Considerations for Sponsors Conducting Protocol Feasibility and Review

For emerging biopharma companies preparing to launch a clinical trial, protocol development is one of the most critical and risk-prone steps. A robust, cross-functionally informed protocol feasibility and review process is one of a sponsor’s strongest tools to prevent mid-study protocol amendments.

Protocol design flaws are a common, yet preventable, threat to the success of a clinical trial. Typically not discovered until a trial is already underway, these issues might appear in the form of recruitment failures, excessive protocol deviations, and poor data integrity.

Ultimately, once identified, many flaws can be resolved through the implementation of a protocol amendment. Unfortunately, even just a single amendment can be a six-figure cost that pushes trial timelines back months.

Bring together a senior multi-disciplinary group to assess your protocol

Updated ICH E6(R3) guidance stresses the importance of incorporating stakeholder input early in the process. In addition to ensuring your trial follows both a patient-centric and risk-based approach, a multi-disciplinary group can help sponsors put fresh eyes and operational perspectives on their protocol to pinpoint potential areas of concern or ambiguity.

Who should this group include?

Outside of perspectives from the sponsor and relevant patient populations, the operational review of a protocol should involve:

• Biostatisticians
• Medical monitor/advisors (MD)
• Pharmacologists
• Clinical trial operations specialists
• Data managers
• Investigators

What should your multi-disciplinary group provide input on?

This group should plan to provide input on aspects such as:

• Statistical design and powering checks
• Dosing and PK/PD feasibility review
• Visit flow and scheduling window analysis
• Safety signal and AE risk projections
• Investigator and site compliance assessment
• Retention and dropout risk modeling
• Input on protocol clarity and refinement

How PharPoint helps sponsors strengthen protocol feasibility

PharPoint’s protocol review and stress-testing services are designed to support supports with a thorough, multi-disciplinary review and suggestions for a clear path forward.

Our clinical trial protocol review services include:

Our aim in offering this service is to prevent costly mid-study amendments; reduce screen failures, dropouts, and protocol deviations; protect study timelines and budgets; and build confidence with internal and external stakeholders.

Final Thoughts

Protocol feasibility and review is a strategic opportunity to de-risk your study and set your team up for success. By engaging the right experts and using data-driven tools to assess operational realities, sponsors can avoid potential pitfalls and move forward with confidence.

If you are looking for protocol optimization support, PharPoint’s team is here to help. Reach out to our team for more information.