Title : Redefining holistic approaches in neurological drug development: Gaps and opportunities
Abstract:
The concept of holistic patient care has gained traction in neurological drug development and clinical trials, emphasizing patient-focused endpoints and real-world measures of quality of life rather than purely biochemical outcomes. The key success factor here is multidisciplinary collaboration across neurologists, psychiatrists, rehabilitation specialists, nurses, psychosocial caregivers, and most of all, the patients. Furthermore, it requires continuous digital monitoring such as wearable devices empowering patients with ability to track symptoms and improvements. However, the flawless integration of biological mechanisms, clinical relevance, and patient life impact is a challenging task, and the technology is advancing limited by regulatory requirements. As a result, a growing body of literature reveals that many so-called “holistic” approaches remain limited in scope. Common gaps include inconsistent inclusion of mental health endpoints, inadequate measurement of functional and quality-of-life outcomes, exclusion of patients with psychiatric comorbidities, and lack of standardized frameworks for measuring the effectiveness of non-pharmacological interventions. Moreover, interdisciplinary collaboration is often limited, and trial designs rarely account for real-world complexities affecting adherence and treatment response. This presentation will provide an overview of these shortcomings and recommendations to advance truly holistic trial design. Recommendations include adaptive trial designs that integrate behavioural and lifestyle interventions; fostering interdisciplinary trial teams; and aligning patient-centered outcomes with regulatory expectations. Example will be provided in the latest effort in pain management.
This presentation will particularly benefit researchers, scientists, clinicians, and digital health innovators involved in neurological drug development. It will also be valuable for healthcare professionals working in multidisciplinary neurological care settings, as well as patient advocacy groups aiming to promote more inclusive and meaningful outcome measures in research. By addressing both strategic and practical dimensions, the session offers insights relevant to decision-makers shaping future trial frameworks and care models in neurological drug development.
