Input analysis for two public consultations on the EU Clinical Trials Regulation.

BACKGROUND: The European Union's (EU) Clinical Trials Directive was replaced by an EU-Regulation as of 2016. The policy revision process was subject to a formal impact assessment exercised by the European Commission (EC) from 2008 to 2014. Following the EU principles of Good Governance, deliberation with stakeholders was an integral part of this impact assessment and the policy formulation process. Hence, two public consultations (PCs) were held by the EC in 2009 and 2011, respectively. Various stakeholders contributed and submitted their written input to the EC. Though often cited in the further revision process, the input gathered in the PC was not communicated with full transparency and it is unclear how and to what extent the input has been processed and used in the policy formulation. The objective of this study was an analysis of submissions to both PCs in order to systematically present what topics have been discussed and which possible policy options have been raised by the stakeholders.

METHODS: All written submissions publicly available were downloaded from the EC's homepage and assessed for stakeholder characteristics. Thematic text analysis was applied to assess the full text of a random sample of 33% of these submissions.

RESULTS: A total of 198 different stakeholders from the EU and the United States of America contributed to one or both of the two PCs. In total, 44 various themes have been addressed that could be clustered under 24 main themes, including the articulation of problems as well as possible policy solutions to face these problems.

CONCLUSION: The two PCs on the Clinical Trials Directive were highly appreciated by the various stakeholders and their input allowed an in-depth view on their particular interests. This input provided a rich source of information for all stakeholders in the field of clinical trials as well as to the EC's impact assessment. Although the EC obviously gathered a large quantity of expert knowledge on practical implications of trials legislation by consulting stakeholders, it remained unclear how this input was used in the development of the new regulation. For the sake of transparency, it is recommended that in future PCs the EC uses better standardized methods for a more transparent analysis and presentation of results.