Cancer,
crab
¡¡The term cancer comes from the Latin word meaning
crab. Cancer was characterized as a crablike disease
by the Greek physician Hippocrates, who observed that
cancers spread throughout the body, eventually cutting
off life. Now cancer generally is defined as the unregulated
growth of specific cells in the body. The word cancer
actually refers to over 100 different diseases, but
in all cases, certain body cells multiply in an abnormal,
unregulated manner.
¡¡Normally, the growth and reproduction of every cell
in the body are regulated. This regulation, in turn,
determines the size and functions of tissues and organs.
If a normal body cell begins to grow abnormally and
reproduces too rapidly, a mass of abnormal cells eventually
develops called a tumor. A tumor generally contains
millions of genetically identical abnormal cells before
it can be detected or felt.
¡¡Cancers are medically classified according to the
organ or kind of tissue in which the tumor originates.
The four major categories of cancers are carcinomas,
sarcomas, leukemias, and lymphomas. Within these major
categories are numerous subgroups that generally describe
the organ in which the cancer originates.
Carcinoma
¡¡A carcinoma is a malignant new growth that arises
from epithelium, found in skin or, more commonly,
the lining of body organs, for example: breast, prostate,
lung, stomach or bowel. Carcinomas tend to infiltrate
into adjacent tissue and spread (metastasize) to distant
organs, for example: to bone, liver, lung or the brain.
Sarcoma
¡¡Sarcoma is a form of cancer that arises in the supportive
tissues such as bone, cartilage, fat or muscle.
Leukemia
¡¡Leukemia is an acute or chronic disease of unknown
cause in man and other warm blooded animals that involves
the blood forming organs, is characterized by an abnormal
increase in the number of leucocytes in the tissues
of the body with or without a corresponding increase
of those in the circulating blood and is classified
according of the type of leukocyte most prominently
involved.
Lymphoma
¡¡A lymphoma is a malignant tumor of lymphoblasts derived
from B lymphocytes. most commonly affects children
in tropical Africa.
Tumor
¡¡A tumor is an abnormal mass of tissue. Tumors are
a classic sign of inflammation, and can be benign
or malignant (cancerous). If the cells of the tumor
remain localized at the site of origin in the body
and if they multiply relatively slowly, the tumor
is said to be benign. Benign tumors, warts, moles,
and polyps, do not spread to other parts of the body.
Malignant tumors are composed of cells that grow rapidly,
have other abnormal properties that distinguish them
from normal cells, and invade other normal tissues.
In particular, malignant cells may have altered shapes
and cell-surface characteristics that contribute to
their rapid proliferation. Many malignant cells also
have abnormal chromosomes or altered genes, and they
manufacture abnormal proteins. The numerous altered
properties of malignant cells enable a pathologist,
who is a physician who specializes in the causes of
diseases, to determine whether the cells removed from
a tumor are abnormal and to what degree.
¡¡There are dozens of different types of tumors. Their
names usually reflect the kind of tissue they arise
in, and may also tell you something about their shape
or how they grow. Diagnosis depends on the type and
location of the tumor. Tumor marker tests and imaging
may be used; some tumors can be seen (for example,
tumors on the exterior of the skin) or felt (palpated
with the hands).
¡¡Treatment is also specific to the location and type
of the tumor. Benign tumors can sometimes simply be
ignored because generally are not a threat to life,
or they may be reduced in size (debulked) or removed
entirely via surgery. In fact, benign tumors weighing
several hundred pounds have been surgically removed
from persons who then recovered fully. Benign tumors
cannot re-grow if all of the abnormal cells are removed
by surgical excision of the tumor. For cancerous tumors,
options include chemotherapy, radiation, and surgery.
Apoptosis
¡¡The apoptosis is a form of cell death in which a
programmed sequence of events leads to the elimination
of cells without releasing harmful substances into
the surrounding area. Apoptosis plays a crucial role
in developing and maintaining health by eliminating
old cells, unnecessary cells, and unhealthy cells.
The human body replaces perhaps a million cells a
second. Too little or too much apoptosis plays a role
in a great many diseases. When programmed cell death
does not work right, cells that should be eliminated
may hang around and become immortal. For example,
in cancer and leukemia. When apoptosis works overly
well, it kills too many cells and inflicts grave tissue
damage. This is the case in disorders such as Alzheimer
and Parkinson diseases. Apoptosis is also called programmed
cell death or cell suicide. Strictly speaking, the
term apoptosis refers only to the structural changes
cells go through, and programmed cell death refers
to the complete underlying process, but the terms
are often used interchangeably.
