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At Kendle we have the capability of creating targeted, country-specific programs to recruit and retain patients who meet your study inclusion criteria. Below are some recent examples where we’ve delivered results, often ahead of specified timelines.
Meeting expectations with CEE
A large biopharmaceutical company recently contracted with Kendle to recruit patients as part of a global Phase III pediatric hepatitis study. Our challenge was to activate sites as quickly as possible in order to enroll 50% of patients in a specified timeline.
However, it quickly became clear to the study team that the required recruitment period needed reassessing. There were changes to the study design, and in Poland the Regulatory Authority had halted the study to assess issues relating to the recently implemented EU Directive.
Kendle and the biopharmaceutical company proactively collaborated and successfully worked through the issues with the Polish Regulatory Authority. In addition, frequent communication between the Kendle project management team and Poland ensured a clear understanding of the aggressive nature of local milestones. This resulted in all five sites being activated within 14 working days and the first patient screened within 10 working days.
The success in Poland led to a dramatic increase in screening and enrollment rates for the study. Kendle met the 50% patients enrolled milestone seven months ahead of schedule – and 61% of these patients were from Poland.
Latin America delivers results
Kendle recently delivered a pediatric lower respiratory trial for a large pharmaceutical company, which randomized almost 600 patients in 13 months. The sample split was 80% Latin America, and 20% US and Canada.
During enrollment we found that the best enrolling sites were Mexico, Panama and Costa Rica. We also found that Latin America yielded 5.5 times as many patients per site as the US.
A successful rescue mission
When a patient recruitment firm recently failed to enroll any patients for a Phase IIA asthma trial, the large pharmaceutical company running the trial asked Kendle to rescue the enrollment. We were enlisted on December 3 to meet an enrollment goal of 160 patients (40% planned screen failure rate) by February 6.
We communicated with the selected 33 sites in the US to increase motivation and discuss efforts to meet the enrollment goal, then quickly set up direct mail, radio and cable television campaigns.
Our success was spectacular. Within one month, we had enrolled 25% of the required randomized patients, and we met the enrollment goal one week before enrollment closed, much to the delight of the pharmaceutical company.
Responding quickly to slow enrollment
When we were asked to recruit patients to a Phase II study of post-herpetic neuralgia, we knew it was going to be challenging. 45 US sites needed to screen 400 patients to complete 184. Patient recruitment was projected to be slow because the study design was complicated, requiring patients to go through two washout periods and a treatment failure phase before randomization. In addition, many patients’ symptoms were too mild for study inclusion, and many patients from site databases were ineligible due to prior medication use. Patients were also particularly hard to identify because post-herpetic neuralgia is usually a transient condition.
So how did we ensure that we completed enrollment successfully? Our approach was to institute a television campaign at selected sites at the first sign of deviation between projected and actual enrollment numbers. By utilizing targeted television advertising we decreased enrollment time by 50% with a minimal increase in cost per patient recruited 
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