Patient and Caregiver
Investigator
Regulator
IRB
Tech, Device,
PayerTrial Design Stage
Published Date: April 29, 2025
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Helpful Terms and Definitions
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 this stakeholder group now?
The final protocol stage allows all stakeholders involved to review and recap feedback and amendments made throughout the trial design process. This fosters a collaborative environment where all parties can reflect on the implemented changes and gain insights from the final protocol. Tech, Device, and Data companies can help bridge the gap between protocol design and patient recruitment and improve engagement in future trials by providing clearer guidance when developing protocols for specific therapeutic areas.
What aspects of the final protocol should they inform?
- Review Amendments & Implemented Changes: ensure all feedback is accurately documented and all stages of the amendments are accounted for.
- Data Compliance: confirmation that data collection methods outlined align with regulatory requirements (e.g., HIPPA compliance.)
- Outcome Measures: confirm that the protocol is clinically feasible and EHR data can be used to assess patient outcomes and study results.
- Stakeholder Concerns: address all concerns raised during the feedback process to maintain transparency
- Feasibility Assessment: confirm that site capacity, data access, and workflow considerations are equipped to support the protocol in its entirety.
- Site Identification: Site-level real-world data enables site identification for clinical trials, helping researchers identify suitable trial sites based on criteria such as site capabilities, previous trial experience, and investigator details.
- Patient Recruitment: Technology and data companies with patient recruitment capabilities can identify potential trial participants based on their electronic health records.
| Issue | Solution or Lesson |
|---|---|
| Not having full visibility into the clinical status of a patient. | Trying to manage a side effect without all available evidence will increase risk to the patient and study |
| Data Privacy | Utilization of appropriate encryption and passwords |
| Ensuring Data Quality | Enabling the sites with a backup plan to include actionality for the patient (must consider patient population when determining appropriate tech) |
| Tech related protocol amendments | Tech focused companies need to be involved in design in order to support the scientific objective |
| Not enough baseline data | Begin wearing device prior to baseline visit (devices) |
| Reluctance for adoption of the technology and burden to the site | Ensure the technology is both fit for purpose and population |
| General issues with devices and applications | Education - 17 to 20 hours to ensure understanding; Ensure staff training on tech solutions is done at final protocol but not too far ahead of study start. Ideally two weeks before study start. |
| Patients feeling as if the device adherence is 'optional' | Early patient training driven by the study objectives. Patient engagement groups can help form a collaborative procedure to better support the individual patients |
| Technology adoption is disruptive | Offer training and support; high acceptance and utilization are key to success. |
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