Improving pediatric clinical trials

What are your ideas to improve pediatric clinical trials?

I personally think we should throw out the current table of procedures in pediatric clinical trial protocols and start fresh.

I had a great conversation a couple of weeks ago with a study coordinator. She was explaining to me that she was struggling with the electronic source documents for a pediatric study visit. Using the tablet and staring at the screen the whole time during the visit interfered with her ability to connect with the child and the parent. She finally put the device down, ignored it for a while and just focused on playing with the child.
The use of electronic medical records and e-source is a topic for a future post, but her story got me thinking. Pediatric clinical trials are very unique. Unfortunately, the clinical trials industry typically approaches them by taking an adult protocol and just decreasing the entry age in the inclusion criteria.

Pediatric studies are so different than adult studies. To start with, the visits take twice as long as adult study visits. Even with all the procedures being identical, they are much longer.

Here are some of my suggestions for new entries into pediatric protocols:
1.    For studies with young participants: Play time listed in the table of procedures – Instead of just rushing into the visit let’s take the time to connect with the child. It’s not about getting the visit done, it’s about getting into their world and helping them feel at ease and important.
2.    Listen time – most parents are quite anxious about anything medical related to their child. Set aside specific time to listen to them and address their concerns.
3.    Check in phone calls. Especially early in the study, call and speak with the parent / guardian to see how things are going. This can also be a time to answer more questions.
4.    Coloring contests. Create events to engage and educate. (BTW – every kid wins a prize in the coloring contest)
5.    Party time. When the study is done, (or midway through a long study) host a party catered to the age of the participants. Not only do the kids love these, it allows the parents & guardians to connect with each other.
6.    After the study when the results are released include communication to share the results – wait a second, that should happen for every study…

I’d love to hear your thoughts on improving pediatric studies. Please share your ideas.