FDA’s use of real-world data

The 21st Century Cures Act required the Food and Drug Administration (FDA) establish a program for evaluating the use of real-world data (RWD) to support the approval of new indications for drugs. Real-world data is typically data from either health insurance claims, electronic health records (EHRs), patient registries, or mobile devices. But how has FDA…

What makes a great economist?

From John Maynard Keynes’ Essays in Biography: The study of economics does not seem to require any specialized gifts of an unusually high order. Is it not, intellectually regarded, a very easy subject compared with the higher branches of philosophy and pure science? Yet good, or even competent, economists are the rarest of birds. An…

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Trump vs. Biden: Impact on the deficit How does mental illness impact COVID-19 mortality rates? 11pt font. Physicians on proposed changes to Medicare Physician Fee Schedule. Shakespeare’s greatest villain Half of black adults won’t get a COVID-19 vaccine. Remdesivir final trial findings.

HTA criteria used to evaluate diagnostics

When evaluating a new diagnostic, HTA agencies must assess two separate issues: analytical and clinical validity. Analytical validity basically indicates whether the test works; is it able to accurately predicts the presence or absence of a particular biomarker of interest. Clinical validity is whether the test matters in clinical practice.  It could be the case…