New Spanish Clinical Trials Register

20 May 2013

Amparo Campos

The 20th of May 2013, on the occasion of the International Clinical Trials' Day, the Spanish Ministry of Health, Social Services and Equality presented a Draft Royal Decree regulating clinical trials, the ethics committees for drug research and the registry of clinical studies, available at: http://www.msssi.gob.es/normativa/docs/Rdensayosclinicosm.pdf

The Draft Royal Decree aims at (i) harmonizing the legal regime of clinical trials carried out in Spain with the latest changes and interpretations arisen at a community level; (ii) improving the approval procedure for clinical trials; and (iii) establishing a framework facilitating the exchange of information among the agents and authorities involved in clinical trials.

The provision sets the basis of a new Spanish Clinical Trials Register, created with the purpose of promoting transparency of clinical drug studies and easing the availability of complete and accurate information about them. Following to the approval of the Draft Royal Decree, the Spanish Agency of Medicines and Health Products will immediately publish at the Register all clinical trials performed with human medicaments that it has authorized (except Phase 1 clinical trials that do not include paediatric population). At a later stage, the Agency will also publish Observational Studies carried out in Spain. Besides, the Agency intends to open the Register for other studies that might be voluntarily recorded. In all cases, sponsors will be obliged to publish the results obtained in the recorded investigations, once these are concluded.

The new Register will be made available to the public at the Spanish Agency of Medicines and Health Products 's website and, apart from the descriptive data required by other international registries, it will reveal, among other information, a brief justification of the study, its stage of activity, the participating centres, the baseline dates of the trial and the dates indicating the end of recruitment and trial completion.

General information about the Spanish Clinical Trials Register can also be found at: http://www.aemps.gob.es/informa/notasInformativas/laAEMPS/2013/NI-MUH_07-2013-reec.htm