Question: Randomized controlled trials (RCTs) are often considered the "gold standard" study design because the exposure being studied is assigned randomly to study participants (randomization).

1. What is the primary (i.e. most important) purpose of randomization in a randomized controlled trial?
2. How does randomization achieve this purpose better than the other methods we use with observational studies (i.e. why is it the gold standard)?
3. Why is it also necessary to use Intent-to-treat analysis even when certain participants did not take the "treatment" as they were assigned (non-adherence)?
4. What threat to internal validity (bias) are we willing to accept when using intent to treat analysis and why are we willing to accept this problem?
5. Even though RCTs are the "gold Standard," if poorly designed and implemented, they can still give us the wrong results.  What are some of the problems that can occur with the design and implementation of an RCT that could lead to incorrect results?

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