Diversity Plan Survey Question Title * 1. Which of the following best describes your organization? Pharmaceutical company Biotechnology company Medical device company CRO Consulting Government Academia Other (please specify) Question Title * 2. Are you familiar with FDA expectations regarding Diversity Plans? Yes No Question Title * 3. Has your organization developed a Diversity Plan? Yes; we have submitted a plan to FDA Yes; we have a plan in development No Not sure Not applicable Question Title * 4. Which function in your organization has primary responsibility for developing Diversity Plans? (May select more than one response.) Biostatistics Chief Development Officer Chief Executive Officer Clinical Development Clinical Operations Medical Affairs Medical Writing Project Management Regulatory Affairs Other (please specify) Question Title * 5. What are the most difficult challenges your organization has encountered in developing Diversity Plans? (May select more than one response.) Demographics of the disease/condition are not well defined Lack of funding Lack of management buy-in Lack of ownership (responsibility is not clear) Lack of personnel or training Lack of precedent or no established procedures Lack of time Unclear regulatory guidance Other (please specify) Question Title * 6. In your organization’s experience, what are the results of failing to achieve enrollment goals defined in a Diversity Plan? FDA requested reanalysis using additional data Postmarketing Requirement (PMR) to better understand safety/efficacy in a more representative population Postmarketing Commitment (PMC) to better understand safety/efficacy in a more representative population Complete response letter There have been no requests from the agency Not sure Not applicable Other (please specify) Question Title * 7. If FDA has requested changes to a Diversity Plan your organization submitted to the agency, which of the following sections were most impacted? (May select more than one response.) Overview of disease/condition Scope of medical product development program Goals for enrollment of underrepresented racial and ethnic populations Specific plan of action to enroll and retain diverse participants Status of meeting enrollment goals Not applicable (we have not submitted a Diversity Plan) Not applicable (no changes were requested by the agency) Other (please specify) Question Title * 8. At what point has your organization first sought FDA advice or feedback on a Diversity Plan? Pre-IND meeting EOP1 meeting EOP2 meeting Pre-NDA/BLA meeting Special Protocol Assessment Informal communication Not sure Not applicable Other (please specify) Question Title * 9. What data sources has your organization utilized to devise enrollment goals for Diversity Plans? (May select more than one response.) Data from previous clinical trials Electronic health records/electronic medical records Medical claims data Patient registries Scientific literature Not sure Not applicable Other (please specify) Question Title * 10. Has your organization succeeded in meeting enrollment goals defined in a Diversity Plan submitted to FDA? Yes No Partially (met enrollment goals for ≥1 subgroups) Not sure Not applicable Other (please specify) Done