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Generally large trials (i.e., many study participants) designed to “confirm” efficacy of an intervention. Trials typically conducted to investigate a dose response relationship, identify an optimal dose, and to investigate safety issues. These trials often have small sample sizes (e.g., <20), may enroll healthy human participants, and are used to investigate pharmacokinetics, pharmacodynamics, and toxicity. The first studies conducted in humans using an experimental intervention. The strategy implies “analyze as randomized” regardless of adherence or treatment received.Ĭlaim that an investigator desires to disprove. Strategy for conducting a trial and analyzing data. The investigator thus assumes that the compliment (called the null hypothesis) is true and then looks for evidence to disprove the null hypothesis and hence claim the alternative hypothesis to be true. ![]() Typically the alternative hypothesis is something that the investigator desires to prove (e.g., that a new treatment is superior to placebo). If sufficient contradictory evidence is observed, then the desired claim has been proven. ![]() The scientific method states that to prove something, assume the compliment is true and then look for contradictory evidence. ![]() Claim that would like to be made at the end of the trial. |
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