Regulatory approval of cancer risk-reducing (chemopreventive) drugs: moving what we have learned into the clinic.

ABSTRACT: This article endeavors to clarify the current requirements and status of regulatory approval for chemoprevention (risk reduction) drugs and discusses possible improvements to the regulatory pathway for chemoprevention. Covering a wide range of topics in as much depth as space allows, this report is written in a style to facilitate the understanding of nonscientists and to serve as a framework for informing the directions of experts engaged more deeply with this issue. Key topics we cover here are as follows: a history of definitive cancer chemoprevention trials and their influence on the evolution of regulatory assessments; a brief review of the long-standing success of pharmacologic risk reduction of cardiovascular diseases and its relevance to approval for cancer risk reduction drugs; th

SUBMITTER: Meyskens FL 

PROVIDER: S-EPMC3059243 | biostudies-literature | 2011 Mar

REPOSITORIES: biostudies-literature