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