Table 2.

Feedback on defining the call for action

Areas for development	Acknowledge What are the current challenges?	Develop What needs to be done to achieve the vision for the 21st Century?	Implement How could this be achieved and by whom?	Communicate and engage Who should this be communicated to?
Regulatory body reforma	Access to and engagement with regulatory bodies Burdensome regulations driving expense and limiting innovation (Industry, reducing loss)  Leading to costly and delayed drugs Different perceptions of risk Opportunity cost Resource cost, i.e., limited pool of patients in trial centers	Improve access to conditional drug approval Promote post-licensing registry Earlier drug approval Learn from diabetes and other conditions Insurance and reimbursement of adverse events	Utilization of a specific opportunity, with coordination of:  Patients/patient societies  Neurologists  Industry	EU Patients Neurology advisory groups Key opinion leaders Agencies
Commitment to research	Reduced charity income Reduced government funding for basic research	A culture of research embedded in all aspects of MS	MS centers of excellence  Research networks  Leverage of funds	Government departments for health and research Foundations EU
New endpoints in clinical trials (and new designs of trials)	Optical coherence tomography, MRI techniques Subgroup analyses No consensus currently on outcome measures and clinical trial design Neuroprotection Fatigue measurement and recognition Composite endpoints and scales New types of clinical trials	Achieve consensus from expert groups with endorsement of regulatory authorities Development of new composite endpoints/scales “De-risking” clinical trials	Physician (expert neurologist)/patient/industry Regulatory bodies Experts	Regulatory Industry Funders of clinical research  Academic  Charities  Experts
Personalized care (healthcare and social care)	Fragmentation of care into different departments  Ability to effect change due to governmental structures and processes	Integration and coordination Provision of information—‘navigating the system’ Patient adherence Effective partnership	Empowerment of MS nurses as central coordinators MS centers of excellence Patient engagement Shared decision-making Education for patients and physicians	Coordination and engagement of other patient organizations Coalition of stakeholders Politicians and bureaucrats
More therapy options	Cost/affordability Safety Tolerance High level of regulatory demands Relevance of placebo arm? Long-term data on therapies Standard approach to all kinds of treatment	Decrease cost and increase available resources Cost-effectiveness strategies Widen focus of research Education and advocacy Public support for longitudinal patient registries	Use expertise from other fields Patient advocacy Make additional resources available for unmet needs Incentivize investments following specific public health interests Widespread educational programs	Regulatory bodies and funding agencies Political decision-makers General public Governments Neurological societies
MS centers of excellence	Quality variation Regional differences Different resources Different levels of experience in clinical trials	Multidisciplinary approach developed Define main standards (country-specific) Full access to information Systems and educational programs	Strengthen current networks Export and share positive experiences Open window for more centers to participate in clinical trials and research	Healthcare authorities Current networks World Health Organization (WHO) European Commission European and country parliaments

EU European Union, MS multiple sclerosis

^aWording changed from “education” to “reform” in the breakout session