Clinical Trials

Clinical Trials

A clinical trial is a research study created to answer specific questions about new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs, new devices or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.

Why are there clinical trials?  

A clinical trial is one of the final stages of a long and careful cancer research process. Studies are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis and treatment are safe and effective.

What are the phases of clinical trials?

Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Clinical trials are usually classified into one of three phases:

  • Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood or injected into the muscle), how often and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.

  • Phase II trials: A phase II trial continues to test the safety of the drug and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.

  • Phase III trials: These studies test a new drug, a new combination of drugs or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics and cancer centers nationwide.

Click here to view the active clinical trials at Moffitt.


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