Some medications can cause extremely rare adverse effects
that are unlikely to appear in small clinical trials but may have serious
consequences once the drug is used in a larger population.

Based on the typical goals, sample sizes, and durations
of clinical trials, at which stage is it MOST LIKELY that such rare adverse
effects would first be detected?

Question

Some medications can cause extremely rare adverse effects
that are unlikely to appear in small clinical trials but may have serious
consequences once the drug is used in a larger population.

Based on the typical goals, sample sizes, and durations
of clinical trials, at which stage is it MOST LIKELY that such rare adverse
effects would first be detected?

Accepted Answer

Phase IV – post-marketing surveillance after the drug is widely used in the general population

Answer

Phase I – small studies focusing on safety and dosing in healthy volunteers

Answer

Phase III – larger studies designed to assess efficacy and common side effects in patients

Answer

Phase II – moderate-sized studies to evaluate efficacy and preliminary safety

Crowdly

Some medications can cause extremely rare adverse effects that are unlikely to ...

Хочете миттєвий доступ до всіх перевірених відповідей на learning.monash.edu?