Communication about results of comparative effectiveness studies: a pharmaceutical industry view.

This article provides a perspective from the pharmaceutical industry on a hypothetical comparative effectiveness research case, highlighting tension between the reality of conducting comparative effectiveness research and the regulation of biopharmaceutical industry communication. Specifically, under current law and regulations, Aesculapion, the hypothetical maker of the fictional migraine headache drug Hemikrane, would have limited ability to communicate findings or to respond to inaccurate "what-if" scenario communications. Principles for communicating drug information could increase decision makers' access to information while making it easier for them to assess the quality and potential biases of different information sources. The article proposes two complementary approaches: formal Food and Drug Administration guidance clarifying how industry can participate meaningfully and proactively in the comparative effectiveness research discourse, possibly based on 1997 legislation governing communication of "health care economic information"; and stakeholder collaboration on development and adoption of voluntary "good communication principles."

The evolution of legislation to regulate pediatric clinical trials: Present and continuing challenges.

Children suffer from many of the same diseases as adults and are often treated with the same agents. However, it was not until 1997 that legislation mandating studies in children was introduced in the United States. A 2000 International Conference on Harmonisation (ICH) Guidance on the Clinical Investigation of Medicinal Products in the Pediatric Population intended to encourage and facilitate timely pediatric clinical trials detailed critical issues in pediatric drug development and ways to ethically study the safety and efficacy of drugs in the unique and vulnerable pediatric population. In 2005, there is draft legislation in Europe. In Japan, pediatric data are not currently required although studies in pediatric populations are encouraged. This chapter describes the history of legislation on the study of drugs in the pediatric population and details present and continuing challenges for the child, parent/guardian, manufacturer and health authority.