Table 1 Important criteria when considering data from clinical study reports and/or other regulatory data
Criteria | Description of criteria |
|---|---|
1 | Monetary cost of the intervention on the healthcare budget (i.e. considering both the price of a course and the number of people in the population that are being—or will be—treated) |
2 | Burden of disease of the indication this product is meant to treat/prevent |
3 | How many people are using or likely to use this product? |
4 | Product new to the market? |
5 | Product from a new drug class or has a new mechanism of action |
6 | Has important interactions with other drugs (e.g. drug-drug interactions) |
7 | High proportion of RCTs evaluating this product are industry funded |
8 | Prominent claims of safety and/or efficacy advantage of this product over currently available treatments |
9 | High degree of media attention surrounding this product |
10 | High proportion of trials of this product are unpublished |
11 | Post-marketing surveillance has identified safety concerns? |
12 | Important or standard outcome measures (also known as ‘endpoints’) have not been published |
13 | Concerns regarding a lack of published data on potential harms of the product |
14 | Marketing authorisation based on surrogate outcomes (rather than clinical outcomes) |
15 | When protocol(s) are publicly available |
16 | When statistical analysis plan(s) publicly available |
17 | Known errors or concerns about trial publications of this product |
18 | Important discrepancies between the journal publication and the trial registry entry? |