A demanding pediatric protocol
This Phase 3 chronic migraine trial brought the added participation demands of pediatric research. Our team approached screening with a focus on preparation and clear expectations for the study commitment.
Phase 3 · Pediatric chronic migraine
A challenging pediatric study. Enrollment above goal.
In a demanding Phase 3 pediatric chronic migraine trial, WCR randomized 8 participants against an original goal of 6. Seven completed the trial, with one participant lost to follow-up.
Explore the study storyStudy outcome
33.3%above the original randomization goal10candidates screened
8participants randomized
7randomized participants completed
Inside the case
Eight randomizations against a goal of six
WCR screened 10 candidates and randomized 8 participants. Against the original goal of 6, the site delivered two additional randomizations, exceeding the goal by 33.3%.
Seven participants completed the entire trial
Seven of the 8 randomized participants completed the trial, an 87.5% completion rate. One participant was lost to follow-up. The site paired enrollment above goal with sustained participation through trial completion.
Participant support throughout the study
Our team emphasized preparation before screening, ongoing relationships, and open communication throughout this challenging pediatric trial. Participants demonstrated high compliance with study requirements during active participation.
The challenge. Our response.
A pediatric protocol has to work in a family’s real life.
Intensive diaries, reliance on minors to complete study tasks, and conflicts with school schedules made this a particularly challenging participation environment.
Intensive diaries completed by minors
The challenge
The diary requirements depended on pediatric participants completing study tasks consistently between visits.
How our team responds
We explain expectations in clear, age-appropriate language and keep communication open with participants and caregivers. Our approach reinforces participant understanding while respecting the protocol’s requirements for diary completion.
School and family scheduling conflicts
The challenge
School commitments and family availability could conflict with study visits.
How our team responds
We discuss school and caregiver schedules early and coordinate appointments within protocol requirements. When conflicts arise, direct communication helps the team and family work through the available scheduling options.
Maintaining engagement across a demanding trial
The challenge
Sustaining participation required an ongoing relationship with both the pediatric participant and the family.
How our team responds
We emphasize preparation, familiar points of contact, and open communication throughout participation. Seven of the 8 randomized participants completed the trial; one was lost to follow-up.
Study outcome
33.3% above the original goal. Eight randomized. Seven completed a demanding pediatric trial.
The participant experience
Support participation in a demanding pediatric trial.
Clear expectations before screening, ongoing relationships, and open communication were central to our participant approach. High compliance during active participation accompanied completion by 7 of the 8 randomized participants; one participant was lost to follow-up.
Set expectations before screening
We discuss the study commitment early, including what participation will require and whether candidates feel ready to meet those expectations. Pre-screening helps establish a shared understanding before the first screening visit.
Build a working relationship
Participants need a team they can talk to. We build relationships throughout the study and keep communication open so questions and practical concerns can be raised with the site.
Keep the focus on follow-through
Our participant engagement approach continues beyond randomization. We stay connected throughout participation to support retention and compliance with study requirements.
Practical participant support
Help with the journey.
Support through the study.
We provide transportation support when needed to help participants attend study visits. We also discuss scheduling concerns early and maintain open communication throughout participation, helping address the practical barriers that can make follow-through difficult.
The result
33.3% above the original goal. Eight randomized. Seven completed a demanding pediatric trial.
Phase 3 · Pediatric chronic migraine · WCR case study
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