Glossary of Clinical Trial Terms Takeda（临床试验专业术语武田）.pdfVIP

Glossary of Clinical Trial Terms ADVERSE REACTION: (Adverse Event): Also known as side effects, adverse reactions include any undesired actions or effects of the experimental drug or treatment. Experimental treatments must be evaluated for both immediate and long-term side effects. APPROVAL: A drug, device or biologic must be approved by a country’s regulatory agency before it can be marketed. The approval process involves several steps including pre-clinical (animal) studies, clinical trials for safety and efficacy, filing of a New Drug Application (NDA) in the United States or Marketing Authorization Application (MAA) in Europe by the manufacturer, regulatory agency review of the application, and agency approval/rejection of application. ARM: Any of the treatment groups in a clinical trial. Most randomized trials have two “arms,” but some have three “arms,” or even more. BASELINE: Baseline information is gathered at the beginning of a study from which variations found in the study are measured. Baseline can also be described as a known value or quantity with which an unknown is compared when measured or assessed. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values. BIAS: When a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomization. BLIND, BLINDED or BLINDING: A clinical trial is “blinded” if the participants are unaware on whether they are in the experimental or control arm of the study. Blinding may also be extended to the investigators so that their patient observations are less likely to be biased by their awareness of the treatment the patient is receiving. CASE CONTROL STUDY: A scientific study that compares a group of people with a disease (such as leukemia) to a similar group of people without that disease. This type of study compares the