Research studies are conducted in phases. A Phase III research study cannot happen unless a Phase I and Phase II research study have been completed successfully. At all times the patient’s safety is the number one priority. At Providence Regional Cancer System we participate in Phase III research studies.
Phase I: Is it safe?
Commonly called the “safety phase,” this is the first time the drug is used in people. In essence the study is determining how safe the drug is for human interaction. Most side effects are revealed during this phase as researchers determine exactly how the drug interacts with the human body. These are typically very small studies of about 20-80 people, usually with healthy participants.
Phase II: Does it work?
If a drug passes Phase I we know it’s relatively safe. What we don’t know is, does it work? Phase II begins using the drug on those individuals with the disease or condition of interest. Control groups are established, meaning one group of participants will receive the new drug (experimental group) and one group of participants will receive a placebo or the current “approved” method of treatment (control group). At the end of the study the results will be closely compared to determine if the new drug actually works. Phase II studies usually involve 100-300 people.
Phase III: Is it better?
After a drug is determined to work for it’s designed purpose it begins to be compared against the gold standard of treatment (ie: what is currently being used for treatment). Is the new drug better, worse, or the same than the current drug? Do the benefits/risks of the new drug outweigh the negative side effects? Phase III studies are fairly large, usually involving 1,000-3,000 participants from multiple sites across the nation. After a successful Phase III a drug will earn FDA approval.
Phase IV: Are there other uses?
Research studies in Phase IV are called “post-market research studies.” Researchers will continue to collect information on risks, benefits and side effects now that the drug is being used in “real-life conditions.” Phase IV will also take into consideration different dosage amounts and schedules as well as the drugs potential benefits for different stages of the disease or even different diseases altogether.
* If you are ever interested in being involved in research studies or learning more call the Providence Regional Cancer System Research Department Directly at 360.412.8939.