The future of statistics and statisticians in European regulatory affairs

Roles of statisticians in drug regulatory agencies include assessment of the adequacy of statistical aspects of the design of the programme of efficacy and safety studies, design of individual studies, data collection and quality assurance in each study, analysis of individual studies, interpretation of individual studies, and interpretation of results of the programme. These assessments should be made in collaboration with medical, pharmacological, and toxicological colleagues, and liaison with company statisticians before, during, and after submission of the application if the procedure is to be efficient. Recommendations for improving statistical quality of drug license applications and provision for their statistical review in Europe include: 1. Employment of more experienced, professional statistical assessors in both national and European Community (EC) regulatory authorities, with a wider group of supporting experts 2. Obligatory statistical coauthorship or validation of expert reports before submission of applications, and 3. Unified statistical guidelines for preparation of applications.