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.
Conducting good, ethical global health research is now more important than ever. Increased global mobility and connectivity mean that in today’s world there is no such thing as ‘local health’. As a collection, these stories offer a flexible resource for training across a variety of contexts, such as medical research organizations, universities, collaborative sites, and NGOs.
Sarah Drew shares her research diary about conducting ethnographic fieldwork in Malawi as part of a Clubfoot study.
This is a great video of a talk given at the Oxford Martin School by Professor Kevin Marsh.
In this podcast Dr Jacob McKnight talks about his experiences in neonatal nursing delivery and research in Kenya.
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.
Become a Cochrane citizen scientist. Anyone can join their collaborative volunteer effort.
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.
This excellent series of videos from Yale University provide an overview of qualitative research by Dr. Leslie Curry leads us through six modules covering essential topics in qualitative research, including what is qualitative research and how to use the most common methods, in-depth interviews and focus groups. These videos are intended to enhance participants' capacity to conceptualize, design, and conduct qualitative research in the health sciences.
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.
Please see this Sky News interview where we were asked by Sky News to comment on the announcement about this bold vision to tackle all diseases.
In this week's episode the team discuss the latest stories on global maternal mortality, chikungunya in India, and sanitary pads in India.
This week, TWiGH looks at the weekly top global health stories grabbing headlines around the world - May 2016.
This framework describes key components of capacity development, indicators for their success and ways to verify capacity development.
This glossary provides definitions of some common terms encountered in clinical research.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
A programme set up by WHO together with major publishers to provide free or very low cost online access to the major journals to local, not-for-profit institutions in developing countries.
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
Social science guidance from the ACT Consortium available for wider research community, including training materials, SOPs, template protoclos and other tools.
A systematic review of barriers to and facilitators of the use of evidence by policymakers (BMC article)by Kathryn Oliver, Simon Innvar, Theo Lorenc, Jenny woodman, James Thomas
The gap between research and practice or policy is often described as a problem. To identify new barriers of and facilitators to the use of evidence by policymakers, and assess the state of research in this area, the authors present a systematic review.
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.
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.
Presentations from D Groups
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.
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.
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.
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)
A range of downloadable templates and tools for Clinical Research, including monitoring checklists, budget spreadsheets, informed consent forms, SOPs and so on.
2010 WHO Technical Report Series on the control of the leishmaniases.
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.
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.
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
Health research: the challenges related to ethical review and informed consent in developing countriesby Raffaella Ravinetto
An 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
A set of 4 consent templates for clinical trials, interview studies, observation studies and sampling only studies.
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
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.
Coming soon! A paper series on clinical trial design for tropical diseases. Read more here and get involved!
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.
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.
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.