Welcome to Clinical Trials and Research
Opportunities for better medical care don’t
just happen. They open up through careful clinical research into investigational
pharmaceuticals, procedures, equipment and devices.
The Clinical Research Center is an exceptional study and trial environment
with a highly qualified staff and an extremely fine performance record.
For both patients and physicians, it represents an opportunity to
obtain access to innovative experimental drugs or procedures and
devices before they are widely available. We believe this is another
way to deliver significant benefits to those it is our mission to
serve and heal.
The Clinical Research Center
The Clinical Research Center at Sarasota Memorial
Hospital has earned a national reputation for research excellence
since it was formed.
It began within the Department of Pharmaceutical Care Services in
1989. Six years later it became a designated research department,
a rarity for a non-teaching hospital.
It reflects a commitment by Sarasota Memorial to remain at the forefront
of technological advances in medicine, the better to serve its patients
with the most advanced and effective care available to improve their
health and well-being.
As a center for inquiry, it is sought after by outside companies
and organizations to participate alongside such distinguished facilities
as those found at Duke or Emory University and the Cleveland Clinic.
Solutions for Life
Research goes on at an active pace with 30 or more
studies underway at any point in time. The search for better answers
covers a wide cross-section of disciplines:
- cardiology & cardiothoracic surgery click here to see list
- dermatology
- family practice
- hematology
- oncology
- gastroenterology
- emergency medicine
- pulmonology click here to see list
- neurology
- obstetrics
- gynecology
- orthopedics
- urology
Recent studies have ranged from neuro-protective agents for stroke,
advanced surgical procedures for cardiac care and minimally invasive
procedures for neurosurgery to therapies for lung diseases.
Raising the Standards of Care
Research at the Center focuses on data collection
for pharmaceutical and device sponsor companies which can be taken
to the Federal Drug Administration to gain regulatory approval. It
is conducted in four phases.
Phase 1 covers feasibility studies and is conducted with healthy
volunteers as subjects.
Phase 2 takes place as experience with a drug grows. First trials
involve safety concerns and are conducted in multiple centers involving
a substantial number of patients.
Phase 3 encompasses large-scale studies in dozens or hundreds of
sites involving thousands of patients. At this level of research,
the drug or device under study might be taken to the FDA to seek
authorization for specific use and indications.
Phase 4 reviews drugs that are already on the market to look at new
formulations of an existing medication or a different way to use
it.
Efforts at the Center concentrate on Phase 2 and 3 type research.
The Sarasota Memorial Health Care System is one of the first nonacademic
hospitals in this country to offer an avenue for clinical studies
to its staff physicians.
A physician is always the principal investigator in a study with
a team of clinical research coordinators (nurses) working closely
with the physician-investigator so that study documentation meets
the highest possible research standards.
A Timely Process
The Institutional Review Board at Sarasota Memorial
Hospital reviews studies monthly to facilitate responsiveness to
the protocol needs of the sponsor and the institution.
Throughout a trial process, the Center’s staff pursues a
constant set of objectives: continuity of service, diligent regulatory
compliance,
efficient patient recruitment and management systems, attainment
of enrollment goals and model data collection.
A
Landmark for Healthcare
Sarasota Memorial Hospital is a public, not-for-profit
hospital located on Florida’s southwest coast.
The second largest public hospital in the state, it is also one of
the most comprehensive of its kind in the United States. It is an
828-bed acute-care facility drawing referral patients from a four-county
area. Its medical staff numbers approximately 700 and has almost
3,000 employees.
The larger community in which this hospital is based has a patient
population that encompasses all ages and ethnic groups with a substantial
concentration of middle-aged and older individuals. The ambience
of the community and the climate make it a magnet for retirees. As
a result, this area offers a broad spectrum of patients with diverse
medical needs.
Satisfaction Is Important
The Center invites study sponsors to evaluate their
performance. A survey allows them to rate us on such items as knowledgeability
of the principal investigator, staff responsiveness and efficient
processing of regulatory documents. On a scale of 1 to 10, our
average score is 9.6. We thought you’d like to know.
Clinical Research Center
Sarasota Memorial HealthCare System
1540 S. Tamiami Trail - 3rd Floor
at Sarasota Memorial Heart & Vascular Institute
Sarasota, FL 34239
Phone (941) 917-2225
FAX (941) 316-4090
karen-gormley@smh.com
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