Lasagna's law: A dish best served early

Area of Science:

• Clinical research
• Healthcare management
• Regulatory affairs

Background:

• Lasagna's Law, introduced over 40 years ago, continues to influence clinical trial patient recruitment.
• Patient recruitment remains a significant hurdle in conducting clinical trials effectively.
• Understanding historical and current challenges is crucial for improving trial success rates.

Purpose of the Study:

• To identify critical roadblocks in patient recruitment for clinical trials.
• To categorize these recruitment challenges based on the stakeholders involved.
• To propose actionable strategies for identifying and mitigating patient recruitment risks.

Main Methods:

• Literature review of clinical trial recruitment challenges.
• Stakeholder analysis to categorize identified roadblocks.
• Risk assessment and mitigation strategy development.

Main Results:

• Identified key barriers to patient enrollment in clinical trials.
• Grouped recruitment obstacles according to relevant stakeholders (e.g., patients, investigators, sponsors).
• Developed a framework for proactive risk management in patient recruitment.

Conclusions:

• Addressing stakeholder-specific recruitment barriers is essential for optimizing clinical trial timelines.
• Proactive identification and mitigation of patient recruitment risks can enhance trial efficiency.
• Modernizing recruitment strategies is necessary to overcome persistent challenges in clinical research.