Challenges, benefits, and factors to enhance recruitment and inclusion of children in pediatric dental research.

BACKGROUND: Historically, children have been excluded from clinical research. Many drugs and procedures have not been tested on children. The International Conference on Harmonization and the Food and Drug Administration guidance now stress that children should be included in research unless there is a reason for exclusion. Compared to adults, recruitment of children at different life stages requires different considerations. OBJECTIVE: To review published studies and gray literature to identify pediatric recruitment strategies and develop recommendations. RESULTS: There is limited clinical research literature available to recommend recruitment strategies and methods for pediatric trials. Formal guidelines for reporting recruitment activities in publications are scant. Recommendations are made based on current practices regarding protocol design, obtaining consent and engaging child, parent and caregiver in research. CONCLUSIONS: A scientific approach is needed to determine the best design for recruitment of pediatric clinical studies. Investigators should report and publish recruitment and retention strategies that facilitate this important aspect of the research process to increase transparency, efficiency, and identification of the most effective methods for dental researchers.

Community Advisory Boards Guiding Engaged Research Efforts within a Clinical Translational Sciences Award: Key Contextual Factors Explored.

BACKGROUND: Engaging stakeholders in research carries the promise of enhancing the research relevance, transparency, and speed of getting findings into practice. By describing the context and functional aspects of stakeholder groups, like those working as community advisory boards (CABs), others can learn from these experiences and operationalize their own CABs. Our objective is to describe our experiences with diverse CABs affiliated with our community engagement group within our institution's Clinical Translational Sciences Award (CTSA). We identify key contextual elements that are important to administering CABs. METHODS: A group of investigators, staff, and community members engaged in a 6-month collaboration to describe their experiences of working with six research CABs. We identified the key contextual domains that illustrate how CABS are developed and sustained. Two lead authors, with experience with CABs and identifying contextual domains in other work, led a team of 13 through the process. Additionally, we devised a list of key tips to consider when devising CABs. RESULTS: The final domains include (1) aligned missions among stakeholders (2) resources/support, (3) defined operational processes/shared power, (4) well-described member roles, and (5) understanding and mitigating challenges. The tips are a set of actions that support the domains. CONCLUSIONS: Identifying key contextual domains was relatively easy, despite differences in the respective CAB's condition of focus, overall mission, or patient demographics represented. By contextualizing these five domains, other research and community partners can take an informed approach to move forward with CAB planning and engaged research.