Trouble at the office

Allison, Malorye
September 2008
Nature Biotechnology;Sep2008, Vol. 26 Issue 9, p967
Academic Journal
The article discusses an investigation into the role of surrogate endpoints used in the approval of drugs by the U.S. Food and Drug Administration's (FDA) Office of Oncology Drug Products (OODP). An example is given of cancer treatment drugs, such as Avastis used in the treatment of breast cancer, and another used to treat colon cancer, which were approved based on the survival data of progression-free patients. Progression-free survival data is a surrogate trial endpoint that oncologists are hoping will be used more often. Topics include the slowdown of oncology drug development and its possible causes, comments from several notable oncologists, and an examination of research data by oncologist Charles Bennett at Northwestern University regarding the FDA's approval process.


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