Ethics in Action: Building Patient Protection in Clinical Trials Through Therapeutic Expertise

Session details:

This panel will explore the essential role of medical and therapeutic expertise in ensuring patient protection throughout the clinical trial journey. Each stage of a trial—whether informed consent, study design, data management, or communication—involves an interaction between patients and the research community. Panelists will examine how ethical frameworks, regulatory standards, technology and patient-led strategies come together to protect participants, reduce burden, and build confidence in clinical research. By engaging representative patient voices, leveraging innovative and accessible trial designs, and committing to transparency, the discussion will underscore how therapeutic expertise can safeguard participants which clinical research depends on.

Key Messages

• Ethics and Expertise Go Hand in Hand: Protecting patients is both an ethical duty and a cornerstone of credible science. Therapeutic and medical expertise must be applied not only to advancing science but also to anticipating risks, respecting autonomy, and ensuring participant well-being.
• Patient-Centered Design Minimizes Burden: Thoughtful trial design—including flexible, decentralized approaches and culturally/linguistically sensitive protocols—reduces unnecessary burden, expands access, and increases inclusivity.
• Transparency and Accountability Drive Equity: Representative participant selection and clear justification for exclusions improve generalizability of outcomes. Transparency in design, data use, and results builds trust across diverse patient communities.
• Engagement is Continuous, Not One-Time: From informed consent to study closure, ongoing communication and respect for participant decisions ensure that patients remain true partners in research, patient input is integral to ethical frameworks, not an add-on.
• Innovation Must Align with Protection: Emerging tools like AI, digital consent platforms, and advanced data-sharing approaches must be harnessed responsibly to strengthen—not compromise—patient rights, privacy, and safety.