An inflection point for psychedelic therapies in TRD
Treatment-resistant depression (TRD) affects roughly one in five US adults across their lifetime, with 20-30% of major depressive disorder patients failing to respond to standard care. Existing pharmacologic and neuromodulation strategies deliver only partial, often short-lived benefits.
As psychedelic-assisted therapies move from promise to practice, sponsors face a new evidence challenge: short-term efficacy alone will not secure access. Durability, safety, comparative effectiveness, and economic value are the questions that will determine adoption.
This white paper uses TRD as a case study to outline how real-world evidence can address the priorities of four stakeholder groups, and how a rigorous evidence strategy can de-risk development and launch.
Four stakeholders, four evidence agendas
Each group brings distinct priorities that should shape how psychedelic-assisted therapies are developed, evaluated, and delivered.
Patients
Living with TRD means cyclic crisis-driven help-seeking, stigma, and weeks-long onset of benefit. Patient-centered endpoints matter as much as symptom scales.
- Faster, more durable symptom relief
- Restored functioning and quality of life
- Reduced stigma and simpler access pathways
Regulators
The April 2026 Executive Order and FDA Breakthrough designations have created momentum, but blinding, abuse potential, and safety monitoring remain open questions.
- Robust safety, abuse potential, and blinding data
- Clear durability and comparative effectiveness
- Governance for supervised administration
Providers
Acute response rates rarely exceed 40-50% with conventional therapy. Supervised psychedelic protocols introduce real workflow, staffing, and training implications.
- Clear positioning within TRD care pathways
- Practical guidance on staffing and workflow
- Implementation-focused real-world evidence
Payers & HTA
Hospitalization can account for over half of TRD direct costs. Decision-grade economic models and RWE are essential to justify high-touch delivery to ICER, NICE, and CDA-AMC.
- Evidence that benefits justify delivery costs
- Impact on hospitalization, disability, absenteeism
- Flexible economic models grounded in RWE
Draw on deep expertise to anticipate stakeholder expectations.
UBC scientists synthesize the most recent evidence available to help sponsors build patient-centric, regulator-ready, and payer-defensible programs in TRD.
- Anticipate patient priorities with PROs and lived-experience insights embedded from protocol design forward.
- Engage regulators early to pressure-test endpoints, blinding strategies, and safety-monitoring frameworks.
- Equip providers with implementation-focused RWE on adherence, staffing, and care-pathway sequencing.
- Build payer value stories on flexible economic models grounded in claims, utilization, and productivity data.
Build the evidence strategy that earns access in psychedelic-assisted TRD.
Get the full white paper for stakeholder-by-stakeholder evidence priorities, regulatory context, and real-world data planning guidance.
Download the Full White PaperReferences
Full citation list (28 sources) included in the downloadable white paper. Includes Fekadu A. et al. (2009), Rush AJ et al. (2006), Goodwin GM et al. (2022, 2023), Price RB et al. (2022), Zhdanava M et al. (2021), Avancena ALV et al. (2025), and the COMPASS Pathways COMP360 phase 2b and phase 3 program reports (2022-2026).
