What is a clinical trial? Clinical trials evaluate the value and merit of a new drug and looks at dosing, acceptable toxicities, as well as prevention and treatment strategies. Before clinical trials are tested on humans, they are tested on animals. When enough human data is recorded, then this information goes to the FDA (Food and Drug Administration) for approval. This is a long, lengthy and expensive process. It is estimated that it may take up to 10-12 years and up to an estimated $80 million dollars to bring a drug to the point that you or I could be taking it. More and more people are looking into clinical trials and there are many phases of a clinical trial before it goes on the market. Clinical trials try to find better ways to prevent, diagnose and treat cancer. There are guidelines to each clinical trial and not all health plans will cover patient care costs in a study. Having these guidelines then will determine if a patient can be included in that clinical trial. A patient must also have informed consent, meaning they understand the possible benefits, expected outcomes, possible side effects and possibilities that at any time a treatment may be stopped. A patient can also withdraw consent when in a clinical trail. The patient must receive all the necessary information to make an informed choice before signing the informed consent. I, myself am in a clinical trial and when I started 5 years ago it was in a later phase of the trial, now what I am receiving has become the gold standard for treatment for breast cancer patients that had the same variables as I did. Much can be learned from clinical trials and it may also give a patient another option in treatment. I would not hesitate to participate in a clinical trial again if needed but I do caution every patient the weigh the benefit and risks and be informed. This may help someone in the future to have a Great day ! S
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AuthorMy name is Sue Kilburn and I am a clinical nurse breast cancer educator at the Yolanda G. Barco Oncology Institute in Meadville, Pennsylvania. Archives
March 2015
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