Following a shake-up by the European Parliament last week, researchers must submit reports of their clinical trials to a publicly accessible database, within strict timelines and regardless of their outcomes.
They must also apply for and receive go-ahead for clinical trials using the online submissions portal, an arrangement intended to streamline the approvals process.
Applicants will need to make just one submission for clinical trial authorisation, and will receive one single decision back from each country involved in the proposed trial, rather than various responses from national authorities and ethics committees. The legislation does not however provide for a single EU-wide judgement.
The EU Portal and Database will be managed by the European Medicines Agency (EMA), in collaboration with EU countries. The law passed on April 2 will become official when it is registered in the Official Journal of the EU, around June this year. It will come into effect in 2016, following a one-year transitional period and dependent on the functioning of the EU portal and database.
Publishing all trial outcomes
The new rules have attracted attention by mandating the publication of clinical trial data, a requirement which will be made possible by the submissions database.
Trials which are ended early will not slip through the cracks, as sponsors will have to register through the portal when a trial ends, temporarily halts or is terminated early within 15 days.
The law also states that “irrespective of the outcome of a clinical trial,” researchers must submit a summary of the results within one year of its end.
This must contain numerous data, including:
- sponsor details,
- trial design,
- objectives of the trial,
- end points,
- the number of subjects and their age, gender and country breakdowns,
- recruitment methods,
- adverse effects,
- substantial modifications and interruptions to the trial, and
- concerns about the efficacy of already authorised medicines brought up during comparator trials.
Trial leaders must also upload a separate summary “written in a manner that is understandable to laypersons.”
In cases where producing a summary within one year is not possible for scientific reasons, trials sponsors must specify when these results will be submitted, and give a justification for their lateness.
For trials which were run to obtain marketing authorisation, sponsors must submit the clinical study report up to 30 days after a decision has been made, whether or not marketing authorisation was given.
All information not considered confidential will be available to the public, as well as to regulators and pharmaceutical companies and the public. The law states “all data held in the EU database shall be in an easily searchable format” and that the database should be “technically advanced and user-friendly so as to avoid unnecessary work.”
The rules set out considerations for the protection of both the personal data of trial subjects and of commercially confidential information, and declare that information in a trial application will not be made public before countries make their decisions , “unless there is an overriding public interest in disclosure.”
All applications, decisions from member states, and exchanges of extra information will take place via the portal.
The legislation, which includes amendments on informed consent, safety reporting and data transparency gives strict timelines for regulators’ decisions.
Each concerned member state must complete its assessment within 52 days of an application. It is allowed to extend this period by up to 31 days if it needs to request extra information about the study.
If member states do not reply within this timeline, applicants are allowed to assume their clinical trial has been approved.
Conversely, applicants must submit any extra requested information within 12 days, or the application will be considered withdrawn.
The concerned country will notify applicants as to whether their clinical trial is authorised, refused, or authorised subject to conditions within five days of its decision.