Advanced Clinical ENT Research of Kentucky and Southern Indiana

Advanced ENT and Allergy Center is a fully accredited, single-specialty, private practice in Louisville, KY. We medically and surgically treat adult and pediatric patients with ear, nose, and throat disorders. Many of our physicians are also clinical faculty at the University of Louisville. The Sinus Center has been developed at our main office. It provides a wide spectrum of state-of-the-art services for the diagnosis and management of otic, nasal and sinus disorders.

Research Experience:

We have a core group of seven physicians who have conducted research studies since 2002. These physicians and research staff have completed GCP training courses on the Protection of Human Subjects. Research Coordinators have completed training for the Transportation of Dangerous Goods. We have experience in Adult and Pediatric Phase II-IV clinical trials for the following indications; acute sinusitis, seasonal allergic rhinitis, xerostomia, muscositis, acute otitis media, recurrent otitis media, chronic sinusitis, perennial allergic rhinitis, AOMT, tinnitus, device studies, PK studies and outcomes studies.
Other Support Services:

Allergy Department onsite
Audiology Department onsite
Computerized patient database of 150,000
CT scanner onsite
Eight regional offices servicing surrounding counties (six in KY, two in IN)
Locked drug storage and locked refrigeration
EDC experience
Both full-time Research Coordinators are CCRC certified
Calibrated equipment
Centrifuge
Rapid regulatory document turnaround
Use central IRB's

We, at Advanced ENT and Allergy Center, are dedicated to clinical research. One of our nurse practitioners, Marti Gardner, serves as clinical research director. Marti has over 13 years experience as both a clinical research coordinator and as a sub-investigator. Gwen Pierce, RN, is our other research coordinator with over 13 years experience as a research coordinator.

Met or exceeded enrollment goals in more than 27 other trials for SAR/PAR, acute/chronic sinusitis, AOMT, AOE, tinnitus, & radiation effects.

Top enroller nationally in a post surgical chronic sinusitis trial

Top enroller nationally in 2 trials for acute otitis media with otorrhea through tympanostomy tubes

Top enroller nationally in a trial for acute otitis externa

Top enroller for a surgical device in chronic sinusitis study

2nd highest enroller in a national trial for xerostomia

2nd highest enroller in a national trial for mucositis prevention during radiation therapy

2nd highest enroller in a chronic sinusitis PK surgical study

2nd highest enroller in a surgical device for chronic sinusitis study

Top 5 enroller in a national acute bacterial sinusitis trial

RESEARCH MISSION

To conduct clinical trials in accordance with the Code of Federal Regulations and our Standard Operating Procedures with respect to Good Clinical Practice. Research is conducted in a high quality, efficient, and ethical manner to assist in the advancement of medical knowledge in our field.

CLINICAL RESEARCH STAFF

Kathleen Sheeley, Clinical Research Coordinator