Danbury Eye Physicians and Surgeons, PC has a long history of being involved in the cutting-edge research that will ultimately bring new pharmaceuticals, devices and drugs to light. We have been involved in over 60 major studies and welcome you the opportunity to participate in these studies.
Why should you participate?
The ultimate reason should be the that you wish to play a part in the development of a new drug that may be helpful to others. While you will be compensated for your time, the commitment on your part to participate must lie in a desire to be altruistic. In most studies you will be randomized into many groups, most of the time unknown to the doctor or the patient, so that you may or may not be getting the active medication. These studies are well monitored by both the FDA (Federal Drug Administration) and pharmaceutical monitoring. However, the physician investigator has your best medical interest as their top priority. Our first goal is to do no harm. Thankfully, almost every study has safeguards to protect you and to identify problems. Before you join a study all of this is made clear to you.
How are new drugs developed?
The process of getting a new drug from the laboratory to the pharmacy is one filled with multiple studies that follow a logical progression- all under the eye and ongoing approval of the FDA.
- PreClinical: These are studies where to compound is tested in the laboratory and, if needed, on animal models.
- Phase I: these are studies, usually on healthy individuals for ophthalmic medications, that see the tolerability of the new medicine.
- Phase 2: These are studies designed to see which strength of medicine is needed to get the desired effect.
- Phase 3: These are larger studies to prove the clinical effectiveness of the new compund.
After all these studies are completed, the FDA reviews the data and either approves or disapproves the medication for sale in the United States.
Why has Danbury Eye done so many studies?
Danbury Eye is recognized in the research community as a trusted location to do research. Danbury Eye is committed to meet the needs of research sponsors with a commitment to the ethics involved to do good clinical research. We are fortunate to have two physicians who are CPIs (Certified PRincipal Investigators). These MDs (Drs Matthew Paul and Richard Scartozzi) have demonstrated an understanding of the medical, ethical and safety issues involved in studies by completing a course of study and passing a qualifying exam. In addition, they have shown past involvement in research. Likewise, Angela Smit, is a certified study coordinator, taking a similar course of study and is well versed in all the aspects of good clinical practice.
How do I make the final decision to participate in a study?
No patient is ever obligated to do research. You and your doctor will discuss the benefits and risks involved in a research study in an informed consent process. This discussion is much more than just signing a form, but an opportunity to explore all aspects of what will be required by you and what will be done to you. If you do decide to do research, you always have the right to withdrawl from a study.
What areas of research has Danbury Eye participated in?
We have done studies in glaucoma, eye infections, allergic eye diseases, laser surgery, cataract surgery, eye pain control, eye inflammations, dry eye, retina diseases - including macular degeneration, both dry and wet, retinal vein occlusions, diabetic retinopathy, intraocular lens implants and more.
Who can I contact to find out more?
Angela Smit can be contacted at 203-791-2020 x 256 or 257 or by email at email@example.com