Achieving equitable representation in the final study population
RECRUITMENT
In October 2020 when enrollment in the COVE study completed, the final study population was representative of the entire spectrum of the intended treatment population in the United States (These recruitment strategies were similarly applied for the TeenCOVE and KidCOVE trials. There were upfront and concerted efforts with trial sites to enroll participants from historically underrepresented groups, and both trials set deliberate demographic objectives. The TeenCOVE trial was rapidly commenced after the COVE trial to include vulnerable population targets, ultimately enrolling 26% participants of color, with an even distribution of male (51%) and female (49%) participants (