Policy Recommendations
on Patient Involvement in Clinical Research
BACKGROUND
The Policy Recommendations on Patient Involvement in Clinical Research are one of the results of the project “Identifying the needs of Patients Partnering in Clinical Research-PatientPartner ” funded by the Seventh Framework Programme. These Policy Recommendations are addressed to European and National Policy makers, however we acknowledge that the stakeholders in clinical research themselves have a major role to play in facilitating patient involvement in clinical research.
PatientPartner is based on the conviction that; Early, active involvement of patient organisations in clinical research will not only contribute to therapies that are better adapted to the needs of the patients, but also to the cost-effectiveness of the clinical trials conducted in the European Union (EU).
The main objectives of the project thus were;
• To identify best practices of patient organisation’s active involvement in clinical research in Europe.
• To facilitate the dialogue between all involved stakeholders in clinical research as to how to establish this involvement and integral part of clinical research
• Develop guidance material to be used by all stakeholders in order to facilitate the future partnerships in clinical research between patient organisations, sponsors and investigators.
The dialogue held during the PatientPartner project generated consensus amongst the stakeholders in clinical research-patient organisations, sponsors and investigators that partnership is not only desirable, it is also achievable. The joint stakeholders in clinical research agreed that;
• Patients have experiential knowledge generated through living with their condition - which is different from any scientifically generated knowledge.
• Patient organisations are the vehicle to communicate to the wider audience the practise-based knowledge on the condition of the patients they represent.
• Patient organisations should therefore be actively involved in all aspects of clinical research, in order to ensure that the resulting therapies are better adapted to the needs of patients.
We acknowledge the very important work-on the value of incorporating the patient’s perspective into health related topics- that has already been done in other EU funded projects and several policy developments at the European Commission (EC). Amongst them:
The Value+ project “Promoting Patients’ Involvement in EU Supported Health Related Projects”, co-funded by the Public Health Programme, whose conclusions were that;
“Meaningful Patient Involvement means that patients take an active role in activities or decisions that will have consequences for the patient community, because of their specific knowledge and relevant experience as patients. The involvement must be planned, appropriately resourced, carried out, and evaluated, according to the values and purposes of:
• The participating patients or patient organisations
• Other participating organisations and funding bodies
• The quality of their experiences during the involvement activity.
The value of the early involvement of patient organisations has also been mentioned in the FP 7 Cooperation Work Programme: Health-2011 reiterating that;
“The early involvement of patients and their advocacy group in the planning, implementation and monitoring of a clinical trial is considered so that patients’ needs are appropriately considered. This may also increase the rate of enrolment of trial participants and can have a positive effect on the performance of a clinical trial. All studies must carefully consider the ethical and regulatory framework at European and national level for the conduct of clinical trials”.
THE RECOMMENDATIONS
The recommendations In this document reflect the need for the facilitation and support of the project’s outcomes by national and European policy makers.
They are based on the findings of the PatientPartner project that were generated based on the inventory of best practices of patient involvement in clinical research as well as the dialogue between patient organisations, investigators and sponsors held during the Regional and Central European workshops.
PatientPartner has developed a number of guidance document to facilitate partnership between patient organisations , sponsors and investigators which can be used as starting point for the implementation of the recommendations in this document;
• Patient involvement in Clinical research; a guide for patient organisations and patient representatives
• Patient involvement in Clinical research; a guide for sponsors and investigators
• Ethical Principles of Partnership between patient organisations, sponsors and investigators in clinical research
The public’s perception of clinical research
As an important result of the multi-stakeholder dialogue held during the PatientPartner project the joint stakeholders reiterated the need for an improved understanding of clinical research by the public at large in Europe.
1. We recommend that the European Commission’s DG SANCO, DG Research and DG Enterprise as well as the Ministries of Health of the European Member States join forces in developing a harmonised approach to inform the public at large about clinical research and its benefits to the individual patient. By raising awareness on clinical research, patients, when confronted with the question whether or not to be a clinical trial participant or to be more actively involved in clinical research trough their patient organisation will know where to find the support and the tools to do so. In return this will stimulate the conduct of clinical trials in the European member states, thus benefiting the European patients.
Capacity Building
In order to enable patient organisations to successfully collaborate with sponsors and investigators-with the objective of providing the patient perspective to the development, conduct and implementation of clinical research- the joint stakeholders agreed that patient representatives’ knowledge of clinical research needs to be increased.
2. We recommend that the European Commission’s DG SANCO, DG Research, DG Enterprise and the European the Member States develop a pan-European approach to the establishment of an adequate training programme for patient organisations in order to increase the capacity of patient representatives to be knowledgeable in clinical research and thus enabled to take over partnering roles with industry and academia
3. In addition to the provision of training we recommend that the European Commission’s DG SANCO, DG Research and the Ministries of Health of the Member States increase access to resources for patient organisations in order for them to build the required capacity they need to fulfil their new role as partner in clinical research.
Building partnerships
In line with increasing the knowledgebase of patient organisations through the provision of training an infrastructure for building the necessary partnerships between sponsors, investigators and patient organisations is essential for the incorporation of the patient’s perspective in clinical research
4. We recommend that the European Commission’s DG SANCO,DG Research and DG Enterprise establish communication channels e.g. via the National Contact Points in the Member States to inform sponsors and investigators on the value of collaboration with patient organisations in clinical research as stated in the 2011 FP7 Work Programme –Health.
5. We recommend that the European Commission’s DG SANCO , DG Research and DG Enterprise combine forced to provide the funds for setting- up a European portal or communication platform contact point for active involvement of patient organisations in clinical research. The European Member States are called upon to fund the building of inventories of patient organisations, sponsors and investigators in their countries and provide the contact details of these stakeholders as well as their areas of indication and kind of interest in research to this portal.
Addressing patient involvement in clinical research legislative and regulatory documents
The active involvement of patient organisations is essential to the development of the legal infrastructure for developing new treatments that are fitted to the patient’s needs.
6. We recommend that the European Commission’s DG SANCO ,DG Research and DG Enterprise address the value of active involvement of patient organisations in the new clinical trials legislation as well as involving patients in the development of regulatory and other main policy documents -in order to stimulate the incorporation of the patients’ perspective into the clinical research process- with particular emphasis on the informed consent procedure and ethical review.
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