Summary
New Royal Decree on clinical trials: main implications for emergency medicine physicians who do research
García Arenillas M, Haj-Ali Saflo O, Sáenz de Tejada M
Affiliation of the authors
Servicio de Farmacología Clínica, Hospital Clínico San Carlos, Madrid, Spain. Instituto de Investigación Sanitaria San Carlos (IdISSC), Madrid, Spain. Facultad de Medicina, Universidad Complutense de Madrid, Spain. Servicio de Farmacia, Hospital Clínico San Carlos, Madrid, Spain.
DOI
Quote
García Arenillas M, Haj-Ali Saflo O, Sáenz de Tejada M. New Royal Decree on clinical trials: main implications for emergency medicine physicians who do research. Emergencias. 2017;29:194-201
Summary
The new European Union directives affecting clinical trials of medicines introduced important changes for Spain, leading to the publication of a Royal Decree regulating the conduct of clinical trials that went into effect in January 2016. The decree sets out the principles for complying with the EU directives, regulates the work of institutional review boards (IRBs) or ethics committees that review research proposals, introduces means to facilitate clinical research, and clarifies the role of the Spanish register of clinical trials, among other topics. This paper discusses the main changes that have been introduced, especially those intended to facilitate research, such as the new concepts of low intervention trial and noncommercial clinical research. These concepts may be particularly useful for clinical trials designed by emergency medicine physicians. We also comment on changes affecting vulnerable populations and the documents that must be
presented to both the researchers’ IRB and the Spanish Agency for Medicines and Health Care Products.