Clinical Trial相关的50个基本概念

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1. Blinding: A method to prevent bias in research by concealing the treatment allocation from one or more parties involved in the trial.
2. Randomization: The process of assigning trial participants to different treatment groups by chance to reduce bias.
3. Placebo: An inert substance given to a control group to test the efficacy of a treatment in the experimental group.
4. Control Group: Participants in a trial who receive either no intervention or a standard intervention, used as a benchmark to measure how the other tested treatments work.
5. Intervention Group: The group in a clinical trial that receives the experimental treatment or intervention being tested.
6. Informed Consent: A process in which participants are given comprehensive information about a study's purpose, risks, benefits, and their rights, and they voluntarily agree to participate.
7. Protocol: A detailed plan that describes the research objectives, design, methodology, statistical considerations, and organization of a clinical trial.
8. Primary Endpoint: The main result measured in a trial to determine if the intervention was effective.
9. Secondary Endpoint: Additional outcomes measured in a trial to gather more data on the intervention's effects.
10. Adverse Event: Any negative or unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the treatment.
11. Serious Adverse Event: An adverse event that results in significant outcomes such as death, life-threatening situations, hospitalization, disability, or permanent damage.
12. Safety Monitoring: Ongoing checks during a trial to ensure the safety of participants, including regular assessment and reporting of adverse events.
13. Efficacy: The ability of an intervention to produce a beneficial effect under ideal and controlled circumstances.
14. Safety: Refers to the absence of harmful effects being within acceptable risk parameters.
15. Inclusion Criteria: The set characteristics that define who is eligible to participate in a clinical trial.
16. Exclusion Criteria: The characteristics that disqualify potential participants from a trial to ensure safety and accuracy.
17. Baseline: The initial set of measurements at the beginning of a study, used for comparison against future measurements.
18. Follow-up: The monitoring of participants in a study over time to assess the long-term effects of the treatment.
19. Dropout: A participant who leaves a clinical trial before it is completed.
20. Data Monitoring Committee: An independent group that monitors the data collected in a clinical trial to ensure the safety of participants and the validity and integrity of the data.
21. Interim Analysis: The evaluation of data at predefined points in a trial before its conclusion, which can influence the continuation of the trial.
22. Hypothesis: A prediction or theory that is tested through research and experimentation.
23. Null Hypothesis: A statement that asserts there is no statistical significance between specified datasets, presumed true until statistical evidence in the form of a hypothesis test indicates otherwise.
24. Alternative Hypothesis: The hypothesis that proposes that there is a difference between groups or an effect of a treatment observed in a trial.
25. Sample Size: The number of participants in a study necessary to adequately detect a significant effect of the treatment being tested.
26. Power: The probability of a study to detect an effect, if there is an actual effect, typically set to 80% or higher.
27. Confidence Interval: A range of values that describe the degree of uncertainty or certainty in a measurement; typically, it is 95%, indicating that if the experiment were repeated, the true values would fall within this range 95% of the time.
28. Statistical Significance: The likelihood that a result or relationship is caused by something other than mere chance.
29. Type I Error: An error that occurs when a true null hypothesis is incorrectly rejected.
30. Type II Error: An error that occurs when a false null hypothesis is not rejected.
31. Intent-to-Treat Analysis: Analyzing trial results based on the initial treatment assignment and not on the treatment eventually received.
32. Per-Protocol Analysis: Analysis of trial data from participants who completed the study exactly as planned.
33. Crossover Trial: A study in which participants receive a series of different treatments over time.
34. Parallel-Group Trial: A clinical trial where two groups of participants are treated simultaneously with different treatments.
35. Single-Blind Trial: A study in which either the participants or the researchers do not know which treatment the participants are receiving.
36. Double-Blind Trial: A trial where neither the participants nor the researchers know who is receiving the specific treatment, preventing bias.
37. Open-Label Trial: A study where both the researchers and participants know what treatments are being administered.
38. Cross-Sectional Study: A study that looks at data from a population at one specific point in time.
39. Cohort Study: An observational study that follows a group of people over time to measure outcomes.
40. Case-Control Study: A retrospective study that compares those with a particular outcome or disease (cases) to those without (controls).
41. Randomized Controlled Trial (RCT): A study design that randomly assigns participants to an experimental group or a control group to measure the effectiveness of interventions.
42. Adaptive Trial: A trial that allows for modifications in the protocol as it progresses, based on interim data.
43. Phases of Clinical Trials: The stages of testing a new drug or therapy, ranging from early small-scale Phase I studies to large-scale, more conclusive Phase III studies, and post-marketing Phase IV studies.
44. Endpoint Adjudication: Independent review of cases in a clinical trial to assess how closely the trial adheres to its protocol.
45. Quality of Life Assessment: Measurement of a trial participant's overall well-being, encompassing physical, mental, and social health.
46. Bioavailability: The rate and extent at which a drug or substance is absorbed into the bloodstream and reaches the site where it is needed.
47. Bioequivalence: A test to determine if the drug in a generic product is absorbed at the same rate and to the same extent as the drug in the brand-name product.
48. Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and excreted in the body.
49. Pharmacodynamics: The study of the biochemical and physiological effects of drugs and their mechanisms of action.
50. Compliance: The extent to which a participant adheres to the prescribed treatment regimen in a clinical trial.