Recruitment in pediatric clinical research was influenced by study characteristics and pediatricians' perceptions: a multicenter survey.

ABSTRACT

OBJECTIVES: The aim of this survey was to quantify refusal rates and identify factors of refusal pertaining to studies and recruiting pediatricians in the research recruitment process. STUDY DESIGN AND SETTING: We performed a cross-sectional survey on all clinical studies conducted in six pediatric Clinical Investigation Centers in France over an 18-month period. Data were retrieved using a data collection form for the characteristics of each of the studies included in the survey and a questionnaire addressed to recruiting pediatricians. Multilevel models were used for the statistical analysis. RESULTS: Overall, 145 pediatricians approached the families of 999 children and adolescents for participation in 44 studies. In the 36 of the 44 studies that enrolled subjects, median refusal rate was 12.5% (Q1-Q3, 0-28%). Lower refusal rates were associated with therapeutic drug use as the focus of the study [odds ratio (OR), 0.51; 95% CI 0.25, 1.05], additional hospital stays required for the study (OR, 0.53; 95% CI 0.28, 0.99), longer duration of the inclusion visit (OR, 0.93/10 min; 95% CI 0.87, 1), and recruitment by a pediatrician with university teaching responsibilities (OR, 0.26; 95% CI 0.10, 0.68). Refusal rate was higher when the recruiting pediatrician perceived the study as generating heavy practical burden for the subject and/or its family (OR, 1.3; 95% CI 1.17, 1.45). CONCLUSION: Refusal to participate in clinical research was low and was influenced by factors associated to the objectives and conduct of the studies and factors related to the characteristics and perceptions of the recruiting pediatricians.