evidence
design of clinical and economic studies
Clinical trials are traditionally aimed at securing regulatory approval, and concentrate on safety and efficacy. These data continue to be required, but the design of efficacy trials can be made more relevant to payors by the inclusion of usual care in comparisons, the use of final outcome measures as well as intermediate clinical endpoints, and the collection of data on resource use.
Efficacy data from selected populations under research conditions usually give a better picture of a product's cost-effectiveness and clinical effectiveness than in general populations receiving routine service provision, where the emerging picture is likely to show more variation.
The relevant comparator for a product (such as a drug or device) may be a procedure in another class of technology (such as surgery, or lifestyle modification) rather than a direct competitor.
Payors look at all clinical and health-related costs and benefits valued from broad social perspectives, which means drawing in a wider range of factors than has traditionally been incorporated into pre-launch studies.
Our study design service can help you to anticipate what questions payors and clinicians will ask when you enter the market, and what their expectations are. On this basis, we can suggest the most appropriate design.
Translucency critiques existing designs or advises on how best to adapt a trial that is already underway.