Cohorts of young children and their caregivers are infamously challenging. Pediatric study teams struggle to meet the needs of everyone involved—from wiggly toddlers to harried parents—to bring safe, effective products to market.
The good news: Decentralized clinical trials (DCTs) offer an effective avenue to mitigate the issues that typify pediatric clinical trials, including recruitment, engagement, retention, and patient-reported data accuracy.
Our experience designing and conducting several successful pediatric DCTs is the proof. Let’s dive into three of ObvioHealth’s recent pediatric studies to understand these common obstacles—and learn how study teams can overcome them with a DCT model.
Recruitment for clinical trials is consistently challenging across therapeutic areas and treatment modalities. But, marketing a research opportunity to caregivers of young children is uniquely difficult—especially because of the perceived participant burden.
Recruiting those who meet enrollment requirements and have the bandwidth to participate is particularly daunting. Understandably, some caregivers are hesitant to enroll their children in clinical research activities. Procedural requirements for multiple caregivers also affect the informed consent process, further inhibiting effective recruitment.
Because delays in recruiting the necessary sample size can increase costs and disrupt timelines, these realities can pose real difficulty for sponsors.
Study teams can break through the recruitment barrier by 1) pivoting outreach to meet caregivers where they are, and 2) offering a convenient, no-fuss enrollment process.
For ObvioHealth’s study with a global consumer health & pharmaceutical brand, we deployed a virtual study design and targeted digital recruitment. Rather than deploying traditional recruitment strategies, the team designed digital advertising assets to capture the attention of mothers with infant children prone to diaper rash. The ads — displayed on social media — flowed seamlessly to a landing page that included information about the study and a pre-screening questionnaire.
The strategy worked: 300 participants enrolled in less than two months. Driven by this highly engaged participant pool, the study substantiated the sponsor’s health claim—paving the way to a successful product launch.
Digital recruitment that leads participants into a digital enrollment process, and ultimately a digital trial, creates a consistent, predictable experience that ultimately supports engagement, retention, and compliance.
Even after recruiting the necessary sample size, keeping this cohort engaged in a study requires an intentional strategy. It bears repeating that caregivers are busy, and study participation can easily slip down the to-do list.
But, noncompliance and participant drop-off jeopardize a study’s success. That’s why digital technology must work together with human-centered study design to support families.
Study teams can drive engagement and retention by putting participants’ needs front and center. For young families, convenience is not a luxury; it’s a necessity.
We’re seeing this firsthand in our work with a consumer health company, for whom we’re assessing the efficacy and tolerability of prebiotic supplementation among formula-fed infants. This virtual observational study is designed to be as easy as possible for the cohorts to ensure engagement, compliance, and retention.
With that in mind, the trial tasks blend seamlessly into caregivers’ and patients’ regular lives. Instead of traveling to a clinic for appointments, as they would in a site-based study, caregivers are using ObvioHealth’s app to capture and submit stool images and electronic diaries with a few taps on their phone.
After the data is submitted, two gastroenterologists conduct expert rating on these electronic patient-reported outcomes, known as ePRO. (These expert ratings are key in mitigating the increased tendency among caregivers toward a placebo effect, as we demonstrated in a subsequent research project.)
Our virtual site team, COACH, has been available throughout the study to monitor data submission and patient engagement. As a key component of our DCT model, COACH team members check in to remind participants of upcoming tasks, answer questions, and encourage patients’ progress.
Patient-reported outcomes and their digital equivalent, ePRO, are vulnerable to human error. Data from participants is inherently subjective, and discrepancies among participants’ outcomes can call data quality into question.
In addition, collecting and submitting outcomes can be burdensome for caregivers without the proper tools. These challenges can threaten data accuracy and, ultimately, trial endpoints.
Study teams can streamline data collection and reporting using a DCT or hybrid approach, which blends traditional and DCT elements. Simple ePRO tools, such as digital questionnaires, make it easy for participants to generate the necessary data.
A recent ObvioHealth study shows this approach in action. We’re partnering with an infant nutrition company on a fully virtual trial to measure and evaluate colic symptoms in breastfed infants who consume a specialized probiotic product.
The first of its kind, this study leverages digital instruments and AI to reduce participant burden and subjectivity in patient-reported outcomes. We’re deploying decentralized methodologies throughout to ease participant burden while also ensuring their safety.
An audio recording device built into an infant onesie automatically records infant cries. This unstructured data is then submitted using the ObvioHealth app and processed via algorithm to measure cry duration, removing opportunities for caregiver subjectivity and false recall. Caregivers are also using the ObvioHealth app to report their babies’ quality of life and health status at the touch of a button. And, as always, our COACH team is present to monitor this data for possible adverse events.
Pediatric research presents several hurdles for study teams, from logistical challenges and caregiver misgivings regarding pediatric research, to concerns around data accuracy. The DCT model directly addresses these challenges—opening new opportunities to validate breakthrough treatments that make a meaningful difference for children and caregivers.
Read about our observational study on infant diaper rash, our work with a consumer health company, and our clinician versus caregiver ratings research. Also related: Digital Diagnostic Solutions for Childhood Pneumonia, Digital Trial Solution