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This module will explain in detail the steps taken to turn an initial trial idea to an active trial recruiting patients. You will learn the importance of choosing an appropriate research question, and how a clinical trial protocol is developed to address trial objectives. We will discuss the stakeholders involved in all stages of a trial, and the role of project management in ensuring effective and efficient trial set-up and conduct, including identifying potential risks and constraints. You will learn how funding for trials is obtained and about the process of making a grant application. Practical aspects of setting up a trial will be covered, including ethical and regulatory approval, pharmacy involvement, and site selection. Finally, how data is collected and databases are designed, as well as formulating data management plans will be explained in detail.

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

1. Explain the steps that must be completed to set up a clinical trial both centrally and at research sites (including the selection of sites)
2. Perform a literature search and use the evidence collated to justify a research question and write a protocol background guided by the SPIRIT guidelines
3. Assess the risks associated with a given clinical trial and propose plans to mitigate those risks.
4. Illustrate the relationships involved in clinical trials; describe the importance of collaboration and good communication in successful trial conduct.
5. Compose Case Report Forms (CRFs) to collect the appropriate data to ensure the outcome measures of different trials can be measured.

Great Britain. Medicines and Healthcare products Regulatory Agency (2012) Good clinical practice guide. [Norwich]: Stationery Office.

Friedman, L. M. et al. (2015) Fundamentals of clinical trials. Fifth edition. Berlin: Springer.

Pocock, S. J. (1983) Clinical trials: a practical approach. Chichester: Wiley.