News introduced by the new Real Legislative Decree 1090/2015 of clinical trials with medicines in Spain

Abstract

Introduction: The participation of Spain in clinical trials is a reliable proof of its development in I+D in the health sector and of trying to follow at the vanguard of medical research.

The new Regulation of the European Parliament and of the Council on Clinical Trials on medicines for human use (EU Regulation 536/2014, 16^th April) derogates the legislation currently in force (Directive 2001/20/EC, 4^th April) and it obliges to modify the Spanish Royal Decree (RD 223/2004, 16^th February) to develop those aspects that are left in the hands of national legislation.

Objetives: To analyze the main changes introduced by the new RD in clinical research (RD 1090/2015, 4^th December), which regulates clinical trials with medicines, the Committees on Ethics of Research with Medicines (CERm) and the Spanish Registry of Clinical Trials and to compare them with the previous legislation.

Material and methods: RD 1090/2015, 4^th December was analyzed against RD 223/2004, 16^th February, and the most important differences between the two regulations were compared.

Results: The new regulatory development introduces important innovations. It opens the option for the unification of the analysis of the applications, so that, together with the authorization of the clinical trial issued by the SAMHP, it is only necessary that an accredited CERm emits its positive opinion that it will be binding. It regulates new definitions, such as the low-level clinical trial, subject to less stringent standards. It differentiates between Research Ethics Committee (REC) and CERm, establishing additional requirements to move from being REC to CERm. It defines non-commercial clinical research (in which the sponsor is a university, hospital, public scientific organization, non-profit organization, patient organization or individual researcher without involvement of the pharmaceutical industry). It opens the option to contract a clinical trial prior to its authorization. It defines compensation for damages and how the evaluation of clinical trials is conducted. It incorporates the figure of the legally designated representative for incapable and minor subjects. It stipulates the conditions in situations of urgency, pregnant and periods of lactation as well as informed consent. The main novelty is the single dossier of the two-part clinical trial, one for European Union (Part I) and another one for National Documentation (Part II). All data must be sent to a database and a European public access web portal.

Conclusions: The new regulation proposes to give an important impulse to the clinical research in Spain with medicines, simplifying the administrative obstacles and speeding up the realization of multicentric studies simultaneously in all Europe. It improves the delimitation of the responsibilities of the agents involved, it increases the safety of the test subjects, and at the same time, it increases the efficiency in the evaluation and communication processes involved.