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Translation glossary: Clinical Trials glossary

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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 
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OFF-LABEL USEA drug prescribed for conditions other than those approved by the FDA. 
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OPEN-LABEL TRIALA clinical trial in which doctors and participants know which drug or vaccine is being administered. 
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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 
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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 
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PHARMACOKINETICSThe processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine. 
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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 
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PHASE II TRIALSControlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disea 
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PHASE III TRIALSExpanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to ga 
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PHASE IV TRIALSPost-marketing studies to delineate additional information including the drug\'s risks, benefits, and optimal use. 
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PLACEBOA placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with pla 
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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 
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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 
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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. 
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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 
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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 
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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. 
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RANDOMIZATIONA method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equal 
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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 
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RISK-BENEFIT RATIOThe risk to individual participants versus the potential benefits. The risk/benefit ratio may differ depending on the condition being treated. 
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SCREENING TRIALSRefers to trials which test the best way to detect certain diseases or health conditions. 
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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 
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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 
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SINGLE-MASKED STUDYSee Single-Blind Study. 
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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. 
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STANDARDS OF CARETreatment regimen or medical management based on state of the art participant care. 
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STATISTICAL SIGNIFICANCEThe probability that an event or difference occurred by chance alone. In clinical trials, the level of statistical significance depends on the number 
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STUDY ENDPOINTA primary or secondary outcome used to judge the effectiveness of a treatment. 
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STUDY TYPEThe primary investigative techniques used in an observational protocol; types are Purpose, Duration, Selection, and Timing. 
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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 
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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 
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TREATMENT TRIALSRefers to trials which test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. 
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