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Should preclinical studies be registered?

Nature Biotechnology volume 30, pages 488–489 (2012)Cite this article

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To the Editor:

In recent years, numerous journals, regulators and ethics guidelines have adopted policies for prospective registration of clinical trials and full reporting of results. Whereas at one time, investigators published controlled clinical trials at their discretion, policies now compel prospective registration and deposition of controlled trial results—including those that are negative and inconclusive—in publicly accessible databases1. In May, an editorial in your journal also supported the full disclosure of trial results in response to a call for more openness from European regulators2. In the following correspondence, we examine whether arguments that justify trial registration also hold for preclinical studies aimed at supporting trials. We argue that the high rate of failure in translating basic research into medical therapies raises concerns about human protections and inefficiencies in the research enterprise; registration and reporting of preclinical studies would partly address these concerns. We close by suggesting that funding agencies and others establish working groups to explore mechanisms for reconciling preclinical registration with the strategic imperatives in drug development.

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References

  1. Laine, C. et al. Ann. Intern. Med. 147, 275–277 (2007).

    Article  Google Scholar 

  2. Anonymous. Nat. Biotechnol. 30, 371 (2012).

  3. Sena, E.S., van der Worp, H.B., Bath, P.M., Howells, D.W. & Macleod, M. PLoS Biol. 8, e1000344 (2010).

    Article  Google Scholar 

  4. Kola, I. & Landis, J. Nat. Rev. Drug Discov. 3, 711–715 (2004).

    Article  CAS  Google Scholar 

  5. Duhem, P.M.M. The Aim and Structure of Physical Theory (Princeton University Press, Princeton, NJ; 1954).

    Book  Google Scholar 

  6. Bath, P.M. et al. Br. J. Pharmacol. 157, 1157–1171 (2009).

    Article  CAS  Google Scholar 

  7. Lorente, J.A. & Marshall, J.C. Shock 24, 107–119 (2005).

    Article  CAS  Google Scholar 

  8. Clarke, J. et al. Regul. Toxicol. Pharmacol. 50, 2–22 (2008).

    Article  CAS  Google Scholar 

  9. Obach, R.S. et al. J. Pharmacol. Exp. Ther. 283, 46–58 (1997).

    CAS  PubMed  Google Scholar 

  10. Ross, J.S. et al. Br. Med. J. 344, d7292 (2012).

    Article  Google Scholar 

  11. Zarin, D.A. et al. J. Am. Med. Assoc. 297, 2112–2120 (2007).

    Article  CAS  Google Scholar 

Download references

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Authors and Affiliations

  1. Department of Social Studies of Medicine, Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada

    Jonathan Kimmelman

  2. Division of Neurology, National Core for Neuroethics, Faculty of Medicine, University of British Columbia, UBC Hospital, Vancouver, British Columbia, Canada

    James A Anderson

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  1. Jonathan Kimmelman
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  2. James A Anderson
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Correspondence to Jonathan Kimmelman.

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The authors declare no competing financial interests.

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Kimmelman, J., Anderson, J. Should preclinical studies be registered?. Nat Biotechnol 30, 488–489 (2012). https://doi.org/10.1038/nbt.2261

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