What 9 Years of Schizophrenia Feasibility Work Taught Us About Trial Success

Why Schizophrenia Feasibility Is Uniquely Challenging 

Unlike many somatic indications, schizophrenia trials involve layers of complexity that are often underestimated: 

• Variability in diagnosis and symptom stability 

• Dependence on caregiver and family support 

• High screen failure rates due to strict inclusion criteria 

• Fluctuating patient compliance and retention risks 

• Site-level differences in patient management practices 

This makes surface-level feasibility dangerously misleading. 

Regional Experience: Central and Southeast Europe 

Across Hungary, Croatia, and Serbia, psychiatry sites are experienced, engaged, and often highly motivated to participate in clinical trials. 

However, our multi-year experience shows that: 

• Reported patient availability often differs from truly eligible populations 

• Recruitment speed is highly dependent on site-specific patient flow dynamics 

• Investigator engagement varies significantly depending on protocol complexity 

• Retention risks must be evaluated early, not reactively 

The Turning Point: Moving from “Feasibility” to “Deep Feasibility”. Our most successful projects shared one common factor: They were based on deep, structured feasibility assessments, not just questionnaire responses. Instead of asking “How many patients do you have?”, the focus shifted to:  How patients are actually diagnosed, treated, and retained in real life 

The Questions That Made the Difference 

In our experience, the most reliable feasibility outcomes came from systematically exploring: 

1. Patient Identification Reality 

• How are schizophrenia patients identified and tracked at site level? 

• Are databases, registries, or only physician memory used? 

2. True Eligibility vs Theoretical Numbers 

• Of all diagnosed patients, how many realistically meet strict protocol criteria? 

• What are the main exclusion drivers? 

3. Standard of Care & Treatment Pathways 

• What treatments are actually used in practice vs guidelines? 

• At what point would a patient be considered for a clinical trial? 

4. Caregiver and Support System Involvement 

• Do patients have stable support systems enabling trial participation? 

• How often do social factors impact retention? 

5. Compliance and Retention Risk. What proportion of patients are likely to: 

• Miss visits 

• Withdraw consent 

• Become non-compliant 

6. Site Operational Readiness. Does the site have: 

• Dedicated study coordinators? 

• Psychiatry trial experience? 

• Capacity for frequent patient monitoring? 

Summary 

Feasibility is often treated as a procedural step in clinical trial planning. In reality, particularly in complex indications such as schizophrenia, it is one of the strongest predictors of study success or failure. 

Over the past decade, Viacrystal has conducted multiple feasibility assessments across Hungary, Croatia, and Serbia, supporting studies at regional and international levels. 

A consistent pattern emerged: The success of schizophrenia trials is not determined by site interest or patient numbers alone — but by the depth and quality of feasibility assessment.