This site uses cookies. Some of these cookies are essential to the operation of the site, while others help to improve your experience by providing insights into how the site is being used. For more information, please see the ProZ.com privacy policy.
Cookie settings

Translation glossary: Clinical Trials glossary

Creator:
LingoConsult
LingoConsult
Filter
Reset
Showing entries 51-82 of 82
« Prev
 
NEW DRUG APPLICATION (NDA)An application submitted by the manufacturer of a drug to the FDA - after clinical trials have been completed - for a license to market the drug for 
English
OFF-LABEL USEA drug prescribed for conditions other than those approved by the FDA. 
English
OPEN-LABEL TRIALA clinical trial in which doctors and participants know which drug or vaccine is being administered. 
English
ORPHAN DRUGSAn FDA category that refers to medications used to treat diseases and conditions that occur rarely. There is little financial incentive for the pharm 
English
PEER REVIEWReview of a clinical trial by experts chosen by the study sponsor. These experts review the trials for scientific merit, participant safety, and ethi 
English
PHARMACOKINETICSThe processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine. 
English
PHASE I TRIALSInitial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to g 
English
PHASE II TRIALSControlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disea 
English
PHASE III TRIALSExpanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to ga 
English
PHASE IV TRIALSPost-marketing studies to delineate additional information including the drug\'s risks, benefits, and optimal use. 
English
PLACEBOA placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with pla 
English
PLACEBO CONTROLLED STUDYA method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested is 
English
PLACEBO EFFECTA physical or emotional change, occurring after a substance is taken or administered, that is not the result of any special property of the substance 
English
PRECLINICALRefers to the testing of experimental drugs in the test tube or in animals - the testing that occurs before trials in humans may be carried out. 
English
PREVENTION TRIALSRefers to trials to find better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approa 
English
PROTOCOLA 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 spe 
English
QUALITY OF LIFE TRIALS (or Supportive Care trials)Refers to trials that explore ways to improve comfort and quality of life for individuals with a chronic illness. 
English
RANDOMIZATIONA method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equal 
English
RANDOMIZED TRIALA study in which participants are randomly (i.e., by chance) assigned to one of two or more treatment arms of a clinical trial. Occasionally placebos 
English
RISK-BENEFIT RATIOThe risk to individual participants versus the potential benefits. The risk/benefit ratio may differ depending on the condition being treated. 
English
SCREENING TRIALSRefers to trials which test the best way to detect certain diseases or health conditions. 
English
SIDE EFFECTSAny undesired actions or effects of a drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or oth 
English
SINGLE-BLIND STUDYA study in which one party, either the investigator or participant, is unaware of what medication the participant is taking; also called single-maske 
English
SINGLE-MASKED STUDYSee Single-Blind Study. 
English
STANDARD TREATMENTA treatment currently in wide use and approved by the FDA, considered to be effective in the treatment of a specific disease or condition. 
English
STANDARDS OF CARETreatment regimen or medical management based on state of the art participant care. 
English
STATISTICAL SIGNIFICANCEThe probability that an event or difference occurred by chance alone. In clinical trials, the level of statistical significance depends on the number 
English
STUDY ENDPOINTA primary or secondary outcome used to judge the effectiveness of a treatment. 
English
STUDY TYPEThe primary investigative techniques used in an observational protocol; types are Purpose, Duration, Selection, and Timing. 
English
TOXICITYAn adverse effect produced by a drug that is detrimental to the participant\'s health. The level of toxicity associated with a drug will vary dependi 
English
TREATMENT INDIND stands for Investigational New Drug application, which is part of the process to get approval from the FDA for marketing a new prescription drug 
English
TREATMENT TRIALSRefers to trials which test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. 
English
« Prev

Public glossaries

My glossaries

Close search
All of ProZ.com
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search