The risks of methodology aversion in drug regulation.
Decisions made by drug regulatory agencies require a high level of expertise in statistical methodologies. Without urgent efforts to enhance the level of such expertise in European regulatory agencies, there is a risk that they will not be able to meet emerging challenges such as quantitative modelling of benefit–risk profiles, wider use of innovative trial designs and greater public transparency of clinical trial data.
Center for Medical Statistics, Informatics, and Intelligent Systems, Section for Medical Statistics, Medical University of Vienna, Spitalgasse 23, 1090 Vienna, Austria.
Peter
P
Bauer
Center for Medical Statistics, Informatics, and Intelligent Systems, Section for Medical Statistics, Medical University of Vienna, Spitalgasse 23, 1090 Vienna, Austria.
Franz
F
König
D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D017277:Drug Approval / Q000379:methods* / Q000706:statistics & numerical data; D004335:Drug and Narcotic Control / Q000379:methods* / Q000706:statistics & numerical data; D005060:Europe; D006801:Humans; D015233:Models, Statistical