Certified Clinical Research Associate (CCRA) Practice Exam

Which type of studies include examining mortality and morbidity outcomes?

1. Phase I studies

2. Phase II studies

3. Phase III studies

4. Comparative effectiveness studies

The correct answer is: Comparative effectiveness studies

Comparative effectiveness studies involve evaluating and comparing the outcomes of different treatment options, particularly in terms of their effectiveness and safety. These studies often focus on key endpoints such as mortality (death rates) and morbidity (the incidence of disease or health complications). By assessing these outcomes, researchers can determine which interventions provide the best overall health benefits and potentially inform clinical practice and health policy decisions. While Phase I, II, and III studies primarily focus on assessing safety, dosage, efficacy, and side effects in specific populations, they typically do not emphasize outcomes like long-term mortality or morbidity to the same extent as comparative effectiveness studies. In Phase I studies, the main aim is to evaluate safety and tolerability, whereas Phase II studies assess efficacy and side effects but still in smaller populations and not focusing on broader health outcomes. Phase III studies often do begin to evaluate efficacy in a more extensive manner, but their design and objectives are generally more focused on proving an intervention’s efficacy compared to standard or placebo treatments, rather than directly examining mortality and morbidity outcomes as their primary focus.