key to midterm

key to midterm - Key to Mideterm 1.a) Allocation...

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Key to Mideterm 1.a) Allocation concealment refers to randomization schemes that cannot be predicted by the patient or the investigator. It could be achieved by a randomization scheme provided to a call center who will reveal treatment assignment only to necessary person at the right time. b) When there is more than one primary endpoint of interest, then they are known as co-primary endpoints. This might occur when investigators or regulatory authorities feel that more than one outcome can fully characterize the efficacy of the treatment. Usually an adjustment to type 1 error is required as most times co-primary endpoints are stated, success criteria is based on at least one of the co-primary endpoint being significant. For example, in EPHESUS trial all cause mortality; CVD morbidity and mortality. c) Active controlled trial is a kind of clinical trial where the control group is also administered with some standard treatment that is expected to produce benefit beyond that of no treatment. For example, suppose we want to see if a newly produced drug for cancer works better than the drug currently used. Here we will be randomizing some patients to the current (standard care) drug and some to the new drug. This is an active controlled trial.
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This note was uploaded on 11/21/2011 for the course PUBH 7420 taught by Professor Ph7420 during the Spring '07 term at Minnesota.

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key to midterm - Key to Mideterm 1.a) Allocation...

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