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 We have a very active research department at ROG being involved in various studies for the treatment of glaucoma/ocular hypertension and dry eyes. But perhaps you are not familiar with the steps which bring an investigational drug to the consumer as an approved medication by the FDA (Food and Drug Administration).
There are four phases of clinical trials - three of which take place prior to the FDA for approval of a new drug. Phase 1 studies are conducted to establish the safety and tolerance of a drug in humans. They are short-term, lasting one day to one week, and are conducted with a small patient population, usually 20-80 subjects. Phase 2 studies are conducted to establish effectiveness of a drug in a specific population and disease. These studies define dose in patients, and are conducted for up to a few months with 200-300 patients. Phase 3 studies are conducted to establish safety and efficacy with a selected dose in a broad sample of subjects involving hundreds to thousands of patients over a period of years.. At this point a new drug application is submitted to the FDA requesting marketing authorization for the investigational agent. There are also Phase 4 studies which are conducted after the FDA has approved a drug and these may involve new age, gender or ethnic groups. They also monitor continued safety in large groups and assess quality of life. The research that we are involved with at ROG primarily involves Phase 3 Phase 4 research trials - five of our ongoing studies are Phase 3 and three are Phase 4 trials. If you would like more information about clinical trials or may be interested in participating in one of our ongoing studies, please give Mindy or Missy a call at 244-6011 ext. 314. |
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