Ultimate fate of oncology drugs approved by the us food and drug administration without a randomized Trial.

@article{Tsimberidou2009UltimateFO,
  title={Ultimate fate of oncology drugs approved by the us food and drug administration without a randomized Trial.},
  author={Apostolia-Maria Tsimberidou and Fadi S. Braiteh and David J. Stewart and Razelle Kurzrock},
  journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology},
  year={2009},
  volume={27 36},
  pages={6243-50}
}
PURPOSE To approve a new anticancer drug, the US Food and Drug Administration often requires randomized trials. However, several oncology drugs have been approved on the basis of objective end points without a randomized trial. We reviewed the long-term safety and efficacy of such agents. METHODS We searched the Web site of the US Food and Drug Administration's Center for Drug Evaluation and Research and MEDLINE for initial applications of investigational anticancer drugs from 1973 through… CONTINUE READING
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