LECTURE 21 2011

LECTURE 21 2011 - Key Issues in Analysis Who gets analyzed?...

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Key Issues in Analysis Who gets analyzed? How are they grouped for analysis?
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Approaches “Treatment received” (also referred to as “per protocol” or “as treated”) Analyze only fully eligible and compliant subjects with no missing data, e.g., “valid” and “evaluable” subjects “Intention to treat” (also referred to as “full analysis” set and “as randomized”) Analyze all randomized subjects utilizing as much information from each as possible See ICH Guidelines E9 for description of analysis sets
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There is a Gray Area Modified Intention to Treat (MITT) population Participants included in assigned treatment group regardless of treatment actually received. Ineligible participants based on measures made before randomization, but delayed, are excluded (e.g., patients with HIV who are in enrolled in an HIV prevention trial or patients without TB who are enrolled in a TB treatment trial). Safety population Participants who take the experimental treatment even if assigned control treatment.
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Example: Randomized Trial of Prevention of HIV with Acyclovir in Couples Where One Partner is Co-infected with HIV and HSV-2 “The primary analysis was a modified intention-to- treat analysis of linked transmissions of HIV-1; unlinked transmissions, seroconversions that occurred among men when their female partners who were infected with HIV-1 were pregnant and not taking the study drug, and seroconversions that occurred after the death of the HIV-1 infected partner were excluded. The secondary analysis was intention-to-treat” N Engl J Med 2010; 362:427-439 .
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Key Points Deviation from intent-to-treat can result in bias from not comparing like with like. This method of analysis needs to be firmly in mind when designing the study, e.g., realistic estimates of treatment effect that account for non-adherence. There are practical difficulties in carrying out a strict intention to treat analysis and a strict per protocol analysis.
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Arguments for Intention to Treat Consistent with randomization – get the right significance probability for hypothesis testing. Addresses the question of practical interest – a comparison of treatment policies. If the objective is to understand the implication of using a specific intervention in practice, this is the right analysis (e.g., non-adherence is a consequence of using a strategy in practice).
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Arguments for Per Protocol Analysis Better estimate of pure pharmaceutical effect of treatment (i.e., including non-compliers dilutes the treatment difference).
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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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LECTURE 21 2011 - Key Issues in Analysis Who gets analyzed?...

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