Glossary
Control - an experiment or observation intended to help minimize the effects of all variables in a study that are not the target of the study itself
Clinical study - an organized research program used to evaluate the safety and effectiveness of a new medical treatment or device
Clinical study coordinator - a person with administrative responsibilities at an individual clinical study site that helps with enrollment and maintaining contact with patients and study organizers
Contract research organization - a third party company often hired to handle the logistics of running a large-scale clinical study that involves multiple clinical study sites
Duration of response (DOR) - time between the initial response to therapy and subsequent disease progression or relapse
Eligibility criteria - pre-defined standards used to determine if a person is able to take part in a clinical study
Endpoints - biomedical or behavioral measures of whether or not a treatment or device is effective determined during study design
First-line treatment - the first treatment a patient receives for a certain stage of disease
Food and Drug Administration (FDA) - a federal agency of the U.S. charged with ensuring the safety of food and drugs. The main federal oversight organization for all clinical studies
Health-related biomedical or behavioral outcomes - conditions that can be used to reflect or measure the overall health of an individual (for example: heart rate, lung capacity, disease progression measures such as tumor size, etc.)
Intervention - a treatment or process that is a focus of a clinical study. For example, giving a study subject a new experimental drug is an intervention, as is giving someone a placebo
MTHF - Methylenetetrahydrofolate
Overall response rate (ORR) - portion of patients with a tumor size reduction of a predefined amount
Phase - the name for a stage of clinical testing
Placebo - an inactive substance or other innocuous intervention that looks the same as and is given the same way as the experimental drug or intervention that is the focus of a study
Principal investigator - the person who is responsible for the scientific and technical direction of the entire clinical study, either at a single clinical study site or over the whole study
Progression free survival (PFS) - time during and after treatment of a disease that a patient lives with the disease without it getting worse
Toxicology - a branch of science concerned with measuring the nature and effects of poisons or other harmful agents
