A biomarker is a biological characteristic of a person that can be measured and serves to indicate something about the person’s health. For example, blood sugar levels are a biomarker for diabetes. Biomarkers are found in blood, other body fluids, or tissues and can indicate normal function or the presence of diseases including cancer. In cancer treatments, biomarkers can be used to match a patient to targeted treatments that are more likely to be effective in preventing toxicity of standard therapies. Examples of cancer biomarkers include presence of certain genetic mutations.

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Biopsies involve the removal of tissue from a body and the examination of what was removed. In cancer clinical trials, biopsies can help researchers understand a patient’s specific cancer, if a certain treatment might be more likely to work and how the patient is responding to therapy.

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Blinding is a method of withholding information that may influence the outcome until after the test. Some clinical trials are blinded. In single-blinded trials, the patient does not know whether they are receiving the therapy being tested or the standard of care. In double-blinded trials, neither the doctor nor patient know which therapy is being received. Blinding and double-blinding can reduce or eliminate bias until after a trial outcome is known.

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A gene mutation is a permanent alteration in the DNA sequence that makes up a gene, such that the sequence differs from what is found in most people. Some gene mutations are inherited (germline mutations). Some gene mutations happen over time (acquired mutations) due to damage such as exposure to tobacco smoke, ultraviolet light, viruses or may happen spontaneously as we age. Gene mutations happen often, but the body is typically able to correct most of them. Often multiple mutations are needed before a cell becomes cancerous.

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Every cancer clinical trial is overseen by a federally-regulated IRB (Institutional Review Board). The IRB is a committee that helps to protect the interests and welfare of particpants. They also ensure participant confidentially and privacy.

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Each clinical trial looks for patients whose health and cancer meet a certain set of traits defined by the study. Inclusion criteria help to ensure that a specific treatment is right and safe for the patient.

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Each clinical trial has a list of conditions or characteristics defined in the study exclusion criteria that would disqualify a patient from participation. These criteria help to ensure that a specific treatment is right and safe for the patient.

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Informed consent is the process of ensuring that a clinical trial participant is fully aware of key aspects of a study and how it will impact them personally. An informed consent document outlines the details about the treatment being studied, potential risks and benefits, as well as the patient’s responsibilities as part of a clinical trial. Each clinical trial participant – or their legal guardian in the case of a pediatric patient – must sign an informed consent document to participate in a clinical trial.

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A placebo is an inactive drug or treatment typically used by a control group in a study. It’s important to note that placebos are rarely used in cancer clinical trials. If they are used, they are typically combined with the standard treatment a patient would receive if they were not in a trial.

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Serial biopsies are a set of biopsies taken at different times during the course of therapy. A series of biopsies provides insight on whether a treatment is working and how the cancer changes in response to the therapy. Often, this is some of the most valuable data collected during a clinical trial.

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The standard of care or standard treatment is the therapy that is widely used to treat a specific type and stage of cancer.

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Tissue banking securely and privately stores tissue samples from biopsies for use in future studies. As science advances, new questions can be answered by examining banked tissues in different ways. This speeds cancer research as the process of reexamining banked tissue is much more efficient than collecting new samples from patients.

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Cancer clinical trials are conducted in a series of steps—or phases from 1 to 4. The phase of the trial indicates the focus of the trial from whether a treatment is safe, to long term side effects or benefits of a treatment.

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