Primary school and its “real life” data, objective of the EMA

Hermenegildo Marcos Carreras, WTO delegate in the UEMO.

The primary care physicians of the European Union and the drug regulatory body of the old continent, the European Medicines Agency (EMA)they want to involve the Family doctors in the earliest stages of drug development. A plan whose main objective is to use the enormous real life database that brings together the network of doctors at the first level of care.

Currently, the clinical trials that carry out the drugs that want to obtain the approval of the EMA comply with strict conditions of safety and proven efficacy, however, the population samples are far from real life patients.

“Sometimes are made in conditions different from real life, excluding children or pregnant women or people with multiple pathologies in the trials. In real life this is not the case and family doctors have a huge amount of database, it is about taking advantage of it”, highlights Hermenegildo Marcos Carreras, delegate of the Collegiate Medical Organization (OMC) in the European Union of General Practitioners ( UEMO), one of the three organizations that, together with the European Forum for Primary Care (EFPC) and the World Organization of Family Physicians, WONCA-Europe, meets annually with the EMA.

Why should Familia collaborate in drug development?

The specialist recalls that all trials are given under laboratory conditions and then extended to a controlled population. “Its extension to the real world is something that the EMA lacks”denounces Marcos Carreras, who believes that family doctors are the ones in the “real world”.

“We are the top drug distributors and those of us who are in contact with people. A medicine that is treated in the hospital is only made from one point of view. For example, the neurologist only looks at the nervous system and the cardiologist only at the heart. However, we treat patients with multiple pathologies and, therefore, with multiple medications. We are a very important alert and secondary effects system. It is essential that we collaborate with the EMA”, claims the specialist.

For Marcos Carreras, the Family database is “wasted” and it is “essential” to use it. “A single family doctor can have 20 or 30 diabetics, but if you take a network there are millions. There are side effects that are rare and only occur in a large volume of patients, that is where our function lies because clinical trials are carried out with 2,000 or 3,000 people”, argues the WTO delegate in the UEMO.

How could the Primary Care database be used?

According to what has been advanced in the annual meetings between the representatives of the Family and the EMA, to carry out this it would be necessary to common computer system that would go through the implementation of a health card valid for the entire EU and where the patient’s history is reflected. In this sense, Marcos Carreras considers that it is vital to develop an operating system where there is interchangeable data: “Computer science must be developed, but the desire for collaboration is there”, details the specialist.

A desire that, as you have been able to know Medical Writing through EMA sources, was expressed in the recent annual meeting between Family representatives and the regulatory body. Specifically, it was agreed to “explore greater collaboration with research networks in Primary Care, with a focus on generating real-world evidence”.

Although it may contain statements, data or notes from health institutions or professionals, the information contained in Medical Writing is edited and prepared by journalists. We recommend the reader that any questions related to health be consulted with a health professional.

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