To ensure quality in trial design, what should sponsors do?

• A. Identify critical factors to quality and manage risks to those factors.
• B. Focus on rapid recruitment at any cost.
• C. Avoid input from stakeholders.
• D. Limit data collection to only essential variables.

Answer: (A)

In trial design, applying a risk-based, quality-by-design approach means identifying the factors that most influence quality and actively managing the risks to those factors. This upfront focus helps protect participant safety and ensure data integrity from the start, reducing the chance of issues arising during the study. That makes identifying critical factors to quality and controlling risks to them the best approach. Rapid recruitment at any cost can undermine procedures and data quality, while stakeholder input is essential for a feasible, acceptable plan, and data collection should be sufficient to meet analyses and regulatory needs rather than unnecessarily limited.