“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, FACC, FAPCR, CPI

Profiles in Recruitment Success

ENCORE Research Group Advantage

ENCORE Research Group (ERG) leads an expanding network of independent, multi-specialty research sites operating throughout the state of Florida. Employing a unique business model designed to maximize the involvement of community based physicians, ERG began independent operations in 1997. Since then, ERG physicians and staff have completed more than 2500 clinical trials, helping sponsors small and large attain their research goals.

Big Pharma Trial, Multi-site Leader

Problem:
A large pharmaceutical company conducting an extensive, multi-center 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 2,400 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.

Encouraging Community Research

Problem:
A small, local company developed a promising topical treatment for acne.  The development team reached out to Encore Research Group for assistance with  protocol development and trial execution.

Problem Solved:
ENCORE Research Group investigators wrote the protocol, provided regulatory, recruitment, operational oversight and database design.  Sixty patients were enrolled and completed in four months. All this enabled the Encore investigators to collect data and publish the results.

Bernhardt MJ, Myntti MF. J Drugs in Dermatol. 2016 June;15(6):677-683.

Diabetic Foot Ulcer

Problem:
A local research and development company launched a research trial with a large medical research center to study treatment of chronic foot ulcers.  Enrollment lagged for nine months.

Problem Solved:
ENCORE’s River City Clinical Research site came on as a rescue site, finishing enrollment of 30 patients in six months as the top enroller in both control and treatment groups.

Patient Passion 

ENCORE Research Group goes above and beyond for patients. When an ENCORE patient completed a pivotal trial with mixed results and learned the sponsor was facing challenges with the FDA, she volunteered to go to Washington and testify on behalf of the medication she believes saved her life. She is a true proponent of Dr. Michael Koren’s statement, “It’s not just about turning a profit, it’s about caring for our patients”.

ANNUAL CLINICAL RESEARCH TRAINING FOR PHYSICIANS

Clinical Research Training for Physicians is a unique CME course presented by physicians for physicians.  This engaging, interactive program includes case studies submitted by investigators reflecting their own real-world experiences.

The course is held each November on the campus of the University of North Florida, in Jacksonville, Florida.

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

For more information visit:
investigatortraining.info