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In this module you will learn about the principles of clinical trials, the fundamentals of trial design and how to choose a research question and outcome measure. You will also learn how to determine the number of patients required for a trial and the various approaches to allocating patients to treatments. You will be given an introduction to some statistical principles required for the design and analysis of trials, and an overview of the Statistical Analysis Plan which must be specified in the protocol at the design stage of any trial. We will discuss how trials are reported in order to meet CONSORT guidance and journal requirements. Finally you will learn how to critically appraise published clinical trials and how to interpret and evaluate systematic reviews.

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

1. Choose the appropriate trial design and intervention in a range of disease settings.

2. Explain the phases of clinical trials, from early to late phase trials and make judgements as to the appropriate populations and outcome measures with each phase.

3. Define and explain the principles of randomisation, blinding and bias in the context of randomized controlled trials.

4. Propose methods to carry out randomisation and blinding, and to prevent bias.

5. Calculate sample sizes for a given set of clinical trial assumptions and evaluate the impact of changes in those assumptions on trial size and duration.

6. Construct a short Statistical Analysis Plan to include in a clinical trial protocol.

7. Investigate a data set using a range of descriptive statistics.

8. Identify analysis methods used, and interpret the results of, analyses for continuous, binary, and time to event data.

This module is compulsory for students on the MSc Clinical Trials and the Postgraduate Diploma in Clinical Trials. This module is also compulsory for students on the MSc Statistics for Clinical Trials and Postgraduate Diploma in Statistics for Clinical Trials.

This course is open to MSc Biotech and Pharmaceutical Management students on request.

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

Greenhalgh, T. (2014) How to read a paper: the basics of evidence-based medicine. 5th ed. Chichester: Wiley.

Altman, D. G. (2010) Practical statistics for medical research. 2nd ed. London: Chapman & Hall.