(Source, National Cancer Institute)
Clinical trials are research studies that demonstrate how well a new therapeutic or prevention agent works on a person. Trials answer scientific questions that try to determine a better approach in treating, preventing, screening or diagnosing cancer.
Clinical trials are important because they answer important questions on how effective new therapies are as compared to standard therapies. By participating in a clinical trial you have the opportunity to contribute to the advancement of cancer research.
Prevention Trials: determine new approaches to lowering the risk of developing cancer. Prevention trials are often done on healthy people who have not had cancer, but perhaps have a higher incidence in developing a specific type of cancer.
Treatment Trials: determines the effectiveness of a new therapy or a new method of using a standard therapy for someone with cancer. Treatment trials test new novel drugs, vaccines, combinations of various therapies, new approaches to surgery and or radiation treatment.
By participating in a clinical trial, you will have access to promising new agents that are often not available outside of a clinical trial. Additionally, the new therapeutic approach in the trial might be more effective than the standard therapy currently given. Participants in a clinical trial receive careful and efficient medical attention from their team of medical professionals. By participating you might be one of the first to benefit from a new method of treatment and you may be helping others in the future who are diagnosed with cancer.
Clinical trials are conducted according to strict scientific and ethical principles. All trials have an action plan that clearly lays out the design of and plan for conducting the trial. The action plan clearly describes what will take place in the trial, how it will be conducted, and why each person is necessary in the trial. All clinical trials that take place at the University of Kansas Cancer Center must be approved by the Institutional Review Board (IRB). The board (made up of doctors, researchers, and community leaders) review the “action plan” to make sure the trial is conducted fairly and participants are not likely to be harmed. The Data Safety Monitoring Board (DSMB) also ensures the risks of participation in a clinical trial are as minimal as possible, and stops a trial if certain safety concerns arise.
To find out if you are eligible for a clinical trial, talk to your doctor or nurse. They will be able to explain if you are eligible for a clinical trial. Each trial has guidelines for who can or cannot participate in a trial. These guidelines are called eligibility criteria, and they describe characteristics that are shared with anyone who participates or is interested in a trial. Criteria differ from trial to trial, but may include: gender, age, medical history and current health status.
Informed consent is a procedure that gives a person who wishes to participate in a clinical trial the facts about the trial to help them better decide if they want to participate. Details about what will take place in the trial, the purpose, the tests and procedures that will be used, and the possible risks and side effects of participating are discussed. If you agree to participate in a trial, you will be asked to sign the informed consent form. If new benefits or side effects are discovered during the trial, your physician will inform you of this new information.
Phase I: represents the first step in testing a new approach to treat cancer. In these trials, safe dosages, how an agent should be delivered, and how often is determined. Phase I trials enroll a small patient population. The highest dose of a therapeutic agent with an acceptable level of side effects is determined to be appropriate for further testing.
Phase II: determines the safety and effectiveness of a therapeutic agent and determine how it affects a person’s body. Phase II trials usually focus on a particular type of cancer, and include fewer than 100 people.
Phase III: trails compare a new agent with the current standard therapy. Participants are randomly assigned to receive the current standard therapy (the best available therapy approved for their type of cancer) or the new agent. Phase III trials often include large numbers of people from across the country.
Phase IV: trials further determine the long-term effectiveness and safety of a treatment. These trials typically take place after a treatment has been approved. These trials are less common than Phase I, II, and III trials.
Risks associated with participation in a clinical trial
include new drugs under study might not be better than the
standard of care that they are being compared to. Unexpected
side effects or risks can occur. Some health insurance
carriers may not cover all patient care costs associated
with a particular trial (talk with your doctor or nurse).
Visit the National Cancer Institute’s website for more information about clinical trials.
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The University of Kansas Medical Center