Metastasis
¡¡The ancient Greeks used the word metastasis to mean
"removal from one place to another." The
metastasis is a process in which cells detach from
the original tumor, enter the lymphatic system and
bloodstream, and are carried to other organs. Once
the malignant cells spread to other organs, they develop
into new tumors that often grow more rapidly than
cells in the original tumor. Metastases and the growth
of new tumors in many organs of the body eventually
disrupt a vital body function, which can cause death.
Metastatic
¡¡Spread of a disease from the organ or tissue of origin
to another part of the body.
Systemic
Pertaining to or affecting the body as a whole.
Squamous cell carcinoma
¡¡A squamous cell carcinoma is a cancer that begins
in squamous cells (thin, flat cells that look under
the microscope like fish scales). Squamous cells are
found in the tissue that forms the surface of the
skin, the lining of hollow organs of the body, and
the passages of the respiratory and digestive tracts.
Squamous cell carcinomas may arise in any of these
tissues. The word "squamous" came from the
Latin squama meaning "the scale of a fish or
serpent."
Lung cancer
¡¡Cancer of the lung, like all cancers, results from
an abnormality in the body¡¯s basic unit of life, the
cell. Normally, the body maintains a system of checks
and balances on cell growth so that cells divide to
produce new cells only when needed. Disruption of
this system of checks and balances on cell growth
results in an uncontrolled division and proliferation
of cells that eventually forms a mass known as a tumor.
Since lung cancer tends to spread, or metastasize,
very early in its course, it is a very life-threatening
cancer and one of the most difficult cancers to treat.
While lung cancer can spread to any organ in the body,
certain organs ¨C particularly the adrenal glands,
liver, brain, and bone - are the most common sites
for lung cancer metastasis.The lung is also a very
common site for metastasis from tumors in other parts
of the body. Tumor metastases are made up of the same
type of cells as the original, or primary, tumor.
For example, if prostate cancer spreads via the bloodstream
to the lungs, it is metastatic prostate cancer in
the lung and is not lung cancer.
¡¡The principal function of the lungs is the exchange
of gases between the air we breathe and the blood.
Through the lung, carbon dioxide is removed from the
body and oxygen from inspired air enters the bloodstream.
The right lung has three lobes while the left lung
is divided into two lobes and a small structure called
the lingula that is the equivalent of the middle lobe.
The major airways entering the lungs are the bronchi,
which arise from the trachea. The bronchi branch into
progressively smaller airways called bronchioles that
end in tiny sacs known as alveoli, where gas exchange
occurs. The lungs and chest wall are covered with
a thin layer of tissue called the pleura.
¡¡Lung cancers can arise in any part of the lung. Ninety
to 95% of cancers of the lung are thought to arise
from the epithelial, or lining cells of the larger
and smaller airways (bronchi and bronchioles); for
this reason lung cancers are sometimes called bronchogenic
carcinomas. Cancers can also arise from the pleura
(the thin layer of tissue that surrounds the lungs),
called mesotheliomas, or rarely from supporting tissues
within the lungs, for example, blood vessels.
Heed and Neck Cancer
¡¡The Head and neck cancer consists in the common carcinomas
of the oral cavity, pharynx, and larynx as well as
other tumors that affect the head and neck. These
include: paranasal sinus and nasal cavity cancer,
l and oral cavity cancer, nasopharyngeal cancer, oropharyngeal
cancer , hypopharyngeal cancer , laryngeal cancer
, salivary gland cancer, parathyroid cancer, thyroid
cancer . There are also metastatic head and neck cancers
in which the primary tumor where the cancer originated
may or may not be known.
Hepatocellular carcinoma,
adult primary liver cancer
¡¡Hepatocellular carcinoma is a tumor in which the
cancer starts during adulthood in cells in the liver.
Primary liver cancer is different from cancer that
has metastasized (spread) from another place in the
body to the liver. The signs and symptoms may include
a hard lump just below the rib cage on the right side
(from swelling of the liver), discomfort in the upper
abdomen on the right side, pain around the right shoulder
blade, or yellowing of the skin (jaundice). There
is often an increase in the blood levels of alpha-fetoprotein
(AFP). A rapid deterioration of liver function may
be the only clue to the presence of the tumor. Hepatocellular
carcinoma is potentially curable by surgery, but surgery
is the treatment of choice for only a small fraction
of patients who have localized disease. Therapy other
than surgery is best as part of a clinical trial.
