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Clinical
Trials: Highly-controlled research studies involving
patient volunteers, that investigate emerging therapies in the hopes
of answering specific scientific questions, and finding different
ways to prevent and treat diseases such as cancer.
Informed Consent: The process,
by which a patient learns the key facts about a clinical trial,
including its benefits and risks, and then decides whether or not
to voluntarily participate. For those who choose to take part, the
process involves signing a form that outlines the research study's
details prior to participation.
Phases: The structure of clinical
trials, ranging from Phase I (small groups of trial participants
who help determine the safety, dosage, and side effects of a study
drug) to Phase IV (testing after the study drug has been marketed
to determine its effect across diverse populations and over the
long-term).
Protocol:
An action plan for a clinical trial, stating the purpose and processes
of the research study. The protocol includes information such as
the number and types of patients participating, the nature and frequency
of tests, and the study drug regimen.
Randomization:
The random assignment of a clinical trial's participants to either
the study drug regimen or control group in order to prevent any
research bias.
Side effects: Problems that
can occur along with either a current standard treatment or a research
study drug that affect healthy cells. Common side effects can include
fatigue, nausea, vomiting, decreased blood cell counts, hair loss,
and mouth sores.
Standard
treatment: The most current and approved treatment known
for a disease, such as a specific type of cancer, based on results
of past research studies.
Study
drug: An investigational agent provided as part of a
clinical trial/research study that is not approved by the U.S. Food
and Drug Administration (FDA) for marketing and sale in the United
States
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