Articles
FDA Guidance Focuses On Cancer Trial Endpoints
March 4, 2008
•Article: FDA Guidance Focuses On Cancer Trial Endpoints
Written and compiled by Ted Gastineau, CEO and Co-Founder of Beacon Bioscience
April 1 is usually a day to expect the unexpected. However, on April 1, 2005, the U.S. Food and Drug Administration (FDA) released a draft guidance document on "Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics." The document describes the agency's "current thinking" while providing "recommendations to sponsors on endpoints for cancer clinical trials submitted to the FDA." In the following article, I will explore the impact this guidance is having on the clinical research industry, and the increasingly important role that imaging has in the assessment of cancer tumors.
An evolving view on endpoints
As part of its 'Critical Path Initiative', the FDA has joined the U.S. National Cancer Institute (NCI), the pharmaceutical industry, and academia in a number of activities that will facilitate the use of medical imaging during product development and the development of new imaging agents. These efforts are focused on finding new surrogate markers and validating new endpoints for clinical trials.
•Article: FDA Guidance Focuses On Cancer Trial Endpoints
