We are an Academic Research Site with an established track record of successfully conducting over 100 industry-sponsored clinical trials and investigator-initiated clinical trials. We have experience in Phase I-IV trials and have established ourselves as a reliable and consistent site providing our sponsors with clean data and meeting our recruitment goals over 90% of the time.

As recognized experts in research, as well as cutting-edge treatments in our community, our site has successfully engaged the Greater Tampa Bay area community in research. Our recruitment area covers over 6 counties with a population of over 3.2 million. The Tampa Bay community is a community rich in diversity - with both family and retirement communities.

Additionally, we are part of a large academic practice site. Our outpatient clinic volume is over 18,000 visits annually with a database of over 6,000 names. We also maintain a database of healthy volunteers for our Phase I studies.

We hope this information will be helpful as you look for qualified investigators for your next clinical trial. We are looking forward to working with you in the future.

Research Emphasis

Basic and clinical research interests include the pathogenesis and treatment of asthma and allergic diseases, aerobiology, primary and secondary immunodeficiency diseases, HIV, bone marrow transplantation, insect hypersensitivity, allergen immunotherapy, co-morbid conditions affecting asthma and upper airway disease, chronic obstructive lung disease, viral respiratory tract infection and asthma, asthma and allergy in the elderly, hereditary angioedema, chronic urticaria and angioedema, atopic eczema, sleep apnea, nasal polyposis, pulmonary interstitial fibrosis, pulmonary artery hypertension and drug allergy.

Clinical & Translational Research Unit

The Division of Allergy and Immunology Clinical Research Unit is a 1600 square foot facility, located just off the main campus, in which pharmaceutical industry sponsored, divisional clinical research projects and federal and non-federal grant funded clinical research projects are conducted. The main goal of the Center is to bring together basic and clinical scientists who translate bench and clinical research into improved treatment of patients who suffer from asthma and allergic and immunologic diseases. All studies performed are done under the supervision of the physicians and the staff and approved by the University’s Human Research Committee. All trainees in allergy and immunology are required to participate in clinical research throughout their training to foster their careers as clinician scientists. Over the past several decades, the Clinical Research faculty have conducted over 500 Phase I, II, III and IV clinical trials and established a working relationship with more than 40 pharmaceutical sponsors, NIH, ALA, VA and many other funding sources. Staffed by five USF clinician scientists, the Division and the Clinical Research Unit are affiliated with various institutions in the Tampa Bay Area including the H. Lee Moffitt Cancer Center, James A. Haley Veterans’ Hospital, Tampa General Hospital, Florida Hospital, the University of South Florida Morsani Center for Advanced Healthcare, and All Children’s Hospital.

Research Capabilities

• Exceeding enrollment requirements is our commitment to quality research.
• Research is conducted in accordance with Good Clinical Practice Guidelines and the highest ethical standards are followed.
• 40 years of experience in over 500 phase I-IV trials.
• Experienced clinical research coordinators.
• Full-time regulatory coordinator which facilitates timely start-up of new students.
• On-site IRB meets weekly for new protocols; expedited review for amendments and informed consent changes.
• Contracted with Western IRB for multi-center trials.
• Contracted with central IRBs: Quintiles, Quorum & Schulman.

Meeting Enrollment Requirements is Standard Practice

Population:

Tampa Bay metropolitan area:
2.5 million population,
Varied ethnic composition,
Easily reached with appropriate media exposure.

Medical Practice

70 new patient and 400 follow-up visits per week computerized patient database.

Clinical Expertise

• Allergic rhinitis
• Allergen immunotherapy
• Angioedema (acute and chronic)
• Asthma
• Atopic eczema
• Bronchitis, acute and chronic
• Contact dermatitis
• COPD
• Exercise-induced asthma
• Hereditary angioedema
• Headaches (migraine and tension)
• Immunodeficiency
• Insect allergy
• Nasal polyps
• Non-allergic rhinitis
• Osteoporosis
• Sinusitis, acute and chronic
• Temporomandibular joint syndrome
• Urticaria (acute and chronic)