New OECD TG 497: Interpretation and application of defined approaches for skin sensitization assessment

14 June 2022

As the name would suggest, patient-centric clinical trials rely on the patient voice. This is especially true in pediatric therapies, where younger patients are engaged to share their unique insights on new investigational products but may be unfamiliar or uncomfortable with advanced clinical trial concepts. As a proud sponsor of the International Children’s Advisory Network (iCAN)—a global consortium founded in 2015 in support of youth voices and leadership within pediatric healthcare—we recognize the value of the youth voice in drug development and embrace the opportunity to engage this population whenever possible.

“I began working with iCAN in 2015 to bring the youth’s perspective to the work I do,” shares Gina Calarco, senior director of strategy and planning for Labcorp’s Rare Diseases, Advanced Therapies and Pediatric Team. “Little did I know how these kids and families would be an instrumental teacher to me. iCAN members are a wealth of information, always eager to share their experiences and insights and full of innovative solutions.” A recent focus group we conducted with iCAN members—patients with an average age of 13 and a diagnosis of Type 1 diabetes (T1DM)—illustrates the advantages of leveraging the patient voice. In this session, patients were asked to weigh in on the possibility of using oral T1DM treatment based on a genetically modified organism, as well as use of a placebo in future study. A key finding from the group revealed a need to reconsider treatment design, as the T1DM patients demonstrated a reluctance to oral dosing that would disrupt meal plans or already established daily routines.

Building stronger focus groups

Other key takeaways included lessons to build more effective focus groups, such as providing additional clarity on advanced topics.

“Placebo is a complex concept for patients to understand for clinical trials, and these young patients were no exception,” Calarco explains. “We need to choose a basic approach in explaining these types of therapies.”

Another important takeaway was the need to continue building rapport and trust with younger patients. Built-in icebreakers to ease familiarity among focus group members are a possible solution, as is having discussions led by young adult advisors to maximize comfort and reduce any intimidation factor.

“Providing the questions ahead of time also helped the patients prepare and provide (sic) more confidence,” says Calarco. “It helped them feel that it wasn’t an exam.”

3 Tips for Planning Focus Groups With Minor Patients

1.Prepare educational materials that bring clarity to advanced clinical topics
2. Plan for icebreaker discussions
3. Provide questions ahead of time

In light of learnings gleaned from the iCAN focus group, we will present at a workshop explaining key concepts of clinical studies at the next iCAN Research and Advocacy Summit, to be held July 11-15 in Lyon, France. Calarco hopes the presentation, roundtable discussion and interactive activity to follow will help the children participating better understand complex clinical concepts and present them to other youths considering clinical trial participation. “The focus group highlighted areas where we need more information and the workshop at the summit will help us refine how we message this.”

Please visit the Labcorp Pediatrics for more information.