Glossary
adjuvant therapy: One or more anticancer drugs used in
combination with surgery or radiation therapy as part of the
treatment of cancer. Adjuvant therapy is given before or after the
primary treatment to increase the chances of a cure. Adjuvant usually
means "in addition to" initial treatment.
adverse effect: See side effects.
Adverse Event Expedited Reporting System: A Web-based
program that enables researchers using NCI-sponsored investigational
agents to expedite the reporting of serious and/or unexpected adverse
events directly to NCI and FDA.
agent: In a cancer clinical trial, an agent is a substance
that researchers believe might be capable of producing an effect that
fights cancer.
assent: Children and adolescents are not deemed capable of
giving true informed consent, so they are asked for their assent, or
agreement, to participation in a clinical trial.
audit: In clinical trials, the onsite monitoring of trial
procedures, documents, and data.
Belmont Report: A 1979 report by the National Commission
for the Protection of Human Subjects of Biomedical and Behavioral
Research that delineated the ethical principles upon which today's
regulations regarding research participants in the United States are
based: respect for persons, beneficence, and justice.
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 correct.
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
encourage 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.
combination chemotherapy: Treatment using more than one
anticancer drug.
combination therapy: The use of two or more modes of
treatment - surgery, radiotherapy, chemotherapy, immunotherapy - in
combination or alternately to achieve optimum results against
cancer.
Common Toxicity Criteria: A Web-based, interactive
application that uses standardized language to identify and grade
adverse events in cancer clinical trials.
NCI-designated Cancer Centers: There are 3 kinds of
NCI-designated cancer centers:
1. Comprehensive cancer centers, which conduct basic, clinical, and
preventive research programs, as well as community outreach and
education programs
2. Clinical cancer centers, which conduct primarily clinical research
programs but may have programs in other research areas as well
3. Cancer centers (formerly called Basic Science Cancer Centers),
which conduct basic or preventive research programs and do not have
clinical programs confidence intervals: These reflect a range of
values surrounding the true score that would be obtained if everyone
with a particular cancer were treated with the treatment under study.
The wider the interval, the more variable the result and the less
likely it is to be close to the true score. Confidence intervals are
typically thought of as the approximate bounds or limits surrounding
the true score. Researchers frequently use either a 95 or a 99
percent confidence interval.
control group: In a clinical trial, the group that receives
the accepted standard treatment being studied. In cases where no
standard treatment yet exists for a particular condition, the control
group would receive no treatment. No patient is placed in a control
group without treatment if there is any beneficial treatment known
for that patient. This group is compared to the group that receives
the investigational treatment. See also investigational group.
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. Members may also include
bioethicists or other clinicians knowledgeable about the trial's
subject matter. The National Institutes of Health requires DSMB
review of all phase 3 clinical trials. A DSMB might also review phase
1 or 2 trials that are blinded, take place at multiple locations, or
employ particularly high-risk interventions or vulnerable
populations.
diagnostic trial: A research study that evaluates methods
of detecting disease.
disease-free survival: The amount of time a participant survives
without cancer occurring or recurring, usually measured in
months.
double-blinded: A clinical trial in which neither the
medical staff nor the person knows which of several possible
therapies the person is receiving.
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): A consumer protection
agency of the U.S. Department of Health and Human Services, FDA is
required by law to review all test results for new drugs to ensure
that they are safe and effective for specific uses.
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 epidemiologic research: Research that involves
looking at tissue or blood samples from large populations of people
in order to determine how one's genetic make-up can influence
detection, diagnosis, prognosis, and ultimately, treatment.
genetics trials: Clinical trials that examine whether gene
transfer therapy can be used to treat cancer, or whether genetic
epidemiology research improves the understanding of cancer at the
cellular level. Actual genetic intervention (such as gene transfer)
trials are few in number, however trials are underway where actual
cellular manipulation at the gene level occurs.
imaging: Tests that produce pictures of areas inside the
body.
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 laypeople from the community,
the board must review the trial protocols and the informed consent
forms participants sign.
intervention: The study agent or method that is being tested in a clincial trial or clinical study. The intervention is usually given to the investigational group while the control group receives standard treatment.
investigational group: In a clinical trial, the group that
receives the new agent being tested. See also control group.
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.
metastasis: The spread of cancer from one part of the body
to another. In cancer, metastasis is the migration of cancer cells
from the original tumor site through the blood and lymph vessels to
produce cancers in other tissues. Tumors formed from cells that have
spread are called "secondary tumors" and contain cells that are like
those in the original (primary) tumor. The plural is metastases.
metastatic cancer: Cancer that has spread from the place in
which it started to other parts of the body.
monoclonal antibodies: Laboratory-produced substances that
can locate and bind to cancer cells wherever they are in the body.
Many monoclonal antibodies are used in cancer detection or therapy;
each one recognizes a different protein on certain cancer cells.
