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European Reform of Clinical Trials: What Will Change for Patients

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European Reform of Clinical Trials: What Will Change for Patients

The train has been stopped in the station since 2014, yet now we risk losing it. The train we are talking about is the reform of the European Regulation on clinical trials: Italy is among the countries lagging behind in its implementation, entrusted to the “Lorenzin Law” (Law 11 January 2018, n.3 then converted into Legislative Decree 52/2019 ), which provides for a series of implementation measures, largely not yet issued, starting with that relating to the reorganization of the Ethics Committees. To mobilize to get on that train before it is too late today are the patients: 16 associations, gathered in the People Group, not just Patients supported by the Roche Foundation. The reform, on the other hand, calls them into question directly, because it provides for the participation of patient associations in the trials at every stage, to ensure – among other things – greater attention to healthcare needs and the needs of patients and equity of access. . For this reason, the coalition has drawn up, together with the CNR, an ethical-deontological charter to define the details of their involvement.

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Here are the main points of the document, which was presented last week in Rome (on the Group’s Fb channel it is possible to review the event):

1 – Patient Associations must be accredited to participate in clinical trials on the basis of satisfactory but not restrictive requirements, valid for the entire national territory and mutually recognized in EU countries.

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2 – Patient Associations must be involved right from the planning phase of new studies and elaboration of the design of clinical trials.

3 – In the enrollment phase, Patient Associations can play a fundamental role in overcoming possible inequities in accessing scientific research and clinical trials, which represent the only prospect of improvement for many pathologies.

4 – The Patient Associations must interact with the investigators to verify that the trial is carried out in accordance with the experimental protocol and to promptly report deviations or new needs that emerged during the trial.

5 – Patient Associations involved in clinical trials are responsible for promoting and enhancing the results of the trial.

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What the new regulation provides

The aim of the new regulation is to make Europe an attractive environment for conducting trials. A decisive step was the entry into force, on January 31st, of the Clinical Trials Information System, a single access point for the presentation and authorization of clinical trial applications in the European Union and in the countries of the European Economic Area. “The competition on clinical trials today is not between companies but between countries”, explains Maurizio de Cicco, Member of the Farmindustria Presidential Committee: “It is therefore in everyone’s interest to win this competition because the most competitive countries attract a greater number of clinical studies. with related investments. From January to April 2022, according to a report published by the European Medicines Agency, 56 applications for clinical trials were submitted on the basis of the new procedures of the European Regulation. Of these, only 12 in Italy, because sponsors tend to concentrate studies in countries that are already in compliance with the new regulations (in 2019, for comparison, 672 new clinical trials were approved, equal to 23%, ed.) . It is essential to complete the implementation of the new European Regulation in such a way as to best express even the clinical excellences that are internationally recognized in Italy and have the opportunity to compete with other countries “.

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The role of patients in study design

In the implementation of the European Regulation, the principle expressly indicated in the Lorenzin Law relating to the involvement of patient associations in all phases of the trial is missing. “The centrality of patients and their Associations in the clinical research system is now an established fact, as also demonstrated by the setting of the recent initiative launched by the European Commission together with the National Regulatory Agencies and the EMA simultaneously with the application of the European Regulation, Accelerate Clinical Trials in the EU (ACT EU) ”, underlines Sandra Petraglia Director of the Pre-Authorization Area, Italian Medicines Agency (Aifa). One of ACT EU’s priority actions is dedicated to the creation of a platform that sees patients and patient associations at the center, with their direct involvement to proactively design a drug development that is effectively oriented to the needs of patients.

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The current situation

Currently the composition of the AIFA Commissions does not foresee the presence of patients. The participation of patients in the discussions of the AIFA Commissions has therefore so far only taken place on a voluntary and occasional basis, explains the expert, in the context of hearings or external meetings with respect to regulatory processes. “A more defined and formal placement of them is to be hoped for – continues Petraglia – in line not only with what is already happening at EMA level, but also with what has been done for the Coordination Center of Ethics Committees, in which by now for four for years the Patient Associations, which are fully present and with equal roles, carry out the requests and the fundamental point of view of the patients with competence and authority ”.

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The goal for the coming months

In the coming months, the “People not just patients” Group will work to accelerate the issuance of the implementing Decrees, ensuring that the principle of the involvement of Patient Associations is safeguarded and that, at the same time, homogeneous and shared requirements are defined, recognized in the countries EU, for the accreditation of Associations as active subjects in clinical trials, guaranteeing them access to all information on European clinical trials within the Clinical Trials System.

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