Enhancing the Incorporation of Patient Perspectives on Clinical Trials; Public Workshop; Request for Comments

摘要

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Enhancing the Incorporation of Patient Perspectives on Clinical Trials" and an opportunity for public comment. The workshop will be convened by the Clinical Trials Transformation Initiative (CTTI). The topic to be discussed is stakeholders' (including patients, caregivers, industry, academic researchers, and expert practitioners) perspectives on challenges and barriers to patients participating in clinical trials and best practices and key considerations for enhancing the incorporation of patient perspectives on clinical trial access, design, conduct, and post-trial followup. The workshop will result in a publicly available report from CTTI on proceedings and recommendations from discussions at the workshop. This workshop is intended to meet an FDA commitment included in the sixth authorization of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI).