Posted by Michael Wonder on 27 Apr 2018
IQWiG in dialogue on 15 June 2018: Do the new "estimand" strategies threaten the standards of benefit assessment?
26 April 2018 - Registration now possible/discussion about current method proposals of the EMA.
Recently, scientists, manufacturers and authorities are increasingly discussing " Estimands", especially in the context of drug approval . Under Estimand (German: "the estimator to end") of the to be estimated in a planned study effect is understood as the difference between two drugs with respect to a patient-relevant endpoint under certain conditions to be selected. Among other things, these depend on the population of interest, the handling of occurring intermediate events and the effect measure used.
With the publication of a paper by the European Admission Board (Addendum to the EMAGuideline ICH E9) in August 2017, the topic has gained in importance. The stipulations made in it could not only change clinical trials and admission practice, but also influence the benefit assessment - as critics say, at the expense of the previously high standards.
