Good Clinical Practice (GCP) Practice Exam

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What does "blinded evaluation" aim to eliminate in a clinical trial?

Variability in participant responses

Bias in the assessment of treatment effects

Blinded evaluation in a clinical trial is primarily designed to eliminate bias in the assessment of treatment effects. When evaluators—who might be responsible for assessing outcomes—are blinded to which participants received the treatment and which received the placebo or alternative interventions, their judgments and observations are less likely to be influenced by their expectations or preconceived notions about the treatment’s efficacy. This is critical because bias can skew results and impact the integrity of the findings.

In trials where assessors know the treatment assignment, they might unconsciously favor one group over another, thus affecting the validity of the results. By blind to the treatment allocation, the evaluations are more objective and help ensure that the conclusions drawn from the trial are based solely on the actual effects of the treatment rather than external influences introduced through bias. This contributes significantly to the credibility and reliability of the trial outcomes, which is a cornerstone of good clinical practice.

Variability in participant responses, error in data interpretation, and participant drop-out rates, while important in clinical trials, are not the primary focus of blinding. Instead, these factors are typically addressed through other methodologies and controls within the study design.

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Error in data interpretation

Participant drop-out rates

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