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What are Clinical Trials?

Clinical trials are studies of drugs or treatments for specific conditions (such as asthma, chronic cough, or COPD). There are several phases of clinical trials.

Phase I:

Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In the description above the key phrase is FIRST TIME. Phase I studies are the first time a drug is tested in a person. Typically these drugs have been tested extensively in the lab and in animals prior to testing in humans. They are also usually only tested in healthy individuals, rather than in people who have the disease the drug is looking to eventually treat. Phase I trials are typically conducted at specialized facilities and may require participants to stay for several days. Parexel and Algorithme are local facilities that conduct Phase I studies. Because of the risk and length of involvement these companies typically pay individuals to participate in the study.  We do not conduct Phase I trials at PCCAB, but you can be assured that almost all drugs that you have been prescribed either here or elsewhere have gone through that process at some point.

Phase II:

The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. In the description above the key word is EFFECTIVE. Phase II studies typically involve people who have the disease or condition the drug is trying to treat so that they can determine if the drug is an EFFECTIVE treatment for that condition or disease.  Notice in the Phase I trial they were not determining if it was effective because the people it was given to do not even have the disease, but in Phase II an asthma drug may be given to asthma patients. PCCAB does conduct some Phase II trials. Sometimes a patient is taken off their current medications and placed on the new medication to see the effects of the new medication – but never without volunteering to do so. The patient is very carefully monitored for side effects and adverse reactions. Usually at the end of the trial the patient is returned to their original medication, even if the new medication seems to help. That is because the drug is not yet approved for widespread use. To get approved a drug must pass a phase III trial. Sometimes the patients in a Phase II trial can go on to participate in the Phase III trial.

Phase III:

The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. In the description above, the key word is COMPARE. The most important thing in the Phase III trial is to make a comparison between treatments to see which one is best. Most of the studies that PCCAB conducts are Phase III trials. If you participate in a Phase III trial at PCCAB, sometimes you may get to try the new medication, but other times you may be given the current standard treatment.  This is so we can compare the new medication to the old ones. Sometimes the new medication may be better and sometimes the old one may be better.

Phase IV:

Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use. Phase IV trials involve drugs that you can already get as a prescription. They have been approved for use. The reason that the drug maker continues to gather information is because the drug is now being used in a wider variety of patients, with many different disease stages, and many other factors that may affect how the drug works.