Patient and Caregiver
Investigator
Regulator
IRB
Tech, Device,
PayerTrial Design Stage
Published Date: April 29, 2025
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Helpful Terms and Definitions
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Final Protocol
Questions To Ask
- Why is this study appealing to the patient community?
- Is the flow burdensome for patients?
- Are the inclusion/exclusion criteria accurate to the current patient population?
- Are these the endpoints and outcomes that matter most to the patients?
- How is patient health information being protected and used?
- What does the risk to benefit analysis look like?
- What types of control groups and treatments are being used?
- What are the options for patients whose disease worsens during treatment?
- What is the long-term strategy - is there an open label extension period?
- How and when are patients diagnosed?
- What type of providers are giving care?
- What are barriers to accessing treatment? Are there solutions?
Why involve technology, device, and data companies now?
The final protocol stage provides an opportunity to review and confirm all feedback and changes made throughout the trial design process. Collaboration with technology, device, and data partners at this stage helps ensure that protocol requirements are operationally feasible, data collection approaches are appropriate, and implementation risks are minimized prior to study start.
Their involvement also helps bridge the transition from protocol design to study startup and patient recruitment by confirming that systems, workflows, and data strategies are aligned with real-world execution.
What aspects of the final protocol should they inform?
- Review of amendments and changes: Confirm that design changes are accurately reflected and operationally feasible
- Data integrity and compliance: Ensure data collection approaches align with applicable regulations (e.g., HIPAA) and data protection requirements
- Outcome measurement feasibility: Confirm that endpoints can be reliably captured using available systems (e.g., EHR, devices, platforms)
- Issue resolution: Address outstanding feedback and ensure prior concerns are incorporated into the final protocol
- Operational feasibility: Validate site capacity, data access, and workflow readiness
- Site identification support: Inform site selection using real-world data on capabilities, experience, and patient access
- Recruitment feasibility: Support identification of potential patient populations using available data sources, where appropriate
| Issue | Solution or Lesson |
|---|---|
| Lack of full visibility into patient clinical status | Ensure data sources are as complete as possible; limited visibility can increase risk to both patients and study outcomes |
| Data privacy risks | Use appropriate security controls (e.g., encryption, access controls) aligned with regulatory requirements |
| Data quality concerns | Implement data validation processes and ensure technology is fit-for-purpose for the target population |
| Technology-related protocol amendments | Involve technology partners early to align capabilities with study requirements |
| Insufficient baseline data | Where appropriate, collect baseline data prior to intervention (e.g., pre-baseline device use) |
| Low adoption or high burden at sites | Select technology that aligns with site capabilities and minimize operational complexity |
| General issues with devices or applications | Provide structured training and support; ensure timing aligns with study start (e.g., shortly before activation) |
| Patient misunderstanding of technology expectations | Reinforce education and engagement to support adherence to protocol requirements |
| Disruptive technology implementation | Provide training, onboarding support, and ongoing assistance to facilitate adoption |
Tech, Device, and Data Company Resources
A Smarter Approach to Clinical Trial Design and Delivery
Using digital technologies in clinical trials: current and future applications
Embracing Hybrid Trial Design - How, When, & Why To Use It
Artificial Intelligence for Clinical Trial Design
Clinical Trial Management Systems