Key Publications

• Drug regulators and ethics: which GCP issues are also ethical issues?

  Rosemarie DLC Bernabe, Ghislaine JMW van Thiel, Nancy S Breekveldt, Johannes JM van Delden Drug Discov Today, doi: 10.1016/j.drudis.2015.11.006. [Epub ahead of print]

• The fiduciary obligation of the physician-researcher in phase IV trials

  Rosemarie DLC Bernabe, Ghislaine JMW Van Thiel, Jan AM Raaijmakers, Johannes JM Van Delden BMC Medical Ethics, 2014; 15; 11

• Decision theory and the evaluation of risks and benefits of clinical trials

  Bernabe RD, van Thiel GJ, Raaijmakers JA, van Delden JJ. Drug Discov Today, 2012 Jul 20. [Epub ahead of print]

• Is informed consent necessary for randomized Phase IV 'observational' drug studies?

  Bernabe RD, van Thiel GJ, Raaijmakers JA, van Delden JJ. Drug Discov Today, 2011 Sep;16(17-18):751-4. Epub 2011 Jun 29.

Related Links

• Ethical Issues in Postauthorization Drug Trials

• An Investigation on the Aristotelian Foundations of Martha Nussbaum's Capabilities Approach and the Disability Issue Utilizing Nussbaum's Earlier Works on Aristotle