Find out the key challenges and achievements from a recently completed Phase III study in stroke patients.

1. USING DATA TO OVERCOME
RECRUITMENT AND RETENTION
ISSUES FOR STROKE PATIENTS
Case Study
In the case study below, we outline key challenges and achievements from a recently completed
Phase III study in stroke patients.
Background
A multicenter, randomized, Phase III study of prevention of stroke and systemic embolism in patients
with acute embolic stroke. The study involved 500 sites and 7,000 patients in over 30 countries in
Americas, Europe and Asia Pacific. Key study points included:
▶ Time from event to randomization: 3-7 days to 6 months (enrolled within 14 days and 30 days for 65% of
study population)
▶ Key assessments: Stroke, Cognition, Patient Reported Outcome (PRO), MRI, Pharmacokinetics (PK)/
Pharmacodynamics (PD)
▶ Independent Data Monitoring Committee for safety monitoring (including bleeding)
Challenges
▶ For this study an Academic Research Organization (ARO) was contracted by the client to complete the site
selection and manage the recruitment. Recruitment was delayed as the expected number of patients per
month projected by the sites was not met.
▶ Due to the study design, the period in between patient’s visits was too long and visits were intense,
increasing risk of high drop out.
▶ The long period in between monitoring visits at the beginning resulted in delayed Source Document
Verification (SDV) completion and difficulties with follow up and query resolution.
Actions
▶ Covance worked very closely with the ARO and client performing re-evaluation and analysis of
recruitment projections and timelines concluding that the number of sites was insufficient to complete
enrollment within targeted timeframe. New sites were then assessed and added to the study. CRAs
contacted the sites to discuss enrollment steps on regular basis including local meeting with the sites.
▶ A second Investigator Meeting (IM) was conducted to motivate the sites already recruiting and the
new sites included. Shared best practices on patient identification and recruitment, refocus on patients
admitted to ER. Non-recruiting sites were not invited to the second IM. Feedback from the sites was
followed up by the CRAs, through meetings with the PIs to review the identification process and referrals.

2. ▶ CRAs contacted the sites on a regular basis to discuss the issue with patient drop out (long time
between visits, intense visits) and ensure proper retention was completed at the site. Regular deep dive
review was performed on the number of potential lost to follow up (LTFU) patients with the study team.
Specific guidelines on how to proceed with patients with premature discontinuation or potential LTFU
were developed and provided to sites.
▶ A proposal to include a Risk-Based Monitoring (RBM) strategy for this study was accepted by the client. This
new strategy was very successful and regular meetings were conducted to review the status of the sites and
focus on the very high-risk sites. The SDV improved during the study. The issues and risks were also closely
followed up with this new strategy and the team was able to prioritize the issues/risks.
Successful Outcome
▶ Recruitment was improved, exceeding the expected numbers and revised enrollment timelines were met
on time
▶ 99% subjects completed study
▶ Successful Database Lock and completion of SDV on time
To learn more about how Covance can help you meet the challenges in
developing neuroscience therapies and delivering them to market quickly
and cost effectively, please contact us at www.covance.com/neuroscience.
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