Glossary
adverse effect: See side effects.
agent: In a cancer clinical trial, an agent is a substance
that produces, or is capable of producing, an effect that fights
cancer.
anthracycline: A member of a family of anticancer drugs
that are also antibiotics.
bias: Human choices, beliefs, or any other factors besides
those being studied that affect a clinical trial's results. Clinical
trials use many methods to avoid bias because biased results may not
be accurate.
biological therapy: Treatment to stimulate or
restore the ability of the immune system to fight infection and
disease. Also used to lessen side effects that may be caused by some
cancer treatments. Also known as immunotherapy, biotherapy, or
biological response modifier (BRM) therapy.
cancer: A term for diseases in which abnormal cells divide
without control. Cancer cells can invade nearby tissues and can
spread through the bloodstream and lymphatic system to other parts of
the body.
cancer vaccine: A form of biological therapy which
may help a person's immune system to recognize cancer cells. These
vaccines may help the body reject tumors and prevent cancer from
recurring.
chemoprevention: The use of drugs, vitamins, or other
agents to try to reduce the risk of or delay the development or
recurrence of cancer.
chemotherapy: Treatment with anticancer drugs.
clinical trial: A research study that tests how well
new medical treatments or other interventions work in people. Each
study is designed to test new methods of screening, prevention,
diagnosis, or treatment of a disease.
Community Clinical Oncology Program
(CCOP): A program that links community physicians with NCI
clinical research programs, enabling more people with cancer to
participate in clinical trials in their own communities.
control group: In a randomized clinical trial, the
group that receives standard treatment.
cooperative groups: Networks of institutions that
jointly carry out large clinical trials following the same
protocols.
data and safety monitoring board (DSMB): An independent
committee whose membership includes, at minimum, a statistician and a
clinical expert in the area being studied. Responsibilities of the
DSMB are to: ensure that risks associated with participation are
minimized to the extent possible, ensure the integrity of the data,
and stop a trial either if safety concerns arise or as soon as its
objectives have been met.
diagnostic trial: A research study that evaluates methods
of detecting disease.
eligibility criteria: Participant eligibility criteria for
clinical trials can range from general (age, sex, type of cancer) to
specific (prior treatment, tumor characteristics, blood cell counts,
organ function). Eligibility criteria may also vary with trial phase.
In phase 1 and 2 trials, the criteria often focus on making sure that
people who might be harmed because of abnormal organ function or
other factors are not put at risk. Phase 2 and 3 trials often add
criteria regarding disease type and stage, and number of prior
treatments.
endpoint: What researchers measure to evaluate the results
of a new treatment being tested in a clinical trial. Research teams
establish the endpoints of a trial before it begins. Examples of
endpoints include toxicity, tumor response, survival time, and
quality of life.
Food and Drug Administration (FDA): An agency of the U.S.
Department of Health and Human Services whose mission it is to
promote and protect the public health: 1) by ensuring that medical
products are proven safe and effective before they can be used by
patients and 2) by monitoring products for continued safety after
they are in use.
gene: The functional and physical unit of heredity passed
from parent to offspring. Genes are pieces of DNA, and most genes
contain the information for making a specific protein.
gene therapy: Treatment that alters a gene. In studies of
gene therapy for cancer, researchers are trying to improve the body's
natural ability to fight the disease or to make the cancer cells more
sensitive to other kinds of therapy.
genetic: Inherited; having to do with information that is
passed from parents to offspring through genes in sperm and egg
cells.
genetic testing: Analyzing DNA to look for a genetic
alteration that may indicate an increased risk for developing a
specific disease or disorder.
genetics research: Research that focuses on how someone's
genetic makeup can assist in the early detection, diagnosis, or
treatment of cancer. Genetics research may be a part of screening or
treatment trials.
investigational group: In a clinical trial, the group that
receives the new agent being tested. See also control group.
imaging: Tests that produce pictures of areas inside the
body.
immune system: The complex group of organs and cells that
defends the body against infection or disease.
immunotherapy: See biological therapy.
informed consent: The process of providing all relevant
information about the trial's purpose, risks, benefits, alternatives,
and procedures to a potential participant, who then, consistent with
his or her own interests and circumstances, makes an informed
decision about whether to participate.
institutional review board (IRB): A board designed to
oversee the research process in order to protect participant safety.
Made up of researchers, ethicists, and lay people from the community,
the board must review the trial protocols and the informed consent
forms participants sign.
investigational new drug (IND): A drug that the Food and
Drug Administration (FDA) allows to be used in clinical trials but
that the FDA has not approved for commercial marketing.
monoclonal antibodies: A form of biological therapy that
may help the body's own immune system fight cancer by locating cancer
cells and either killing them or delivering cancer-killing substances
to them without harming normal cells.
oncology: The branch of medicine that deals with tumors,
including study of their development, diagnosis, treatment, and
prevention.
National Cancer Institute (NCI): Part of the National
Institutes of Health of the United States Department of Health and
Human Services, is the Federal Government's principal agency for
cancer research. NCI conducts, coordinates, and funds cancer
research, training, health information dissemination, and other
programs with respect to the cause, diagnosis, prevention, and
treatment of cancer. Access the NCI Web site at www.cancer.gov.
