Table 2

Criteria for assessing whether to include regulatory data of a drug or biologic in a Cochrane review (not in order of priority)

CriteriaDescription of criteria
1Monetary 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)
2Burden of disease of the indication this product is meant to treat/prevent
3Number of people using or likely to use the product
4Product new to the market
5Product from a new drug class or has a new mechanism of action
6Has important interactions with other drugs (eg, drug-drug interactions)
7High proportion of randomised controlled trials evaluating this product are industry funded
8Prominent claims of safety and/or efficacy advantage of this product over currently available treatments
9High degree of media attention surrounding this product
10High proportion of trials of this product are unpublished
11Postmarketing surveillance has identified safety concerns
12Important or standard outcome measures (also known as ’end points') have not been published
13Concerns regarding a lack of published data on potential harms of the product
14Marketing authorisation based on surrogate outcomes (rather than clinical outcomes)
15When protocol(s) are publicly available
16When statistical analysis plan(s) publicly available
17Known errors or concerns about trial publications of this product
18Important discrepancies between the journal publication and the trial registry entry