International Society For Pharmacoeconomics and Outcomes Research Chief Science Officer Dr. Richard Wilke says a core principle of CER is its focus on effectiveness rather efficacy. Through CER, researchers can “measure the degree of beneficial effect under ‘real-world’ clinical settings,” according to Wilke.
Wilke says one of CER’s strong points its ability to add “real-world decision-making value at both the micro level … and at the macro level.”
“The results of well-designed CER studies provide value to decision makers throughout the international community, but are particularly important to those in the United States, where regulatory approval for new-molecule pharmaceutical products is typically based primarily or exclusively on (random clinical trials) using placebo-controlled or non-inferiority study designs,” Wilke writes in ISPOR’s Value and Outcomes Spotlight.
Although CER studies are conducted by non-governmental entities, the federal government often sponsors larger prospective CER studies, which are “limited in number and scope,” according to Wilke, and more expensive.