EPF publishes a position statement on clinical trialsEPF formally published its position paper on the European commission’s legislative proposal for a regulation on clinical trials on 25 February. Our position paper contains EPF’s views and the key aspects of the legislative proposal, building on the work done during the last years, and two recent rounds of member consultation.
EPF stresses that the new regulatory framework will be with us for many years, and it is vital to get it right also from the patients’ perspective. Science is undergoing an evolution towards wider transparency and a more participatory approach, including an increasingly central role played by patients.
It is for the benefit of patients that trials are conducted in the 1st place. It is also patients who voluntarily lend their bodies to research, and who ultimately bear the risks of doing so. Patients therefore must be at the centre of the new regulation.
- The Commission’s proposals for a single submission through an electronic portal and coordinated assessment jointly by the concerned member states
- The Commission’s recognition patient involvement in clinical trials assessment
- The introduction of a new category of low-intervention clinical trials, which can facilitate research that is currently neglected because it is not commercially attractive, though it may be valuable for patients
- The national indemnification mechanism, which aims to solve the problem of insurance costs that pose a barrier in particular to non-commercial research
- The creation of an EU database open to the public, on which all relevant information about all clinical trials undertaken in the EU must be posted
Nevertheless, the proposal is not perfect from the patients’ point of view. EPF has put forward a number of points for improving the Commission’s proposal further and to focus on some issues that are not addressed in it. We continue to liaise with key legislators to ensure that the new legislation is truly centred around patients’ needs.