Pediatric clinical studies need to be tailored to the needs of children and their families.
A recent study from the American Academy of Pediatrics found that 20 percent of pediatric trials were canceled mid-study, and 30 percent went unpublished. Of the 20 percent that were discontinued, recruitment difficulties were cited as the primary reason.
Enrollment of children into clinical trials is challenging. There are ethical concerns around their participation, and many parents feel hesitant to consent to therapies outside of the standard of care.
This, among other pain points, means there isn’t enough clinical data on this younger population. As a result, children are treated like “smaller adults” - often prescribed adult medications in smaller doses.
This needs to change. ObvioHealth has conducted multiple studies in pediatrics, and we’re committed to continuing our research for the health of our future generations.
A fortune 500 sponsored study to understand infant stools and inform better product development. 100 mothers and their infants and toddlers used the ObvioHealth app to upload images of their childrens’ stools.
1000 healthy infants and toddlers provided ePRO data to assess the prevalence and management of FGIDs, their impacts on QoL, and efficacy of treatments.
Caregivers recorded their infants’ crying /fussing frequency 2-4 times higher than audio-recorded events.Read Full Case Study
Virtual data collection was used to produce evidence necessary to substantiate two new consumer-centric claims.
1200 parents were digitally recruited for a web-based survey from four countries (Mexico, Colombia, Peru, and Dominican Republic) in less than one month.
Data was collected virtually through a chat function in the app that asked participants daily questions about stress levels, infant nutrition and sleep.
Our proprietary application brings clinical research into people’s homes, making it easier for them to participate, and easier for researchers to collect robust data sets which reflect real behaviors.
Recruitment is often a huge barrier to trial success. ObvioHealth uses digital targeting methods to find untapped family populations. We identify the online behaviors of parents that point to their positive pre-disposition for a specific trial and, because our studies are virtual, we are not geographically tied to site locations.
Once recruited, we enroll families through virtual prescreening/screening and e-consent. This eliminates the burdensome cost of site retention and staffing requirements, and often shortens the recruitment period.
Parents are more willing to contribute to research, knowing they and their children can participate from the comfort of their homes without the burden of traveling to site visits.
The ObvioHealth platform and app incorporates multiple data capture technologies to adapt to the needs of any given trial. These include simple survey-type completion of questionnaires and diaries, image, video and audio capture and use of wearables. This virtual data collection method means infants or children and their caregivers can participate without ever leaving their homes.
We understand parents are busy so we make our app intuitive and easy-to-use. This convenience increases our compliance & retention rates. We send push notifications to help remind participants to complete study activities. Our study team is always available to answer questions.
Our platform makes it easy to trigger, track and manage products and payment of incentives. ObvioHealth can reimburse participants with the stipend program that is fully virtual. We ship any needed study supplies or devices directly to the participant’s home.
An important advantage of ObvioHealth’s app is the real time remote monitoring of medication adherence and potential adverse events. Our escalating system of reminders and immediate AE/SAE detection make our studies safer, while also improving medication adherence.
Our easy-to-use, convenient app makes it easier for children and caregivers to remain compliant. There is little to no time wasted travelling to clinical sites, so there are fewer drop-outs. All of this means that studies end on time or ahead of schedule. And because participants are able to report more real world and real time experiences, the resulting data is more accurate and reliable.