Main Paper

Ethical considerations in industry-sponsored Multiregional clinical trials†‡

  1. Ekopimo Ibia1,*,
  2. Bruce Binkowitz1,
  3. Jean-Louis Saillot1,
  4. Steven Talerico1,
  5. Chin Koerner2,
  6. Irene Ferreira3,
  7. Anupam Agarwal4,
  8. Craig Metz4,
  9. Marianne Maman2

Article first published online: 7 SEP 2010

DOI: 10.1002/pst.458

Issue

Pharmaceutical Statistics

Pharmaceutical Statistics

Special Issue: Special Issue: Multi-Regional Clinical Trials – What Are The Challenges?

Volume 9, Issue 3, pages 230–241, July/September 2010

Additional Information

How to Cite

Ibia, E., Binkowitz, B., Saillot, J.-L., Talerico, S., Koerner, C., Ferreira, I., Agarwal, A., Metz, C. and Maman, M. (2010), Ethical considerations in industry-sponsored Multiregional clinical trials. Pharmaceutical Statistics, 9: 230–241. doi: 10.1002/pst.458

Author Information

  1. 1

    Merck & Co., Inc., Whitehouse Station, NJ, USA

  2. 2

    Novartis Pharmaceutical Corp, Rockville, MD, USA

  3. 3

    Amgen Inc., Cambridge, Cambridgeshire, UK

  4. 4

    GlaxoSmithKline plc, Collegeville, PA, USA

*601 Pennsylvania Avenue, NW, Suite 1200 North Building, Washington, DC 20004, USA 

  1. †

    This article represents the views of the authors, and not necessarily the positions of their respective companies or affiliations.

  2. ‡

    This article is published in Pharmaceutical Statistics as a special issue on Multi-regional Clinical Trials–What are the challenges?, edited by Sue Jane Wang, Office of Biostatistics, Office of Translational Sciences, CDER, U.S. Food and Drug Administration, MD, USA

Publication History

  1. Issue published online: 22 SEP 2010
  2. Article first published online: 7 SEP 2010

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Keywords:

  • ethical principles;
  • Multiregional Clinical Trials;
  • global trials;
  • post-trial benefits;
  • informed consent process;
  • data monitoring

Abstract

During the last several decades, the scientific and ethics communities have addressed important ethical issues in medical research, resulting in the elaboration and adoption of concepts, guidelines, and codes.

Ethical issues in the conduct of Multiregional Clinical Trials have attracted significant attention mainly in the last two decades. With the globalization of clinical research and the rapid expansion to countries with a limited tradition of biomedical research, sponsors must proactively address local ethical issues, the adequacy of oversight as well as the applicability and validity of data, and scientific conclusions drawn from diverse patient populations.

This paper highlights some core ethical principles and milestones in medical research, and, from an industry perspective, it discusses ethical issues that the clinical trial team may face when conducting Multiregional Clinical Trials (MRCT, clinical trials conducted at sites located across multiple geographic regions of the world). This paper further highlights the areas of consensus and controversies and proposes points to consider. Copyright © 2010 John Wiley & Sons, Ltd.

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