Clinical Trials: What Are They?


Have you ever wondered how your birth control pill, your allergy medicine, or any other pill in your medicine cabinet arrived in your hands? The answer is via clinical trials. Clinical trials are the "real world" tests where researchers study medications taken by real people. To get to that point, medications must pass through many, many steps.


Scientists create new medications, then see if they might work in similar or different ways compared to current medications. Then they have to submit applications to the FDA to take the first steps in trying out medications in people. The FDA has strict guidelines to test the safety and effectiveness of medications. First, a new medicine has to go into a phase 1 trial, which is designed to test the safety of the medication. If the medication is determined to be safe, then it passes into a phase 2 trial. Phase 2 trials are designed to figure out if the medication actually works...does the allergy medicine make patients stop sniffling and sneezing? Does the high blood pressure medicine actually lower blood pressure? Phase 2 trials also look for any potential side effects.


About 1/3 of medications in Phase 2 trials are found to be effective and therefore make it into Phase 3 trials. Phase 3 trials continue to study effectiveness but also determine how a medicine compares to other drugs or to a placebo (a pill that doesn't have actual medicine in it). This is the step where our office comes in. We are like old-fashioned matchmakers, matching patients who have certain medical problems with clinical trials trying to fix those problems. For example, we are currently enrolling patients with migraine headaches into a trial to test a new migraine medicine.


Patients enter clinical trials for different reasons. Some have tried many medications to improve symptoms of a medical problem, such as endometriosis, without success. Some are trying to help increase scientific knowledge. Another perk is that clinical trials pay study subjects for their time. Finally, it's important to know that all clinical trials are governed by what's called Good Clinical Practice (GCP), which means that researchers must do their best to protect patients in clinical trials.


If you are interested in learning more about clinical trials, click here!

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