Development and impact of an intervention to boost recruitment in a multicenter pediatric randomized clinical trial

Area of Science:

• Clinical research methodology
• Pediatric clinical trials
• Recruitment strategies

Background:

• Recruitment is crucial for the quality, generalizability, and cost-effectiveness of clinical research.
• Effective recruitment strategies and assessment tools for randomized clinical trials (RCTs) are lacking, especially for pediatric studies.
• Challenges in patient recruitment can hinder the progress and validity of clinical research.

Purpose of the Study:

• To develop and evaluate an intervention aimed at enhancing patient recruitment in multicenter pediatric randomized clinical trials (RCTs).
• To assess the sustained impact of the recruitment intervention beyond the initial 120-day period.

Main Methods:

• The study involved 17 academic centers participating in a pediatric RCT.
• An intervention utilizing a recruitment assessment tool was implemented during site visits or teleconferences with key personnel.
• Patient enrollment numbers were tracked to evaluate the intervention's effectiveness.

Main Results:

• A statistically significant increase in patient enrollment was observed across all 17 sites at 120 days postintervention (mean increase of 1.12 participants per site, P = .04).
• No significant differences in recruitment rates were detected beyond the 120-day mark.
• The intervention demonstrated effectiveness in boosting enrollment within the initial 120-day timeframe.

Conclusions:

• The developed recruitment intervention can effectively enhance patient enrollment in RCTs.
• Sustained recruitment beyond 120 days may necessitate repeated implementation of the intervention.
• This study addresses the need for evidence-based recruitment strategies in clinical research, particularly for pediatric populations.