Clinical Research and Patient Studies                                                  Sitemap Research Department Dr. Sheta participates in Clinical research studies funded by various Pharmaceutical companies.  Each study is unique and requires careful selection of participants, strict rules to drug administration and FDA review to determine the suitability of drug administration. If you are interested in becoming a participant in one of our research studies, you can view our ongoing,  past and upcoming studies here. Background on Research Studies  Clinical trials are ordered from Phase I to Phase IV. Phase I trials evaluate safety and tolerability by administering a new medication to a small number of normal people without the disease under study. Phase II trials, conducted at 10 to 30 sites, evaluate dosing ranges and effectiveness for a few hundred patients with the disease under study. Phase III trials are usually multi-center randomized trials involving several thousand patients and 100 or more sites. These trials are powered to evaluate many clinical or statistical endpoints about the effectiveness of the drug in question. Phase I, II, and III trials are conducted before the study medication or device is approved by the FDA and released for general consumption. Phase IV trials, structured to further evaluate safety and effectiveness, are usually multicenter trials conducted after FDA approval. Our site has participated in phase II, III, and IV studies with as few as 10 sites and as many as 200. In addition to keeping meticulous records, collecting quality data, and retaining clinical staff, the ability to recruit subjects is paramount. Prospective subjects are provided with both an informed-consent document written in lay language and a patient bill of rights. Potential benefits for participation include a positive treatment effect for the disease under study, close monitoring of patient illness, patient education, access to  specialists, and medication at no cost. In virtually all of these trials, the treatment under study is compared with either conventional therapy or a placebo. As required by the informed consent process, all study patients will be made fully aware that as a result of the randomization process, they might not receive the study drug and/or device (ie., unique way to administer a drug).