Implementation Strategies for Strengthening Community and Stakeholder Engagement in Clinical and Translational Pilot Studies.

This article details participatory strategies in modestly funded, short-term studies that shape larger clinical and translational research. Specifically, we document engagement practices and strategies used in small-scale pilot studies for which the funder required applicants have a community and stakeholder engagement (CSE) plan. Drawing on the broadly-engaged team science framework, we identify practices that facilitate engagement in these studies, challenges, and potential strategies for addressing identified challenges. Investigators can implement many of the identified practices and strategies, whereas others require system-level changes by funders and/or research support organizations. At the project level, investigator practices that facilitate initial engagement include seeking alignment between stakeholder priorities and study goals and using existing personal and professional networks. Sustained and valuable CSE is enabled by drawing on relevant stakeholder expertise, clear PI communication, and building collaborative teams. Challenges and potential solutions include conducting effective team meetings, particularly with larger groups, which could be optimized by building and sustaining authentic stakeholder relationships prior to online interactions. Additionally, seeking to understand and be responsive to stakeholders' perspectives on what makes engagement meaningful - at the beginning and throughout the study - is essential to build trust and facilitate productive and authentic engagement. Funders and research support organizations play important roles in shaping a research context conducive to authentic stakeholder participation. For example, investigators experience challenges with engagement throughout a study lifecycle, and research support organizations can provide accessible CSE expertise. Establishing new stakeholder contacts is a barrier for many investigators, and funders and research support organizations can address this by training investigators, facilitating connections, and preparing stakeholders for engagement. Insufficient CSE funding, limited stakeholder capacity, and barriers to non-scientist engagement due to standard research practices present additional obstacles that require funders to promote the cultural change required to foster engagement. These participatory strategies and recommendations can facilitate the implementation of CSE into the full translational process by beginning with preliminary studies.