Non-inferiority trials will be popular with ACA
Analysis of cost savings and quality care
With the dissemination of the Affordable Care Act into the healthcare system, clinical pathways and efficiency in treatment will be mainstays within medicine. Hospitals and institutions will have to find ways to provide quality care in an economically viable fashion both for patients and the "bottom line."
Healthcare professionals are always looking at ways to cut costs. One way that researchers will be able to assist in these endeavors is to promote the use of non-inferiority designs. By providing a cheaper treatment that is JUST AS GOOD as the current "gold standard" treatment, costs can be reduced dramatically as it relates to clinical treatment regimens.
There must be an empirically and clinically validated margin of non-inferiority. Sample sizes will increase as relevant margins decrease. These trials are most relevant when 1) secondary endpoints are better, 2) treatments are cheaper or easier to administer, 3) randomized controlled trials are not feasible or ethical, and 4) when compliance to treatment will be higher in comparison to the "gold standard."*
Better secondary endpoints, cheaper and more patient-friendly treatments, and higher rates of compliance will all be necessary as the Affordable Care Act promulgates into the healthcare marketplace.
Healthcare professionals are always looking at ways to cut costs. One way that researchers will be able to assist in these endeavors is to promote the use of non-inferiority designs. By providing a cheaper treatment that is JUST AS GOOD as the current "gold standard" treatment, costs can be reduced dramatically as it relates to clinical treatment regimens.
There must be an empirically and clinically validated margin of non-inferiority. Sample sizes will increase as relevant margins decrease. These trials are most relevant when 1) secondary endpoints are better, 2) treatments are cheaper or easier to administer, 3) randomized controlled trials are not feasible or ethical, and 4) when compliance to treatment will be higher in comparison to the "gold standard."*
Better secondary endpoints, cheaper and more patient-friendly treatments, and higher rates of compliance will all be necessary as the Affordable Care Act promulgates into the healthcare marketplace.
*Lesaffre, E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2): 150-154.