New clinical trials regulation in Spain: analysis of royal decree 1090/2015

• M. Martin Jimenez ^[1] ; A. Calvo Ferrandiz ^[1] ; J. Aparicio Urtasun ^[8] ; R. Garcia-Campelo ^[2] ; E. Gonzalez-Flores ^[3] ; M. Lazaro Quintela ^[4] ; M. Muñoz Mateu ^[11] ; C. A. Rodriguez Sanchez ^[9] ; A. Santaballa Bertran ^[8] ; J. M. Sepulveda Sanchez ^[5] ; R. Vera Garcia ^[6] ; J. A. Virizuela Echaburu ^[7] ; M. A. Segui Palmer ^[10]
  1. [1] Hospital General Universitario Gregorio Marañón

     Hospital General Universitario Gregorio Marañón

     Madrid, España

     
  2. [2] Complexo Hospitalario Universitario da Coruña

     Complexo Hospitalario Universitario da Coruña

     A Coruña, España

     
  3. [3] Hospital Universitario Virgen de las Nieves

     Hospital Universitario Virgen de las Nieves

     Granada, España

     
  4. [4] Complexo Hospitalario Universitario de Vigo

     Complexo Hospitalario Universitario de Vigo

     Vigo, España

     
  5. [5] Hospital Universitario 12 de Octubre

     Hospital Universitario 12 de Octubre

     Madrid, España

     
  6. [6] Gobierno de Navarra

     Gobierno de Navarra

     Pamplona, España

     
  7. [7] Hospital Universitario Virgen Macarena

     Hospital Universitario Virgen Macarena

     Sevilla, España

     
  8. [8] Hospital Universitari I Politècnic la Fe, España
  9. [9] Hospital Clínico Universitario, Salamanca, España
  10. [10] Hospital de Sabadell-Consorcio Sanitario Parc Taulì, España
  11. [11] Hospital Clinic i Provincial, Barcelona, España

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• Localización: Clinical & translational oncology, ISSN 1699-048X, Vol. 19, Nº. 3 (March 2017), 2017, págs. 291-300
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • 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 Thus, Regulation 536/2014, that repealed Directive 2001/20/EC, with the aim of decreasing the growing bureaucratization and stimulating clinical research in Europe, established simplified procedures,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.