This module will cover health economic evaluation in clinical trials.

An introductory session concerning the very basics of health economics in clinical trials will be offered as part of a preceding compulsory module, and this optional module will expand on certain topics, covering them in greater detail.

These topics will include: health-related quality of life patient-reported outcome measures, resource use information and application of unit costs, data collection, trial protocol, health economic analysis techniques (calculation of quality-adjusted life years (QALYs) from clinical trials data, cost-benefit, cost-effectiveness, and cost-utility analysis among others) including sensitivity analysis and exploring uncertainty, and presentation and interpretation of results, as well as their use in policy-making. Health economic methods and their interpretation will be compared to standard hypothesis-test-based statistical techniques.

We will also discuss operational aspects of designing and running a clinical trial in a way that facilitates the conduct of a high-quality health economic analysis, and ways to enhance collaboration between the statistician, health economist, and the rest of the trial team. You will have the opportunity to put your learning into practice using examples from ICTM clinical trials, preparing you for a career as an applied statistician or as a methodologist in clinical trials.

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

Appraise a health economics analysis based on clinical trial data
2. Identify challenges in data collection for health economic evaluations alongside trials (especially resource use and other cost data) and consider overlaps with data required for the primary statistical analysis that will be performed by the statistician

3. Compare patient-reported outcome measure(s) (PROMs) in terms of their strengths and weaknesses for health economic evaluations alongside trials and understand how their outputs can be valued and used to calculate quality-adjusted life-years for use in cost-utility analysis

4. Evaluate analysis approaches used in trial-based economic evaluations and the relationship of these with trial planning and data collection, and compare these to hypothesis testing approach used in the trial statistical analysis

5. Explain the importance of clarity and consistency of the protocol’s health economic evaluation section with other aspects of the protocol, and justify strong collaboration between statistician and health economist in writing the analysis plans and conducting the analyses 

6. Interpret the results of economic evaluations alongside trials.

7. Assess when health economics and decision analytic modelling is relevant in clinical trials (aims, objectives, interpretation and limitations), and how it complements and differs from the main clinical/statistical analysis

This module is compulsory for students on the Statistics for Clinical Trials route of the MSc Clinical Trials.

Drummond, Michael F., et al. Methods for the economic evaluation of health care programmes. Oxford University Press, 2015.

Glick, Henry A., et al. Economic evaluation in clinical trials. OUP Oxford, 2014.

Petrou, Stavros, and Alastair Gray. "Economic evaluation using decision analytical modelling: design, conduct, analysis, and reporting." Bmj 342 (2011).

Kernick, David P. "Introduction to health economics for the medical practitioner." Postgraduate medical journal 79.929 (2003): 147-150.