How do we test new medicines before they are released to the public?
Let’s say for the sake of this example that there’s a new drug that is potentially effective at treating people with muscle pain. The process to test that treatment is called clinical trials. To test the medicine, clinical trials occur in different stages, called phases. Phase I testing is done on healthy volunteers without muscle pain. If the drug is found have unsafe side effects, it would fail phase 1 and be withdrawn from further testing. If the drug passes Phase 1, it goes on to Phase 2 which studies a small group of patients with muscle pain to see if the new drug is effective in treating the condition without producing serious side effects. If the drug passes Phase 2 it goes on to Phase 3 which tests a larger group of patients with muscle pain to confirm the effectiveness and safety found in Phase 2.
There are strict guidelines that researchers must follow when conducting clinical trials to ensure the safety of their human subjects. Regulatory bodies such as the FDA monitor clinical trials to ensure that all guidelines are being followed. If the physicians in charge of a new drug trial are found to not follow the guidelines, they are removed from their trial and may lose their ability to participate in any future trials.
Participation in a new drug study can be an exciting experience–especially when it results in a decrease or elimination of your symptoms. Before a patient begins a clinical trial, all the possible risks that may occur during the study are spelled out in a document called the consent form. The consent form is signed by the participant before they start treatment. The consent form makes it clear that declining to participate in a study will not affect the participant’s future care, and that they may withdraw from the study at any time for any reason.
A drug study is an experiment. To ensure that enthusiasm about the new drug doesn’t influence the outcome–for example hoping that the treatment is going to work will make you believe that it works–some participants will receive an inactive drug called a placebo. Whenever possible, the physician administering the drug will not know if they are giving you the real drug or the placebo. This type of study, where the physician and the study participant do not know which medication they receive, is called a double-blind study. Participants are informed at the end of the study if they received the active drug or the placebo.
Some drug trials provide financial compensation for time and participation. Some trials will only compensate you for any expenses that you incur in the process of participating in the study. Participation in a study may or may not benefit you directly but will potentially benefit many patients in need of new effective treatments.
Filed under: pain management
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