Global stakeholder engagement for mapping psychiatric biomarkers: an ECNP-led international initiative for precision psychiatry

Background

Biomarkers have transformed many areas of medicine by improving diagnosis, prognosis, patient stratification and treatment selection. In psychiatry, advances across genetics, molecular biology, neuroimaging, electrophysiology, cognition, behaviour and digital phenotyping have generated a growing number of promising candidate biomarkers. Yet routine clinical implementation remains limited. Progress is slowed by fragmented evidence, heterogeneous study designs, inconsistent reporting standards, uncertain validation status, and limited clarity regarding the intended clinical context of use [1-3]. As a result, potentially informative findings remain difficult to compare, synthesise and translate into practice.

Aims

To support the transition towards precision psychiatry, we launched an international stakeholder-engaged biomarker mapping initiative within the ECNP Precision Psychiatry Roadmap. The objectives are to: (1) create an open, structured inventory of completed and ongoing biomarker initiatives in anxiety, depression and psychosis; (2) characterise biomarkers according to readiness for clinical translation; (3) identify scientific and implementation gaps across populations, modalities and applications; and (4) inform future international consensus building on biomarker validation, harmonisation and deployment.

Methods

A structured international survey was developed for academic consortia, clinical researchers, industry partners, data platforms and other relevant stakeholders. Researchers and clinicians are invited to contribute information on identified or validated biomarkers for mental disorders in completed or ongoing studies through a short structured survey: Biomarker Mapping Survey Link. The survey captures key characteristics of identified or validated biomarkers, including modality, biological level, target population, disorder-specific versus transdiagnostic scope, intended context of use (e.g. diagnosis support, prognosis, treatment selection, monitoring, staging), and stage of validation (discovery, internal validation, external validation, clinical utility, implementation). Survey data will be integrated with evidence from parallel literature searches and (umbrella) systematic reviews. The results will be catalogued and organised onto an expanded version of the ECNP Knowledge Hub, forming an open-access, user-friendly searchable database for the psychiatric biomarker research community to support descriptive analyses, evidence visualisation and gap analyses.

Results

The stakeholder engagement phase is ongoing, with dissemination through international research networks and ECNP-linked collaborations. The platform infrastructure will be designed to generate a user-friendly, searchable evidence catalogue spanning biological, behavioural and digital biomarkers. By organising evidence according to function and readiness rather than diagnosis alone, the initiative is expected to reveal underrepresented domains, populations and geographical regions, as well as areas where replication, standardisation or implementation studies are most needed. Outputs from the survey and the systematic mapping exercise will be discussed through three upcoming ECNP-led multi-stakeholder consensus meetings involving researchers, clinicians, regulators, industry representatives and people with lived experience.

Conclusions

Precision psychiatry requires more than biomarker discovery alone. It also depends on shared infrastructure, common language, transparent evidence standards and coordinated international collaboration. This initiative addresses these unmet needs by transforming dispersed findings into a field-aligned framework for decision-making. Through systematic mapping and stakeholder consensus, it aims to accelerate the development of clinically useful, biologically informed approaches to mental disorders.

Acknowledgements: The biomarker mapping exercise is funded by the Wellcome Trust.

References

References 1. Kas, M. J. H. et al. Biomarker innovations in precision psychiatry diagnostics and treatment strategies. European Neuropsychopharmacology 105, 112762 (2026). 2. Kas, M. J. H. et al. Precision psychiatry roadmap: towards a biology-informed framework for mental disorders. Mol. Psychiatry https://doi.org/10.1038/s41380-025-03070-5 (2025) doi:10.1038/s41380-025-03070-5. 3. Kas MJH, Hyman S, Williams LM, Hidalgo-Mazzei D, Huys QJM, Hotopf M, Cuthbert B, Lewis CM, De Picker LJ, Lalousis PA, Etkin A, Modinos G, Marston HM. Towards a consensus roadmap for a new diagnostic framework for mental disorders. Eur Neuropsychopharmacol. 2025 Jan;90:16-27. doi: 10.1016/j.euroneuro.2024.08.515. Epub 2024 Sep 28. PMID: 39341044.