Monoclonal antibodies can be used alone, or they can be used to
deliver drugs, toxins, or radioactive material directly to a
tumor.
multimodality therapy: Therapy that combines more than one
method of treatment.
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.
Office for Human Research Protections (OHRP): Safeguards
participants in federally funded research and provides unity and
leadership for 17 Federal departments and agencies that carry out
research involving human participants. OHRP enforces an important
regulation called the Common Rule, which sets standards for the
informed consent process; formation and function of IRBs; involvement
of prisoners, children, and other vulnerable groups in research; and
many other protective measures.
oncologist: A doctor who specializes in treating cancer.
Some oncologists specialize in a particular type of cancer treatment.
For example, a radiation oncologist specializes in treating cancer
with radiation.
p-value: A statistics term. A measure of probability that a
difference between groups during an experiment happened by chance.
For example, a p-value of .01 (p = .01) means there is a 1 in 100
chance the result occurred by chance. The smaller the p-value, the
more likely it is that the difference between groups was caused by a
difference between the tested treatments.
peer review: Scientific review by a panel of experts. The
primary responsibility of these experts is to assess the scientific
and technical merit of research proposals.
pharmacokinetics: The activity of drugs in the body over a
period of time, including the processes by which drugs are absorbed,
distributed in the body, localized in the tissues, and excreted.
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: An inactive substance that looks the same as, and
is administered in the same way as, a drug in a clinical trial. A
placebo may be compared with a new drug when no one knows if any drug
or treatment will be effective.
preclinical testing: A process in which scientists test
promising new cancer treatments 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 an agent 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: The person responsible for
overseeing all aspects of a clinical trial, specifically, for
developing the concept and writing the protocol; submitting the
protocol for institutional review board approval; recruiting
participants; obtaining informed consent; and collecting, analyzing,
interpreting, and presenting data.
protocol: A written, detailed action plan for a clinical
trial. The protocol provides the background, specifies the
objectives, and describes the design and organization of the trial.
Every center participating in the trial uses the same protocol,
ensuring consistency of procedures and enhancing communication among
everyone working on the trial. This uniformity ensures that
participant information from all centers can be combined and
compared.
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 overall 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
radiolabeled monoclonal antibody, that circulates throughout the
body. Also called radiotherapy.
randomization: A method used to prevent bias in research. A
computer or a table of random numbers 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.
recurrence: The return of cancer, at the same site as the
original (primary) tumor or in another location, after the tumor had
disappeared.
regimen: A treatment plan that specifies the dosage, the
schedule, and the duration of treatment.
regression: A decrease in the size of a tumor, or in the
extent of cancer in the body.
relative risk: In cancer treatment trials, the
likelihood that cancer will recur within a specific timeframe in one
intervention group versus another.
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.
risk/benefit ratio: The relation between the
risks and benefits of a given treatment or procedure. An
institutional review board, usually located where the clinical trial
is to take place, determines whether the risks in the trial are
reasonable with respect to the potential benefits. It is up to
individual potential participants to decide whether it is reasonable
for them in particular to participate.
sample size: In clinical trials, the number of
people participating in a trial.
screening trials: Clinical trials that assess the
effectiveness of new means of detecting cancer early in healthy
people, especially the earliest stages of cancer. For many types of
cancer, early detection results in improved outcomes. In addition,
these trials examine whether early treatment, as a result of early
detection, actually improves overall survival or disease-free
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.
single-blinded: Describes clinical trials set up in
such a way that participants do not know which therapy or
intervention they are receiving.
stage: The extent of a cancer, especially whether the
disease has spread from the original site to other parts of the body.
Numbers with or without letters are used to define cancer stages
(e.g., stage IIb).
standard treatment: A currently accepted and widely
used treatment for a certain type of cancer, based on the results of
past research.
statistical power: The chance of getting a
statistically significant result when there is one. Ideally, in
clinical trials statistical power should be .80 or .90--in other
words, there is an 80 to 90 percent chance that the true difference
in effectiveness between the treatments is the smallest size
considered medically important to detect.
statistically significant: Describes a mathematical
measure of difference between groups. The difference is said to be
statistically significant if it is greater than what might be
expected to happen by chance alone.
stratification: A separation process used in randomized
trials when factors that can influence the intervention's success are
known. For example, participants whose cancer has spread from the
original tumor site can be separated, or stratified, from those whose
cancer has not spread. Assignment of interventions within the two
groups is then randomized. Stratification enables researchers to look
in separate subgroups to see whether differences exist.
toxicity: Harmful side effects from an agent being
tested.
treatment group: See investigational group and
control group.
treatment trials: Treatment trials are designed to
test the safety and effectiveness of new drugs, biological agents,
techniques, or other interventions in people who have been diagnosed
with cancer. These trials evaluate the novel treatment against
standard treatment, if there is one.
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 cancer or to microorganisms, such
as bacteria or viruses.
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