High-performing sites during COVID-19 in Women’s Health

A biotechnology company, dedicated to transforming Women’s Health, was running a phase 3 study in the treatment of moderate-to-severe vasomotor symptoms in postmenopausal women with a global enrollment target of 1,200 patients. The study regimen included several invasive procedures, including gynaecological and breast exam, transvaginal ultrasound, and endometrial biopsy, placing a significant burden on patients. Many of these procedures required study sites to setup and manage external vendors, adding to the site burden as well.

The COVID-19 pandemic created additional challenges with patient recruitment and study management, as vendors and laboratory supplies were significantly impacted due to the prioritisation of laboratory kits and services for COVID-19 patients and studies. Many sites had to reschedule screening appointments due to a lack of essential study supplies. Accellacare sites were activated with only a third of the study’s recruitment period remaining.

Accellacare sites implemented a rapid start-up program by identifying and engaging potential patients prior to each site activation. Over 6,000 pre-screening calls and visits were performed to ensure patients were aligned with the study prior to screening. Proactive management of patients, vendors and study supplies were required to facilitate COVID-19 safe measures and ensure laboratory kits were available.

On average, Accellacare sites achieved more than twice the recruitment rate of other sites, with six Accellacare sites ranking in the top 25% globally. Due to the rapid start-up program, Accellacare sites went from site activation to first-patient-in (FPI) within just 3-7 days, compared to the global average of 33 days for all other sites. The Accellacare sites in the UK enrolled 79% of the study’s UK target.