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These definitions will help you better understand some of the common terms you may encounter related to your child's participation on a clinical trial.
Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy.
A side effect of your child's cancer treatment that is not intended or wanted. (e.g. hair loss following chemotherapy.)
Treatment with an antibody, a substance that can directly kill specific tumor cells or prompt the immune system to kill tumor cells.
An older child or teenager may be asked to give assent, or verbal agreement to participate in a clinical trial.
Independent, able to make choices, and act without being swayed or influenced by others.
An X-ray technique which uses a computer to produce pictures of the organs inside your child's body.
A controlled study which evaluates how safe and effective a new drug or treatment is for humans.
A group of people with some characteristic in common who are followed over time. For example, in the case of a clinical trial it may be the group of people who are receiving the same dose of a new medication.
A treatment or medicine that you use in addition to your doctor's standard care.
Keeping the medical and personal information about your child secret or protected.
a group of people who are not given the new drug or treatment in a study and are used to compare against those people who are receiving the treatment.
A special situation where giving a particular drug or treatment may be harmful. For example, if your child is allergic to a particular medication it would be potentially harmful to include that medication in his treatment.
A clinic setting where your child will receive treatment. It is open from early morning until late in the day Monday through Friday.
A test done to identify a disorder or disease in your child.
Any chemical compound that may be given to a person to help diagnose, prevent, treat or cure a disease.
The ability of a drug or treatment to improve your child's cancer.
A branch of medicine that studies what causes disease, how frequently it occurs, and who might be expected to get the disease.
Fair or just
A group of professionals that advise what is the right thing to do in relation to research or treatment.
A drug or treatment that has not yet completed the necessary testing to gain approval for mainstream use.
A clinical trial to look at a drug, a device or a procedure that is unproven or not yet scientifically validated with respect to safety and efficacy.
Treating hereditary disease by altering the genetic structure of cells.
Tests to identify persons who are at risk of producing offspring with inherited diseases or disorders.
The genetic makeup of an individual.
Funding provided for a research study designed and proposed by the leading investigator(s).
An individual who may legally give permission for a child to receive medical care.
While receiving a monoclonal antibody treatment for his/her cancer, a child may develop an immune response which could compromise the effectiveness of the treatment. This response is known as the Human Anti- Human Antibody.
People who are participating in the clinical trial and whose responses to the treatment are being carefully evaluated.
The use of the child's own immune system to fight cancer.
A person's voluntary agreement to participate in research after achieving a full understanding of the medical facts and risks involved.
A special group set up to protect the health and welfare of persons recruited to participate in biomedical or behavioral research.
A drug or device permitted by FDA to be tested in people, but not yet approved for use in the general population and not yet licensed for marketing.
The doctor who actually conducts the clinical trial. Your child's drug or treatment is given under the immediate direction of the investigator.
A surgical procedure to insert a central venous catheter which can then be used to administer intravenous treatment. Having this line in place allows for the child to experience fewer ‘needle sticks.' There are different types of lines and your nurse will show you how to take care of this line at home.
The highest dose of a drug that can be given without causing unacceptable side effects.
The way a drug is broken down and removed from the body.
When the likelihood or chance of harm or discomfort from proposed research is no greater those ordinarily encountered in daily life. For example, the risk of drawing a small amount of blood for research purposes is no greater than the risk of doing so as part of routine physical examination.
Antibodies that target one site on a cancer cell.
A test that uses a magnetic field and pulses of radio wave energy to make pictures of organs and structures inside the body.
A unique type of imaging test that helps the doctor to see how the organs and tissues inside your child's body are actually functioning. The test involves injecting a very small dose of a radioactive chemical, called a radiotracer, into the vein of his/her arm. The tracer is absorbed by the organs and tissues being studied. Next, your child lies down on a flat table that is moved into a doughnut-like shaped machine. This machine detects and records the energy given off by the tracer substance and, with the aid of a computer; this energy is converted into three-dimensional pictures. A physician can then look at cross-sectional images of the body organ from any angle in order to detect any functional problem.
Treatment that concentrates on reducing the severity of symptoms rather than on curing the disease. The goal is to relieve suffering and to improve quality of life for people facing serious illness.
The parent(s) or guardian's agreement for the child to participate in research.
The study of the effect of a drug on the body. Most often, this will be done by evaluating a small amount of blood drawn from your child at specific time points.
A series of tests that measure the amount of drug concentration and how the drug is broken down by the body. Most often, this will be done by evaluating a small amount of blood drawn from your child at specific time points.
The scientific discipline that studies the action of drugs on living systems (animals or human beings).
A clinical trial which looks at a drug not yet proven to be effective and tests the drug to determine the highest dose which is safe to give in children.
A clinical trial in which the dose proven to be safe in the Phase I is used to determine how effective the drug is against the cancer.
The lead scientist or scholar with primary responsibility for the design and conduct of a research project.
Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
A study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
Materials that stop radiation that is passed through the body, creating an outline on film of the organ(s) being examined. Contrast agents, sometimes called "dyes," do not contain radioisotopes and so exposure to radiation results only from the X-ray equipment used in the examination.
Not responding or yielding to treatment.
Disappearance of evidence of cancer or other disease
A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.
An experienced Registered Nurse with specialized training in clinical trials who will work closely with you and your child to coordinate study activities and blood draws required for the study. She may administer your child's treatment and can answer questions regarding the protocol study requirements, symptom management, etc.
A member of the research team who is responsible for the way information is collected from your child's medical chart.
The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study.
During this phase the doctor will examine your child and carefully review your child's records to make certain that his/her history meets the eligibility criteria for this particular study. Additional scans, biopsies or line placement procedures may be performed.
A person or entity that initiates a clinical investigation of a drug usually the drug manufacturer or research institution that developed the drug. The sponsor distributes the new drug to investigators and physicians for clinical trials. The sponsor is responsible for obtaining FDA approval to conduct a trial and for reporting the results of the trial to the FDA.
An individual who both initiates and actually conducts a clinical investigation.
Treatment given to prevent, control, or relieve complications and side effects and to improve the patient's comfort and quality of life.
The research physician's intent to provide some benefit to improving a person's condition (e.g., prolongation of life, shrinkage of tumor, or improved quality of life) as well as assessing the safety and pharmacology of a drug.
Treatment intended and expected to alleviate a disease or disorder.
It may be necessary to wait a certain amount of time between the last treatment your child received and starting this new regimen. We call this the “washout period” which ensures that the prior drug is completely out of your child's system and there will be no interaction between the two drugs.
Take a closer look at what it's like to be involved in a clinical trial from the first consultation through the treatment.
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Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy.
A side effect of your child's cancer treatment that is not intended or wanted. (e.g. hair loss following chemotherapy.)
Treatment with an antibody, a substance that can directly kill specific tumor cells or prompt the immune system to kill tumor cells.
An older child or teenager may be asked to give assent, or verbal agreement to participate in a clinical trial.
Independent, able to make choices, and act without being swayed or influenced by others.
An X-ray technique which uses a computer to produce pictures of the organs inside your child's body.
A clinic setting where your child will receive treatment. It is open from early morning until late in the day Monday through Friday.
A test that uses a magnetic field and pulses of radio wave energy to make pictures of organs and structures inside the body.