There is little consensus-based guidance on how to conduct patient engagement or assess whether an approach to patient engagement will yield meaningful results for all parties involved. From a researcher and drug developer perspective, little guidance exists to determine who should be involved, how and what role the patient community should have, and at what points in the process the patient community should be engaged.
From a patient community perspective, expectations are unclear about how their input will be used to inform the process. In addition, there is little understanding of how to build sustained capacity throughout the patient community for engaging in the research and drug development process.
To address this challenge, the NHC seeks to identify and implement best practices for integrating the patient voice into the conduct of research and health care decision making.
The NHC has undertaken an initiative to address current barriers to patient engagement through a multi-stakeholder approach by building a consensus-based conceptual framework for patient engagement and agreement on best practices in research and development in drug development. This approach has led to the development and submission of the first in a series of documents containing language recommended on patient engagement in drug development to the FDA.
The NHC also developed an information collection tool to help patient advocacy organizations systematically capture and organize patient concerns and comments about the benefits and risks of treatment options. The tool is designed to ensure that the FDA captures the comprehensive information it needs from patients, family caregivers, and patient advocates, and better engage patients in its work.