Management of Increasing Complexity of Phase I Trials: A Retrospective Analysis from the Niguarda Cancer Center Phase I Unit

Key Points

• The analysis shows a notable increase in complexity within phase I trials over recent years, affecting clinical outcomes.
• Key metrics indicate that specific management strategies have been associated with successful adjustments to this complexity.
• Through a retrospective analysis of data from the Niguarda Cancer Center Phase I Unit, trends and outcomes were systematically evaluated.
• This highlights the urgent need for adapting clinical trial management to ensure optimal patient safety and data integrity.