Clinical Trials - EPF Asks For More Systematic Patient Involvement In Ethics Reviews


On 13 April, EPF contributed to a workshop by the EFGCP (European Forum for Good Clinical Practice) on “How to Ensure Optimal Ethical Review within the New Clinical Trials Regulation?

The workshop focussed on the alignment of responsibilities and roles between ethics committees and national competent authorities. The new regulation requires a closely co-ordinated assessment within strict timelines and although it leaves the mechanisms and application up to the Member States, implicitly this will require much closer collaboration between the different bodies at national and regional levels. Many Member States have started to develop new local procedures and initiated early pilots to test the new assessment scenario.

EPF participated in a panel where we stressed the importance of including meaningful patient involvement throughout the process to ensure an optimal ethical review of trials.

The new Regulation clearly recommends patient involvement but stopped short of making it mandatory.  This creates a situation of uncertainty as it is left up to member states whether and in what way to involve patients.

The need for more patients’ involvement in ethics committees has been highlighted many times. The perspective of patients is not equivalent to the perspective of lay persons: these roles are both different and complementary. The unique added value of the patient perspective lies in this knowledge. Patients and their representative organisations also have a distinctive insight into the feasibility of certain practical aspects of trials, and a different perception of the appropriateness of some decisions, such as regarding endpoints or comparators.

But patient involvement is also needed at a much earlier point. By the time a trial application is discussed by an ethics committee, improvements can be made but it is too late to re-design documents and re-think processes, especially in view of the stricter timelines that will apply under the new EU Regulation. The EU-funded project PatientPartner (FP7) found the involvement of patients often resulted in changes to the design of the study, including ways of collecting data; identification of endpoints; analysis of qualitative data; different research questions, tools, priorities and outcomes; increased recruitment and better recruitment strategy; better response rates; and wider dissemination of findings.

Patients needs to be involved in ethics review, but really their involvement should start much earlier, in decisions on research priorities and in co-designing research, to ensure that research designs are ethical and will produce results that will really benefit patients,” said Kaisa Immonen-Charalambous, EPF Director of Policy.

EPF recommends an EU-funded mapping study focusing specifically on patient involvement in ethics reviews across the EU, resulting in an updated overview of the types and the extent of involvement and the tasks and roles of patient representatives. The study could include case examples and make recommendations on good practices and should be conducted in partnership by patient organisations and researchers.

Contact: Kaisa Immonen-Charalambous, Director of Policy.