Increasing globalization of the pharmaceutical industry has fueled changes in the regulatory environment, including increased data requirements at the various stages of product development, validation, approval, and production. In particular, regulatory agencies around the world are requiring additional data about the long-term safety and efficacy of new products.

In this environment, late-phase studies constitute a rapidly expanding segment of the clinical research environment and regulation of the biopharmaceutical marketplace. NAI President Rita E. Numerof, Ph.D. offers highlights key considerations in structuring late-stage clinical trials in her article, What You Need to Know about Late-Stage Clinical Trials, published in eyeforpharma, September 27, 2012.