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.