Federal Drug Administration Clinical Trial Details and Information

Completed by volunteers, FDA (short for Federal Drug Administration) clinical trials are a series of tests, experiments, and surveys that are done to collect safety information regarding drugs and other materials. In a long and lengthy process, these are performed only after an extensive number of tests have been done and enough information has been completed and deemed as being satisfactory. From there, the Health Authority and Ethics Committee give their stamp of approval to the country whom is running the trials.

However, before getting to the final step, a lot of work has to be done. Due to the fact that FDA clinical trials are so expensive, in the beginning, only a small portion of volunteers are chosen to start off with. The number of people used in these studies can change, due to one or more factors. These include but are not limited to: the product in question, its current stage of development, etc. Assuming that the initial round of trials go well, then the number of volunteers involved automatically increases. This is done as a means to compare and contrast, between the product in question, and an already prescribed drug. The size of FDA clinical trials can vary, going anywhere from one center to dozens.

According to the United States National Institute of Health, there are five types of clinical studies, which all are broken down in the following list:

Treatment Trials. These test new drug combinations, radical approaches to surgery, and/or experimental treatments.

Screening Trials. These test health conditions and diseases.

Supportive Care Trials. These test and explore various ways of comforting the quality of life in individuals with chronic illnesses.

Prevention Trials. These test ways that can prevent certain diseases from returning, or prevent diseases at all through the use of better lifestyle changes and/or medications.

Compassionate Use Trials. These are used as a last resort, as the FDA must personally review each case by case, one by one, to determine if these tests are necessary or not. When demonstrated, these tests provide patients with experimental therapy whom have previously had less than desirable or unsuccessful remedies in the past.

The majority of the time, most FDA clinical studies are completed in reference to some type of experimental drug. When this is decided, volunteers undergo a process of three different phases, which have been listed and broken down as follows:

Phase I Clinical Studies. As the beginning phase in this process, this phase strictly deals with the first time the drug is used, and how safe, or unsafe, the drug itself is. Usually completed in a hospital, these particular studies are done on a number of volunteers ranging in size from 20 – 100. The reason why these trials take place in a hospital is so that the individuals participating can easily be watched, and in the event that something goes wrong, can receive treatment for any adverse side effects that may take place.

Phase II Clinical Studies. As the intermediary phase, these tests are proceeded with only once it has been established at this point that the drug in question is indeed safe to use by healthy individuals. Now, the drug is tested by other individuals who are stricken with the disease or medical condition that the drug in question is expected to cure or improve. These clinical trails are much longer than the first phase, lasting anywhere from a few months to a few years. The number of volunteers used to complete these trials can easily start at 200 and escalate to more. Once these are complete, it is imperative that the FDA reviews the results in order to compare and contrast the information regarding the safety, dosage, and effectiveness of the drug in question. When it comes to success rates, only about 1/3 of every experimental drug that is tested completes Phase I and Phase II.

Phase III Clinical Studies. As the final phase in this process, these clinical studies last many years. At this point, the drug in question gets tested in anywhere from 500 – 2,000 volunteers who do, in fact, have the disease or medical condition that relates to the drug. These tests are often random. Just as the Phase II studies are done, these clinical studies are also reviewed by the FDA for a more detailed understanding of the effectiveness, advantages, disadvantages, and side effects of the drugs. Typically, the number of studies that are completed at this phase range from 70 – 90 percent. A great example of this is the drug called flibanserin.