Evaluate the implications of pharmacogenomic variations in metabolizing enzymes when designing a clinical trial for a new cardiovascular drug.

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BlackTom AI · Accepted Answer

When evaluating how pharmacogenomic variations in metabolizing enzymes affect clinical trial design for a cardiovascular drug, several plausible implications arise.
Option 1: 'It is necessary to standardize genetic backgrounds to avoid skewed data on drug efficacy.' This statement captures a key methodological consideration: genetic differences in drug metabolism can influence pharmacokinetics and pharmacodynamics, potentially confounding efficacy and safety outcomes. Standardizing or at least stratifying by genotype helps ensure that observed effects are not driven by underlying metabolic diversity.
Option 2: 'Pharmacogenomic variations are irrelevant unless the trial involves genetic therapies.' This is misleading. Pharmacogenomics influences how individuals metabolize and respond to many conventional drugs, not just genetic therapies. Even for a cardiovascular agent, variations in enzymes like CYP450s can alter exposure and response, making this option incorrect.
Option 3: 'Only the dosage of the drug should be adjusted without considering genetic variations.' While dose adjustment is important, ignoring pharmacogenomic variation entirely is incomplete. Some trial designs incorporate genotype-based stratification or adaptive dosing to account for metabolic differences; thus this option is overly simplistic and incorrect.
Option 4: 'Genetic variations should not influence the trial design as they are rarely significant.' This statement undervalues the impact of pharmacogenomics. In cardiovascular drugs, metabolic enzymes can cause substantial interindividual differences in drug levels and effects, so claiming rarity of significance is inaccurate.
Overall, the most accurate interpretation emphasizes accounting for genetic background to prevent confounded results, while the other choices either dismiss a real influence or propose insufficient or incorrect approaches.

PCOL2021 2025 Practice MCQ Section A - 2025

Evaluate the implications of pharmacogenomic variations in metabolizing enzymes when designing a clinical trial for a new cardiovascular drug.

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