Streamlined processes for study startup, coupled with experience in vaccine trials and solid relationships with study sites and investigators, helped this Quintiles team meet the challenge of starting an influenza vaccine trial late in the influenza season.
Starting late in the influenza season drastically shortened the timeline for study startup.
Initial site selections were conducted over the telephone instead of on-site, allowing for 88 sites to be identified in 14 days. Many of Quintiles' partner sites were used. These sites have proven performance records and experience in vaccine trials.
To accelerate startup time, a parallel startup process was used. Rather than starting all sites after final site selections had been made, each identified site immediately began startup procedures. For instance, each site obtained Institutional Review Board approval, signed the confidentiality agreement and completed the feasibility survey.
Of the 88 sites identified and primed to begin study procedures, only the top 35 sites were ultimately selected for the study. All 88 identified sites were compensated for their time. The selected sites recruited patients at the rate of 45 per hour. Recruitment was completed within 4 days.