Table 2 The final seven criteria selected for inclusion in the survey, their definitions and possible range of values
Metric | Definition |
|---|---|
Unmet need | The trial addresses a problem either without a solution or a very poor solution. This could be a rare disease with no treatment options and poor survival. The 5-year survival rates of particular cancers can range from 85% (Good treatment options and therefore there is little to be learnt from another trial) to 18% (There are poor treatment options and thus research in this area will likely be very beneficial or impactful). |
Size of target population | The burden or prevalence of the target disease the trial seeks to address. A rare disease may only affect 0.2 people / 100,000 while a common disease may affect 1000 people / 100,000. |
Eligible participants can access the trial (access to trials) | Eligible patients have equal opportunity to enrol in a clinical trial regardless of their geographic location and its associated limitations. Possible responses range from 1 to 5. With 1 = Less than 20% of eligible patients have access to a trial due to geographic limitations and 5 = 100% of eligible patients have access to a trial. |
Patient outcomes | The increase in overall survival for patients. From a 3 month increase, to 3 years additional survival. |
Total trial cost | The total cost of running the trial to completion. This ranges between 105 million AUD (expensive) to 3 million AUD (least expensive). |
Academic impact | The number of citations the primary publication of trial results receives in the academic and clinical literature. This could range from 10 to 1000 citations. |
Use of trial results | Whether the results of the trial directly influenced future directions of the research. There are four options: (1) No use of results; (2) informing research decisions such as continuation to another phase, e.g. phase I to II; (3) granting of regulatory approval e.g. FDA or PBS approval; (4) was used to inform policy. The trial results in order of increasing value are, (1) no use of results, (2) informed research decisions, (3) granted regulatory approval, (4) informed policy. |