Clinical trials are research studies conducted with human volunteers to evaluate medical treatments and devices, aiming to assess their safety, efficacy and potential side effects before they can be approved for wider use in healthcare. There are three phases of clinical trials necessary before there is enough data gathered for the FDA to approve a medication. There is also a fourth phase where the FDA tracks the ongoing safety and efficacy of the treatment after it has been approved.
Here's a breakdown of phases typically seen in clinical trials-
- Phase I studies assess the safety of new medications or devices. Studies at this phase are designed to examine how the medication is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur when the drug is administered at various doses. These trials commonly focus on healthy participants to rule out safety variables.
- Phase II studies test the efficacy of the new drug or device. Most phase II studies are randomized, meaning one group of patients receives the study medication and the second "control" group receives a standard medication or placebo. Most phase II studies are "double blinded" meaning neither the patients nor the research staff know who received the experimental medication.
- Phase III studies involve randomized and blind testing on a much larger scale. These studies provide the FDA with a better understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions. Once phase III trial is complete, the pharmaceutical company can request FDA approval for marketing of the medication.
- Phase IV studies are conducted after a drug or device has been approved for consumer sales. The main objectives for this phase are to compare a drug with current drugs already on the market, monitor a drug's long-term effectiveness and impact on the patient, and determine the cost-effectiveness of a drug relative to other options on the market.
Clinical trials are crucial because they provide data to the FDA, so the FDA can approve a drug for safe and effective use. By participating in a clinical trial, you are opening a door to better solutions for future patients that struggle with the same condition or symptoms you experience.
At Advanced Research Institute, before consenting to participate in a trial, patients are given a comprehensive list of risks related to trial medications. Trials are completely voluntary, and patients are allowed to discontinue the study at any time for any reason. If you or someone you know are interested in participating in a trial, please fill out the “learn more” form to be contacted by one of our recruitment team members or call us at 801-409-2040.
