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Isofol Medical AB (publ)

Biotech Center
Arvid Wallgrens Backe 20
SE-413 46 Gothenburg, Sweden
Phone: +46 (0)31 797 22 80
Email: info@isofolmedical.com

Isofol Agent Study

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For a glossary of more terms related to clinical studies, please see: https://clinicaltrials.gov/ct2/about-studies/glossary

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


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GLOSSARY

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