The Challenges of Recruiting for Pediatric Trials

Welcome to the September 2026 edition of Citeline’s Patient Recruitment Pulse. In this monthly blog, we discuss the trends shaping today’s patient recruitment landscape. This month, we focus on the challenges and opportunities inherent in patient recruitment for pediatric clinical trials.

Recruiting patients for pediatric clinical trials presents unique obstacles. It can be hard to get the word out to parents of patients that a trial exists. Parents must give consent to allow their children to participate in a trial, and many hesitate to do so because their fear of potential risks outweighs their hope for potential benefits. Or they withhold their consent because the burden of participation is too overwhelming for them.

Sponsors who fail to prepare for these challenges when drafting pediatric clinical trial protocols are likely to face low enrollment and high dropout rates.

Make the trial more feasible

Building recruitment feasibility into the trial protocol is essential. An article in Pediatrics Nationwide recommends setting realistic patient volume, conversion rates, and staff support from the beginning. Overestimating any of these could lead to costly delays and possible trial failure.

This isn’t a one-time task. Any of these numbers could change as the trial progresses, so sponsors must be ready to make adjustments where necessary. Metrics to monitor, enabling quick shifts in recruitment strategy, include number of contacts, consent rates, and reasons for refusal.

Know where your patients are

Sometimes it’s necessary to go beyond the healthcare provider when seeking trial participants. In addition to pediatricians and parent advocacy groups, sponsors should consider targeted outreach to school nurses, parent-teacher associations, and childcare centers. Working with trusted community leaders can help gain access to more diverse patient populations.

To reach parents and caregivers, sponsors should couple traditional notification methods like flyers and ads with messages sent via text or social media. While parents aren’t likely to respond to direct calls or emails, they may respond to a text or contact through social media channels like a Facebook group about the disease. Parents who participate in online forums and support groups for their child’s disease (like Citeline’s Community Portal) may also be more open to receiving information about potential trials.

Participation in community health fairs or other local events is another way to inform parents of potential participants about clinical trials in a relaxed setting.

Make benefits and risks clear

Once contact is made with the parents, the challenge becomes convincing them to allow their child to participate. There are many reasons why parents may be leery of enrolling their child in a clinical trial. They may not want to risk their child ending up on placebo rather than the active treatment. Possible side effects, some of which can be serious, may give them pause. They may think the treatment their child already is receiving is good enough.

It’s up to the recruitment team to clearly explain the benefits and risks of the trial in language the parents can understand. When describing side effects, try to make clear the actual likelihood their child may experience those effects. Serious side effects tend to be rare, but to worried parents, even a 2% chance may seem too dangerous unless it’s explained in a way that shows them just how small a risk that is — especially when balanced against the real benefits the child may experience.

Keep in mind that, when age-appropriate, the child must also assent to participate in clinical trials. It may be a good idea to have materials specifically designed to explain the trial and its risks and benefits to the child. Make sure the child understands exactly what to expect from the trial so they can make an informed decision about participating. Visual elements can help, whether static images or video. For example, the Center for Information and Study on Clinical Research Participation (CISCRP) has a pediatric education video series that explains what a trial is, who is involved, what it means to consent to be in a trial, and what treatments are given in a trial.

Relieve burden where possible

Sometimes the parents and child are willing to participate in the trial, but the burden proves to be too great. The clinic site may be far away, making travel expensive and time-consuming. The amount of time needed for each clinic visit could be taxing to a child with disabilities or certain conditions. It could be difficult for the parents and child to take that much time away from work or school. If the parents have other children or elderly parents, trying to arrange for care for them could be too complicated and costly.

Conducting some site visits virtually can help relieve much of this burden, as can compensation for travel, time off work, or child/elder care. Also, consider a more decentralized trial model where the child receives care at a local site that meets the clinical and regulatory requirements of the study protocol.

Pediatric trials are demanding for both sponsors and patients. Following the right steps from the start can ensure pediatric patients and their parents enroll in the trial and remain committed participants throughout.