Webinar: Pregnant Women & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research, and Response, 5 March 2019by The Editorial Team
Several of Global Health Trials' Regional Faculties have implemented exceptional, cost-effective blended learning schemes, using a computer room and the Global Health Network's free eLearning courses to create a novel way of building their research teams' skills and knowledge. The Nigerian faculty explain their experiences here, and you can download their "how to" document on the right hand side of the screen, to use at your own site!
Scholarships available for early career scientists to help advance research in human milk and lactationby The Editorial Team
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)
The Nigerian Global Health Trial Conference 2018 took place on the 30th and 31st of January 2018 the Sickle Cell Centre, Idi-Araba, Lagos. The full report here is shared to allow others to experience and learn from the event.
To highlight the types of activities run by The Global Health Network's innovative regional faculties, and how those can raise the capacity for research, dedicated faculty leaders Glory Oluwagbenga Ogunfowokun (Nigeria) and Jackeline Alger (Honduras) have created these video interviews
The Data Safety and Monitoring Board (DSMB) or Data Monitoring Committee (DMC – these are synonymous terms) is a group of individuals put together by the sponsor or CRO (if contracted out) with relevant expertise to carry out the important role of monitoring the safety of a clinical trial study.
The Nigerian Regional Faculty ran a workshop about Biostatistics on May 20th-21st, 2017. The workshop was well attended with 61 participants, and covered a useful range of topics. You can download the presentations from the day here.
Do you have research ideas for using big data to fill gender data gaps? Announcing the Big Data for Gender Challenge! Research proposals are due on July 7, 2017
FutSci (Future Science), www.FutSci.com, is the crowdfunding platform dedicated to raising funds for Research, Innovation and Technology projects within the Life Sciences arena. The platform is designed by scientists and aims to support all researchers, particularly those at an early stage in their careers by providing a complement to traditional funding avenues.
A 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.
This paper proposes a generic ordinal sequential trial design (GOST) for a randomised clinical trial comparing an experimental treatment for an emerging infectious disease with standard care. The design is intended as an off-the-shelf, ready-to-use robust and flexible option. This article was first published in PLOS.
This is a great video of a talk given at the Oxford Martin School by Professor Kevin Marsh.
The World Health Organization Fetal Growth Charts: A Multinational Longitudinal Study of Ultrasound Biometric Measurements and Estimated Fetal Weightby Kiserud et al
WHO made it a high priority to provide the present fetal growth charts for estimated fetal weight (EFW) and common ultrasound biometric measurements intended for worldwide use. This study provides WHO fetal growth charts for EFW and common ultrasound biometric measurements, and shows variation between different parts of the world.
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.
Become a Cochrane citizen scientist. Anyone can join their collaborative volunteer effort.
The following invitation to take part in trials methodology research comes from the Network of Hubs for Trials Methodology Research (HTMR) which was established by the UK Medical Research Council (MRC) to improve the quality of clinical trials.
This book is a collection of fictionalised case studies of everyday ethical dilemmas and challenges, encountered in the process of conducting global health research in places where the effects of global, political and economic inequality are particularly evident.
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).
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.
Around half of the clinical trials done on medicines we use today are not published; a tragic truth that needs to be changed.
Research in pregnant and breastfeeding women is a complex area, with both the wellbeing of the mother and child paramount. Careful monitoring of any intervention to treat, or prevent, illness is required to ensure the benefits outweigh any harms. Read this article to find out more and download some of the safety tools developed by experts from the Malaria in Pregnancy Consortium.
BMJ Blog - Richard Smith: The “micro-macro problem” and the difficulty of using evidence to make policyby The Editorial Team
In this BMJ blog, Richard Smith discusses the challenges and process of getting research evidence into policy and practise
This video seminar describes research to develop a low-cost, field-based test to detect several slow-clearing ACT drug compounds from unprocessed fingerstick blood samples
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.
