Initial Steps in Creating a Patient-Centric Addendum to Clinical Trial Informed Consent Forms

Area of Science:

• Clinical trial methodology
• Patient advocacy and engagement
• Health literacy and communication

Background:

• Informed consent forms (ICFs) are crucial for outlining clinical trial risks and benefits.
• Current ICFs can be lengthy and complex, potentially hindering patient understanding.
• Improving the accessibility of trial information is essential for informed decision-making.

Purpose of the Study:

• To assess the feasibility of a concise addendum to ICFs.
• To identify key information most relevant to potential clinical trial participants.
• To explore patient perspectives on improving ICFs.

Main Methods:

• Reviewed 20 ICFs for readability and compliance with U.S. federal regulations.
• Conducted focus groups and interviews with 9 lung cancer patients using a hypothetical Phase 3 ICF.
• Assessed patient preferences for information inclusion in an ICF addendum.

Main Results:

• ICFs averaged 21 pages with a 10th-grade reading level, exceeding the U.S. average of 8th grade.
• Patients reported feeling "overwhelmed" by lengthy ICFs.
• A patient-suggested addendum, referencing detailed ICF sections, was well-received.

Conclusions:

• Variations in ICF structure and readability impede informed patient decisions.
• Developing a patient-centric addendum can enhance understanding and trial participation.
• Findings offer a roadmap for improving ICFs beyond lung cancer trials.