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About Studies

Clinical studies 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 studies 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 studies are often published in peer-reviewed, scientific journals. Once a new approach has been proven safe and effective in a clinical study, it may become standard practice.

The protocol

Every clinical study has a protocol, or action plan. The plan describes:

• What will be done in the study
• How the study will be conducted

All clinical studies that are federally funded or that evaluate a new drug or medical device that is subject to U.S. Food and Drug Administration 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

Informed consent is a process by which people learn the important facts about a clinical study to help them decide whether or not to participate. This information includes details about:

• the purpose of the study
• the tests and other procedures used in the study
• the possible risks and benefits.

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.

Study phases

Clinical studies are usually conducted in a series of four steps, called phases:

Phase I studies: These initial studies evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A Phase I study usually enrolls only a small number of participants.
Phase II studies: These studies continue to test the safety of the drug, and begin to evaluate how well the new drug works. Phase II oncology studies usually focus on a particular type of cancer.
Phase III studies: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III studies often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide.
Phase IV studies. After a treatment has been approved and is being marketed, the drug's maker may study it further to evaluate the side effects, risks, and benefits of a drug over a longer period of time. Thousands of people are involved in a phase IV study.

There are both benefits and risks to participating in clinical studies. Among the benefits:

• You may gain access to promising new approaches that are often not available outside the clinical study setting.
• You may have access to an approach or drug that may be more effective than the standard approach.
• You may receive regular and careful medical attention from a research team of doctors, nurses and other health professionals. You may be among the first to benefit from the new method under study.
• You will have the satisfaction of knowing that results from the study may help others in the future.

Among the risks:

• The new drug or approach under study may not be better than the standard care to which it is being compared.
• You may experience side effects that doctors could not anticipate or that are worse than those resulting from standard care.
• In randomized studies, you will not be able to choose the approach you receive.
• Health insurance and managed care providers may not cover all of the study costs.

You may be required to make more visits to the doctor than you would if you were not in a clinical study.

adapted from http://www.nccn.com/