Statistics and Statisticians in European Drug Regulatory Agencies

Abstract

The importance of adequate provision for expert statistical review of license applications by European regulatory agencies has been increased by several developments including moves toward international harmonization. A brief questionnaire on the roles of statisticians and statistical review procedures was sent to the director of the national drug regulatory agency in each of 18 European countries (current and prospective members of the European Union [EU] and other related countries). The topics covered included: 1. The number of statisticians employed by the authority or used as advisers, and the extent of this use, 2. Which license applications are statistically reviewed, how these are selected, and which parts of applications are considered, and 3. The potential impact of the setting up of the European Medicines Evaluation Agency and adoption of the EU Note for Guidance on Biostatistical Methodology in Clinical Trials.

Of the 14 full responders, three (Sweden, German, and the United Kingdom) reported employing professional statisticians to review license applications and/or clinical trial protocols. In most countries only selected license applications are reviewed statistically, selected on statistical complexity by nonstatistical assessors. There are some restrictions on discussion of applications/protocols with statisticians working for the sponsors. As a result of adoption of the EU Biostatistical guidelines, Germany intends to employ more statisticians and the possibility is under consideration in The Netherlands, Greece, and Switzerland. Almost all of the remaining responders report that they do not intend to employ (more) statisticians. Austria, Belgium, Denmark, Ireland, and Finland, however, are proposing to make more use of statistical advisers. International harmonization may be impeded by the evident range of resource provision and procedures within Europe.