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At Kendle we’ve been responsible for many successful late phase programs. Below are some recent examples where we’ve delivered results, often ahead of specified timelines.
Delivering more patients, at a lower cost
A large pharmaceutical company asked Kendle Late Phase to recruit patients for a Phase IIIB North American study of rheumatoid arthritis. A tough 12-month enrollment target, patient flare criteria and a placebo arm increased the difficulties of recruitment and retention.
Our experienced team managed patient recruitment in the US, while a patient recruitment firm managed a national campaign in Canada. Kendle provided patient recruitment that addressed enrollment issues and expectations as well as best practices at the investigator meeting. We instituted a patient retention program and kept trial visibility high at trial sites through branding of study and frequent communication.
The results? Three patients completed “Visit 1” in advance of the “first patient in” deadline, and enrollment closed three months early. While the patient recruitment firm only managed to recruit 147 patients at a cost of $3,376 per patient, we delivered 492 patients at a cost of $106 per patient – more patients at a lower cost. A great result for the customer and the Kendle Late Phase team.
Centralized monitoring and IVRS lowers costs and speeds quality study conduct
When a large pharmaceutical company needed to enroll nearly 5,000 patients to a late phase hypertension clinical trial with an aggressive timeline, they came to Kendle. We were able to select 430 appropriate sites to maximize patient recruitment in a challenging timeframe. We used interactive voice response system (IVRS) technology as our tool to manage inclusion/exclusion and randomization of patients, patient visit tracking, and medication distribution.
We enhanced communication with sites via frequent and consistent centralized phone monitoring combined with randomized on-site monitoring, and provided extensive written guidance to investigators to ensure quality and share best practices and key learnings with all sites during frequent phone contacts. A statistically controlled sample was taken for on-site interim monitoring.
We enrolled 4,868 patients within four months, and maintained a high level of motivation among our investigators due to frequent and consistent contact. In addition, dramatic time and cost savings were achieved due to the reduced travel and onsite monitoring time associated with our centralized monitoring approach. A post-study survey conducted with participating sites was overwhelmingly positive about our innovative study conduct.
Positive post-study survey results
- 75% of survey recipients responded
- 95% responded positively to the centralized monitoring approach
- 75% responded positively regarding written guidance and updates
- 80% responded positively regarding rapid resolution of queries by telephone and fax
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