The Spanish Agency for Medicines and Health Products (AEMPS) has communicated that Royal Decree 957/2020, of November 3, which regulates observational studies with drugs for human use, in force since January 2, provides for the Publication in the Spanish Registry of clinical studies (REec) of the information on observational studies with drugs (EOm) carried out in Spain.
This regulation establishes that “it is the responsibility of the promoter of the observational study with drugs to carry out the publication of the study in REec”, as well as that “the publication of information in the REec is mandatory for observational studies with prospective and voluntary follow-up drugs for the rest of these studies ”.
In turn, this text states that, “at the beginning of the study, information must be published, at least on the title, the promoter, the drugs under study, the main objective and the sources of funding. This information will be updated in the event of substantial modifications throughout the study ”.
“Once the study is completed, the promoter will provide information on the results obtained, both positive and negative, either through a summary of the results or through a bibliographic reference of the scientific publication that contains them,” argues Royal Decree 957/2020.
With the GESTO telematics platform
To date, only the inclusion in the REec of information from clinical trials with drugs was enabled; From now on, it is possible to record information on the EOm, through the telematics platform GESTO (Management of Observational Studies with medicines), launched by the AEMPS. This telematics platform is available from this Wednesday, April 14.
Also, this Agency remarks that “registration is voluntary for EOs that are not prospective follow-up, their inclusion in the REec will allow researchers to identify synergies in their research lines and promote future collaborations between research teams.”
Royal Decree 957/2020 provides that the AEMPS publishes instructions in which the procedures, deadlines and the format of the data that the REec will include are indicated. These instructions are available on the website of this Agency in Observational Studies with Medicines for Human Use, under the heading New regulations in force as of January 2.