Posted by Michael Wonder on 02 Oct 2019
How to ensure that novel analytic methods are fit for decision-making
2 October 2019 - The past decade has seen the increased generation and availability of new data sources such as real-world evidence, as well as patient-level data from completed randomised clinical trials.
While these data provide an opportunity to learn more about a medicine’s benefits and risks, and can complement the main body of evidence coming from randomised clinical trials, they will not necessarily translate into credible evidence for regulators and other decision-makers in the absence of adequate statistical methods to extract, analyse, and interpret them.
In an article published in Clinical Pharmacology & Therapeutics, regulators and academics explain how proper methodological validation can ensure the credibility of these data sources and allow authorities to rely on them to draw reliable scientific conclusions. The article is co-signed by a number of EMA staff members, academics and experts from national regulatory authorities, including EMA’s Executive Director Guido Rasi, its Senior Medical Officer, Hans-Georg Eichler, and the Chair and Vice-Chair of EMA’s human medicines committee (CHMP), Harald Enzmann and Bruno Sepodes.
