Patient and Caregiver
Investigator
Regulator
IRB
Tech, Device,
PayerTrial Design Stage
Published Date: April 29, 2025
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Helpful Terms and Definitions
*This list is not exhaustive, nor does CTTI officially endorse the resources created by other organizations.
Synopsis
Does the study reflect the standard of care that clinicians are actually practicing—not just what is described in guidelines?
Questions To Ask
- Can the site realistically implement the study as designed?
- Does the site have the technical capability required (e.g., hospitalization, invasive procedures, specialized assessments)?
- How feasible is the study design within real-world site workflows?
- Is there sufficient patient population available at the site?
- What recruitment challenges are anticipated, and how can they be addressed proactively?
- How can sites effectively reach and enroll a diverse patient population?
- What operational challenges are commonly encountered, and how can they be mitigated early?
- What support is needed from the sponsor (e.g., recruitment tools, consent support, staffing, technology)?
- Are visit schedules, procedures, and data collection requirements manageable within routine clinical practice?
Who should represent investigators and sites now?
- Investigators and site personnel involved in feasibility assessments
- Experienced investigators engaged during the concept phase
- Site operations representatives (e.g., coordinators, feasibility/startup teams)
Where will you find them?
Build on existing networks while expanding to include new perspectives and site types.
- Engage site feasibility assessment teams
- Identify investigators and sites based on disease prevalence and treatment settings
- Explore both established research centers and community-based sites to broaden access
Use publications, conferences, and research networks to identify clinicians active in the disease area
Why involve investigators and sites now?
At the synopsis stage, engagement focuses on refining study design with greater operational detail.
Investigators and site teams can:
- Validate whether the protocol is realistic in a clinical setting
- Identify operational barriers that could impact recruitment, retention, and compliance
- Provide input on workflow integration and site burden
- Help shape recruitment strategies and patient access approaches
Early and continued engagement also supports site readiness, strengthens communication planning, and reduces the likelihood of downstream protocol amendments or delays.