Research

Research Process

The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and ophthalmic technicians or technicians who check the health of the participant at the beginning of the trial, give instructions for continued participation in the trial and carefully monitor the participant during the trial.

Every clinical 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.

To protect the privacy and safety of study participants, all names remain secret and are never mentioned in any reports or presentations. In addition, ethical and legal codes that govern medical practice also apply to clinical trials. The rights of study participants are fully protected.

Clinical trials are conducted in four phases. Each phase has a different purpose and helps scientists answer different questions.

Phases

Phase I: A small group of healthy people (20-80) test an experimental drug or treatment for the first time to evaluate its safety, determine a safe dosage range and identify side effects.

Phase II: People with a disease are given the experimental drug or treatment in order to see if it is effective and to further evaluate its safety. Phase II trials involve a larger group of between 100 and 300 people and study results begin to be published.

Phase III: At this point the experimental study drug or treatment is given to large groups of people (1,000-3,000). Studies at this phase confirm the drug’s effectiveness in addition to determining drug interactions and side effects and comparing it to commonly used treatments. After completion of all Phase III studies, all of the data from all Phases are submitted to the FDA to begin the approval process.

Phase IV: This clinical trial phase occurs after FDA approval in order to continue gathering information which will help identify the drug’s risks, benefits and optimal use.