Recently, FDA told a medical device start-up company that, in regard to the company’s proposed clinical trial, “The equivalence of the device to the predicate can be demonstrated if the confidence ...

For survival probabilities with censored data, Rothman (1978, Journal of Chronic Diseases 31, 557-560) has recommended the use of quadratic confidence limits based on the assumption that the product ...

Sometimes it’s hard to have confidence in science. So many results from published scientific studies turn out to be wrong. Part of the problem is that science has trouble quantifying just how ...