1 | Monetary cost of the intervention on the healthcare budget (ie, 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 | Number of people using or likely to use the 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 (eg, drug-drug interactions) |
7 | High proportion of randomised controlled trials 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10 | High proportion of trials of this product are unpublished |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 | Postmarketing surveillance has identified safety concerns |
12 | Important or standard outcome measures (also known as ’end points') 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 |