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This module will introduce students to more specialist clinical trial designs, and discuss the circumstances in which these may be used. This will include understanding the output of the statistical program Stata to interpret the methods discussed on output from clinical trial data. You will also learn some advanced statistical methods to address more complex research questions and datasets, including how to handle missing data and adjusting for confounding. You will learn how to conduct a systematic review and meta-analysis, and how to critically appraise published reviews. We will evaluate measurement tools for patient reported outcomes and discuss how to analyse such data. You will also learn how health economics relate to clinical trial design and planning.

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

1. Define and describe different specialist types of clinical trial design and their application.

2. Appreciate more advanced statistical considerations when interpreting the results from clinical trials.

3. Critique the findings from published systematic reviews and meta-analyses.

4. Formulate a plan to conduct a systematic review and meta-analysis.

5. Identify and evaluate different questionnaires/measurement tools for assessing patient reported outcomes

6. Appraise the relationships between the outcomes of a clinical trial and the costs associated with the intervention

This module is compulsory for students on the MSc Clinical Trials and MSc Statistics for Clinical Trials, plus the Postgraduate Diploma’s in each stream. The module is open to students registered for the Postgraduate Certificate in Clinical Trials, and to students from other courses on request.

Centre for Reviews and Dissemination, 2009. CRD’s guidance for undertaking reviews in healthcare, 3. ed. ed, Systematic reviews. York Publ. Services, York.

Parmar, M.K.B., Barthel, F.M.-S., Sydes, M., Langley, R., Kaplan, R., Eisenhauer, E., Brady, M., James, N., Bookman, M.A., Swart, A.-M., Qian, W., Royston, P., 2008. Speeding up the Evaluation of New Agents in Cancer. JNCI Journal of the National Cancer Institute 100, 1204–1214. h

Petrou, S., Gray, A., 2011. Economic evaluation alongside randomised controlled trials: design, conduct, analysis, and reporting. BMJ 342, d1548–d1548.

Sydes, M.R., Parmar, M.K., James, N.D., Clarke, N.W., Dearnaley, D.P., Mason, M.D., Morgan, R.C., Sanders, K., Royston, P., 2009. Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial. Trials 10, 39.