Clinical trials are an essential part of cancer research. A canceris a study conducted with cancer patients, usually to evaluate a new treatment. Clinical trials for may provide possible treatment alternatives to patients who have not had success with standard and approved therapies. You may want to discuss clinical trials options with your physician prior to beginning therapy.
To visit the click hereClinical Trials Dashboard
To learn about new clinical trials for click here.
An investigational drug is a drug that has not been approved for marketing by the U.S. Food and Drug Administration (FDA) and has not yet been proven to be both safe and effective for the diagnosis, prevention or treatment of a defined disease or condition. An investigational drug can also be a drug that has been approved by FDA and available to the public, but is being studied for a different disease or condition. Most clinical trials involve an investigational drug in order to study the drug’s safety and effectiveness.
There are 4 types of clinical trials that are most often conducted when studying investigational drugs:
- Phase 1 trials are the first step in testing an investigational drug in people and are often the first time a drug is given to humans. In these studies, researchers evaluate of the drug, what dose is safe, how the drug should be given (by mouth, injected into a vein, or injected into the muscle), and how often the drug should be administered/taken. Phase I trials usually enroll a small number of participants.
- Phase 2 trials study the safety and effectiveness of an investigational drug and evaluate how it affects the human body. Phase 2 studies usually focus on a particular type of cancer.
- Phase 3 trials continue to study the safety and effectiveness of an investigational drug. These studies often compare an investigational drug with the current standard therapy. In most cases, studies move into Phase 3 testing only after they have shown promise in Phases 1 and 2. Phase 3 trials often include large numbers of participants across the country.
- Phase 4 trials are conducted to further evaluate the long-term safety and effectiveness of a drug. They usually take place after the drug has been approved for standard use. Several hundred to several thousand people may take part in a Phase 4 study.
A placebo is an inactive substance (often called a “sugar pill”) that looks the same as, and is given the same way as, an active or investigational drug being tested. The effects of the active/investigational drug are compared to the effects of the placebo.
The use of a placebo in cancer clinical trials is very uncommon. Generally, in cancer clinical trials “standard therapy” (best treatment available for a specific cancer) is given in place of a placebo.
In medicine, standard therapy (also called “standard of care” or “best practice”) is the treatment that experts agree is appropriate, accepted, and widely used. Healthcare providers are obligated to provide patients with standard therapy.
In clinical trials, experimental therapy (also called “investigational therapy”) is most often an investigational drug (which could be a new drug, new dose, combination with other drugs, or route of administration) that has undergone basic laboratory testing and needs to be tested in humans to see if it is safe and effective. Experimental therapy has not been approved for marketing by the U.S. Food and Drug Administration (FDA) and is usually not available to the public outside of a
Informed consent is a process by which people learn the important facts about ato help them decide whether to participate. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. The research team also provides a written informed consent form that includes details about the study, such as its purpose, duration, required procedures, risks, potential benefits and key contacts. Potential participants can then read over the information, discuss it with family members, and ask the research team questions in order to help them decide whether to participate or not.
People who agree to take part in theare asked to sign the informed consent form. The informed consent form is not a contract and signing the informed consent form does not mean participants must stay in the trial. Participants can leave the trial at any time—either before the trial starts or at any time during the trial.
Health insurance and managed care providers may or may not cover the treatment costs associated with a www.medicare.gov or by calling Medicare’s toll-free number for beneficiaries at 1–800–633–4227 (1–800–MEDICARE).
Additional information about clinical trials can be found at:
Clinical trials are typically designed to test investigational drugs for specific conditions, for example a certain type or BCAN/Emerging Med’s cancer . matching and referral serviceof cancer. Before you may participate in a , the research team will ask you many questions to determine your eligibility. If you are interested in participating in a , you can also find ongoing cancer trials that may be suitable for you by using
To view webinars on clinical trials and click here.,
The information and services provides by theAdvocacy Network (BCAN) are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. If you are ill, or suspect that you are ill, seek professional medical attention immediately! BCAN does not recommend or endorse any specific physicians, treatments, procedures or products even though they may be mentioned on this site