Profiles in Recruitment Success

"Clinical trial recruitment success starts not by searching for the perfect patients for a study, but by recruiting interested patients and matching them with the perfect trial."

- Michael J. Koren, MD, CPI, FACC, FAPCR

Big pharma trial, multi-site leader

Problem:

A large pharmaceutical company conducting an extensive, multicenter statin study struggled with site recruitment and enrollment.

 

Problem Solved:

Encore Research Group leveraged relationships with insurance companies and sites across Florida to enroll 500 of the 2400 subjects and to oversee operations in nearly half the enrolling sites nationwide.

 

Koren MJ, Hunninghake DB. J Am Coll Cardiol. 2004 Nov;44(9):1772-1779

Major Lab's Study Design and Execution

Problem:

A large laboratory company posited that a specific panel of biomarkers could identify peripheral vascular disease but didn't have data in a primary care population.

Problem Solved:

Encore Research Group designed, executed and completed, throughout the network of its sites, a 200 patient study in less than 10 months, demonstrating the biomarkers to be ineffective in general populations and providing significant savings to the company.

Phase 1 Dilemma Solved!

Problem:

A pharma company with an innovative heart failure product faced recruitment and enrollment challenges in a Phase 1 study for African Americans with a specific phenotypic variation.

Problem Solved:

Encore Research Group employed creative recruitment strategies to quickly identify a large number of potential subjects and randomize over half of all patients recruited globally. Local doctors were engaged to reach out to their patients with great success screening over 30 difficult to find patients.

Small Device Company Success

Problem:

An Israeli medical technology start-up company innovated and developed a device to administer heat, vibration and motion simultaneously. The study was placed at a large medical academic center with poor recruitment results.

Problem Solved:

Encore Research Group rescued the enrollment in the study. Working with a local orthopedic group, Encore led a research team to complete enrollment of 70 patients in six months and published results. Based on the published report, the device company secured lucrative money from a large international group.

Kitay GS, Koren MJ, Helfet DL, et al. Osteoarthritis and Cartilage. 2009 Oct;17(10):1269-74.