Insights from a Multi-company Workshop to Apply a Patient Participation Burden Algorithm to Protocol Data

Area of Science:

• Clinical Trial Operations
• Patient Participation Burden Measurement
• Pharmaceutical Research & Development

Background:

• A previously developed participation burden algorithm was utilized.
• A workshop involving 8 pharmaceutical companies aimed to validate the methodology.
• Benchmarking retrospective protocols against prospective protocol design was the focus.

Purpose of the Study:

• To validate a methodology for benchmarking patient participation burden.
• To compare participation burden between retrospective and prospective clinical trial protocols.
• To gather feedback on data collection processes and reporting for burden assessment.

Main Methods:

• Eight companies collected data for 66 retrospective protocols.
• Participation burden scores were calculated for retrospective protocols.
• Prospective burden scores were compared to mean retrospective scores; feedback was collected.

Main Results:

• Lab and blood procedures exhibited higher comparative burden in retrospective vs. prospective protocols.
• Most requested data were obtainable, but some burden-influencing variables were unavailable.
• Time constraints presented a challenge during the data collection phase.

Conclusions:

• Establishing a larger database is crucial for therapeutic area/indication-specific comparisons.
• Investigating the impact of standard of care burden by indication is recommended.
• Encouraging sponsors to collect more accurate site-level participation burden data is essential.