results that could be compared across regions and countries. It is designed to help identify system bottlenecks and the stakeholders to be involved, formulate appropriate research questions, conduct the research and develop a plan for implementing the study results.
Seven principles for strengthening research capacity in low- and middle-income countries: simple ideas in a complex worldby ESSENCE on Health Research Initiative
This good practice document of the ESSENCE on Health Research initiative is designed to provide broad guidance on how best to strengthen research capacity with the maximum possible benefit.
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 getting grants and funding in Global Health.
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 working in Global Health.
We have recently obtained permission to share some very interesting videos on The Global Health Network. The videos are from Global Health Videos by Greg Martin. You can follow more videos from him at his YouTube channel. This series of videos deal with Glolbal Health and Ethics.
Reliable ultrasound charts are necessary for the prenatal assessment of fetal size, yet there is a wide variation of methodologies for the creation of such charts. This paper evaluates the methodological quality of studies of fetal biometry using a set of predefined quality criteria of study design, statistical analysis and reporting methods. Eighty-three studies met the inclusion criteria, and although multiple regression analysis shows that quality of studies has improved over time, there is considerable heterogeneity in study methodology still observed today. Standardisation of methodologies is necessary in order to make correct interpretations and comparisons between different charts. A checklist of recommended methodologies in proposed. http://www.ncbi.nlm.nih.gov/pubmed/22882780
Helpful, interactive eBook that aids those deciding how to further their career in research, or considernig whether to study as a post graduate.
This resource was used to train health professionals on how to record key data on pregnancies and deliveries for women participating in the Fetal Growth Longitudinal Study (FGLS) and Newborn Cross Sectional Study (NCSS). http://www.medscinet.net/Intergrowth/patientinfodocs/Pregnancy%20and%20Delivery%20Form%20Instructions.pdf
The INTERGROWTH-21st Project used this manual to standardize definitions, treatment and management recommendations of neonatal morbidities. http://www.medscinet.net/Intergrowth/patientinfodocs/Neonatal%20Manual%20Final.pdf
This handbook describes the methods used to perform accurate, precise and standardized anthropometric measurements for all components of the INTERGROWTH-21st study, including:
- height and weight of pregnant mothers
- birth weight, length and head circumference of newborns
- weight, length and head circumference of preterm babies
This protocol outlines the technique for measuring symphysis fundus height. http://www.medscinet.net/Intergrowth/patientinfodocs/Measurement%20of%20Symphysis%20Fundus%20Height.pdf
This protocol outlines the technique for taking a pregnant woman's blood pressure. http://www.medscinet.net/Intergrowth/patientinfodocs/BP%20protocol.pdf
The aims of this manual are to ensure all trained ultrasonographers are familiar with the standardized way measurements should be taken for the purposes of using the INTERGROWTH-21st growth standards, including standardization of the way the equipment should be used, ultrasound findings are recorded, data is entered and transfered, and how to train, asesses and certify these standardized techniques. http://www.medscinet.net/Intergrowth/patientinfodocs/US%20Manual%20FINAL.pdf
The aim of this manual is to ensure all trained ultrasonographers are familiar with the standardized way crown-rump length measurements should be taken for the purposes of using the INTERGROWTH-21st fetal growth standards. http://www.medscinet.net/Intergrowth/patientinfodocs/CRLstandardisation_Website.pdf
This manual details the technique for assessing sleep-wake cycles in children. http://www.medscinet.net/Intergrowth/patientinfodocs/Sleep-wake%20cycle%20assessment%20manual%20July%202014.pdf
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.
Social science guidance from the ACT Consortium available for wider research community, including training materials, SOPs, template protoclos and other tools.
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.
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.
We share a brief on the MCL shared at at the Women Deliver Conference 2013.
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.
Despite published guidance on writing the abstract in the PRISMA Statement guiding the reporting of systematic reviews in general and elsewhere, evaluations show that reporting of systematic reviews in journal and conference abstracts is poor. Teh authors developed consensus-based reporting guidelines as an extension to the PRISMA Statement on good reporting of systematic reviews and meta-analyses in abstracts.
Research 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.
Participant retention refers to keeping enrolled participants in a trial for the duration of the study. This article explains the concept of participant retention, and provides a template retention plan.
Critical issues in conducting non-commercially sponsored clinical research in South Africa: Meeting report 1st Feb 2013by Elizabeth Allen - Regional Faculty Lead, Lesley Workman - Senior Contributor, Cordelia Reddy
On 1st February 2013, Global Health Trials Southern African Regional Faculy held the first of its Clinical Trials Skills-Sharing Workshops in South Africa, hosted by the University of Cape Town. Here you can find the presentations from the day.
Report on a one-day skills sharing workshop for improved clinical trials and research in East Africa, hosted by UVRI/MRC, EACCR and Global Health Trials and held on 15th February 2013.
A Skills Sharing Workshop took place in Blantyre on 2nd October 2012. Presentations given on the day are shown here.
Research reporting guidelines are standard statements that provide guidance on how to report research methodology and findings. These are in the form of checklists, flow diagrams or texts. Most of the biomedical journals require authors to comply with these guidelines. Guidelines are available for reporting various study designs:
- CONSORT Statement (reporting of randomized controlled trials)
- STARD (reporting of diagnostic accuracy studies)
- STROBE (reporting of observational studies in epidemiology)
- PRISMA (reporting of systematic reviews)
- MOOSE (reporting of meta-analyses of observational studies)
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 - Expert Committee
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.
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.
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
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.
This article was written by a researcher from Sri Lanka and presents a very helpful overview on Biomedical Ethics. This article will be helpful to all levels of research staff and others who might want an accessible overview
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.
The site initiation process is important as it ensures that all the logistics are organised and the site is ready to begin recruiting subjects.