Four Reasons to Participate in a Phase Four Clinical Trial
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Post-marketing surveillance studies help participants as well as researchers
As a member of the rare community, you may know something about the process a new medication must go through before it receives FDA approval. Clinical trial phases 1 through 3 are conducted to establish the safety, effectiveness, and optimal dosage of a new treatment before it is made available to the public. But did you know that some drugs undergo an additional step post-approval to track their performance in the real world? These post-marketing studies, called phase 4 studies, help manufacturers learn more about long-term benefits and risks and offer a number of benefits to study participants.
Why participate in a phase 4 study? Here are 4 good reasons:
You will be taking a medication that is already FDA-approved for your rare disease.
As a study participant, you will receive the new FDA-approved medication free of charge.
You will work with the top researchers studying your rare disease.
Phase 4 studies provide real-world evidence that benefits real patients and advances understanding of your condition.
Phase 4 studies typically involve a much larger number of participants than earlier phases and take place over a longer period of time. Investigators try to involve people from varied patient populations at multiple study centers, helping to eliminate any bias that might affect the results. While phases 1 through 3 are carefully controlled, phase 4 studies look at drugs under real-life conditions. For example, in a phase 3 trial, participants may be instructed to eat a certain diet and/or avoid taking additional medications. But in phase 4, patients go about their normal lives while taking the medication, following no special restrictions.
Phase 4 studies are not conducted on all drugs. They may be mandated by the FDA or undertaken voluntarily by a pharmaceutical manufacturer to learn more about the effects of a treatment or to determine its cost-effectiveness. Phase 4 studies may also offer patients access to medications under “compassionate use” conditions, in which new treatments are made available to those who are not eligible for other clinical trials.
If you are interested in taking part in a phase 4 trial, ask your doctor for advice. For more help finding clinical trials that may be appropriate for you, use the Know Rare clinical trial finder.