Such trials evaluate the efficacy of systemic or infusional
chemotherapy, hepatic artery ligation or embolization,
percutaneous ethanol (alcohol) injection, radiofrequency
ablation, cryotherapy (freezing the tumor), and radiolabeled
antibodies, often in conjunction with surgical resection
(removal) and/or radiation therapy. The prognosis
(outlook) depends on the degree of local tumor replacement
and the extent of liver function impairment. Primary
liver cancer (hepatocellular carcinoma) is the most
common cancer in some parts of the world. Its incidence
is rising, principally in relation to the spread of
hepatitis B and hepatitis C. People who have a disease
of the liver called cirrhosis are also more likely
to get adult primary liver cancer. Hepatitis B and
C appear to be the most significant causes of hepatocellular
carcinoma worldwide. People who have both hepatitis
B and hepatitis C may be at a higher risk if they
consume more than 3 oz. (80 grams) of alcohol a day.
A first-degree relative with hepatocellular carcinoma
also increases the risk. Hepatocellular carcinoma
is associated with cirrhosis in 50% to 80% of patients;
5% of cirrhotic patients eventually develop hepatocellular
cancer. Aflatoxin has also been implicated as a factor
in the etiology (causation) of primary liver cancer
in parts of the world where this mycotoxin occurs
in high levels in food. Workers exposed to vinyl chloride
before controls on vinyl chloride dust were instituted
developed sarcomas in the liver.
Bone marrow
¡¡The bone marrow is a soft, spongy tissue found in
the centre of most large bones that produces the cellular
components of blood: white cells, red cells and platelets.
It is also the most radiation sensitive tissue of
the body.
Vocabulary related to Virus
Virus
¡¡Viruses are obligate intracellular parasites of living
but non-cellular nature, consisting of DNA or RNA
and a protein coat. They range in diameter from 20-300nm.
The majority of viruses are recognized by the diseases
they cause in plants, animals and prokaryotes. Viruses
of prokaryotes are known as bacteriophages.
Adenovirus
¡¡An icosahedral (20-sided) virus that contains DNA,
there are over 40 different adenovirus varieties,
some of which cause the common cold.
Cytomegalovirus
¡¡The cytomegalovirus is probably the most widespread
of the Herpetoviridae group. Infected cells enlarge
and have a characteristic inclusion body (composed
of virus particles) in the nucleus. Causes disease
only in utero (leading to abortion or stillbirth or
to various congenital defects), although can be opportunistic
in the immunocompromised host. Patients who have been
exposed to the virus will remain cytomegalovirus IgG
positive.
Replication
¡¡Replication is the process of duplicating or reproducing.
Viral
¡¡Pertaining to, caused by or of the nature of virus
Synthesis
¡¡The artificial building up of a chemical compound,
by the union of its elements or from other suitable
starting materials
Vocabulary related to the cell
Nucleus
¡¡The major organelle of eukaryotic cells, in which
the chromosomes are separated from the cytoplasm by
the nuclear envelope.
Eukaryote, eukaryotic
cell
¡¡An eukaryote is an organism whose cells have chromosomes
with a special structure and separated from the cytoplasm
by a two membrane nuclear envelope and compartmentalization
of a function in distinct cytoplasmic organelles.
Prokaryote, prokaryotic
cell
¡¡A prokaryote is a unicellular organism lacking a
nuclear membrane, a discrete nucleus, and other specialized
compartments within the cell. Bacteria and viruses
are prokaryotes. Prokaryotes are unicellular organisms
that do not develop or differentiate into multicellular
forms. Some bacteria grow in filaments, or masses
of cells, but each cell in the colony is identical
and capable of independent existence. The cells may
be adjacent to one another because they did not separate
after cell division or because they remained enclosed
in a common sheath or slime secreted by the cells.
Typically though, there is no continuity or communication
between the cells. Prokaryotes are capable of inhabiting
almost every place on the earth, from the deep ocean,
to the edges of hot springs, to just about every surface
of our bodies. Prokaryotes are distinguished from
eukaryote on the basis of nuclear organization, specifically
their lack of a nuclear membrane. Prokaryotes also
lack any of the intracellular organelles and structures
that are characteristic of eukaryotic cells.
Organelle
¡¡The organelle is a structurally discrete component
of a cell.