Launch of Mesh: a new online platform co-created by its users and aiming to improve Community Engagementby The Editorial Team
Today,The Global Health Network launches Mesh: a new online platform co-created by its users and aiming to improve Community Engagement with health in low and middle income countries.
Professor Sallie Lamb talks about the history of clinical trials, and explains important concepts such as randomisation, masking and minimisation of bias.
Professor Scheffler provided a conceptual framework that shows how pay for performance works in health, and discusses the results of selected case studies.
The European Mobile Laboratory, EMLab, was the first EBOV diagnostics unit deployed to the outbreak epicentre by WHO in March 2014.
This paper proposes an ethical framework for Community Engagement. The framework is grounded in the insight that relationships between the researcher and the community extend beyond the normal bounds of the researcher-research participant encounter and are the foundation of meaningful engagement.
HOW TO COLLABORATE? Applicants with research interests relevant to CoLab (complications of pregnancy) may apply to collaborate with CoLab. Please note that to obtain samples and/or data from CoLab cohorts, you will need a member of CoLab to be your sponsor. We can help assist you in getting a sponsor. All CoLab projects are considered collaborations and you will work directly with CoLab members and cohorts to obtain data and/or biological samples for your project. However, you will work directly with the CoLab office thorough the application process, to give quarterly updates, and to work with a protocol committee regarding your project.
This framework describes key components of capacity development, indicators for their success and ways to verify capacity development.
U.S. efforts to combat the Zika virus in the US and abroad
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.
Strategy for Standardization of Preeclampsia Research Study Design
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.
The INTERGROWTH-21st global references and z scores for head circumference, length and weight at birth of very preterm newborns are available to download below.
New INTERGROWTH-21st very preterm size at birth reference charts have been published in The Lancet.
Abstract The luncheon for research nurses, supported by the Global Health Trials’ South African faculty and Global Research Nurses, was held at the University of Cape Town on 6 November 2015. The purpose of the event, which attracted 65research nurses, was to provide face to face interaction for research nurses and a platform for sharing challenges and triumphs for both UK and South African research nurses.
With Zika infection rates now seeming to be on the increase, the Oxford Science Blog talked to Professor Lang about why it is so important to develop capacity for doing research in places where research doesn't normally happen.
Reporting missing participant data in randomised trials: systematic survey of the methodological literature and a proposed guideby Akl et al 2016
Authors conducted a systematic survey of the methodological literature to identify recommended approaches for how and what randomised clinical trial (RCT) authors should report on missing participant data and, on the basis of these approaches, to propose guidance for RCT authors. Most identified approaches invite trial authors to report the extent of MPD and the underlying reasons. Fewer approaches focus on reporting missingness patterns, methods for handling MPD and implications of MPD on results.
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.
Damalie Nakanjako (MBChB, MMED, PhD) is an internist whose work focuses on optimizing HIV treatment outcomes and reducing HIV-associated morbidity and mortality in sub-Saharan Africa.
Twitter plays role in information distribution during emergencies, and it is widely used by public health organisations during public health crises.
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 articles from the African Society for Laboratory Medicine (ASLM).
Professor Lang talks about doing difficult trials in difficult places - including malaria and ebola trials.
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).
Scientific title: Infectious disease aetiologies of uncomplicated febrile illness in children <5 years of age in rural Zanzibar. As a result, Zanzibar has turned into a low transmission area with a decline of P. falciparum malaria among children with fever from approximately 30% to 1%, as well as a significant reduction of the crude child mortality.
Scientific title: Effectiveness of Malaria Rapid Diagnostic Tests in fever patients attending primary health care facilities in Zanzibar. Over the past decade, Zanzibar has adopted artemisinin-based combination therapy (ACT), long lasting insecticide treated nets and indoor residual spraying
Strategies for expanding access to quality malaria diagnosis in south-central Asia where malaria incidence is lowby ACTConsortium
Scientific title: An examination of ACT strategy in south-central Asia on P. falciparum malaria in a context where P. vivax is the major species. With the exception of Sub-Saharan Africa, most areas that are endemic for malaria have a combination of two species: Plasmodium falciparum and P. vivax. P. vivax is often the dominant species, accounting for a greater proportion of malaria cases.