New Drug Application (NDA):The application filed with FDA
by the trial sponsor once a trial has generated adequate data to
support a certain indication for a drug (usually by finding that the
drug is safe and superior to standard treatment in a definitive phase
3 trial).
Office for Human Research Protections (OHRP): This office
safeguards participants in federally funded research and provides
unity and leadership for many federal departments and agencies that
carry out research involving human participants.
phase 1 trial: Small groups of people with cancer are
treated with a certain dose of a new agent that has already been
extensively studied in the laboratory. During the trial, the dose is
usually increased group by group in order to find the highest dose
that does not cause harmful side effects. This process determines a
safe and appropriate dose to use in a phase 2 trial.
phase 2 trial: Phase 2 trials continue to test the safety
of the new agent and begin to evaluate how well it works against a
specific type of cancer. In these trials, the new agent is given to
groups of people with one type of cancer or related cancers, using
the dosage found to be safe in phase 1 trials.
phase 3 trial: Phase 3 studies are designed to answer
research questions across the disease continuum. Phase 3 trials
usually have hundreds to thousands of participants, in order to find
out if there are true differences in the effectiveness of the
treatment being tested.
phase 4 trial: Phase 4 trials are used to evaluate the
long-term safety and effectiveness of a treatment. Less common than
phase 1, 2, and 3 trials, phase 4 trials take place after the new
treatment has been approved for standard use.
Physician Data Query (PDQ): PDQ is an online database
developed and maintained by the National Cancer Institute. Designed
to make the most current, credible, and accurate cancer information
available to health professionals and the public, PDQ contains
peer-reviewed summaries on cancer treatment, screening, prevention,
genetics, and supportive care; a registry of cancer clinical trials
from around the world; and directories of physicians, professionals
who provide genetics services, and organizations that provide cancer
care.
placebo: A treatment, often a drug, designed to look like
the medicine being tested but that doesn't contain any active
ingredient. Some people call a placebo a "sugar pill." Placebos are
almost never used in cancer treatment trials.
preclinical testing: A process in which scientists test
promising new anticancer agents in the laboratory and in animal
models. This is done to find out whether agents have an anticancer
effect and are safely tolerated in animals. Once a drug proves
promising in the lab, the sponsor applies for Food and Drug
Administration approval to test it in clinical trials involving
people.
prevention trials: Trials involving healthy people who are
at high risk for developing cancer. These trials try to answer
specific questions about and evaluate the effectiveness of ways to
reduce the risk of cancer.
principal investigator (PI): The person, usually a doctor,
who is in charge of a clinical trial. The PI prepares a protocol for
the trial.
protocol: A written plan that acts as a "recipe" for
conducting a clinical trial. The protocol explains what a trial will
do, how it will be carried out, and why each part of the trial is
necessary.
quality of life: The overall enjoyment of life. Many
clinical trials measure aspects of an individual's sense of
well-being and ability to perform various tasks to assess the effects
of cancer and its treatment on the quality of life.
radiation therapy: The use of high-energy radiation from
x-rays, gamma rays, neutrons, and other sources to kill cancer cells
and shrink tumors. Radiation may come from a machine outside the body
(external-beam radiation therapy) or it may come from radioactive
material placed in the body in the area near cancer cells (internal
radiation therapy, implant radiation, or brachytherapy). Systemic
radiation therapy uses a radioactive substance, such as a radio
labeled monoclonal antibody, that circulates throughout the body.
Also called radiotherapy.
randomization: A method used to prevent bias in research. A
computer generates treatment assignments, and participants have an
equal chance to be assigned to one of two or more groups (e.g., the
control group or the investigational group).
randomized clinical trial: A study in which the
participants are assigned by chance to separate groups that compare
different treatments; neither the researchers nor the participants
can choose which group. Using chance to assign people to groups means
that the groups will be similar and that the treatments they receive
can be compared objectively. At the time of the trial, it is not
known which treatment is best. It is the patient's choice to be in a
randomized trial.
remission: A decrease in or disappearance of signs and
symptoms of cancer. In partial remission, some, but not all, signs
and symptoms of cancer have disappeared. In complete remission, all
signs and symptoms of cancer have disappeared, although there still
may be cancer in the body.
screening: Checking for disease when there are no
symptoms.
screening trials: Clinical trials that focus on what tests
can help find cancer in people before they have any cancer symptoms.
The goal of early detection/screening trials is to discover new
methods for finding cancer as early as possible. For many types of
cancer, the ability to find and treat the disease at an early stage
provides a better chance for survival.
side effects: Problems that occur when treatment affects
healthy cells. Common side effects of cancer treatment are fatigue,
nausea, vomiting, decreased blood cell counts, hair loss, and mouth
sores.
stage: The extent of a cancer, especially whether the
disease has spread from the original site to other parts of the
body.
standard treatment: A currently accepted and widely used
treatment for a certain type of cancer, based on the results of past
research.
toxicity: Harmful side effects from an agent being
tested.
treatment trials: Clinical trials conducted to examine new
treatment approaches for people who have cancer and to determine the
most effective treatments.
tumor: An abnormal mass of tissue that results from
excessive cell division. Tumors perform no useful body function. They
may be benign (not cancerous) or malignant (cancerous).
vaccine: A substance or group of substances meant to cause
the immune system to respond to a tumor or to microorganisms, such as
bacteria or viruses.
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