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About Clinical Trials
Q: What is a clinical trial?
A: A clinical trial, commonly referred to as a clinical study or research study, is designed to determine if a new drug or treatment will work on a disease or will potentially be of benefit to patients. Trials allow doctors and researchers to gain information on the benefits, side effects, and possible applications of new drugs, as well as different combinations, doses, and new indications of existing drugs. As a result, the medical community may be able to determine new ways to detect, diagnose, avoid, and control clinical factors responsible for disease.
Q: What are the phases of a clinical trial?
A: Clinical trials have four research phases.
A Phase I study is the first use of a new drug or a new drug indication in humans. It is used to test for safety and side effects, and to determine how the drug should be given. Only a limited number of patients are accepted for participation in Phase I trials.
If the Phase I trial shows safety.
A Phase II trial is initiated to investigate the ideal dosing range of the drug. The therapy is tested in a larger number of patients to determine how well it works, and other possible, less common side effects.
In a Phase III trial, experimental treatments are compared to placebo (an inactive substance that looks like the experimental treatment) or common or standard therapies. Patients who participate in Phase III trials are randomized (randomly chosen) to receive the experimental treatment or to receive placebo or a standard therapy. Those patients who are selected to receive placebo or standard therapy are referred to as the control group. The purpose of a Phase III trial is to determine if patients receiving the experimental therapy do better than those in the control group.
A Phase IV clinical trial may be conducted to continue evaluation of the safety and efficacy of therapies that are already FDA approved and available for general use.
For more information on clinical trials, visit http://www.cancer.gov/clinicaltrials/search
Q: What are the pros and cons of participating in a clinical trial?
A: In addition to receiving high-quality care, there are many benefits to enrolling in a clinical trial. Your participation could potentially benefit others by increasing knowledge about a disease and its potential treatments. Also consider that, as a clinical trial participant, you may be one of the first patients to experience positive results from a new therapy. On the other hand, it is possible that new treatments may not provide any benefit and/or you may experience unexpected side effects. Also, you may be placed in a control group that receives placebo (an inactive substance that looks like the experimental treatment) or standard care instead of the study treatment. These are factors you need to be comfortable with before deciding to join a clinical trial.
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