Clinical Eye Research Overview
Clinical research is a unique aspect of medicine and Ophthalmology in which Dr. Lee Shettle has a special interest, because of his commitment to delivering the most recent modes of treatment to his patients. Through clinical research in his office in association with various pharmaceutical companies, he is able to potentially help his personal patients and people in the community on a local level with new ophthalmic forms of treatment.
Clinical trials involve research studies performed with human subjects to evaluate and test the effectiveness and safety of new ophthalmic medicines, medical devices or specific procedures and treatments. The Food and Drug Administration (FDA) requires clinical trials be performed prior to approving any new medications for physicians to prescribe to patients. Patients who agree to participate in clinical trials may receive many important benefits. Subjects willing to participate in clinical trials are able to receive access to new treatments and study medication for various medical and ophthalmic conditions before they are available for prescription use, as well as receiving diagnostic and hematologic testing, and physician care. They also usually receive compensation for their time and for following the instructions according to the protocol. Each clinical trial has a different protocol with diverse exclusion and inclusion criteria to determine which subjects are able to participate in the study.
Clinical research studies at the office of Dr. Lee Shettle are open to the public. You can find out which studies Dr. Shettle is currently conducting by either looking on the Research Opportunities section of our website or by calling our office at (727) 674-2500. You can then schedule an appointment with Dr. Shettle to determine if you may qualify for entry into a study after explaining the protocol to you personally in his office. Dr. Lee Shettle takes great pride in the data he obtains from doing research studies and meeting or exceeding enrollment goals, while maintaining quality data with superior standards of care in accordance with the FDA regulations and guidelines and good clinical practices. He does this by performing most if not all of the exams himself.
Value of Clinical Research
Dr. Lee Shettle began his clinical research experience in 1990 during his Neuro-Ophthalmology fellowship at Michigan State University. He participated in the Optic Neuritis Treatment Trial and presented clinical research cases and papers at the Association of Research and Vision and Ophthalmology.
Since 2005, Dr. Lee Shettle has been selected as principal investigator on many ophthalmic related clinical research trials in Phases II-III. He believes strongly that continuing medical education and advanced training with an emphasis on detail is the key to ensuring the highest ethical and superior quality clinical research trials. He and his staff have been trained in Good Clinical Practices with federal research guidelines. It is very rewarding to both patients who have participated in clinical trials and to Dr. Shettle when a study medication which they worked together on is approved by the FDA, knowing that thousands of other people worldwide will be able to hopefully improve their quality of life because of their hard work.
The Clinical Research Process
The clinical trial process begins with Dr. Lee Shettle completing the necessary paperwork and documentation to be approved and selected by the pharmaceutical company. A meeting for all principal investigators is then held so the protocol can be explained to the physicians and their staff, informing them of specific details of the protocol. Dr. Shettle will then post the research opportunity on his website for you to review.
If you are interested in participating, you should call our office or send us a request to contact you from our website. We will then schedule an appointment for you to be seen by Dr. Shettle, where he can explain the purpose and duration of the protocol and answer fully any questions you may have about the study. During the explanation of the protocol, Dr. Shettle will also inform you of your obligations to participate and follow, which are very important to obtain the best data to report to the pharmaceutical company. All of your information and test results are protected by HIPAA. To protect your privacy, you are assigned a subject number and your initials are also used to indicate which patient you are. Your name is not mentioned in any communications regarding any report we submit. Your rights as a study participant are also fully protected and the studies are completely voluntary.
Each clinical study is reviewed independently by an Investigational Review Board, which is made of up nurses, doctors, allied personnel, etc. to protect and ensure that all study volunteers are treated ethically. The same legal codes that govern medical practices also apply to clinical trials. There are usually four phases to clinical studies, and each phase has a different purpose and goal which progresses throughout the evaluation of a new study medication.
Current Research Opportunities
- Dry Eye Syndrome Treatment