The COVID-19 pandemic forced a sudden shift in the conduct of clinical trials to ensure patients stay safe and retain access to their treatments. But how has this shift affected trials that focus on pediatric populations? To better understand the voice of pediatric patients, our team recently held an interactive, web-based workshop focusing on COVID-19 with young members of the International Children’s Advisory Network (iCAN). This article discusses the results of this initial survey and highlights our plans for a more in-depth, global survey to better understand this demographic’s thoughts about clinical trial participation during this unique time.
The importance of capturing the pediatric patient perspective
Important perspectives are often overlooked – and valuable insights lost – when clinical trial planning happens without participant involvement. Children, adolescents and young adults often lack the opportunity to contribute to planning discussions, and because of this, their voice is not heard. Given that pediatric clinical trials have fewer patients and have only been mandated for a relatively short period of time compared to adult trials, it’s understandable that there would be less data, overall, on the needs of the younger patient population.
We believe that it’s important to give drug development sponsors as much patient feedback as possible to enable success in their research efforts. Pediatric patients can also feel more involved and engaged to participate in a clinical trial if they are encouraged to share their thoughts and experiences during clinical trial planning. With a better understanding of the present thoughts and needs of pediatric trial participants, we can help drive strategic decisions, improve current trial execution and proactively plan for future trials.
Running a survey with iCAN members
To capture the voice of the pediatric population, our team has been actively engaging with the iCAN youths (ages 8-20), learning about their needs, interest and experience with clinical trials, and encouraging them to share their perspectives on their clinical care during COVID19 and social distancing practices. During their recent international conference, we held an interactive web presentation with iCAN youth members; a majority whom have a disease/disorder impacting their health. The speakers gave a COVID-19 presentation, and we were able to directly poll participants and receive instant feedback. Participants were also able to use chat functionality to submit comments during the presentation.
Evaluating our survey findings
- Participants used handmade (cloth) masks:
20 participants indicated they preferred cloth masks over professional/medical masks (preferred by 13 participants).
- Participants biggest fears regarding COVID-19 relate to their family’s well-being:
Twelve participants selected “My family’s health/safety/access to medication and treatments” as their biggest fear, followed by “the unknown, uncertainty of the situation and how long it will go on” (7 participants). No one chose the “my own health” option as their biggest fear.
- Routine, specialty, maintenance, and ongoing care have changed since the pandemic began:
12 participants selected “required social distancing, masks and spaced visits to decrease time in office” as a change experienced in relation to their healthcare. Nine select “virtual visits/telehealth/telemedicine” as the change. Six of the participants have had to “cancel or postpone routine medical visits.” Only two of 30+ participants polled had seen “no changes” to their healthcare from COVID-19-related medical restrictions.
- Online communications were the main source of COVID-19-related information:
The main source of COVID-19 information for the participants was online news and social media (n=16), followed by friend/parent (n=7), conventional or streaming TV (n=4), public health organizations and the WHO (n=3). None of the participants noted that they receive information from their care team/doctor.
The COVID-19 information that participants most valued concerned the impact on school/social/work (n=12), followed by cases/hospitalizations/deaths (n=9) and testing/treatment (n=4).
Insights from the interactive chat platform
An analysis of the live chat during the presentation found a few insights:
- Mask fit and personalization are important (and likely driving the popularity of cloth masks).
- Frequent handwashing and furniture cleaning (immediately after use) are reassuring in medical facilities and they hope to see that remain post-pandemic.
- During a medical visit, being called in from the car, rather than the waiting room, was considered to be a smart thing to do.
- There was an expressed perception that the healthcare teams and doctors were too busy or overwhelmed to contact them regarding COVID-19 questions
Planning for a larger scale survey
The team’s next steps involve using the polling and chat analysis results to build a more in-depth survey to poll a larger number of iCAN members. We plan to elaborate on the questions and drill down into the responses we’ve received to gain a better understanding of this population to inform how we plan for and support clinical trial participation. We will also use the in-depth survey as another opportunity to directly connect with iCAN members, emphasizing that their experiences are important, and that their concerns are being heard.
Our ultimate goal is to publish results from the in-depth survey, help other drug development sponsors better understand trial participants’ needs, design protocols that incorporate the youth perspective, and enable best practices for meeting pediatric participants’ needs during the current and future crises.