All modern health care treatments go through clinical trials – human research studies – as the final steps toward demonstrating their safety and effectiveness. The most promising new medications, devices, and procedures eventually must be tested with clinical trial participants, and these studies often lead to better standards of care for managing or even curing certain medical conditions.
As a research institution, UAB Medicine conducts hundreds of clinical trials across many medical specialties at any given time. Our clinical trials program promotes innovation, improves patient care, and helps attract talented clinicians and researchers. UAB Medicine clinicians and their colleagues often are involved in conducting the clinical trials they recommend for patients.
The clinical trial process
Clinical trials are managed by experts and must follow a carefully monitored process that is overseen by the U.S. Food and Drug Administration (FDA) to maximize safety for participants. From among thousands of potential treatments, only the safest and most promising ones make it to clinical trials, and they are tested in laboratories for years before being considered for clinical trials.
The FDA is responsible for approving clinical trials for both public and private organizations that demonstrate the laboratory effectiveness and safety of a new treatment. Clinical trials are led by clinicians and researchers at institutions that have the expertise and resources needed to conduct them, and often they are conducted at multiple sites around the world, which results in thousands of participants.
The clinical trials process includes three phases, which lead to approval or further research. Each phase involves more participants than the one before it. A treatment will not advance through the phases unless the results from each phase continue to show that it is safe and effective.
- Phase I clinical trials usually test the treatment on healthy people to find the best dosage and evaluate any side effects.
- Phase II determines the treatment’s effectiveness on people with a certain medical condition.
- Phase III studies different dosages among various patient populations, and the new treatment is tested alongside existing treatments.
If the FDA approves a treatment for use, phase IV clinical trials are conducted to monitor for long-term effects.
Benefits and risks
Participating in a clinical trial helps advance health care for everyone, and participants may receive treatments that are not yet available elsewhere. Many clinical trials offer hope for people whose conditions have no treatment or haven’t responded to the standard treatments, and they help improve health care for everyone. Treatment received as part of a clinical trial is usually provided at no cost, and participants may even be paid for their time.
All treatments have risks. Clinical trials often last a long time, and participants may have to endure some side effects. The treatment may not work as well on a participant’s condition as researchers had hoped. Participants can opt out of a clinical trial at any time, for any reason. It is up to patients to discuss clinical trials with their clinicians and decide if any may be right for them.
UAB Medicine participates in hundreds of clinical trials at any given time, so we encourage you to ask your doctor about studies that may be right for you. Also, you may click here to search our active clinical trials by type or keyword.
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Clinical trials are the path to safer and more effective health care
Imagine choosing from among medicines and treatments that made bold claims about managing or curing serious conditions without knowing which could be taken seriously. If drugs and treatments were not studied and held to consistent standards, it would be up to patients to make a guess based on word of mouth, advertising messages, simple observations, and folk wisdom. Thanks to clinical trials, we don’t have to guess.
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