Cytoplasm
¡¡The cytoplasm consist in the all of the substance
of a cell outside of the nucleus. The cytoplasm contains
a number of different types organelles such as the
mitochondria.
Protoplasm
¡¡The protoplasm is the entire contents of a live cell
Vocabulary related to blood
Red blood cell
¡¡The red blood cells are cells that supply oxygen
to tissues throughout the body. They are biconcave,
7nm diameter in mammals.
White blood cell, leucocytes,
lymphocytes
¡¡The white blood cells are the blood cells that fight
infections and other diseases. They are spherical,
colorless.
Platelets
¡¡A platelet is a particle found in the bloodstream
that binds to fibrinogen at the site of a wound to
begin the blood clotting process. Platelets are formed
in bone marrow.
Serum
¡¡The serum is the clear liquid that can be separated
from clotted blood. Serum differs from plasma, the
liquid portion of normal unclotted blood containing
the red and white cells and platelets. It is the clot
that makes the difference between serum and plasma.
Bloodstream
¡¡The bloodstream is the flowing blood as it is encountered
in the circulatory system as distinguished from blood
that has been removed from the circulatory system
or sequestered in a part; thus, something added to
the bloodstream may be expected to become distributed
to all parts of the body through which blood is flowing.
Vocabulary related to the proteins
Protein
¡¡Any of a group of complex organic compounds which
contain carbon, hydrogen, oxygen, nitrogen and usually
sulphur, the characteristic element being nitrogen
and which are widely distributed in plants and animals.
Proteins, the principal constituents of the protoplasm
of all cells, are of high molecular weight and consist
essentially of combinations of a amino acids in peptide
linkages. Twenty different amino acids are commonly
found in proteins and each protein has a unique, genetically
defined amino acid sequence which determines its specific
shape and function. They serve as enzymes, structural
elements, hormones, immunoglobulins, etc. And are
involved in oxygen transport, muscle contraction,
electron transport and other activities throughout
the body and in photosynthesis.
Amino-acid
¡¡An amino-acid is a class of organic molecules that
containing an amino group and can combine in linear
arrays to form proteins in living organisms.
Peptide
¡¡A peptide is a compound of two or more amino acids
where the alpha carboxyl group of one is bound to
the alpha amino group of another.
HSP, Heat Shock Protein
¡¡Families of proteins conserved through prokaryotic
and eukaryotic cells and bacteria in response to hyperthermia
and other environmental stresses, although some are
constitutively expressed. They increase thermal tolerance
and perform functions essential to cell survival under
these conditions. Some serve to stabilize proteins
in abnormal configurations, play a role in folding
and unfolding of proteins and the assembly of oligomeric
complexes and may act as chaperones. Hsp90 complexes
with inactive steroid hormone receptor and is displaced
upon ligand binding. Four major sub classes are recognized:
hsp90, hsp70, hsp60 and small hsps.
HSP70
¡¡Widely distributed group of conserved heat-shock
proteins of average weight 70kD. Possess ATP binding
domains and may be involved in protein folding or
export
AFP, Alfa feto-protein
¡¡The AFP is a protein substance that is normally produced
by the liver cells. It can appear in the adult serum
during certain pathologic states. Measurement of the
alpha-fetoprotein level in the bloodstream has been
used as a early detection test for some forms of cancer
(hepatocellular carcinoma). The level produced by
liver tumors (hepatomas), germ cell tumors (teratocarcinoma
and embryonic cell carcinomas) permits the monitoring
of response to treatment of these tumors.
Vocabulary related to genetics
Gene
¡¡A gene is a detectable genetic trait or segment of
DNA that can be identified and tracked. A marker gene
can serve as a flag for another gene, sometimes called
the target gene. A marker gene must be on the same
chromosome as the target gene and near enough to it
so that the two genes (the marker gene and the target
gene) are genetically linked and are usually inherited
together.
Genome
¡¡The total set of genes carried by an individual or
cell
Chromosome
¡¡Threadlike bodies found in the nucleus, or center
part, of a cell that carry DNA, the information of
heredity. The DNA of eukaryotes is subdivided into
chromosomes, that consist of a number of chromosomes
whose DNA is associated with various proteins. The
chromosomes become more tightly packed at mitosis
and become aligned on the metaphase plate. Each chromosome
has a characteristic length and banding pattern. In
prokaryotes, chromosomal DNA is circular, and the
entire genome is carried on one chromosome.
