|
Executive Summary |
|||||||||
|
Clinical Investigations are one of
the final steps to getting a product to market. They
are also known as Clinical Trials and Clinical Research. Clinical Trials
are a method of testing medical devices and pharmaceuticals on human
subjects. This form of testing allows clinicians to see how well their
product does in comparison to the existing product or treatment
available to the general public.
Each product, whether it be a device or drug, undergo some sort of trial process. However each process is different for each product. Therefore there is not only one way for a clinical trial to occur. There are many different types of clinical trials, as well as many different people who are involved in the process. Clinical Investigations because they are used to answer questions do not have a time limit, so instead they are divided up into four different phases, three of which occur before the product can be sold to the general public. Each phase has a different number of test subjects, and are used to answer different questions that the clinician may want to know before releasing the product. Some questions that the trial may answer are what are the effects of taking this product, how safe is it, and how effective is the product in treating the condition. Because of clinical trials many product have not made it to market because they do not stand up to the regulations set by the FDA. The FDA has the approval of whether or not a product is able to be approved for sale in market, but there are a few times when even though a product has been FDA approved it has provided some adverse reactions in individuals (For example Phen-Fen). None the less Clinical trials are an important aspect to our daily life. Without them anyone would be able to sell a product to you and claim that it cures the common cold, and what it may do it cause you to have a heart attack. It is because of the FDA and clinical trials that we have regulations that must be followed to ensure the safety of the masses. These trials also allow experimental drugs to be tested on individuals who have incurable disorders who have the hopes that they drug that they are testing may alleviate or cure the pain they are enduring.
|