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