The findings synthesize key outputs from a dialogue event held on March 2 at the Food and Drug Administration (FDA) where stakeholders representing the patient advocacy community, federal government, academia, research community and industry convened to discuss challenges associated with meaningful patient engagement in drug research, development and approval.

Three primary barriers to meaningful patient engagement were identified:

1. Uncertainty regarding how the FDA will evaluate patient-provided data during the product approval process
2. Cultural divide among stakeholders over the use of patient information
3. Lack of communication among stakeholders and the general public on patient engagement methods, best practices and successes

To begin to address these barriers, the group suggested action steps that target specific issues:

• Create regulatory guardrails and enhance FDA division alignment on the use of tools for evaluating patient information
• Promote a culture shift to encourage buy-in of patient engagement by holding stakeholders accountable for collecting and integrating patient perspectives and educating researchers
• Employ tactics for facilitating open communication by creating a feedback system to inform patients of how their contributions impact decisions as well as making patient engagement successes and best practices comprehensible and publicly available

As awareness of the challenges around meaningful patient engagement grow, the healthcare community is continuing to take steps in the right direction to address these gaps. This guidance represents an initial conversation among stakeholders to begin to close the considerable information and communication gap and build consensus around a vision for advancing patient engagement.