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Phases of a Clinical Trial

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Phase I: First Time In Humans, Safety Study.

The first phase of clinical research is primarily a safety study, with somewhere between 20-100 healthy volunteers. Volunteers will remain in a controlled environment for around 7-10 days, where they will have physical exams and testing to measure how the body interacts with a drug or device.

Once this data is collected, it is taken to the FDA for review. If the FDA is confident the data meets all the criteria for patient safety, the trial will advance to phase II.

Phase II: Multiple Doses, Safety & Efficacy Study.

Several hundred people are enrolled in the second phase of a clinical trial. This stage is usually a few weeks long and involves multiple uses of a medication, treatment or device. Multiple doses are studied to determine a dosing range to propose for the market.

During this phase, volunteers will be in a less controlled environment than those in Stage I. Additionally, Phase II participants may have a few health problems or be taking other medications. This allows us to gradually test how a method interacts with a variety of health conditions and medications.

Once the data from Stage II is collected, it is taken to the FDA again for the review. The trial will either be advanced to phase III, or the FDA will ask for additional trials for clarification.

Phase III: Multiple Doses, Long Term Trials.

The third phase of research is when a drug, treatment or device is being prepared for FDA approval. Up to several thousand people are enrolled in this phase. Volunteers will either receive the method being tested, or a placebo. A placebo is used to ensure the validity of the results and provide a control group in which to compare findings.

This phase of the research study can take several months to a year for completion. We will continue to review safety data, as well as determine an optimal dosing range. Volunteers with multiple stable illnesses are enrolled, as well as participants who are prescribed a range of medications.

The results from multiple doses over an extended period of time will be taken to the FDA for final approval.

Phase IV: Post Marketing, Open Label

Once a medication, device or treatment has been approved by the FDA, it will be available to the public. This period is known as Phase IV.

Even after a method has been approved for public use, it is important to continue collecting as much data as possible. One way to collect this data is through open label clinical trials. During these trials, researchers will continue to explore how a drug, device or treatment is being received, as well as any unexpected side effects or drug interactions.

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