Why should you consider being a part of a clinical trial?
- To be among the first to benefit from new treatments.
- To gain access to promising new treatments that are not widely available.
- To obtain high-quality care from doctors who are cancer experts.
- To help future patients with the same type of cancer.
- The approach being studied may be more effective than the standard approach.
- New drugs or procedures under study are not always better than standard care to which they are being compared.
- New treatments may have side effects or risks that doctors do not expect or that may be worse than those resulting from standard care.
- Participants in randomized trials will not be able to choose the approach they receive.
- To help future patients with the same type of cancer.
- Health insurance and managed care providers may not cover all patient costs in the study (see the cost of clinical trials)
- Research with people as the study subject is conducted according to strict scientific and ethical standards. Every clinical trial has a protocol, or action plan, which acts like a "recipe" for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. The same protocol is used by every doctor or research center taking part in a particular trial.
- The government has a system designed to protect human research subjects. The Institutional Review Board must review and approve all federally funded trials. They also evaluate new drugs or medical devices.
- Regulations require that the patients are fully informed about a study's treatment and tests. They are also informed about the possible benefits and side effects and risks. This process is called Informed Consent.
All clinical trials that are federally funded or that evaluate a new drug or medical device subject to Food and Drug Administration regulations are reviewed by an IRB. Many institutions require that all clinical trials, regardless of funding, are reviewed and approved by the IRB. The board includes doctors, researchers, community leaders and other members of the community. They review the protocol to make sure the study is conducted fairly and safely. The IRB decides how often to review a trial once it has begun. The IRB can stop a clinical trial if researchers are not following the protocol or if the trial appears to be causing undue harm. Informed Consent is a process in which you learn the important facts about a clinical trial before you decide whether or not to participate. This information includes details about: In addition to talking with the doctor or nurse, you will receive a copy of the information to take home and discuss with your family before signing. If you agree to be in the study, you can leave at any time- either before the study starts or any time during the study or follow-up period. If new benefits, risks or side effects are discovered during the study, your doctor will inform you of these. Here are some questions you may want answered by the doctor or nurse. Hopefully, the website will have answered many of your questions. If you still need additional information, a list of questions is provided for your use to get a better understanding of the study.
Possible Risks and Benefits
Participation and Care
Personal Issues
