Correspondence | Published:

Challenges stemming from NIH’s extended registration and reporting requirements

Nature Human Behaviourvolume 2page97 (2018) | Download Citation

Access optionsAccess options

Rent or Buy article

Get time limited or full article access on ReadCube.

from$8.99

All prices are NET prices.

References

  1. 1.

    Riley, W. T., Riddle, M. & Lauer, M. Nat. Hum. Behav. https://doi.org/10.1038/s41562-017-0265-4 (2017).

  2. 2.

    Notice of revised NIH definition of “clinical trial” (NIH, 23 October 2014); https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html

  3. 3.

    National Institutes of Health NIH policy on dissemination of NIH-funded clinical trial information. Fed. Reg. 81, 64922–64928 (2016).

  4. 4.

    Dickersin, K. Control. Clin. Trials 13, 170–177 (1992).

  5. 5.

    Food and Drug Administration Amendments Act (FDAAA). 42 USC § 8012007 (2007).

  6. 6.

    Mayo-Wilson, E. et al. J. Clin. Epidemiol. 91, 95–110 (2017).

  7. 7.

    Mayo-Wilson, E. et al. J. Clin. Epidemiol. 86, 39–50 (2017).

  8. 8.

    Zarin, D. A., Tse, T., Williams, R. J., Califf, R. M. & Ide, N. C. N. Engl. J. Med. 364, 852–860 (2011).

  9. 9.

    Cybulski, L., Mayo-Wilson, E. & Grant, S. J. Consult. Clin. Psychol. 84, 753–767 (2016).

Download references

Author information

Affiliations

  1. Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA

    • Evan Mayo-Wilson
    •  & Kay Dickersin

Authors

  1. Search for Evan Mayo-Wilson in:

  2. Search for Kay Dickersin in:

Competing interests

Up to 2008, K.D. served as an unpaid expert witness for the plaintiffs’ lawyers (Greene LLP) in litigation against Pfizer related to reporting of gabapentin trials. Thomas Greene has donated funding to Johns Hopkins University for scholarship related to reporting clinical trials. E.M.-W. and K.D. conduct research about reporting clinical trials, and they have received funding for their research from multiple funders including the National Institutes of Health and the US Food and Drug Administration.

Corresponding author

Correspondence to Evan Mayo-Wilson.

About this article

Publication history

Published

Issue Date

DOI

https://doi.org/10.1038/s41562-017-0286-z

Further reading

Newsletter Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing