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Case Study

Site engagement helps randomize 50% more patients than projected

Service reinvigorates difficult respiratory trial, saving sponsor $1.2 million versus budget projections

$6,200

Cost per randomized patient—an $8,300 reduction from the projected budget of $14,500 per randomization

19

Average number of days Continuum helped reduce timeline between Site Initiation Visit and First Patient Screened

67%

higher enrollment at study sites with Continuum’s site engagement support than those without

Patient Population

Current or former smokers living with COPD (history of heart disease, stroke or other cardiovascular risk factors)

Therapeutic Area

Respiratory

Study Indication

CVOT

Study Region

North America

Study Type

Phase IV

The Challenge

After two years into enrollment, the sponsor was 1,000 patients short of meeting its randomization target. The low enrollment resulted from inconsistent sponsor support—the initial sponsor was acquired; the acquirer then sold the compound to another sponsor tasked with completing the study. Consequently, recruitment rates came to a halt. In order to complete enrollment, the sponsor had to overcome a credibility issue to reengage its study sites and demonstrate a renewed commitment to the study.

The Strategy

To regain the trust and confidence of the study sites, we listened to them. We interviewed dozens of PIs and study coordinators to learn about their frustrations and communication gaps in order to identify opportunities to turn things around. Through this research, we learned about site’s eagerness to receive physician referrals as they were likely to be the most qualified and would require the least amount of effort. We also learned that sites would benefit from more direct contact since both the time between visits and the visits themselves were so long and required extensive preparation on the part of both the patient and site. We leveraged this learning to provide 1:1 support for more than 300 sites and developed and nurtured a physician referral network to generate leads with little to no media spending.

“We knew we needed to develop a new way to solve this problem and piloted a program to help keep the study top of mind and engage the clinical community as well. It's a true example of Continuum Clinical's entrepreneurial mindset in action.”

Laura Lentz, Vice President, Advocacy and Account Leadership
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The Results

This study enrolled more patients in the 11 months Continuum was involved than it had in the 24 months prior to our involvement. Our combined efforts delivered a total of 472 randomizations – 152 more than predicted. Sites that utilized our engagement support had 67% higher enrollment than sites without support, with nearly 10% of randomized patients coming from our physician referral network.