Approval of the royal decree regulating observational studies with drugs
- Royal Decree 957/2020, of November 3, which regulates observational studies with medicines for human use, has been published, which will enter into force on January 2, 2021.
- The objective of this new regulation is aimed at simplifying administrative procedures by facilitating independent research, obtaining a more efficient evaluation of the quality and suitability of each study and updating the guarantees of transparency and access to the information of these studies.
The Official State Gazette has published the Royal Decree 957 / 2020, of November 3, 2020, which regulates observational studies with medicines for human use. This Royal Decree will enter into force on January 2, 2021 and will replace the regulations currently in force, Order SAS / 3470/2009, and Chapter VI relating to Post-authorization Studies of Royal Decree 577/2013.
Observational studies with drugs are essential to obtain data on their safety and effectiveness in the real context of healthcare, which allows profiling the conditions in which the benefits of drugs outweigh their risks, in addition to providing information to position the place of medicine in therapeutics.
The need to update the regulations on observational studies, different from that of clinical trials, arises from the publication of European and national legislation with an impact on the performance of these studies and from the experience acquired over the past years that it has put in evidence the complexity of the current procedure.
The main objectives of the new regulations are:
- Simplify the administrative procedures required to carry out studies, facilitating in particular independent research.
- Enable a more efficient evaluation and a single decision on the suitability and quality of the protocol, regardless of the subsequent assessment of the feasibility and relevance for its implementation in specific health centers.
- Orient the intervention of the health administrations towards those observational studies that are prospective follow-up, due to their possible impact on the use of the drugs under study in the National Health System.
For all studies that are not prospective follow-up, it will only be required before starting to have the favorable opinion of a single Ethics Committee for Drug Research (CEIm) in Spain and the agreement to carry them out by the center / s. sanitary / s where they will be carried out.
In the case of studies carried out with secondary data sources (such as those carried out with patient records or population-based databases), the conditions established by the person responsible for processing said data must be met.
For prospective follow-up studies, in addition to the above requirements, the autonomous communities may develop their own regulations based on their competencies, except for those that are non-commercial clinical investigations. For this they will have an additional year from the entry into force of this royal decree.
The new regulations indicate the aspects of the study to be evaluated by the CEIm, methodological, ethical and legal evaluation of the research protocols.
Among other aspects that are updated, it is worth highlighting the guarantees of transparency and information of the studies, and specifically the publication of information on the observational studies in the Spanish Registry of Clinical Studies (REec), including information on the results of the studies.
Finally, the new royal decree provides for the publication in the website of the Spanish Agency for Medicines and Health Products (AEMPS) of the instructions for conducting observational studies with drugs, which will be prepared in collaboration with the CEIm and the competent health administrations of the autonomous communities.
