PVC Benefit-Risk Assessment 2

Question 1

Which framework uses a structured, quantitative approach to express benefit-risk balance as a single numeric value for regulatory decision-making?

Accepted Answer

Multi-Criteria Decision Analysis (MCDA)

Answer

MCDA assigns weights to criteria and aggregates them into a single numeric score, enabling quantitative comparison of benefit-risk profiles.

Question 2

In the BRAT framework, what is the primary purpose of the 'value tree'?

Accepted Answer

To organize and categorize key benefit and risk outcomes

Answer

The BRAT value tree hierarchically organizes key benefit and risk outcomes to ensure systematic and transparent benefit-risk assessment.

Question 3

A drug shows a 40% reduction in cardiovascular events but causes a 2% incidence of severe liver toxicity. Which metric best compares these outcomes on a common scale?

Accepted Answer

Quality-adjusted life year (QALY)

Answer

QALYs incorporate both the quality and duration of life effects, enabling comparison of benefits and harms on a single utility-weighted scale.

Question 4

When a regulatory agency requests a 'benefit-risk communication plan' during a product review, what is its primary goal?

Accepted Answer

To ensure patients and prescribers understand risks and benefits to make informed decisions

Answer

A benefit-risk communication plan is designed to convey the benefit-risk profile clearly to patients and healthcare providers to support informed decision-making.

Question 5

Which ICH guideline specifically addresses the benefit-risk considerations in the context of clinical trial design for medicinal products?

Accepted Answer

ICH E8

Answer

ICH E8 (General Considerations for Clinical Studies) provides guidance on study design principles that incorporate benefit-risk thinking from early development.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Benefit-Risk Assessment 2