Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

Reporting guidelines for clinical trials evaluating artificial intelligence interventions are needed

An Author Correction to this article was published on 12 November 2019

This article has been updated

As artificial intelligence moves into the realm of clinical trials, consideration is needed on whether the current CONSORT and SPIRIT reporting statements are sufficient to ensure transparency.

Access options

Rent or Buy article

Get time limited or full article access on ReadCube.

from$8.99

All prices are NET prices.

Change history

  • 12 November 2019

    An amendment to this paper has been published and can be accessed via a link at the top of the paper.

References

  1. 1.

    US Food and Drug Administration. Artificial Intelligence and Machine Learning in Software as a Medical Device (accessed 18 September 2019). https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device

  2. 2.

    Chalmers, I., Glasziou, P., Heneghan, C., Shepperd, S., Loudon, K. & Bossuyt, P. M. Avoidable waste in the production and reporting of research evidence. Lancet 374, 86–89 (2009).

    Article  Google Scholar 

  3. 3.

    Schulz, K. F., Altman, D. G. & Moher, D., for the CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int. J. Surg. 9, 672–677 (2011).

    Article  Google Scholar 

  4. 4.

    Chan, A. W., Tetzlaff, J. M., Altman, D. G., Dickersin, K. & Moher, D. SPIRIT 2013: new guidance for content of clinical trial protocols. Lancet 381, 91–92 (2013).

    Article  Google Scholar 

  5. 5.

    EQUATOR Network. Reporting guidelines under development (EQUATOR Network, accessed 4 August 2019); http://www.equator-network.org/library/reporting-guidelines-under-development/

  6. 6.

    Collins, G. S. & Moons, K. G. M. Reporting of artificial intelligence prediction models. Lancet 393, 1577–1579 (2019).

    Article  Google Scholar 

Download references

Acknowledgements

This initiative is funded by the Wellcome Trust, Health Data Research UK and the Alan Turing Institute.

Author information

Affiliations

Consortia

Corresponding author

Correspondence to Alastair K. Denniston.

Ethics declarations

Competing interests

The authors declare no competing interests.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

The CONSORT-AI and SPIRIT-AI Steering Group., Liu, X., Rivera, S.C. et al. Reporting guidelines for clinical trials evaluating artificial intelligence interventions are needed. Nat Med 25, 1467–1468 (2019). https://doi.org/10.1038/s41591-019-0603-3

Download citation

Further reading

Search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

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