The REec reaches 10,000 published clinical trials

Publication date: October 23, 2024

Category: medicines for human use
Reference: MUH, 25/2024

• This database includes permanently updated public information on all authorized clinical trials since 2013.
• This milestone explains why Spain is one of the leading countries internationally in the authorization of clinical trials.
• The objective is that both patients and health professionals have a primary, reliable, accessible and free source of information on drug research in Spain.

The database of clinical trials and observational studies with medicines authorized in Spain has reached the figure of 10,000 published clinical trials. He Spanish Registry of Clinical Studies (REec)managed by the Spanish Agency for Medicines and Health Products (AEMPS), meets this milestone that explains why Spain, thanks to the collaboration between health authorities, researchers, patients and the pharmaceutical industry, has become one of the countries international leaders in the authorization of clinical trials.

REec contains permanently updated public information since 2013 whose objective is that both patients and health professionals have a source of primary, reliable, accessible and free information on drug research in Spain. The website allows you to search for clinical trials available in a specific pathology or in a specific location and to contact the promoter and the different centers where the trial is being carried out to obtain direct information and thus encourage participation in these studies.

The AEMPS makes a great effort to develop and keep this registry updated, whose information has been previously evaluated by the Agency’s technicians, giving veracity and confidence to the data presented. In addition, it publishes a summary of the results of each clinical trial for lay people, thus strengthening the institution’s commitment to bringing the general public, and especially patients, closer to the world of research.

When searching for each trial, REec displays the most relevant data through an infographic that makes it easy to know the key aspects at a glance. Among others, it indicates the phase in which the study is, the number and type of participants, their gender and age range, the geographical coverage or whether the trial includes the study of a rare disease or an advanced therapy. Detailed information on the therapeutic area, the disease investigated, the rationale and objective of the trial, or the inclusion and exclusion criteria is provided below. The information is completed with an updated calendar that indicates the current status of the clinical trial, the contact information of the sponsor and the drug research ethics committee (CEIm), the participating centers, the medications it includes and the results.

The publication of the results of all completed clinical trials is one of the most relevant aspects, since it allows any citizen to consult them and, in turn, generates new research projects based on the available information. The legislation requires that, one year after the completion of the trial, a report (whether the results are positive or negative) and a technical summary of results be published, in addition to the summary for lay people already mentioned.

Any clinical trial with medicines must follow an evaluation procedure by the AEMPS and the CEIm, and once the AEMPS authorizes the trial, the Agency is responsible for publishing all the information in the registry. Subsequently, any modification that occurs throughout the trial (inclusion criteria, opening of new centers, notification of important dates…) is also evaluated and published by the AEMPS, in such a way that updated results can be obtained at all times. .

The AEMPS reminds that for any incident or query related to the REec, you can contact the mailbox [email protected].