Patient and Caregiver
Investigator
Regulator
IRB
Tech, Device,
PayerTrial Design Stage
Published Date: April 29, 2025
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Helpful Terms and Definitions
Synopsis
Does the study outline the standard of care that clinicians are actually prescribing?
Questions To Ask
- Can a site truly implement the study/program
- Technical capability - hospitalization, invasive procedures, etc.
- How can the site recruit a diverse patient group?
- What is the recruitment strategy?
- What are common operational challenges?
- How can these be addressed before they happen?
- How feasible is the study design?
- Infrastructure, access, capabilities and support of the study design
- Is there a patient base available?
- What support is needed from the sponsor for recruitment and consent?
Who should represent Investigators and Sites now?
- Site feasibility group outputs
- KOLs from concept stage
Where will you find them?
Branching out to new investigators and sites - research for all; making research accessible to all types of communities
Need to reference the science/process to identifying the locations/sites of interest for the particular disease area.
- Employ Site feasibility assessment teams
Why involve Investigators and Sites now?
The reasons for engaging investigators and sites at the synopsis phase may be similar, if not the same, as the reasons at the study concept phase. However, at this point, the goal is to add more detail. Obtaining feedback from sites throughout the early stages of planning allows the sites to become more invested in the study, creating a sense of ownership. Engaging investigators and sites early and often will ensure sites are equipped with the information and tools they need, facilitate the development of a site communication plan utilizing an agreed upon platform, and identify and mitigate common operational challenges.