DNA
¡¡The DNA is the molecule that encodes genetic information
in the nucleus of cells. It determines the structure,
function and behaviour of the cell. DNA is a double-stranded
molecule held together by weak bonds between base
pairs of nucleotides. The four nucleotides in DNA
contain the bases: adenine (A), guanine (G), cytosine
(C), and thymine (T).
P53
¡¡The P53 is a gene which encodes a protein that regulates
cell growth and is able to cause potentially cancerous
cells to destroy themselves.
Genetically engineered
, genetically modified
¡¡The genetic engineering is a general term covering
the use of various experimental techniques to produce
molecules of DNA containing new genes or novel combinations
of genes, usually for insertion into a host cell for
cloning.
Chemotherapy
¡¡Chemotherapy is the treatment of cancer with drugs
that can destroy cancer cells. These drugs often are
called "anticancer" drugs. This is a treatment
of disease by means of chemicals that have a specific
toxic effect or that destroy cancerous tissue (anticancer
therapy).
Immunotherapy, biological
therapy, biotherapy
¡¡Immunotherapy therapy, a more recent approach to
the treatment of cancer, holds considerable promise.
It utilizes the body's immune system to fight the
cancer and/or to protect it from some of the side
effects of other treatments. Tumor cells from the
patient are inactivated and then injected into a laboratory
animal, where they stimulate the production of specific
antibodies to the cancer. These antibodies are then
removed from the animal and injected into the patient,
in whom they make a beeline directly for the tumor,
attacking it and sparing healthy tissue. These antibodies
can also be attached to chemotherapy drugs and other
antitumor agents, which selectively search out the
tumor. In a biological therapy, patients are given
various natural substances such as interferon, interleukin
2, and several types of colony-stimulating factors,
all of which enhance the body's own defenses. The
side effects of biological therapy depend on the type
of treatment.
Immune system
¡¡The immune system is a complex system that is responsible
for distinguishing us from everything foreign to us,
and for protecting us against infections and foreign
substances. The immune system works to seek and kill
invaders. A key part of the immune system's role is
to differentiate between invaders and the body's own
cells.
Radiotherapy, radiation
therapy
¡¡The radiation therapy is a cancer treatment that
uses radiation (high-energy rays). It may be an option,
either when surgery is not feasible or when the surgeon
isn't able to remove the tumor completely. However,
it may be the first choice when the cancer is localized
and its cells are radiosensitive, as, for example,
in prostate cancer. The high-energy rays destroy the
cancer cells, or damage them so that they stop growing
and dividing. Radiation is delivered either externally
or internally from an implant, in which case a small
radioactive container is placed directly into or near
the tumor. External radiation is usually administered
on an outpatient basis five days a week for several
weeks. It doesn't leave you radioactive; you can't
spread the rays to those near you. Internal radiation
therapy, on the other hand, requires an operation
in order to implant the radioactive receptacle. Implants
may be permanent or removed after a certain period
of time.
CSF, Colony Stimulating
Factor
¡¡The Colony Stimulating Factor substances that stimulate
the production of blood cells. Treatment with colony-stimulating
factors (CSF) can help the blood-forming tissue recover
from the effects of chemotherapy and radiation therapy.
These include granulocyte colony-stimulating factors
(G-CSF) and granulocyte-macrophage colony-stimulating
factors (GM-CSF).
Onyx-015
¡¡Onyx-015 is developed by ONYX Pharmaceuticals in
the United States. Onyx-015 is a conditionally replicating
adenovirus with E1B-55KD gene deletion, enabling the
selective replication in tumor cells . It is the most
explored oncolytic virus in clinical trial of treating
tumor especially head & neck cancer.
Side effects
¡¡Side effects are any undesired actions or effects
of a drug or treatment. Negative or adverse effects
may include headache, nausea, hair loss, skin irritation,
or other physical problems. Experimental drugs must
be evaluated for both immediate and long-term side
effects. For example: hair loss may be a side effect
of chemotherapy, fatigue may be a side effect of radiation
therapy.
Toxicity
¡¡Toxicity is an adverse effect produced by a drug
that is detrimental to the patient's health. The level
of toxicity associated with a drug will vary depending
on the condition that the drug is used to treat.
Cytotoxic
¡¡Chemicals that are directly toxic to cells, preventing
their reproduction or growth. Cytotoxic agents can,
as a side effect, damage healthy, non-cancerous tissues
or organs which have a high proportion of actively
dividing cells, for example, bone marrow. These side
effects limit the amount and frequency of drug administration
Myelotoxic
¡¡A myelotoxic is a compound that is toxic or destroy
the bone marrow.
