Results
The cohort had altogether 87 guidelines for analysis. Table 3 indicates how the guidelines were distributed across the years and their classification, and the volume of submitted comments. The distribution was relatively even across the years, with a range of 14 guidelines per year as the lowest total and 20 at the highest.
The total volume of comments increased steadily. For the period as a whole (2013-2017), industry provided 36% of all comments, just slightly below the share submitted by trade bodies (38%). As a share of all comments, 2014 was exceptional, with individual companies providing nearly two-thirds of all comments. In that year (2014), the majority of guidelines under review were more general in nature and impacted both pharmaceutical and device manufacturers, which may have increased the volume of industry comments (see Table 3 ).
The second most active group included academics and NGOs (civil society). In the analysis, they were grouped together because across the years, patient associations and NGOs submitted altogether 10 submissions, which as a separate stakeholder would not have given a meaningful statistical result. The governmental stakeholders, including regulators from the EU, outside of the EU as well as HTA bodies, submitted approximately 8% of the comments. Although a relatively smaller share amongst commenting organizations, the number of governmental stakeholders submitting comments is growing, almost tripling over the years from 5 to 14.
Table 3. Overview of the included guidelines and comments from stakeholders