Investigator and Site : Study Concept

Investigator and Site : Study Concept

Trial Design Stage

Published Date: April 29, 2025

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Helpful Terms and Definitions

ClinicalTrials.gov Glossary Terms

NIH Glossary of Common Terms

FDA Drug Development and Review Definitions

Resources*

*This list is not exhaustive, nor does CTTI officially endorse the resources created by other organizations.

Study Concept

To reach a representative patient population, a diverse mix of site types is often required. This may include academic centers, community sites, and international locations. If relationships are new, additional time, resources, and coordination will be needed to establish trust and ensure successful collaboration.

Questions To Ask

open drawer
  • Was a risk–benefit assessment performed and is it aligned with clinical practice?
  • What options are available if a patient’s condition worsens during treatment?
  • Is there a long-term strategy (e.g., open-label extension)?
  • Why will this trial be of interest to both patients and clinicians?
  • What recruitment challenges are anticipated?
  • Where is the disease most prevalent and treated?
  • Which countries, regions, or site types should be prioritized?
  • What common operational challenges may arise, and how can they be mitigated early?

Who makes up investigators and sites?

Investigators and sites include more than the principal investigator. This group may include:

  • Investigators and sub-investigators
  • Study coordinators and research nurses
  • Site operations and startup personnel
  • Feasibility and operational experts

Engaging a diverse mix of perspectives (community sites, academic centers, and global locations when applicable) helps identify feasibility challenges, operational burden, and potential delays early in design.

Where will you find them?

Leverage both existing networks and new connections to ensure broad input.

Approaches include:

  • Mapping disease landscapes (prevalence, treatment settings, provider types)
  • Identifying investigators through publications and conference participation
  • Engaging professional societies and research networks
  • Exploring new site types for broader representation

Why involve investigators and sites now?

Early engagement helps ensure that study design reflects real-world clinical practice and site capabilities.

Investigators and site teams can:

  • Validate study feasibility and protocol realism
  • Identify operational burdens that may affect enrollment
  • Highlight workflow constraints and competing priorities
  • Provide insight into local patient populations and recruitment drivers
  • Improve alignment with standard of care

Early collaboration also supports stronger relationships, better planning, and more predictable study execution.

Recommended Methods of Engagement

What aspects of the study concept should they inform?

Site Identification and Feasibility Framework

Step 1: Conduct feasibility assessment

Step 2: Build site identification strategy

Step 3: Integrate early investigator input

Step 4: Evaluate and prioritize sites

Step 5: Finalize site network

Suggested tools for feasibility assessment

Note

These approaches are intended as general guidance and may be adapted based on study design, therapeutic area, and organizational strategy.

Investigator and Site Resources