Hepatotoxic
¡¡An hepatotoxic is a compound that is toxic to liver
cells.
Nausea
¡¡Nausea is an unpleasant sensation, vaguely referred
to abdomen and often culminating in vomiting.
Anemia
¡¡Anemia is the fact of having too few red blood cells.
The symptoms of anemia include feeling tired, weak,
and short of breath
Blood cell count
¡¡The blood cell count is the number of red blood cells,
white blood cells, and platelets in a sample of blood.
This is also called complete blood count (CBC).
Neutropenia
¡¡Neutropenia is a reduction of the number of leucocytes
in the blood chiefly in neutrophils (a particular
type of leucocytes).
Clinical trials
¡¡Clinical trials are studies that test new medical
treatments. Clinical trials are conducted with volunteers
and concentrate on one of the following aspects of
cancer: preventing cancer, treating cancer, or improving
the quality of life of patients with cancer. A clinical
trial is a research study to answer specific questions
about new therapies or new ways of using known treatments.
Clinical trials are used to determine whether new
drugs or treatments are both safe and effective. Carefully
conducted clinical trials are the fastest and safest
way to find treatments that work in people. Trials
are in four phases: Phase I tests a new drug or treatment
in a small group; Phase II expands the study to a
larger group of people; Phase III expands the study
to an even larger group of people; and Phase IV takes
place after the drug or treatment has been licensed
and marketed.
Phase I
¡¡The Phase I consists in initial studies to determine
the metabolism and pharmacologic actions of drugs
in humans, the side effects associated with increasing
doses, and to gain early evidence of effectiveness;
may include healthy participants and/or patients.
Phase II
¡¡The Phase II consists in single-arm or controlled
clinical studies conducted to evaluate the effectiveness
of the drug for a particular indication or indications
in patients with the disease or condition under study
and to determine the common short-term side effects
and risks.
Phase III
¡¡The Phase III consist in expanded controlled and
uncontrolled trials after preliminary evidence suggesting
effectiveness of the drug has been obtained, intended
to gather additional information to evaluate the overall
benefit-risk relationship of the drug and provide
an adequate basis for physician labeling.
Phase IV
¡¡The Phase IV consists in post-marketing studies to
delineate additional information including the drug's
risks, benefits, and optimal use.
Preclinical
¡¡It refers to the testing of experimental drugs in
the test tube or in animals - the testing that occurs
before trials in humans may be carried out.
Injection
¡¡Using a syringe and needle to push fluids or drugs
into the body; often called a "shot."
Regimen
¡¡Regimen means administration.
Dose
¡¡A quantity to be administered at one time, such as
a specified amount of medication.
Efficacy
(of a drug or a treatment)
¡¡The maximum ability of a drug or treatment to produce
a result. A drug passes efficacy trials if it is effective
at the dose tested and against the illness for which
it is prescribed. In the procedure mandated by the
FDA, Phase II clinical trials gauge efficacy, and
Phase III trials confirm it.
Control group
¡¡A control group is the standard by which experimental
observations are evaluated. In many clinical trials,
one group of patients will be given an experimental
drug or treatment, while the control group is given
either a standard treatment for the illness or a placebo.
Randomization
¡¡Randomization is a method based on chance by which
study participants are assigned to a treatment group.
Randomization minimizes the differences among groups
by equally distributing people with particular characteristics
among all the trial arms. The researchers do not know
which treatment is better. From what is known at the
time, any one of the treatments chosen could be of
benefit to the participant.
Randomized trial
¡¡A randomized trial is a study in which participants
are randomly (i.e., by chance) assigned to one of
two or more treatment arms of a clinical trial. Occasionally
placebos are used.
Informed consent document
¡¡The informed consent is a document that describes
the rights of the study participants, and includes
details about the study, such as its purpose, duration,
required procedures, and key contacts. Risks and potential
benefits are explained in the informed consent document.
The participant then decides whether or not to sign
the document. Informed consent is not a contract,
and the participant may withdraw from the trial at
any time.
Peer review
¡¡The peer review is the review of a clinical trial
by experts chosen by the study sponsor. These experts
review the trials for scientific merit, participant
safety, and ethical considerations.
SFDA
¡¡The SFDA is the Sate Food and Drug Administration
of the P.R. of China. For more information: http://www.sfda.gov.cn/eng/.
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