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Online European clinical trials registry

1 April 2011. Related: Other news.

EU press release

Public online register gives access to information on clinical trials

The EU Clinical Trials Register (www.clinicaltrialsregister.eu) was launched on 23 March 2011 by the European Medicines Agency. The online register gives for the first time public access to information on interventional clinical trials for medicines authorised in the 27 EU Member States and Iceland, Liechtenstein and Norway. The database also allows the public to search for information on clinical trials authorised to be carried out outside the EU if these trials are part of a paediatric investigation plan.

The information contained in the EU Clinical Trials Register is extracted from EudraCT, the EU clinical trials database. It is provided by the sponsor of the clinical trial, and is a component of its application to a national medicines regulatory authority for authorisation to conduct a trial. The information from the sponsor is loaded into the EudraCT database by the national medicines regulatory authority. The authority adds to this information the authorisation of the clinical trial and the opinion from the relevant ethics committee. Information on third country trials that are listed in a Paediatric Investigation Plan (PIP) is provided by the PIP addressee directly, via the EMA, to the system.

Throughout the project the Agency worked together with stakeholders, including patients and healthcare professionals, to ensure that their needs were taken into account, to the extent possible at this stage, when designing the register.

The Agency will continue to work with stakeholders to improve the functioning of the EU Clinical Trials Register, in particular by enhancing the quality and completeness of data, and improving the search functionality. Plans for the future also include the publication of summaries of clinical trial results, on which draft guidance has already been published for consultation by the European Commission. Publication of trial results summaries will require a major upgrade to the existing system, the start of which will depend on finalisation of the guideline and availability of budget and resources.

The details in the clinical trial description include the:

  • design of the trial;
  • sponsor;
  • investigational medicine (trade name or active substance identification);
  • therapeutic areas;
  • status (authorised, ongoing, complete).

Unfortunately the EU Clinical Trials Register website does not:

  • provide information on the results of clinical trials;
  • provide information on non-interventional clinical trials of medicines (observational studies on authorised medicines);
  • for the period May 2004-March 2011 provide information on clinical trials where investigator sites are outside of the European Union and the European Economic Area. (However, information on clinical trials which are part of an agreed paediatric investigation plan (PIP) and were conducted outside the European Union and the European Economic Area will be published retroactively on the website by March 2012.);
  • provide access to the authorisation document from the national medicine regulatory authority or the opinion document from the relevant ethics committee;
  • provide information on clinical trials for surgical procedures, medical devices or psychotherapeutic procedures;
  • manage the process for joining any clinical trial published on the website;
  • provide navigation and web content in languages other than English.

comment

This development by the European Medicines Agency (EMA) on interventional clinical trials on medicines is an important first step in this resource for European patients.

Treatment advocacy is severely restricted when even a basic registry of ongoing studies is not mandatory. Transparency in ongoing research is an issue of public safety.

Source: EU press release. European clinical trials registry now online. (21 March 2011).

Links:

The EU clinical trials register is at:
https://www.clinicaltrialsregister.eu

Information on EudraPharm:
http://eudrapharm.eu/eudrapharm

Information on EudraCT
https://eudract.ema.europa.eu/

Links to other websites are current at date of posting but not maintained.