Glossary of CT terms


Updates on COVID-19 Vaccines


A GLOSSARY TO UNDERSTAND CTs

Sources: WHO, FDA, Wiley Online Library

  • Adverse reaction -  An unwanted effect caused by the administration of drugs
  • Clinical trial - A research study involving humans to determine whether new drugs or treatments or vaccines are both safe and effective
  • Control group - The standard by which experimental observations are evaluated. In many clinical trials one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo
  • Data safety and monitoring Committee (DSMC) - An independent committee composed of community representatives and clinical research experts that review data while a clinical trial is in progress to ensure that participants are not exposed to undue risk.
  • Dosage - The amount of drug administered to a patient or test subject over the course of the clinical study
  • Effectiveness The extent to which a specific intervention, when used under ordinary circumstances, does what it is intended to do. 
  • Efficacy The extent to which an intervention produces a beneficial result under ideal conditions.
  • Eligibility criteria - The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial
  • Good clinical practice (GCP) - The rules for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. GCP provide assurance that data and results are based on sound scientific and ethical research
  • Informed consent - The process of learning the key facts about a clinical trial before deciding whether to participate. It is also a continuing process throughout the study to provide information for participants.
  • Institutional review board (IRB) A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected
  • Interim analysis - Analysis comparing intervention groups at any time before the formal completion of a trial, usually before recruitment is complete.
  • Investigational new vaccine - A new vaccine that is used in a clinical investigation
  • Pharmacovigilance - The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem
  • Placebo - An inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment ’ s effectiveness. 
  • Placebo effect - A physical or emotional change, occurring after a substance is taken or administered, that is not the result of any special property of the substance
  • Preclinical - The testing of experimental therapies in the test tube or in animals — the testing that occurs before trials in humans may be carried out. 
  • Protocol - A 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 specific research questions.
  • Randomization - A method based on chance by which study participants are assigned to a treatment group. 
  • Side effects - Any undesired actions or effects of a drug or treatment. Experimental drugs must be evaluated for both immediate and long-term side effects.