What are clinical trials?
Clinical trials, also known as medical research studies, are carefully designed tests of medicines and treatment options under the supervision of a physician. These studies rely on people, called study participants, to try the new medicine or treatment that may have fewer side effects, or provide an effective treatment that is better than the one currently in use.
Who oversees clinical trials?
Clinical trials must follow strict rules set by the Food and Drug Administration (FDA), and each trial must be approved by an Institutional Review Board (IRB)Ña group of both medical and non-medical community members responsible for protecting the study participants and making sure that the study complies with the law.
Why should I enroll in a clinical trial?
Being in a clinical trial gives you the opportunity to receive therapy that may be more effective or better tolerated than therapies that are currently on the market. Another benefit to enrolling in a clinical trial is that it gives you the opportunity to help future generations with the same disease. Every treatment and drug that is currently used had its beginnings with clinical trials, with patients who were willing to help science find new and better ways to treat disease.
Can I leave the trial any time I want to?
You can withdraw at any time. All you need to do is notify your physician you no longer wish to continue.
First-in-man, Phase I, Phase II, what do all those terms mean?
Clinical trials involve several phases. These include:
- Phase I: testing the safety of the drug in humans
- Phase II: testing the effectiveness of the drug, including dosage and timing of treatments
- Phase III: comparing the new treatment to the one currently in use
- Phase IV: following the drug after it is licensed and approved by the FDA, to track its safety and gain more information about its risks, benefits and optimal use
First-in-man means that it is the first time the drug has been tested in humans and that, up to this point, the drug has only undergone pre-clinical and animal testing.
What else should I know about clinical trials?
Before you enroll in a study, you will receive an "Informed Consent Form" that provides the following information:
- A detailed description of the study
- Any possible risks and benefits of participating
- Information about any financial obligations you may incur by participating
Your physician and research staff will make sure you are completely educated before the trial begins and answer any questions you may have before and during the trial.
How can I find out if I'm a candidate for a clinical trial?
For more information about clinical trials, contact your physician or our Ask Sarah information service by calling (844) 482-4812 or by email. "Learn About Clinical Trials" on the Sarah Cannon website, or Cancer.gov's "Learn About Clinical Trials."