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In this module you will have an in-depth look at trials in different phases and research settings. For example, we will discuss the use of vulnerable populations in trials and ethical issues concerning these groups. Areas covered will include: primary care, mental health, complex environments, cancer, infectious diseases, medical devices, advanced therapies, paediatrics, neuroscience and international trials. We will consider the challenges in study design and conducting trials in such settings, including eligibility criteria, monitoring adverse events in trials and adhering to regulations around medical devices, advanced therapies and surgical trials.

At the end of the module you will be able to:

1. Compare and contrast requirements for clinical trial design and analysis in a range of different healthcare situations and with a range of different interventions.

2. Propose appropriate trial designs for a range of diseases / populations / interventions describing the strengths and weaknesses of different designs.
3. Recognise the complexities faced in carrying out clinical trials in a range of disease/population settings and propose solutions to particular challenges.

4. Propose critical findings from a clinical trial or systematic review and present to your peer group in a clear and succinct manner.

Lundgren, J. D., Babiker, A. G., Gordin, F., Emery, S., Sharma, S., Avihingsanon, A. -. C., . . . Neaton, J. D. (2015). Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. NEJM, 373 (9), 795-807.

Walker, A. S., Mason, A., Quan, T. P., Fawcett, N., Watkinson, P., Llewelyn, M., . . . Peto, T. E. (2017). Mortality risks associated with emergency admissions during weekends and public holidays: electronic health records study. Lancet.