Training
There are two types of training needs that we aim to provide support for on Global Health Trials.org:
- Researchers need to train their site staff in how to run a specific trial.
- There is a need for professional training for clinical trialists.
We aim to provide resources to meet both of these needs. These resources will be free and specific to the requirements of clinical trials in low income settings and there will be a wide range of e-learning courses open to all.
Training Resources and e-learning
We are developing this area so that you can download slide sets, hand-outs and other materials that you can adapt to support the wide range of training needed for your specific clinical trials. This includes the training that site and trial staff need when planning trials and prior to study start as well as specific skills and technical topics for ongoing training and skill development for your site staff. There will also links to any other free and related training. Please get involved and send in any training links to keep this current and comprehensive. We also welcome any training material or course content. All will be acknowledged and attributed to the contributor, a good chance to raise the profile of your centre and share your knowledge with other groups.
These resources can and should be adapted to suit the needs of each trial. This is important - every trial is different and researchers need to assess the specific training needs for their staff and sites to ensure they are tailored to the requirements of the protocol, its relative risk and complexity of design. Experience of the staff and vulnerability of the trial population are also key factors to consider when developing a training plan. Training requirements should be considered early in the development of a protocol. Then once all the trial operating procedures have been developed further task-specific training requirements are likely to become evident.
There will be a comprehensive range of e-learning short courses available here for free. To begin with we offer the courses that can be found on this page. This is just a start. The intention is that in time most courses can be found here as either a slide set or an e-learning module (for trial activities that are generic enough for a standard course). At this early stage of developing this platform we have a small selection of the large list we have planned. We will also link our e-learning courses to the CPD scheme and so points can be gained and certificates issued.
The aim is that researchers take these resources, adapt them for their specific needs and then once they have shown they have worked by using them on their trial, they resubmit them here for another group to adapt again. In time this will result in a range of disease or task related resources that are specific and practical for researchers working on trials in many varied settings.
Please do suggest further topics and we also encourage people to contribute as course authors and tutors. The best way to learn is to teach and contributing to e-learning teaching is a credible teaching experience that reflects very strongly on CV’s. Each contribution will be recognised by authorship and will be awarded CPD points.
Free On-line Courses
Below is some initial courses to give some examples for this pilot website. They can be played on audio or video as audio might be better if you have a slow connection speed. These are MP3 (audio) and MP4 (video) files and for this you will need a media player (the lastest windows have these already installed). If the links do not work you could try installing quicktime. This is an 'apple' product that runs on PC's and Macs and is free.
www.apple.com/quicktime/download/
An Introduction to Clinical Trials
George Warimwe from the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya presents an introduction to clinical trials aimed at trial site staff and anyone new to the field. Topics covered include: equipoise and hypothesis, protocol, trial design, comparative effectiveness, pharmacovigilance, ICH-GCP basics, informed consent, essential documents, databases and statistics.
Audio Version
Video Version (requires high-speed internet)
The Story of ICH-GCP: An introduction for investigators and site staff
Dr Roma Chilengi, Head of Clinical Trials at the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya gives an introduction to ICH-GCP. This overview covers the historical background, context and evolution to ICH-GCP, summarises its key principles and describes the role of regulatory authorities. The talk highlights some of the accomplishments of ICH-GCP but also critiques some aspects of GCP application in non-pharmaceutical settings.
Audio Version
Video Version (requires high-speed internet)
Introduction to Research Ethics
Dr Roma Chilengi, Head of Clinical Trials at the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya gives an introduction to research ethics. This overview covers the historical origins and landmark events that have influenced current understanding of research ethics. Some of the major ethical codes and fundamental ethical principles are identified and their application in research is discussed. Finally, there is an overview of the role of ethics committees.
Audio Version
Video Version (requires high-speed internet)
Clinical Trial Protocol Development
Dr Phaik Yeong Cheah, Head of Clinical Trials at the Mahidol-Oxford Research Unit in Bangkok, Thailand discusses clinical trial protocol development. This lecture is an introduction to the topic and gives an overview from initial concept through to GCP requirements, ethical considerations, study drugs and procedures and safety reporting.
Audio Version
Video Version (requires high-speed internet)
Data Safety Monitoring Boards: Their Place and Role in Trials
Dr Roma Chilengi, Head of Clinical Trials at the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya discusses clinical trial data safety monitoring boards (DSMBs). This introduction starts with a definition of a DSMB and discusses their roles and when they are required. DSMS constitutions, charters and considerations for under developed settings are also discussed.
Audio Version
Video Version (requires high-speed internet)
The Role of Laboratory in Clinical Trials
Ken Awuondo, Clinical Trials Laboratory Manager for the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya gives an overview of the role of the laboratory in clinical trials. In clinical trials, laboratory tests are used to establish inclusion and exclusion criteria, determine baseline parameters, monitor the safety of the participants and demonstrate the efficacy of the investigational product. The talk wraps up by discussing some of the challenges facing labs in clinical trials.
Audio Version
Video Version (requires high-speed internet)
Setting Up a Laboratory for Clinical Trials in Resource-Poor Settings
Ken Awuondo, Clinical Trials Laboratory Manager for the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya gives an overview of the requirements for setting up a laboratory in resource-poor settings. From logistics planning to infrastructure development to setting up quality systems, this lecture gives a concise overview of the challenges facing laboratories based in resource-poor settings and provides some constructive advice.
Audio Version
Video Version (requires high-speed internet)
Measurement of Drug Levels in Clinical Trials
Dr Simon Ndirangu, Bioanalytical Laboratory at the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya describes the basic concepts of pharmacological clinical trials, pharmacokinetics and pharmacodynamics. The talk goes on to discuss the various methods used and costs involved as well and other important factors to consider as well as addressing some of the challenges faced in Measuring Drug Levels in Clinical Trials.
Audio Version
Video Version (requires high-speed internet)
Occupational Health and Safety in a Research Setting
Dr Simon Ndirangu, Bioanalytical Laboratory at the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya discusses the importance of implementing occupational health and safety standards in research settings. Effective occupational health and safety programmes reduce work related injuries and illnesses, improve morale and productivity and reduce workers' compensation costs. The success of these programmes relies on committed management, adequate risk assessment, hazard prevention and control and appropriate health and safety training.
Audio Version
Video Version (requires high-speed internet)