Published on July 17, 2020
slide 1: Clinical Trials Terminologies Adverse Reaction: An unwanted effect initiated by the administration of drugs. In the pre- approval clinical experience with a new drugs or its new usages particularly as the therapeutic doses may not be established. It can be sudden or develop over a period of time. They may or may not be related to a treatment. Clinical trials are often both short-and long-term adverse events related to a treatment. Some adverse events can be considered too serious and are reported to regulatory authorities. Fusion Technology Solutions – Best Clinical Research Courses in Pune which explains detail concepts of Clinical Trial terminologies. Approved Drugs: These are the drugs which have undergone and passed the vigorous U.S. Food and Drug Administration FDA tests and approval process. Adverse Event: An unfavorable health change of an aspirant including all the abnormal laboratory findings during the clinical study certain timeframe after the end of study. The change may or may not be produced by the intervention being studied. Arm: Treatment groups in a randomized trial. Most of these groups with randomized trials have two to three "arms" or even more. Baseline: Timeframe during a clinical trial before an aspirant accepts the drug or treatment being studied. The measurements of baseline are compared to measurements taken after the participant initiates using the drug or treatment. BIAS: Bias is used when a design or analysis is likely to favor a particular outcome. Bias can happen if a researcher understands about the treatment of a participant is receiving which interferes with the researcher’s ability to be impartial. Blind: The term is used when participants are not informed if they are receiving the actual treatment or a placebo. Clinical Investigator: The medical researcher who is in charge of the particular clinical trials protocol. He is also responsible for directing your study. Clinical Trial: Research study using human volunteers to see and check if certain medications or treatments are effective and safe. Control: Control also called as standard treatment is compared against the investigational treatment. Cross-over Trial: Here the volunteers are administered with two or more interventions with a specific order. Double-Blind: In this study the pharmacist knows the study medications received by the participants aspirants nurses doctors and the other staff involved in the clinical trial is not informed. slide 2: Dosing Discontinuation: Time period when a patient volunteer stops taking study drug permanently for any reason. It can be at the end of the study or also before the end conditionally if the patient is willing to stop taking the medications for some reason. Eligibility Criteria: It is the term for the participants in the clinical study meeting all the requirements. It should include all the exclusive and inclusive criteria defined in the protocol. Early Patient Withdrawal: Time period when a patient exits from a trial prior for the completion of all investigational drug administration and all assessments accordingly. Epoch: The stage planned of the volunteers’ participation in the trial. Health Authority: International health agency having authority over and regulates a clinical study. FDA: Government agency within the U.S. Department of Health and Human Services. Food and Drug Administration. Interventional Study: It is a clinical study in which participants receive interventions according to the protocol. Which further helps researchers to evaluate the effects of the intervention on a health condition. Medication Number: A unique number on the drug package used in a trial to dispense and track medication. It makes sure the drug is supplied in the right quantities to different research centers. Outcome Measure: Set of measurement described in the protocol used to evaluate the effect of an intervention on participants. Wash-out period: Particular span allowed for all of the administered drug to be removed from the body. Subject Number: An exclusive number allocated to each participant who joins into a clinical trial. Serious Adverse Event: An adverse event which is considered to be life-threatening requires hospitalization leads to the ongoing or significant incapacity causing the birth defects congenital anomalies or results in death.