The role of patients’ participation in the new therapies generation processes

How the role of patients in the new therapies generation processes is conceived and where and when their contribution is needed? These were the main topics of the conference organized by SIAR (Italian Society on Regulatory Sciences), in collaboration with Fondazione Gianni Benzi and Cittadinanzattiva scheduled in Rome on July 10.

After a contribution in the opening session, Prof. Adriana Ceci moderated the morning roundtable on patients involvement in the different phases of the generation process of a new therapy.

The role of patients’ participation is recognized in the world legislation starting from the aspects related to clinical trials aspects, simply because it has been realized that the subject of the research, the patients indeed, generates a lot of ethical issues.

This is what happened after the Nazi period, when the experiments on human beings, especially the Jews, became more and more savage and cruel. It was from then on that emphasis was placed on safeguarding the subject of clinical trials through the Helsinki Declaration. Since then, there is no country in the world that does not recognize the fact that clinical experimentation is a shared act between patient and researcher, and that this act needs guarantees, provided by the opinion of the ethics committee and the consent expressed in the written form by the patient. Only with these two guarantees the contract between patient and scientist can give life to the trials.

After many years, these tools have been strengthened thanks to the support provided by the European Union. The European patient today has innovative tools such as the experimentation regulation (no. 536/2014) and the new GDPR, also concerning patients data protection and safety.

The experimentation regulation explicitly states that in the ethics committees there must be active, participatory patients. Furthermore, it is recognized for the first time that there is no age term for the definition of a patient, but that all ages must be represented.

The patient’s involvement is increasingly significant: for example, the EMA supports the importance of involving patients in the preparation of the patient package inserts, with a simple and understandable language. But the most extraordinary tool is the presence of patients in many scientific committees, starting from the COMP, in which a representative of the Giambrone Foundation was recently appointed.

The climax of this process that sees the patient increasingly protagonist of the experimentation and all that
revolves around it, is the creation of the Patients’ Consumers Working Party, which also includes the common citizens. This is a working group that allows all members to open the window on all the problems related to the development of new therapies and new drugs. All organizations can apply to participate in subgroups, but only so-called expert patients can participate, those who can not only bring their own direct experience (failures and benefits of treatment, for example), but are also able to inform themselves, understand and keep up-to-date on wider topics, becoming able to confront on the scientific, economic and technical working groups. This is a load of expertise that is transmitted within the institutions and is an invaluable asset for the world of scientific research.

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