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February 21, 2019

Evaluating New Rules on Transparency in Cancer Research and Drug Development

Author Affiliations
  • 1Harvard Medical School, Boston, Massachusetts
  • 2University of Zürich and University Hospital Zürich, Zürich, Switzerland
  • 3Washington University School of Law, St Louis, Missouri
JAMA Oncol. 2019;5(4):461-462. doi:10.1001/jamaoncol.2018.7093

Transparency in the development of new medicines has the potential to improve the efficiency and quality of clinical research by allowing investigators and companies to learn from successes and failures of similar products. It also reflects the ethical responsibility of regulators and sponsors to inform patients and involve them in the translation of research into clinical care. Recent regulatory changes issued in the United States, Europe, and Canada have substantially expanded transparency into the drug development enterprise (Table). Herein, we examine differences in these new transparency policies and assess how these policies could benefit cancer research and drug development.

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