Why are Clinical Trials Important?

Clinical trials are important for two reasons: 1) They contribute to the knowledge of and fight against cancer; 2) They may benefit individual patients by helping them feel better, live longer or beat the disease. Much of what we know today about cancer treatment is a result of what was learned from past clinical trials. Clinical trials may answer important scientific questions and suggest future research directions.

In a clinical trial, patients receive the most current cancer care available from cancer experts. They receive either a new treatment that's being tested or they receive the best available standard treatment for their cancer. Because clinical trials deal with a very serious disease, there's no guarantee that either the new treatment or the standard treatment will produce the hoped-for results.

Although new treatments have unknown risks, a new treatment may prove to be as effective or more effective than the best available standard treatment. If so, patients participating in clinical trials are among the first to benefit. Patients receiving standard treatment often benefit from the trial, too.

What Happens in a Clinical Trial?

When a person participates in a clinical trial, they receive excellent care from a team of physicians, nurses, social workers and other health care professionals. Since a patient's progress is followed closely, the patient may have additional office visits, laboratory tests and hospital stays. Before deciding to participate in a clinical trial, a patient should check with their insurance provider to see if these costs are covered by their plan.

In clinical trials, research concerns are important, but patient well-being is most important. Participants receive excellent care from physicians who are sensitive to the experience of a clinical trial participant. Clinical trial participants go through a process of informed consent, during which they learn about the clinical trial, including the benefits and risks. Participants are asked to sign a consent form and should keep a copy of it for later reference. Patients have other rights, including the right to:

• Leave the clinical trial at any time—even after it begins
• Be taken off the study if physicians learn during the trial that the treatment is inferior or toxic
• Have their health monitored throughout the duration of the clinical trial
• Understanding patient rights is very important. Part of that is having an understanding of a clinical trial's built-in patient protections.

Each clinical trial has an action plan or protocol that explains how the trial will work. The study's investigator prepares a protocol for the study. The protocol outlines what will be done in the study and why. It notes how many people will participate and what medical tests will be given and how often. It also details the treatment plan. Each physician that takes part in the clinical trial uses this protocol.

For patient safety, each protocol must be approved by the organization that sponsors the study (such as the National Cancer Institute) and an Institutional Review Board (IRB). An IRB is a group of physicians, healthcare providers, consumers and others who are selected because they have no interest in the results of the study that may cause them to have a personal bias.

A Clinical Scientific Review Committee (CSRC) assures critical and fair scientific review of clinical trials that have not previously undergone external peer-review. CSRC membership includes clinicians, basic scientists, a cancer control specialist, a geneticist, biostatisticians, a nurse and a research pharmacist. The IRB's responsibility is to ensure that the study is managed fairly and that participants are not likely to be harmed by participating in the study.