Exceeding expectations in a c. diff vaccine study

Five Accellacare sites were selected to participate in a clostridium difficile (c. diff) vaccine study being conducted by a large pharma sponsor and ICON. Patients were required to be 50 years of age and older, and at risk for developing c. diff infection through hospitalisation, residence in a nursing facility, or frequent outpatient interactions with the healthcare system. Because c. diff is not a common source of concern for most people, patient education regarding c. diff and its risks was a necessary element of patient recruitment. Accellacare sites had an initial enrollment goal of 106 patients, later extended to 256, with patients to be enrolled within a seven month timeframe.

Accellacare deployed its network resources to ensure an efficient partnership, from contracting through study completion. Source documentation and patient recruitment materials were developed centrally by Accellacare specialised staff, ensuring consistency in training, execution, and quality across all Accellacare sites. Dedicated patient engagement strategists created customised enrollment plans for each site based on patient population, practice profile, historic performance, and local area demographics. To deliver highly targeted messaging, recruitment materials were tailored to align with the varied patient populations and inclusion criteria.

Clinical Research Coordinators worked closely with Investigators, referring Physicians, and hospital networks, communicating in real-time to identify potential participants. In-depth chart review of both electronic medical records (EMR) and the Accellacare database ensured that pre-screening efforts resulted in high number of
randomised patients and a low screen fail rate. Accellacare project management collaborated closely with the ICON study team for streamlined communication among sites, so that the study closed on time at the targeted randomisation rate.

Accellacare sites randomised 270 patients, exceeding the extended goal, with a 3% screen fail rate and a 96% retention rate. All sites had first patient randomised within 24 hours of activation.