Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety

Author:

Pinheiro Simone P.,Rivera Donna R.,Graham David J.,Freedman Andrew N.,Major Jacqueline M.,Penberthy Lynne,Levenson Mark,Bradley Marie C.,Wong Hui-Lee,Ouellet-Hellstrom Rita

Publisher

Elsevier BV

Subject

Epidemiology

Reference24 articles.

1. US Food and Drug Administration. Methodological considerations in evaluation of cancer as an adverse outcome associated with use of non-biological drugs and biological products in the post-approval setting; public meeting. Presentations, transcripts, agenda background Mater available. Available at: http://www.fda.gov/Drugs/NewsEvents/ucm401452.htm. [accessed 20.12.2014].

2. Hallmarks of cancer: the next generation;Hanahan;Cell,2011

3. Colorectal cancer: molecules and populations;Potter;J Natl Cancer Inst,1999

4. Journeys into the genome of cancer cells;Stratton;EMBO Mol Med,2013

5. Aspirin as adjuvant therapy for colorectal cancer—reinterpreting paradigms;Chia;Nat Rev Clin Oncol,2012

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