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