On April 16, 2018, the FDA will hold a public meeting on “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The purpose of the meeting is to bring the stakeholder community together to discuss topics related to eligibility criteria in clinical trials and their impact on patient access to investigational drugs. The meeting will be held at the National Press Club in Washington DC, and there will also be a live webcast for those unable to attend in person. Register at https://healthpolicy.duke.edu/events/evaluating-inclusion-and-exclusion-criteria-clinical-trials (Federal Register)
FDA will hold public workshop on trial design & statistical methods in rare disease
On March 19, 2018, the FDA will hold a 1-day public workshop on “Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Settings.” The purpose of the workshop is to bring together rare disease stakeholders to discuss the challenges associated with the development and regulatory decision-making for rare disease treatments. The workshop will be held in Silver Spring, MD, and you may register to view a live webcast of the meeting if you are unable to attend in person. Register at https://healthpolicy.duke.edu/events/innovative-tools-and-statistical-methods-treatment-development-rare-disease-settings (Federal Register)