9 episodios

The goal of the Global Health Clinical Trials Programme is to promote and make easier the conduct of non-commercial clinical research across all diseases in resource-poor settings. We present a series of short lectures to provide an introduction to clinical trials and explore some of the challenges facing clinical trialists in resource-limited settings.

Clinical Trials in Resource-Limited Settings Oxford University

    • Cursos

The goal of the Global Health Clinical Trials Programme is to promote and make easier the conduct of non-commercial clinical research across all diseases in resource-poor settings. We present a series of short lectures to provide an introduction to clinical trials and explore some of the challenges facing clinical trialists in resource-limited settings.

    • video
    An Introduction to Clinical Trials

    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.

    • 28 min
    • video
    The Story of ICH-GCP: An introduction for investigators and site staff

    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.

    • 24 min
    • video
    Introduction to Research Ethics

    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.

    • 25 min
    • video
    Clinical Trial Protocol Development

    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.

    • 34 min
    • video
    Data Safety Monitoring Boards: Their Place and Role in Trials

    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.

    • 22 min
    • video
    The Role of Laboratory in Clinical Trials

    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.

    • 14 min

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