Checklist for the Design and Protocols to Collect Economic Data Alongside Clinical Trials in Australia

There is growing interest in Australia and overseas in the incorporation of economic evaluations alongside randomised clinical trials of new versus existing pharmaceutical products. The most common use of data resulting from such trials will be for the purpose of industry gaining listing under the Pharmaceutical Benefits Scheme (PBS) for specific drugs. Other uses of data include: applications for hospital formulary listing; post-marketing support for price justification; and publication of study findings in academic journals. When designing a clinical trial with an economic component a number of considerations need to be taken into account. These include: from whose perspective are the costs and outcomes to be measured (eg. societal, governmental, personal); which costs are to be included (eg. treatment, complications, retreatment, disease sequelae, indirect costs); the choice of outcome measures (short, intermediate or long-term outcomes); the appropriate duration of the trial necessary to measure the important costs and key outcomes. Decisions about each of the above can have a significant influence on study design. A multi-disciplinary approach is required to ensure appropriate study design. Direct input from clinician investigators, clinical research associates, economists, marketing personnel and statisticians is important at the early stages of protocol development. This is necessary to ensure an appropriate trial design, and to minimise the potential for key data not being collected alongside the trial.