As you consider clinical study participation, you may encounter certain words that describe the study design, study procedures, or clinical outcomes. Below are a few for your reference.
A type of study in which the patients (single-blind) or the patients and their doctors (double-blind) do not know which drug or treatment is being given.2
Researchers follow clinical study guidelines when deciding who can participate, in a study. These guidelines are called Inclusion/Exclusion Criteria. Factors that allow someone to participate in a clinical study are inclusion criteria. Those that exclude or not allow participation are exclusion criteria.2
Informed consent explains risks and potential benefits about a clinical study before someone decides whether to participate.2
Intravenous refers to giving medicines or fluids through a needle or tube inserted into a vein.
A substance that has been tested in the laboratory and has been approved by the U.S. Food and Drug Administration (FDA) for testing in people. Clinical studies test how well investigational drugs work and whether they are safe to use.3
An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.4
A Protocol is a carefully designed plan to safeguard the participants’ health and answer specific research questions.2
A doctor who leads the clinical research team and, along with the other members of the research team, regularly monitors study participants’ health to determine the study’s safety and effectiveness.5
Quantitative MG Score is a measurement of disease severity determined by a standardized scoring system developed specifically for MG6
Randomization is the process by which two or more alternative treatments are assigned to volunteers by chance rather than by choice.7
An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. This change may or may not be caused by the treatment being studied.4
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