Scientific title: A cost-effectiveness analysis of provider and community interventions to improve the treatment of uncomplicated malaria in Nigeria. Private-sector providers are a major source of malaria treatment in Nigeria, and many patients in Enugu state seek treatment at pharmacies and drug stores as well as public health centres.
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
Cost-effectiveness of interventions to support the introduction of malaria rapid diagnostic tests in Cameroonby ACTConsortium
Scientific title: A cost-effectiveness analysis of provider interventions to improve health worker practice in providing treatment for uncomplicated malaria in Cameroon. Testing patients before prescribing medication is important, and should ensure patients receive the most appropriate treatment. This is important because unnecessary and inappropriate treatment has costs –incurred by patients, but also governments and donors working to control malaria.
New INTERGROWTH-21st Fetal Growth Standards charts for 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.
This study evaluates whether the use of rapid diagnostic tests by community medicine distributors – with the aim to improve diagnosis and treatment of malaria in the community – is feasible, well accepted and cost-effective. This cluster randomized trial compares two approaches.
Improving Clinical Research Data: The Understanding and Implementation of Laboratory Quality Management System (LQMS)by Augustine Onyeaghala. MSc, PhD, MSQA, PGDQA, FMLSCN
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.
Healthcare associated infections (HAI) are of important concern in patient care. This talk discusses Visual Analytics techniques which have been developed to help detect, monitor, analyse and understand trends, clusters and outbreaks of HAI.
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.
Research Nurse Jerome Ackeneck discusses what's involved in his role on a Cameroonian HIV Study
Consulting research stakeholders in Kenya on fair practice in research data sharing: Findings and Policy Implications - Dr Vicki Marsh
In this video, Professor Theonest Mutabingwa discusses the two key challenges that face developing countries to progress their malaria research.
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.
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.
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.
This article published in PLOS Medicine on April 14th, 2015 discusses how best to test Ebola treatment.
Links to the SPIRIT guidelines for protocol development and information about these guidelines - all free and open access.
Practical chart for health practitioners to use to assess newborn size (weight, length, head circumference) at birth against global standards. This version of the chart is being piloted within the University of Oxford hospital network, and plans to pilot in the INTERGROWTH-21st study sites and in Boston area hospitals are developing quickly. Practitioners can download and use this version of the chart freely. To connect with the INTERGROWTH-21st team regarding your experience with piloting this chart, or to request modifications to the chart (e.g. language; different institutional logo), please contact email@example.com.
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 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.
Global standards and z scores for length at birth, with information related to their use. Online calculators will be available shortly.
Global standards and z scores for head circumference at birth, with information related to their use. Online calculators will be available shortly.
Global standards and z scores for birth weight at birth, with information related to their use. Online calculators will be available shortly.
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.
International standards for fetal growth based on serial ultrasound measurements: the Fetal Growth Longitudinal Study of the INTERGROWTH-21st Projectby INTERGROWTH-21st
Using the same methods and conceptual approach as the WHO child growth standards, the Fetal Growth Longitudinal Study of the INTERGROWTH-21st Project developed international growth and size standards for fetuses for clinical interpretation of routinely taken ultrasound measurements and for comparisons across populations.
On the 8th of July 2014 The Global Health Network launched the Global Health Research Process Map, the first digital toolkit designed to enable researchers anywhere in the world to conduct rigorous global health research.
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.
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.
