Children are not little adults, but due to a lack of pediatric clinical trials, children are often prescribed drugs that have only been approved for use in adults. Fortunately, more pediatric clinical trials are being conducted to study and approve more drugs for use in children. In some ways, clinical trials in children are identical to those conducted with adult participants. In other ways, they are drastically different. For example, scheduling a pediatric clinical trial requires careful consideration of families’ busy schedules and school calendars, and if a trial requires lengthy sessions, frustrated families may walk away. The strategies outlined below can improve the success of clinical trials in children by ensuring that a trial’s schedule addresses the needs of the pediatric population and their families.
Take Families’ Schedules into Consideration
For a clinical trial to be successful, it is important that the trial participants are available for the clinical visits and treatments established in the trial’s parameters. However, there are many things to work around when studying a pediatric population. First, it’s important to remember that children can’t miss an excessive number of school days to participate in clinical trials. Families also can’t control the hours of each school day, so the trial must accommodate their schools’ schedules. Trials scheduled during breaks from school (summer break, spring break, the holiday season) have higher rates of success. In addition, providing after-school time slots for clinical treatments can increase a trial’s success.
Families participating in clinical trials may also need to work around the parents’ work schedules and siblings’ school and activity schedules. Therefore, pediatric clinical trials with flexible and accommodating schedules are more likely to attract and retain participants.
Set Realistic Timelines
The overall length of a pediatric trial also impacts how many families join the trial and how many stick with it. Children and their families may not be able to tolerate lengthy trials or lengthy sessions, so it’s best to keep these to a minimum. A trial length of four or five months is ideal. In addition, full-day treatment sessions with complex procedures don’t often work well with young children. It’s best to keep clinical visits for children to about two hours or less.
Eliminate Obstacles to Alleviate Families’ Concerns
It’s common for families to drop out of pediatric clinical trials for a variety of reasons, so trials are more likely to succeed if they’re designed to minimize disruptions to family life. Trials should be as easy as possible to complete and incorporate pediatric-friendly trial protocols, such as the following:
- Minimize In-Patient Requirements: By exploring ways to observe and capture information outside of a clinical setting, trials can gather critical data with fewer participant visits. This may involve journal entries or remote monitoring devices.
- Shorten Placebo Periods and Offer Extensions: Long placebo periods may lead to families dropping out of a clinical trial, so shortening them can increase retention rates. In addition, families participating in blind trials are more likely to stick with it if they know the child will eventually receive a treatment, so offering a guaranteed extension will increase the likelihood that the child will finish the trial. Families want to feel that their participation in a clinical trial is worthwhile, and these strategies help satisfy that desire while also boosting the trial’s likelihood of success.
Setting realistic timelines, minimizing patient requirements and shortening placebo requirements are three key elements in successful pediatric clinical trials. Careful attention to these details will bolster and support your next pediatric clinical trial, paving the way for success.
Since 1995, QPS has provided discovery, preclinical, and clinical drug development services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. For more information, visit www.qps.com or email [email protected].