title: New clinical trials regulation in Spain: analysis of royal decree 1090/2015.
abstract: The coming into force of Directive 2001/20/EC represented a step forward in harmonising clinical trial regulation in European countries, guaranteeing a uniform protection of subjects participating in clinical research across Europe. However, it led to a disproportionate increase in the bureaucratization, and thus, it became evident that procedures needed to be simplified without detriment to patient's safety. Thus, Regulation 536/2014, that repealed Directive 2001/20/EC, with the aim of decreasing the growing bureaucratization and stimulating clinical research in Europe, established simplified procedures, such as regulating a common procedure for authorising trials in Europe, the institution of strict assessment timelines, or the definition of new concepts, such as "low-intervention clinical trial". The legal form of a Regulation allowed the norm to be directly applied to Member States without the need for transposition. By means of the new Royal Decree, the national legislation is adapted to make the application of the regulation feasible and it allows the development of the aspects that the Regulation leaves to national legislation. Both documents seek to stimulate clinical research with medicinal products to foster knowledge, facilitate transparency, and reinforce subjects' safety. This will surely be the case, but with this revision, we will look at the novelties and key aspects that are most relevant to investigators and we will analyse the consequences for all parties involved in clinical research.
authors.affiliation: Hospital Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Martin Jimenez
authors.affiliation: Hospital Universitario Gregorio Marañón, Madrid, Spain. aitanacalvo@hotmail.com.
authors.forename: A
authors.identifier: http://orcid.org/0000-0002-7470-8517
authors.initials: A
authors.lastname: Calvo Ferrandiz
authors.affiliation: Hospital Universitari I Politècnic la Fe, Valencia, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Aparicio Urtasun
authors.affiliation: Complexo Hospitalario Universitario A Coruña, La Coruña, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Garcia-Campelo
authors.affiliation: Hospital Universitario Virgen de las Nieves, Granada, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Gonzalez-Flores
authors.affiliation: Complejo Hospitalario Universitario de Vigo, Vigo, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Lazaro Quintela
authors.affiliation: Hospital Clinic I Provincial, Barcelona, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Muñoz Mateu
authors.affiliation: Hospital Clínico Universitario, Salamanca, Spain.
authors.forename: C A
authors.initials: CA
authors.lastname: Rodriguez Sanchez
authors.affiliation: Hospital Universitari I Politècnic la Fe, Valencia, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Santaballa Bertran
authors.affiliation: Hospital 12 de Octubre, Madrid, Spain.
authors.forename: J M
authors.initials: JM
authors.lastname: Sepulveda Sanchez
authors.affiliation: Complejo Hospitalario de Navarra de Pamplona, Pamplona, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Vera Garcia
authors.affiliation: Complejo Hospitalario Regional Virgen Macarena, Seville, Spain.
authors.forename: J A
authors.initials: JA
authors.lastname: Virizuela Echaburu
authors.affiliation: Hospital de Sabadell-Consorcio Sanitario Parc Taulì, Sabadell, Spain.
authors.forename: M A
authors.initials: MA
authors.lastname: Segui Palmer
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006801:Humans; D013030:Spain
keywords: Clinical trials; Low-intervention clinical trials; Non-commercial trials; Regulation 536/2014; Royal Decree 1090/2015; Transparency