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[Group meetings for patient recruitment in clinical trial in pediatrics]
J P Collet1, D Floret, P Cochat
1Unité de Pharmacologie Clinique, Lyon.
Insights
Recruiting infants for clinical trials requires clear communication. Group meetings with physicians explaining study details significantly improved pediatric patient recruitment rates.
Area of Science:
- Pediatric clinical trial recruitment
- Informed consent in research
Background:
- Patient recruitment for clinical trials presents challenges, particularly in pediatrics.
- Obtaining informed consent from parents for infant participation is complex.
Purpose of the Study:
- To describe a method for recruiting infants into a randomized clinical trial.
- To assess the effectiveness of group meetings in enhancing pediatric recruitment.
Main Methods:
- Organized group meetings with families (4-40 participants) to explain study procedures.
- Discussions covered random allocation, double-blind assessment, and follow-up.
- Meetings were led by a pediatrician and a clinical trial specialist.
Main Results:
- Forty-nine percent of eligible infants were recruited into the study.
- Success was linked to open communication and physician qualifications.
Conclusions:
- Franc and open communication with families by qualified physicians is key to successful pediatric recruitment.
- Group meetings effectively informed parents and facilitated informed consent for clinical trials.
Abstract:
Recruitment of patients in a clinical trial is often difficult and probably more difficult in pediatrics where parents are asked to give the informed consent. In order to recruit infants in a randomized clinical trial we organized group meetings with families (4 to 40 at a time) in order to describe the study procedures: random allocation to treatment or placebo and double blind assessment, and ask them to allow their child to participate. All meetings were conducted by both a pediatrician and a RCT specialist. Parents asked questions about the effects of the drug, the evaluation process and the follow-up procedures. Forty nine % of all eligible infants participated in the study. The success rate was related to franc and open communication with the family, provided by highly qualified physicians.