Development of a protocol complexity tool: a framework designed to stimulate discussion and simplify study design.

Area of Science:

• Clinical trial management
• Pharmaceutical research
• Regulatory science

Background:

• Clinical trials are becoming increasingly complex, lengthy, and costly.
• This complexity leads to significant delays in trial implementation, execution, monitoring, recruitment, data cleaning, and interpretation.
• There is a need for tools to streamline clinical trial processes without compromising scientific integrity or data quality.

Purpose of the Study:

• To develop a Protocol Complexity Tool (PCT) to objectively measure and simplify clinical trial protocols.
• To assess the impact of the PCT on trial complexity and key performance indicators.

Main Methods:

• A collaborative design process involving 20 cross-functional experts developed the PCT, featuring 26 questions across 5 domains.
• The PCT was applied to 16 difficult phase II-IV clinical trials, calculating individual domain and total complexity scores (TCS).
• Correlation analysis assessed the relationship between TCS and trial indicators like time-to-site activation and participant enrollment.

Main Results:

• The PCT reduced Total Complexity Score (TCS) in 75% of assessed trials.
• Complexity decreased most significantly in operational execution and site burden domains.
• Higher TCS correlated with longer time-to-site activation and participant enrollment.

Conclusions:

• The developed Protocol Complexity Tool (PCT) provides an objective, consistent, and transparent method for measuring study protocol complexity.
• The PCT facilitates protocol simplification, enhances collaboration among stakeholders, and increases confidence in trial designs.
• The tool is expected to support earlier discussions for developing more executable and cost-effective protocols.