Clinical Scorecard: Why We Need Biomarkers in Psychiatry

At a Glance

Key Highlights

• Need for standardization and validation of psychiatric biomarkers
• Current reliance on symptom-based patient recruitment in clinical trials
• Proposed framework for moving biomarkers from discovery to clinical use
• Importance of analytical validation for candidate tests
• Potential applications include predicting treatment response and monitoring safety

Guideline-Based Recommendations

Diagnosis

• Incorporate biomarkers into clinical trials with sufficient analytical validation

Management

• Use a combination of measurements for more informative results

Monitoring & Follow-up

• Focus on safety monitoring and treatment response prediction

Risks

• Insufficient analytical validation may limit clinical interpretation

Patient & Prescribing Data

Patients with varying psychiatric disorders

Biomarkers may help identify patient subgroups for tailored treatment

Clinical Best Practices

• Engage regulators early in the biomarker development process
• Establish common data elements and harmonized protocols across studies
• Ensure tests fit into laboratory and healthcare workflows

Related Resources & Content

• American College of Neuropsychopharmacology Consensus Statement