|Guide to Clinical Trials|
Clinical trials are research studies that test how well new medical approaches work in people. The goal of oncology studies is to find better ways to treat cancer and improve the overall standard of cancer care.
Clinical trials take place in doctors’ offices, cancer centers, other medical centers, community hospitals and clinics, and veterans’ and military hospitals across the U.S. and throughout the world. The results of clinical trials are often published in peer-reviewed, scientific journals. Once a new approach has been proven safe and effective in a clinical trial, it may become standard practice.
Every clinical trial has a protocol, or action plan. The plan describes:
All clinical trials that are federally funded or that evaluate a new drug or medical device that is subject to U.S. Food and Drug Administration (FDA) regulation must be reviewed and approved by an Institutional Review Board (IRB). These Boards, which include doctors, researchers, community leaders, and other members of the community, review the protocol to make sure the study is conducted fairly and participants are not likely to be harmed.
Informed consent is a process by which people learn the important facts about a clinical trial to help them decide whether or not to participate. This information includes details about:
In addition to talking with the doctor or nurse about the study, potential participants receive a written consent form explaining the study.
People who agree to take part in the study are asked to sign the informed consent form. However, signing the form does not mean people must stay in the study. People can leave the study at any time—either before the study starts or at any time during the study or the follow-up period.
The informed consent process continues throughout the study. If new benefits, risks, or side effects are discovered during the study, the researchers must inform the participants. They may be asked to sign new consent forms if they want to stay in the study.
Clinical trials are usually conducted in a series of four steps, called phases:
There are both benefits and risks to participating in clinical trials. Among the benefits:
Among the risks:
Paying for Clinical Trials
Health insurance plans and managed care providers may not cover certain costs associated with a clinical trial. However, if enough data show that the approach is safe and effective, a health plan may consider the approach as “established” and cover some or all of the costs. For more information, see our Finances and Financial Assistance and Insurance Guidance pages.
Find a Clinical Trial
To locate a clinical trial, visit: