CLINICAL RESEARCH
Years of academic achievement and involvement in research blended with private practice and patient care creates an ideal climate for clinical research and is one of the unique aspects of our practice.
We are dedicated to providing the most technologically advanced, cost effective patient care with the highest quality of professionalism and are devoted to improving the quality of care to patients worldwide through the development of innovative techniques, devices and medications.
A strong commitment to clinical research results in our focus on the highest standards set by the industry, such as strict adherence to protocols and good clinical practices, as well as complete and accurate documentation. Our experience and attention to detail set us apart and provide the expertise, knowledge, and background required to conduct clinical trials in a compliant and proficient manner.
Our research experience encompasses Phase II, III and IV studies, as well as post-marketing evaluations and includes the following:
- IDE and IND studies
- Compassionate use
- Therapeutic opportunity assessments
- Pilot study/early technology assessments
- Protocol and study design assessments
- Study medical monitoring
- Study document development
- Staff training
- Regulatory submissions
- Test article accountability
- Specialized ophthalmic testing, including:
- Contrast sensitivity testing
- Corneal topography
- Corneal wavefront analysis
- Dynamic pupillometry
- ETDRS visual acuity
- Specular microscopy
- Visual function analysis
- Visual field testing
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We partner with medical device and pharmaceutical industry leaders, as well as smaller companies with innovative technologies in bringing new technology and investigational products to market in a compliant and efficient manner.
Our Research Partners include:
- Advanced Medical Optics
- Advanced Vision Science
- Allergan
- Alcon Surgical
- Allergan
- Bausch & Lomb
- Carl Zeiss Meditec
- eyeonics
- GlaxoSmithKline
- ISTA Pharmaceuticals
- I-Therapeutix
- Johnson & Johnson
- Morcher GmbH
- OPHTEC USA
- Pfizer (Pharmacia)
- Rayner Surgical
- SIRiON Therapeutics
- STAAR
- Vision Care Technologies
- Visiogen
- WaveTec Vision
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I. Howard Fine, MD completed his undergraduate training at the Massachusetts Institute of Technology and his medical and ophthalmology training at the Boston University Medical Center. Dr. Fine is a Clinical Professor of Ophthalmology at the Oregon Health & Science University (OHSU) in Portland, Oregon. Dr. Fine has designed surgical instruments and implants and has innovated many surgical procedures. He has participated as a Principal Investigator or Sub-investigator in more than 50 clinical trials over the years.
Richard S. Hoffman, MD, a native of south Florida, completed his undergraduate degree in Molecular Biology at Haverford College in Pennsylvania. He received his medical degree and completed his ophthalmology residency at Tulane University School of Medicine in New Orleans. Dr. Hoffman is an Associate Clinical Professor of Ophthalmology at the Oregon Health and Science University (OHSU) in Portland, Oregon. Dr. Hoffman has designed new surgical instruments for anterior segment surgery and has been an investigator for multiple FDA clinical trials over the years.
Mark Packer, MD, FACS Dr. Packer grew up in Los Angeles and graduated cum laude from Harvard University, receiving both an Honorary National Scholarship and a Harvard Scholarship. He received his medical degree from the University of California at Davis and completed his residency training in Ophthalmology at Boston University Medical Center He currently serves as Clinical Associate Professor of Ophthalmology at Oregon Health & Science University (OHSU).
Dr. Packer’s research focuses on refractive surgery, intraocular lens technology, functional vision and glaucoma surgical devices. He has served as Principal Investigator and Medical Monitor for many clinical investigations sponsored by well known and respected ophthalmic device and drug companies.
Tina Callina, COMT, CCRC, our Director of Research, spent two years at Tufts Medical School Department of Ophthalmology in Boston, MA and maintains certification in both ophthalmology (COMT) and research (CCRC). Her experience includes drug and device studies, compassionate use submissions, FDA audits, regulatory compliance (including electronic records) and staff education.
Our Study Coordinators are certified ophthalmic assistants (COAs), technicians (COTs), and technologists (COMTs) who are highly qualified and trained in clinical research conduct, ethics and compliance.
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Choosing to participate in a clinical trial is an important personal decision. The following frequently asked questions provide detailed information about clinical trials. After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials.
What is a clinical trial?
Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol.
What is a protocol?
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment. [ back to questions ]
Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Before joining a clinical trial, a participant must qualify for the study. It is important to note that inclusion and exclusion criteria are not used to reject people personally. The criteria help ensure that researchers will be able to answer the questions they plan to study. [ back to questions ]
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses or technicians who check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, and monitor the participant carefully during the trial.
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the study team members involved in the trial explain the details of the study to the participant and provide an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time. [ back to questions ]
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.
What is an Institutional Review Board (IRB)?
A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. All clinical trials in the U.S. must be approved by an IRB before they begin. [ back to questions ]
Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
What is a placebo?
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment's effectiveness. [ back to questions ]
What is a control or control group?
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
What are the phases of clinical trials?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
Phase I: Researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II: The experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
Phase III: The experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
Phase IV: Post marketing studies delineate additional information including the drug's risks, benefits, and optimal use. [ back to questions ]
What is a double-masked study?
A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental treatment and which are receiving a placebo (or another therapy).
What is the Food & Drug Administration (FDA)?
The U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices. [ back to questions ]
What is an Investigator?
A specially selected physician who conducts the clinical research trial at the study site.
What is a Study Coordinator?
A specially trained nurse or technician who supports the investigator by performing study assessments and managing data collection for the study. [ back to questions ]
For more information about clinical trials:http://www.clinicaltrials.gov/
For more information about clinical trials that Drs. Fine, Hoffman and Packer are currently conducting please contact our Clinical Research Director at 541-349-5186.
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