Where Statisticians can Contribute to Address Future Challenges for Drug Regulatory Agencies: A View from the European Medicines Agency (EMEA)

摘要

Drug regulatory agencies require a high level of biostatistical expertise and experience. In this article we briefly discuss how an evolving environment will bring about new areas in regulatory sciences where statistical input will be required, including the emerging need to review and increasingly conduct meta-analyses; pro-active pharmacovigilance; regulatory outcomes assessment; and novel methodologies of benefit-risk assessment and communication. For a number of regulatory agencies, including those within the European Regulatory Network, this may create a need to broaden their biostatistical skill base, and for closer collaboration between medical biostatisticians, pharmaco-epidemiologists, and other quantitative scientists.