Some of our research studies are conducted with FDA-approved therapies. Some of our clinical trials are research studies composed of patients who agree to undergo new therapies in order to gain FDA approval. However, not all clinical trials are the same and there are different phases that they must go through along the way. Each different phase marks the beginning of a brand new clinical trial and has different risks associated with it. At DeNova, most of our studies are Phase III and Phase IV trials, meaning that many of our treatments have been tested in humans and companies are trying to see if the product “works”.
|
Phase |
Goal |
Typical Number of Participants |
|
Phase 0 |
-Understanding how a treatment works in/on a patient’s body |
10 |
|
Phase I |
-Watching how a treatment works in/on a patient over a longer period of time.
– Determining dosing and safety |
20-100 |
|
Phase II |
-Testing treatment on healthy volunteers
-Determining whether or not the treatment works at that dose |
100-300 |
|
Phase III |
-Testing treatment for its intended use
-Determining if the treatment gives desired results |
300-3000 |
|
Phase IV |
-Watching treatment use on the general public
-Determining any long term effects/ how to market the treatment |
Anyone who wants the treatment |
Phase 0 – In this phase the smallest dose possible of a treatment is used to see if it will even do what the scientists want it to do in patients. If the results look promising, it moves on to Phase 1.
Phase I– This is the first stage of testing a treatment on human patients. In this phase, scientists make sure that the treatment is safe for the patients and they watch how it is actually working on a patient’s body. This is where the best and safest dose is usually determined. These trials are usually done in a clinic so that the patient can be watched at all times by certified medical staff.
Phase II – Now that the safety of the treatment has been shown, Phase II trials are done on many more people. The main goal at this point is to figure out the best dose to get the desired effect. For example, if the aim of a device is to get rid of fine lines and wrinkles, how many treatments does it take?
Phase III – At this stage, the treatment and the dose is set and now it needs to be determined if it does what it says it is going to do. Also, if another treatment is already available that does the same thing, it needs to be shown that this treatment has an advantage over what is already out there. For example, if a device is supposed to get rid of wrinkles, how well does it work? Does it do a better job than the wrinkle treatment already available at the store?
Phase IV – Many times these trials are performed after a treatment is already on the market. These trials could be testing the long-term results or even looking at the best way to market the product. For example, now that the treatment is available, the company who makes it might want to figure out on what type of skin it works best on. Once they know this answer, they can focus their commercials and product packaging to draw in that specific type of patient.
Are you interested in learning more about DeNova Research? Call us today at 1-855-DENOVA1 or contact us online.
