Clinical trials are research studies that involve people. Through clinical trials, doctors find new ways to improve treatments and the quality of life for people with disease.
How are cancer clinical trials conducted?
Clinical trials are designed by physicians and researchers and are conducted according to strict scientific and ethical principles. Before the study begins, a protocol is developed describing what will be done in the study, how it will be conducted and why each part of the study is necessary. This research protocol is reviewed by third-party experts to make sure that study is conducted fairly and that patients are well-informed of their rights. Each study has eligibility criteria for who can or cannot participate in the study, which may include type of cancer, age, gender, medical history and current health status.
Do I have to participate in a clinical trial?
No. Your participation in a clinical trial is completely voluntary at all times. It is important to ask lots of questions and consider all your treatment options before you decide if taking part in a study is right for you.
What are the benefits of participating in a clinical trail?
Clinical trials provide access to promising new therapies not yet available outside the study. These therapies are being studied because doctors hope they will prove to be more effective or less toxic than the standard treatment.
Patients can play an active role in their cancer care by expanding their treatment options. Patients in clinical trials are contributing to the greater knowledge of cancer that may also help other cancer patients in the future.
What are some of the possible risks of participating in a clinical trial?
- Participants in randomized studies will not be able to choose the approach they receive.
- Health insurance and managed care providers may not cover all patient care costs in a study.
- New treatments may have unknown side effects or risks.
What are my rights during a clinical trial?
The research team will discuss your rights, including your right to:
- Make a decision about participating
- Leave the study at any time
Before agreeing to take part in a trial, you have the right to:
- Learn about all your treatment options
- Learn all that is involved in the trial, including all details about treatment, tests and possible risks and benefits
- Discuss the trial with the principal investigator and other members of the research team
- Both hear and read the information in language you can understand
Once I have decided to take part in the study, what is the next step?
After discussing the study with you, the research team will give you an informed consent form to read. The form includes written details about the information that was discussed with you and describes the privacy of your medical records. If you agree to take part in the study, you will be asked to sign the form. But, even after you sign the consent form, you can leave the study at any time. You can always ask questions. And, as new information becomes available, the research team will inform you.