Delivering a talk on the best ways to collect data from children in clinical trials, CRF Health’s VP, product and service manager, Paul O’Donohoe said ePRO (electronic patient-reported outcomes) is the best method.
He said: “There is this increasing need to prove drug efficacy in children, and ePRO is a powerful solution.
“Taking into consideration the differences, you need to adapt the design of your study to the age group. A program can autonomously adapt to the correct age range, displaying the scale most suitable for the child".
O’Donohoe added that making electronic data collection more engaging for the child is the key to keeping compliance levels high adding, “You want them to see that they are progressing and that they are not just putting data into boxes. You want to give rewards”.
However he admitted that making the program “fun” is often a mine field for researchers, suggesting that the only way forward is to ask the experts.
Speaking to Outsourcing-Pharma about the potential of partnering with gaming firms to design the data capture he said: “We have actually talked to some computer game developers and they were the ones who interestingly drove home the whole don’t try to make it fun point, because unless you are that age group, it’s tough to know what is fun to them.
“I think there is scope in the idea of this whole gamification of every day life where you get feedback and some kind of rewards, points or something, for doing an every day task they don’t necessarily enjoy doing and get some kind of reward somehow.”
He said that though there has been no solution yet, he is sure there will be developments in the not-too-distant future.
For older children and teenagers, integrating programs into their own devices, such as cell phones, is also something paediatric trial developers are looking into more, O’Donohoe added.
“Teenagers and children are very technology savvy now, and they are very comfortable putting information into their own device,” he said.
Issues
Though there are obvious benefits to the use of ePRO for paediatric clinical trials, instrument validation is a long going issue O’Donohoe added.
“You must have different scales for different subsets,” he said. “Infants can’t talk, small children can’t talk but can communicate, older children can be mindful of what they are presented with, teens can give complex data but you often run into motivational problems.”
A common issue, he said, is proving the equivalence between those difference scales.
But with a high compliance rate, O’Donohoe said this is a mere glitch in an otherwise successful method.
He said: “ePRO trials have high compliance – 90 per cent or more in recent studies for us. You can program in alarms and reminders on the device, and most importantly they are interactive and adaptable.”