The Recommendations and Conclusions from the European Month of the Brain have now been published by the European Commission. EFNA played a key role on the scientific steering committee for the Month, and we are glad to report that the role of patients is central to the recommendations.
You can read the summary below or access the full report by CLICKING HERE.
1. Promote the role of patients in all stages of research and evidence-based healthcare.
Consideration should be given to enhancing the engagement of patients in all steps of the research cycle. Patients need to be actively involved in the planning of research approaches, the execution of services and the maintenance of standards of healthcare practice
2. Tackle the stigmatization of patients with brain disorders.
Patient-led campaigns to raise awareness should be supported and enabled. Scientists need to engage in public debate about neuroscience, brain disorders and brain health
3. Continue supporting interdisciplinary research approaches.
This could be achieved, for example, by bringing together fields such as information technologies, social, environmental and educational sciences, economics, law and humanities towards neurosciences
4. Foster innovative and more relevant approaches to clinical development.
This could include novel trial methodologies, novel endpoints, biomarkers and diagnostics and increased involvement of population groups such as children, elderly patients and patients with co-morbidity in an ethically responsible manner. Such an approach would help achieve the necessary paradigm shift from population-based medicines to personalised medicines for the benefit of patients, healthcare systems and society.
5. Promote new ways of implementing healthcare solutions.
This should involve the implementation of multidisciplinary healthcare practices in caring for people with brain disorders in addition to neurological or psychiatric consultations
6. Encourage data sharing by finding the right equilibrium between privacy considerations and the need to exploit data for research purposes, including anonymised healthcare data and patient registries. Regulations should facilitate the creation, maintenance and use of large data sets for research purposes
7. Attract and align public and private investment into brain research and healthcare.
Investment must be coordinated, aligned across Europe and re-allocated or increased where necessary to better reflect the scale of the scientific, medical and socioeconomic challenges. In this context, it is essential to ensure continuous support for basic, clinical, social and other brain-related research at national and EU levels
8. Expand smart and innovative strategies for supporting brain research and healthcare.
Learning from existing interdisciplinary or transnational examples, this should include public-public (such as the Joint Programming on Neurodegenerative Diseases) and public-private (such as the Innovative Medicines Initiative) partnerships
9. Reward innovation in drug development, new technologies and healthcare delivery.
Areas of opportunity include the development of financial and tax incentives, the introduction of the EU patent, improvement of regulatory policies and support to SMEs. Incentivising collaboration between academia, industry, regulators and HTA bodies, healthcare and patients should be central to initiatives developed.
10. Adapt the regulatory landscape.
While ensuring patients’ safety, addressing some of the specific issues mentioned in the above recommendations would necessitate adapting the regulatory landscape to allow for more innovative approaches in clinical development. Those adaptations can include the use of alternative types of evidence beyond randomized clinical trials, patients’ participation in decision-making and inclusion of relevant population groups such as children and elderly people, and those with co-morbidity.