Randomized controlled trial phases, blinding methods, randomization techniques, and intention-to-treat versus per-protocol analysis, one concept per card.
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- What is the primary goal of a Phase I clinical trial?
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To assess safety, tolerability, and appropriate dosage in a small group of participants.- Phase I trials typically enroll how many participants?
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A small group, often 20 to 100 participants (frequently healthy volunteers).- What is the primary goal of a Phase II clinical trial?
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To evaluate preliminary efficacy and further assess safety.- Approximately how many participants are typically enrolled in a Phase II trial?
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Roughly 100 to 300 participants.- What is the primary goal of a Phase III clinical trial?
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To confirm efficacy and monitor side effects in a large population, often compared to the standard treatment.- Phase III trials typically enroll how many participants?
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Several hundred to several thousand participants.- What happens during a Phase IV clinical trial?
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Post-marketing surveillance to monitor long-term safety and effectiveness after the drug is approved.- What is a Phase 0 trial?
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An exploratory trial using very small, subtherapeutic drug doses to gather early pharmacokinetic data.- What does RCT stand for?
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Randomized controlled trial.- What is the main purpose of randomization in a clinical trial?
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To distribute known and unknown confounding factors evenly between treatment groups.- What is simple randomization?
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Assigning participants to groups purely by chance, like a coin flip, with no restrictions.- What problem can simple randomization cause, especially in small trials?
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It can result in unequal group sizes by chance.- What is block randomization?
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A method that assigns participants in fixed-size blocks to keep group sizes balanced throughout the trial.- What is stratified randomization used for?
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To ensure balance of a known prognostic factor, such as age or disease severity, between treatment groups.- What is cluster randomization?
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Randomizing whole groups, such as clinics or communities, rather than individual participants.
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