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Study Participant Information

Participating in a research study means that you can make a difference in the future of health care. Drug research and development occurs in several phases, each with different goals for the developmental process.

Phase 1 Studies

Phase 1 studies are the first time an investigational drug is used in humans. Phase 1 studies are usually conducted in a small number of healthy volunteer subjects (typically between 20 and 80) and are closely monitored. The goals are to determine how the drug is absorbed and eliminated from the body, to determine a safe dose range for the drug and to gather information that will help researchers design a study for the next phase, phase 2.

Phase 2 Studies

Phase 2 studies are the first examination of the effectiveness of an investigational drug for a particular condition. These studies are conducted in several hundred patients (200-300) who have the disease or condition. Phase 2 studies are typically well controlled and closely monitored to determine the preliminary effectiveness, short-term side effects and risks associated with the drug.

Phase 3 Studies

Phase 3 studies are performed if there is preliminary evidence of effectiveness for a particular condition (from phase 2 studies). Phase 3 studies are needed to gather more information about a drug’s effectiveness, safety and appropriate dosage in different clinical settings. The goal is to evaluate the overall benefit-risk relationship (does the benefit outweigh the risks?) and to gather enough information for physicians and product labeling. Phase 3 studies are performed in a variety of clinical settings and in large numbers of patients (400-1,000).

Once the sponsor has gathered enough information from carefully designed studies and is able to show that the drug is safe and effective, the sponsor applies to the FDA for approval to market the drug.

Phase 4 Studies

Phase 4 studies are after-market studies. The FDA may ask the sponsor to gather additional information about the drug. Phase 4 studies may focus on gathering additional information about the drug’s risks and benefits, different doses or dosing schedules, different patient populations, different stages of the disease or effects of the use of the drug over longer periods of time.

Protecting You

Through all phases of drug development, the Code of Federal Regulations provides sponsors and investigators with guidelines for research and development. Sponsors and investigators must abide by these regulations when conducting clinical trials. These guidelines dictate various requirements of research including the informed consent process, safety monitoring, quality of the data and many more.

This means that when you participate in a study all study procedures will be completely explained to you before you decide if you want to participate. All procedures that are performed for the study are at no cost to you and the results are closely monitored by the investigator. Your research records are confidential. You may be compensated for your time and travel.

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