This module will introduce some alternative trial and study designs, and circumstances in which these may be used. You will also learn some advanced statistical methods to address more complex research questions  and data sets, including how to handle missing data, subgroup analysis and adjusting for confounding, using the statistical program Stata to apply the methods discussed to example trial data. 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. Finally you will learn how to conduct a systematic review and meta-analysis and how to critically appraise published reviews.   



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

Define and describe different types of clinical trial design and their application.
 Understand more advanced statistical considerations when interpreting the results from clinical trials .
 Identify and evaluate different questionnaires/measurement tools for assessing patient reported outcomes
 Appraise the relationships between the outcomes of a clinical trial and the costs associated with the intervention
 Formulate a plan to conduct a systematic review and meta-analysis.
 Critique the findings from published systematic reviews and meta-analyses.
This module is compulsory for students on the MSc Clinical Trials and the Postgraduate Diploma in Clinical Trials. The module is open to students registered for the Postgraduate Certificate in Clinical Trials, and to students from other courses on request.

You will learn how to read research papers critically and evaluate their strengths and weaknesses, as well as how to use the Stata program to carry out appropriate statistical analysis for clinical trials.

Mahesh K. B. Parmar (2008) Speeding up the Evaluation of New Agents in Cancer, JNCI Journal of the National Cancer Institute. Oxford University Press, 100(17).

Matthew R Sydes (2009) Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial, Trials. BioMed Central, 10.