Translating research into practice: the introduction of the INTERGROWTH-21st package of clinical standards, tools and guidelines into policies, programmes and servicesby INTERGROWTH-21st
This paper describes the approach to translating the findings, tools and resources generated by the INTERGROWTH-21st Project into practice. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12416/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Seattle, USA. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12126/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Oxford, UK. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12033/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Muscat, Oman. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12043/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Nairobi, Kenya. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12045/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Turin, Italy. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12124/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Nagpur, India. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12058/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Beijing, China. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12044/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Pelotas, Brazil. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12046/abstract
The INTERGROWTH-21st Project presented a complex set of ethical challenges given the involvement of health institutions in geographically and culturally diverse areas of the world, with differing attitudes to pregnancy. This paper addresses how the research team dealt with some of those issues. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12030/abstract
Statistical considerations for the development of prescriptive fetal and newborn growth standards in the INTERGROWTH-21st Projectby INTERGROWTH-21st
This paper considers the statistical aspects of the three components of the INTERGROWTH-21st Project - the Fetal Growth Longitudinal Study, the Preterm Postnatal Follow-up Study, and the Newborn Corss-Sectional Study - as they relate to the construction of the INTERGROWTH-21st standards, in particular, the sample size. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12031/abstract
Given the multicentre nature of the INTERGROWTH-21st Project and the expected number of preterm births, it is vital that all centres follow the same standardised clinical care protocols to assess and manage preterm infants, so as to ensure maximum validity of the resulting standards as indicators of growth and nutrition with minimal confounding. Moreover, it is well known that evidence-based clinical practice guidelines can reduce the delivery of inappropriate care and support the introduction of new knowledge into clinical practice. The INTERGROWTH-21st Neonatal Group produced an operations manual, which reflects the consensus reached by members of the group regarding standardised definitions of neonatal morbidities and the minimum standards of care to be provided by all centres taking part in the project. This paper describes the process of developing the Basic Neonatal Care Manual, as well as the morbidity definitions and standardised neonatal care protocols applied across all the INTERGROWTH-21st participating centres. Thoughts about implementation strategies are presented. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12312/abstract
Anthropometric standardisation and quality control protocols for the construction of new, international, fetal and newborn growth standards: the INTERGROWTH-21st Projectby INTERGROWTH-21st
The INTERGROWTH-21st Project involved taking anthropometric measurements, including head circumference, recumbent length and weight of infants, and the stature and weight of parents. In a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes, in detal, the anthropometric training, standardisation and quality control procedures used to collect data for these new standards. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12127/abstract
Standardisation and quality control of ultrasound measurements taken in the INTERGROWTH-21st Projectby INTERGROWTH-21st
Meticulous standardisation and ongoing monitoring of adherence to measurement protocols during data collection are essential to ensure consistency and to minimise systematic error in multicentre studies. Strict ultrasound fetal biometric measurement protocols are used in the INTERGROWTH-21st Project so that data of the highest quality from different centres can be compared and potentially pooled. A central Ultrasound Quality Unit (USQU) has been set up to oversee this standardisation, training and quality control process. This paper describes the procedures used, which can form a model for research settings involving ultrasound measurements.
