Patient and Caregiver
Investigator
Regulator
IRB
Tech, Device,
PayerTrial Design Stage
Published Date: April 29, 2025
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Helpful Terms and Definitions
Draft Protocol
Create a consistent contact program with clear expectations
Questions To Ask
- Study feasibility and site need(s) - requires clear and continuous communication
- How does the study design impact patient enrollment?
- What are common operational challenges? How can these be addressed before they happen?
Why involve Investigators and Sites now?
Engaging investigators and sites at the draft protocol phase gives sponsors the opportunity to further understand patient enrollment, gain feedback from the clinical research coordinators, identify and mitigate common operational challenges, and introduce any technology that will be utilized during the study and discuss any technological challenges.
Early engagement and site selection are not two separate processes.
They are two halves of an integrated strategy that ensures:
- A realistic, patient‑centered protocol
- Strong investigator buy‑in
- High enrollment and retention
- Fewer deviations
- Stronger operational execution
- Greater trust between sponsors, sites, and participants
Engage investigators early → refine the design → identify the right sites → empower sites for success
Recommended topics and methods of engagement
| Protocol Element | Recommended Engagement |
|---|---|
| Study Design | Talk to potential investigators who see high volumes of targeted patients but not necessarily the highest volume recruiters in prior trials--opportunity to understand how study design can impact their ability to enroll patients. |
| Endpoints | Utilize an advisory board with key opinion leaders who have significant experience with clinical trials in this therapeutic area (primary endpoint) and also site clinicians who see underrepresented trial populations who may have significant input for secondary endpoints. |
| Enrollment / Withdrawal
Inclusion / Exclusion |
Gain broad input by engaging investigators and clinical research coordinators (CRCs) who are seeing the patients needed in the trial (this is particularly important for phase 3 trials). |
| Study Agent & Control | Discuss the study agent in terms of preparation and/or storage; it is important to engage a diverse group from the site, potentially including a pharmacist. |
| Study Schedule, Procedures & Evaluations | Deeply engage both investigators and CRCs. |
| Clinical Monitoring | Aim to involve the investigator and more importantly the CRC from the site as they would be doing a large part of clinical monitoring. |
| Informed Consent | Engage Sites, allow them to flag if the process is too complex for their specific patient population (e.g., ICU patients or elderly participants) and suggest a more streamlined approach. |
| Ethics / Protection of Human Subjects | Engage a steering committee (with patient advocate) to discuss any ethical considerations, ensuring it includes different people at the sites who interact with the patient, from investigator to CRCs. |
Example Standard Operating Procedure for Near Final Protocol Engagement
Obtaining and Integrating Site & Investigator Feedback During Protocol Finalization (PDF)
Refine the Design
Sponsors streamline endpoints while Sites review the Schedule of Events to ensure the timing of procedures is realistic in a clinical setting.
Empower Sites for Success
The Site Startup Meeting: Use the SIV (Site Initiation Visit) as a collaborative "Risk Workshop" rather than a one-way lecture.
Actionable Step for Sites: Conduct a "Feasibility Walkthrough." Have the site staff walk through a patient visit from check-in to discharge. Use this to surface operational, ethical, and scientific considerations that a Sponsor might miss from an office setting .
Who should be involved? Think broadly: Clinical investigators, coordinators, lab techs, technology vendors, and patients/advocacy groups. Their unique lenses on logistics help identify barriers before they become protocol deviations, resulting in trials that are both scientifically sound and operationally practical
What aspects of the draft protocol should they inform?
Less reform at this stage and more review