Efficient evidence generation to assess the clinical and economic impact of medical therapies is critical amid rising healthcare costs and aging populations. However, drug development and clinical trials remain far too expensive and inefficient for all stakeholders. On October 25–26, 2023, the Duke Clinical Research Institute brought together leaders from academia, industry, government agencies, patient advocacy, and nonprofit organizations to explore how different entities and influencers in drug development and healthcare can realign incentive structures to efficiently accelerate evidence generation that addresses the highest public health needs. Prominent themes surfaced, including competing research priorities and incentives, inadequate representation of patient population in clinical trials, opportunities to better leverage existing technology and infrastructure in trial design, and a need for heightened transparency and accountability in research practices. The group determined that together these elements contribute to an inefficient and costly clinical research enterprise, amplifying disparities in population health and sustaining gaps in evidence that impede advancements in equitable healthcare delivery and outcomes. The goal of addressing the identified challenges is to ultimately make clinical trials faster, more inclusive, and more efficient across diverse communities and settings.

Step therapy, also termed fail-first policy, describes a practice of insurance and pharmacy benefit management companies denying reimbursement for a specific treatment until after other treatments have first been found ineffective (i.e. failed). Laws to limit step therapy have been passed in 29 states of the United States. Using extrapolated data on fully insured employees, we find that except for New York and New Mexico, enacted State laws don't apply to even one-third of a state's population. Using the more robust Kaiser Family Foundation (KFF) data, which do not include fully insured employees, we find that only 2–10% of a state's population is covered. Advocating for these laws has been an expensive and time-consuming process, likely to become more so for the 21 states without such laws. The laws that have been enacted can be near impossible, to enforce, and loopholes exist. As a result, using KFF data, more than 90% of people in the United States with health insurance may still be unable to access the treatment chosen as most appropriate for them with their physician. Based on these data, we conclude federal step-therapy legislation is needed.

Physical health monitoring is crucial in the light of current knowledge about the risks associated with schizophrenia and its treatment. Cooperation between psychiatrists, patients and informal carers can significantly enhance patient wellbeing in this regard. Moreover, an advocacy approach elevates patients from being passive recipients of care to active participants in an integrated system that has outcome benefits for all stakeholders. Considerable progress is being made in this regard, although there is still a long way to go to maximise the benefits of carer involvement in the global management of schizophrenia.

Mental illness has been long associated with denial of certain human rights, social exclusion and political disempowerment. Too often, the effects of adverse social, economic and political circumstances, along with stigma, constitute a form of ‘structural violence’, which impairs access to psychiatric and social services, and amplifies the effects of mental illness in the lives of sufferers and their families. Existing literature indicates that voting rates are low among people with mental illness and, whereas voting preferences in the mentally ill may tend towards the liberal end of the political spectrum, they do not differ dramatically from the overall population. Rates of voting could be improved by mental health service users, service providers, advocacy services and others through (a) improved awareness of voting rights; (b) provision of information, especially to inpatients; (c) assessments of voting capacity, where indicated, using standardised, well-proven tools; and (d) pro-active voter-registration programmes.