Two papers from CTTI’s Peds Trials work on barriers to enrolling children in clinical trials were recently published in Contemporary Clinical Trials Communications. Despite the fact that pediatric trials are required for new drugs, these trials can be especially difficult to design, enroll, and complete. CTTI’s papers explore the challenges from both the provider and parent perspective and suggest ways to overcome them.

• “Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative” shares findings from an online survey conducted by CTTI of pediatric providers across the U. S. The survey found that lack of awareness of existing pediatric trials was a major barrier to patient referral by providers, in addition to consideration of trial risks, distance to the site, and time needed to discuss trial participation with parents. The paper notes “understanding the barriers that limit pediatric providers from collaboration or inhibit their participation is key to designing effective interventions to optimize pediatric trial participation.”
• “Parents’ perceived obstacles to pediatric clinical trial participation: Findings from the Clinical Trials Transformation Initiative” discusses the results of in-depth interviews with parents who were approached to enroll their children in a clinical trial. The interviews found that establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents’ decisions. The paper recommends solutions related to budget allocations, staffing, and the consent process as ways to make parents’ priorities and considerations a central focus in clinical trials.

Based on feedback from parents, providers, and other stakeholders, CTTI developed actionable recommendations to address the challenges of enrolling children in clinical trials. These recommendations offer practical, evidence-based strategies that can be applied by research sponsors, investigators, and site staff to improve the quality and efficiency of pediatric trials.