Clinical research into neurological diseases is often hindered by a myriad of patient related problems. What can be done to overcome these issues and improve the efficacy of neuroscience trials?
In the wake of the pandemic, new opportunities and challenges for neuroscience clinical trials are emerging. After years of slow progress, mental health is now the focus of major fundraising and legislative efforts. In the US, for instance, National Institutes of Health (NIH) support rose from $6,460 million in 2016 to $10,967 million in 2022 and Congress recently proposed an FDA neuroscience Centre of Excellence.
A literature data analysis of global trends in neuroscience research through 2019 demonstrates an accelerating trend in
neuroscience progress leading up to the pandemic. Now, Alzheimer’s and major depressive disorder studies are seeing a resurgence, while new types of medications are under clinical investigation for disorders such as schizophrenia.
However, myriad factors are making patient recruitment and engagement more complicated for these studies. Geopolitical disruptions and pandemic outbreaks are rendering previously fruitful geographies inaccessible. Outreach for enrolment and engagement of younger people requires a different approach than traditionally successful methods. High inflation and gas prices discourage patients from travelling to distant investigative sites. Meanwhile, increased expectations for inclusion, as in the FDA guidance on enhancing diversity in clinical trial populations, requires inventive
approaches for finding and retaining study patients.
We all want a silver bullet: unfortunately, the varied and complex issues preclude a simple solution. Nevertheless, with patience and the right approach, these studies can be completed. This paper discusses the roadblocks and considerations for tackling patient recruitment and engagement for neuroscience and other difficult-to-enrol studies in today’s research climate.