A unified protocol is essential to ensure that fetal ultrasound measurements taken in multicentre research studies are accurate and reproducible. This paper describes the methodology used to take two-dimensional, ultrasound measurements in the longitudinal, fetal growth component of the INTERGROWTH-21st Project. These standardised methods should minimise the systematic errors associated with pooling data from different sites. They represent a model for carrying out similar research studies in the future. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12313/abstract
This paper outlines the objectives, design and implementation of the INTERGROWTH-21st Project, a multicentre, multiethnic, population-based project conducted in eight geographical areas (Brazil, China, India, Italy, Kenya, Oman, UK and USA), with technical support from four global specialised units, to study growth, health and nutrition from pregnancy to early infancy. It aims to produce prescriptive growth standards, which conceptually extend the World Health Organization (WHO) Multicentre Growth Reference Study (MGRS) to cover fetal and newborn life. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12047/abstract
Zulfiqar Bhutta, Chair of the INTERGROWTH-21st Steering Committee, introduces the rationale for the INTERGROWTH-21st Project. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12032/abstract
Professor Sir Sabaratnam Arulkumaran, President of FIGO, introduces the methods of the INTERGROWTH-21st Project. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12314/abstract
This study protocol descibes the the objectives, design and implementation of the Fetal Growth Longitudinal Study (FGLS), the Preterm Postnatal Followup Study (PPFS), and the Newborn Cross Sectional Study (NCSS). Data from these studies inform new, international fetal and newborn growth standards and a package of accompanying resources, including a new international equation for estimating gestational age through ultrasound. http://www.medscinet.net/Intergrowth/patientinfodocs/Intergrowth%20Protocol%20Sept%202009.pdf
This operation manual was used to implement the Fetal Growth Longitudinal Study (FGLS), which involved screening healthy women between 9 and 14 weeks gestation at the time of their early antenatal visit, and followed-up with standard clinical and 2D ultrasound examinations every 5 weeks, i.e. up to six times during a term pregnancy. The results of the FGLS inform new, international fetal and newborn growth standards and a package of supportive tools, guidelines and resources, including a new international equation for estimating gestational age through ultrasound. http://www.medscinet.net/Intergrowth/patientinfodocs/FGLS%20Manual%2015-09.pdf
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
The basic requirements for new sites wanting to take part in clinical research - What sites need to know!by Caroline Sibeko
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.
The authors present the story of building a succesful research laboratory in Cameroon, including how they managed building up the infrastructure, equipment maintenance, staff training.
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.
In this article, the authors illustrate five basic statistical concepts that can significantly impact the interpretation of the medical literature and its application to the care of patients, drawing examples from the vaccine literature: (i) consider clinical and statistical significance separately, (ii) evaluate absolute risks rather than relative risks, (iii) examine confidence intervals rather than p values, (iv) use caution when considering isolated significant p values in the setting of multiple testing, and (v) keep in mind that statistically nonsignificant results may not exclude clinically important benefits or harms.
Transnational Working Group on Data management of the ECRIN, the European Clinical Research Infrastructures Network, present recommendations for quality and harmonisation for data management. In addition good data management practices in general are identified.
Clinical Data Management: Current status, challenges and future directions from industry perspectives.by Harry van Loen
This guidance article aims to provide a fully comprehensive, pragmatic guide for researchers of all roles, but especially ethics reviewers, to explain the details of each type of ethics review. The article is available in English, Spanish, Portuguese and Chinese, and has been kindly provided by www.ctmagnifier.org.
Essential Interventions, Commodities and Guidelines for Reproductive, Maternal, Newborn and Child Healthby Jai K Das
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)
Point of Care Testing for Infectious Diseases: Diversity, Complexity and Barriers in Low- and Middle Income Countriesby Nitika Pant Pai, MD MPH PhD, Caroline Vadnais, Claudia Denkinger, Nora Engel, Madhu Pai
This article is an introduction to cluster randomised trials.
“Piggy-Backing” on Diagnostic Platforms Brings Hope to Neglected Diseases: The Case of Sleeping Sicknessby Joseph M Ndung'u, Sylvain Bieler, Giorgio Roscigno
Five 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.
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.
This articles explores some of the ethical issues arising in the context of collaborative global health research networks involving partners in developing and developed countries.
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.
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
The WHO invite comments on these new guidelines: Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants
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.
An overview on trial registration. Here you can find out why trials need to be registered and what the difference is between all the registries - and how to register your study.
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
This tool has been designed to help researchers run randomised controlled trials. This is available in both English and Spanish
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
Global Health Trials is a free open-access collaborative programme. We encourage clinical trials in difficult settings such as those with limited resources. We want to make it easier to conduct better trials and use the expertise and experience that already exisits by sharing best practice.
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.
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.
What is the definition of a clinical trial? Is there an international consensus? Read on to find out.
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.
Setting the right question is crucial to the success of a clinical trial and there are additional considerations for trials conducted in resource-limited settings.