The FDA's Patient Engagement Advisory Committee (PEAC) met on October 30, 2024, to discuss improving patient-centered informed consent in clinical studies of FDA-regulated medical products. The meeting focused on strategies to enhance trial participant engagement and understanding, moving beyond the traditional view of informed consent as a mere formality.
Patient-Centric Approach and FDA Initiatives
FDA Commissioner Robert M. Califf, M.D., urged sponsors to embrace "shared decision-making" and involve patients in shaping research policies. Michelle Tarver, M.D., PhD., Director of FDA’s Center for Devices and Radiological Health (CDRH), highlighted initiatives such as "Home as a Healthcare Hub" and a recent CDRH paper on Health Equity, emphasizing inclusive and accessible healthcare solutions. The FDA's Office of Clinical Policy stressed that informed consent should be a continuous dialogue, referencing the FDA’s March 2024 Guidance on Informed Consent and the potential of e-consent to improve accessibility.
Addressing Gaps in Informed Consent Practices
Despite advancements in guidance, real-world consent processes often fall short in ensuring patient understanding. Factors contributing to this include lengthy, complex forms, communication barriers, and non-tailored information. The committee addressed several key points to bridge these gaps:
- Gaps in Practice: Speakers noted a significant challenge in improving participant comprehension and engagement, despite substantial research and new FDA guidance. Measures to address this include a proposed rule in 2022 suggesting key information at the start of consent documents and updated guidance in 2023 emphasizing varied media and simplified language.
- Patient-Centric Approach: The meeting underscored the need to communicate in a way that fosters actual understanding, requiring additional resources and time to develop patient-centric materials.
- Challenges with Adherence: Ensuring comprehensive and accessible informed consent involves creating supplemental materials, which can be resource-intensive for trial sponsors.
- Accessibility and Inclusivity: Speakers discussed pathways for participation inclusive of individuals with disabilities, outreach efforts to rural communities, and ensuring cultural competency in consent documents.
Best Practices for Informed Consent Forms
The presenters discussed best practices for creating effective informed consent documents, aligning with FDA guidance and targeting enhanced patient comprehension and engagement. Key recommendations include:
- Essential Provisions: Forms should explain why participants should consider joining, whom to contact with questions, and post-trial considerations.
- Summaries: Providing brief summaries at the beginning and end to reinforce key points.
- Question-Based Headings: Framing headings as questions to structure information in a participant-friendly way.
- Visual Aids: Including diagrams, pictures, and illustrations to help participants understand complex information.
- Translations: Making the document available in the primary languages of the participants.
- "Key Information Section": Including a "key information section" at the beginning, as suggested in FDA’s 2024 draft guidance.
- Use of Electronic and Visual Media: Utilizing videos, animations, and interactive online formats.
- Effective Communication: Using clear, concise language and encouraging ongoing discussions between participants and trial staff.
- Patient Community Input: Involving patients early in the process to determine critical information.
- Measuring Comprehension: Gauging effectiveness through questions, quizzes, or dialogue.
Special Considerations for Medical Devices
For studies involving medical devices, particularly those with long-term or permanent implants, the informed consent process requires additional considerations:
- Addressing the post-trial period and ongoing care.
- Explaining whether the device is explantable.
- Clarifying potential interoperability issues.
- Specifying whether the device collects real-time data and how it will be used.
- Providing long-term contact information for support.
- Providing longitudinal information to maintain participant engagement.
Future Directions
The FDA is committed to partnering with stakeholders to ensure informed consent documents and processes consider the needs of a broad range of prospective clinical trial participants. This involves innovative and flexible approaches and gathering input from patients and their communities early in the product development lifecycle.
