The OrthoCarolina Research Institute, Inc participates in three types of studies regulated by the Food & Drug Administration (FDA). These include: Investigational Device Exemptions (IDEs), Investigational New Drugs (IND), and post-market studies.
Investigational means that the drug or device cannot be used or prescribed to the general population - only participants involved in the clinical trial can receive these products because they are still being tested for safety and effectiveness in human volunteers. The FDA may require drugs to be studied under an IND if they have never been tested in humans before, if they are being tested for a new indication (diagnosis), if they are being tested in a new population (i.e., a drug approved in humans is being tested in children), or if there is a new dose. The FDA may require implants to be studied under an IDE if there is a significant change to the design, function, or materials used in the device compared to others that are commercially available. For example, even though hip replacement surgery has been available for decades, the OrthoCarolina Research Institute, Inc. will often participate in IDE studies testing new designs, such as a ceramic liner coupled with a ceramic cup.
These IND and IDE clinical trials have strict reporting guidelines to ensure that when these products become commercially available, that they are relatively safe. Data is collected at specified intervals after treatment and adverse events (medical events that could be related to treatment with the investigational product) are collected. Common and/or serious adverse events often end up as the 'side effects' listed on the drug or device label. The approval process to get a new drug or device to market can take 5-10 years and an estimated $1.3-1.7 billion dollars.
In addition to IND and IDE trials, the FDA will sometimes require a post-market study. Post-market means that the product is being studied after the FDA has approved it to be marketed and sold in the general population. These studies are often conducted to get long-term follow-up or marketing data.
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