Key Current Statistical Issues in Drug Development and Review: an Industry Perspective
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*José Pinheiro, Johnson & Johnson PRD 

Keywords: statistical designs, novel methods, guidance documents

The challenging environment facing the pharmaceutical industry, with increasing development costs and a tougher regulatory environment, has led to great interest in statistical designs and methods to increase the efficiency and success rate of drug development. This talk will present an overview of current statistical issues in drug development, including an industry perspective on recent FDA draft guidance documents. Methodological interactions between regulatory and industry statisticians have always played an important role in advancing statistical and regulatory sciences, but were recently challenged by the discontinuation of PhRMA’s technical groups (TG), an accepted communication channel between FDA and industry. A new quantitative sciences industry representative group that emerged to fill the gap left by PhRMA’s TG will be presented and its activities discussed.