A new publication, published in the prestigious review JAMA Psychiatry and co-authored by NeuroCentury’s Pawel Swieboda, presents a blueprint for transformative change in the implementation of precision medicine in psychiatry. The paper analyses the reasons behind past failures in drug discovery for mental disorders and outlines pathways to move the field forward. It argues that the right combination of scientific innovation, regulatory reform, and sustained financial investment can usher in a transformative shift in mental health care.
The publication was led by Prof. Marion Leboyer, with the other co-authors including Husseini Manji, Andrew Miller, Brenda Penninx, Martien Kas, Carmine Pariante, Livia De Picker, and Federico Cevoli.
To date, many scientific discoveries have not been effectively translated into clinical practice due to the lack of precision in patient selection for clinical trials, leading to lack of clear and persistent results. To break this cycle of stagnation, psychiatry must adopt a biomarker-driven approach, shifting away from the conventional one-size-fits-all clinical trial model. Incorporating specific clinical profiles and/or neurobiological variables in trial designs could significantly improve drug development success rates.
Apart from a revamped scientific methodology, increased public and private investment are needed, and a different attitude of regulatory agencies, relying more on flexible and biomarker-informed trials, as seen in oncology and other medical fields. The successful shift from symptom-based to biomarker-based classification in dementia offers a valuable parallel for psychiatry. In dementia, the use of biomarkers has drastically changed how diagnoses are made and treatment in clinical trials is evaluated.
Although mental health research benefits from a satifsfactory rate of return on investment, the current funding levels are not commensurate with the societal and economic impact of mental health issues. To support the discovery of new diagnostic tools and therapeutic strategies, there is an urgent need to engage the public in international efforts to gain support from private and public funders.