” The staff was very caring and respectful. I was a little nervous about being in a research study but I was put to ease after my first visit.”
Why are clinical trials important?What happens after a study is complete?
There are a several reasons why clinical trials are important. First, the participant may have a positive response to the study medication, and their disease or condition may improve. In addition, participants receive laboratory and medical testing at no charge. More often than not, the study medication is in development because it works differently than other drugs on the market, and therefore, it may present an alternative course of treatment for the patient. Second, participation in a clinical trial helps manufacturers make informed decisions about whether to pursue getting a particular drug approved. Finally, data from one patient (who completes the entire study) can be an important part of a drug development program. In the best case scenarios, this data can help get an exciting new drug approved and ultimately, continue the industry's efforts in developing medications that are safer, more effective, and work faster than any before them.
After a study is complete the information is reviewed and decision is made whether to continue or halt the drug's development. If it remains in development, the manufacturer may build in a "compassionate use" extension for the study. This means that eligible patients may receive the study drug for a predefined amount of time without having to undergo any typical study procedures, such as blood tests or clinical ratings. This usually occurs in later studies, such as Phase III and Phase IV (post-marketing surveillance). In some cases, a study doctor may dispense approved medication samples and provide additional care at no charge.