Clinical Trial results reporting mandatory in EU from July 21

From July 21 2014, clinical trial Sponsors must post results from their trials in the European Clinical trials Database (EudraCT) managed by the European Medicines Agency (EMA) for any interventional trials registered in EudraCT and for clinical trials that have ended within a certain period of time. Voluntary reporting had been encouraged from October last year, but in December, a committee of representatives from every EU member state government agreed on the proposal for mandatory posting of clinical trial results.

The mandatory reporting includes clinical trials conducted outside the EU where the product has been used in the paediatric population and the trial is sponsored by the marketing-authorisation holder of a medicinal product covered by an EU marketing authorisation.

Sponsors will have to post results within six or twelve months following the end of the trial for interventional clinical trials that ended on or after 21 July 2014, depending on the type of trial concerned. For trials that ended before that date, sponsors will need to submit the results retrospectively, in accordance with the specific timeframe laid out in the European Commission Guideline and publication of result-related information on clinical trials.

Guidance on the content and level of detail of the clinical trial summary results is provided in the European Commission guideline and in its technical guidance. Links to guidance on the content of protocol-related and results-related information are provided in the EMA announcement of the mandatory reporting on June 19 2014.

Reporting clinical trial results was one of the changes included in the new rules for clinical trials conducted in the EU adopted on 14 April 2014 ( Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use). The new legislation will take the legal form of a Regulation. This will ensure that the rules for conducting clinical trials are identical throughout the EU which will make it easier to conduct clinical trials in more than one Member State in the EU. It includes rules for clinical trials which are conducted outside the EU but referred to in a clinical trial application within the EU. For these trials, the rules require compliance with regulatory requirements at least equivalent to those in the EU, including rules on transparency.

July 21 marks the date for the launch of additional changes to the EudraCT, to enable the posting of results by sponsors on a compulsory and systematic basis. The Clinical Trials Regulation is expected to enter into force six months following the full functionality and single online EU Portal (hereafter “EU Portal”) created under the new Regulation. However, the Regulation states that, in any event, it will enter into force no later than two years following its publication in the Official Journal of the European Union.

Original article is available on the EMA website here.

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