INFECTIOUS DISEASE
11 %
Of the total pediatric cohort for the Pfizer COVID-19 vaccine trial across the globe
Shaping the Protocol continued
“ They were asking questions about study design for the vaccine , and I helped with some of that ,” he recalls . “ And then they asked me if I wanted to do a large study here . They proposed 500 subjects . Immediately after I got off the phone with their Senior VP , I talked to Erin .”
“ We ’ re talking about a randomized , blinded trial — it ’ s a lot more complicated than just here ’ s your shot ,” says Sandene . “ There are a lot of moving parts , making sure you ’ re not unblinding , dispensing drug or placebo . It ’ s a huge amount of required documentation and regulations to consider . There ’ s no way one person could do it all .”
The team ultimately committed to enrolling 250 children to the trial — a massive effort in itself , representing 16 % of the total enrolled population in the U . S . The project team included a 23-person staff , including a process improvement specialist , a project manager and an external vendor to help with scheduling . The goal : to enroll 25 children per day over the course of 10 days , eventually enrolling 252 children total . Pfizer agreed to pay the salaries of the staff necessary to support the effort .
“ That ’ s kind of unheard of ,” says Sandene . “ Pharma companies usually see that kind of thing as a cost of doing business . But in this case , there were a lot of bases to cover .”
“ I ’ ve been doing clinical trials for years ,” says Chief Quality and Outcomes Officer Lalit Bajaj , MD , MPH , who served as executive sponsor for the trial . “ Never have I been involved in something this quick , under this much scrutiny , involving so many people .”
RECRUITING FOR REPRESENTATION
The ZIP codes surrounding Children ’ s Colorado ’ s Anschutz Medical Campus , where the study would occupy a wing of the Outpatient
Pavilion , are both racially and economically diverse . The team felt the study population should reflect that demography .
“ We wanted to enroll populations that often get excluded from studies like these ,” Sandene says .
Dr . Simões and team centered recruitment efforts on pediatric practices that care for medically underserved communities from Longmont to Colorado Springs . Chief Administrative Officer and General Counsel Michelle Lucero personally handed out materials in Spanish . And once the applications were in , Dr . Simões and team created a survey to ask applicants to self-identify their demographics . They used statistical methods to randomly select numbers that reflected the Colorado population .
And ultimately , they enrolled a population that was more than racially and ethnically diverse . They enrolled patients with autism spectrum disorder , Down syndrome , mental health challenges . They enrolled monolingual speakers of Spanish and Korean . They brought on interpretation services and a full-time child life specialist to help participants feel comfortable and informed .
“ Dr . Simões was adamant ,” adds Sandene . “ He really influenced Pfizer in the view that we needed representation that met or exceeded our local demographics , because those were the populations that were most adversely affected by the pandemic . We helped shape Pfizer ’ s protocol .”
They also helped shape future protocols at Children ’ s Colorado . A pilot program built into the electronic medical record will collect cultural data moving forward , so research teams can better understand what their communities look like and work to correct disparities between clinical and research populations .
“ I ’ m optimistic this isn ’ t going to be a decades-long effort ,” says Dr . Bajaj . “ In the next two or three years , we ’ re going to get better at this .”
8 | CHILDREN ’ S HOSPITAL COLORADO