This new European Clinical Trial Regulation redefines and tightens the basic regulatory framework covering clinical trials performed anywhere within the European Union (EU). This requirement had originally been planned to take effect in 2018, but the creation of the database and upload portal was delayed, and so it is likely that it will not be implemented before 2020.
The aim of the new regulation is to create an environment favourable to conducting clinical trials within the EU, with the highest standards of safety for participants. It also establishes new rules of conduct for clinical trials, consistent throughout the EU and transforms the level of information publicly available for each clinical trial by requiring transparency on the authorisation, conduct, and results of the trial.
Specific provisions of the new regulation with significant impact on the clinical documentation obligations are as follows:
- To increase transparency, clinical trial data may in future only be submitted in support of a clinical trial application if that clinical trial has been recorded in a publicly accessible and free of charge database which is a primary or partner registry of, or a data provider to, the international clinical trials registry platform of the World Health Organization (WHO ICTRP). Relevant data will be expected to be submitted via EMA’s European Portal to the European Database.
- Sponsors will be required to submit a summary of the clinical trial results to the publicly available European Database, and to provide an accompanying summary that is understandable to a layperson. Delay is only permissible if it is not possible to submit the summary of the results within the defined timelines for scientific reasons, for example when the clinical trial is still ongoing in third countries, and data from that part of the trial are not available – making a statistical analysis not relevant. In this case, the sponsor must justify the delay in the trial protocol and specify when the results are going to be submitted.
- The public will be able to access extensive details of all clinical trials, including the major characteristics of the trial, the start and end of recruitment, end date of the trial, and substantial modifications to the trial. These details will be made public as they occur, starting with the decision on the trial. A summary of results and lay summary will be published 12 months after the end of the trial. For trials included in a marketing authorisation application in the EU, clinical study reports will also be published 30 days after the procedure for granting the marketing authorisation has been completed or the application has been withdrawn.