Table 2

Number and percentage of all referrals (n=52) that use each type of evidence for each purpose

Type of evidenceUsage*
Mechanism, (%)PK/PD, (%)Efficacy, (%)Risk—overall, (%)Risk—subgroup, (%)Usage of product, (%)Effectiveness of risk minimisation measures, (%)
Preclinical evidence16 (31)6 (12)2 (4)10 (19)1 (2)0 (0)0 (0)
Non-randomised trials1 (2)10 (19)18 (35)14 (27)2 (4)0 (0)0 (0)
Randomised trials3 (6)9 (17)40 (7736 (69)7 (13)0 (0)1 (2)
Non-interventional3 (6)4 (8)18 (35)31 (60)5 (10)14 (27)0 (0)
Non-interventional using routinely collected data0 (0)1 (2)8 (15)25 (48)4 (8)10 (19)0 (0)
Non-interventional using data collected for research2 (4)4 (8)13 (25)20 (38)3 (6)7 (13)0 (0)
Spontaneous reports2 (4)0 (0)3 (6)37 (71)6 (12)4 (8)0 (0)
Systematic review of randomised trials0 (0)0 (0)19 (37)10 (19)1 (2)0 (0)0 (0)
Systematic review of non-interventional studies0 (0)0 (0)0 (0)4 (8)1 (2)0 (0)0 (0)
Systematic review of randomised trials and non-interventional studies0 (0)1 (2)2 (4)4 (8)0 (0)0 (0)0 (0)
Unclear study design1 (2)8 (15)12 (23)10 (19)0 (0)1 (2)0 (0)
Legend
Percentage of referrals that use evidence type for each purposeColour
<10
10–19
20–29
30–39
40+
  • *Usage was categorised, as detailed in the table, into: mechanism of adverse event with product usage, PK/PD of product, efficacy of product, risk of adverse events with product, risk of adverse events with product in a subpopulation, usage/misuse of a product and effectiveness of regulatory risk minimisation measures.

  • PK/PD, pharmacokinetics/pharmacodynamic.