What is the role of patients or participants in shaping clinical trial design according to ICH E6?

In the context of ICH E6 guidelines, the role of patients or participants in shaping clinical trial design is primarily to ensure that research is relevant to their needs. This emphasizes the importance of incorporating the perspectives and experiences of those who are directly impacted by the trial treatments and interventions. By doing so, the designed studies can address actual patient concerns, outcomes, and priorities, leading to more effective and meaningful research.

The involvement of patients ensures that the trials target relevant health issues and that the methodologies used are patient-friendly, which can improve recruitment, retention, and overall outcomes. Their input often guides the selection of endpoints that matter most to them, contributing to the overall significance and applicability of the trial results.

While feedback for regulatory purposes, assistance in data collection, and help with data analysis might involve participants to some extent, their core role is fundamentally about ensuring that the clinical research aligns with patient needs and expectations. This patient-centered approach fosters trust and enhances the ethical conduct of clinical trials, ultimately leading to more patient-centric healthcare innovations.