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Welcoming new guidelines for AI clinical research

Nature Medicine volume 26, pages 1318–1320 (2020)Cite this article

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With only a limited number of clinical trials of artificial intelligence in medicine thus far, the first guidelines for protocols and reporting arrive at an opportune time. Better protocol design, along with consistent and complete data presentation, will greatly facilitate interpretation and validation of these trials, and will help the field to move forward.

Randomized clinical trials became commonplace in the early 1980s to provide the basis of evidence for medical practice, but it was not until nearly two decades later that the Consolidated Standards of Reporting Trials (CONSORT) were developed in 1996 (ref. 1). In contrast, the use of AI in medicine, and specifically the use of deep neural networks, is still in the early stages — clinical trials using AI have been initiated only in the past two years. Two new companion pieces in this issue of Nature Medicine are devoted specifically to clinical-trial guidelines for protocols (SPIRIT-AI Extension) and publication (CONSORT-AI extension)2,3.

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References

  1. Moher, D. et al. Br. Med. J. 340, c869 (2010).

    Article  Google Scholar 

  2. Liu, X. et al. Nat. Med. https://doi.org/10.1038/s41591-020-1034-x (2020).

  3. Rivera, S. C. et al. Nat. Med. https://doi.org/10.1038/s41591-020-1037-7 (2020).

  4. Liu, X. et al. Lancet Digit. Health 1, e271–e297 (2019).

    Article  PubMed  Google Scholar 

  5. Nagendran, M. et al. Br. Med. J. 368, m689 (2020).

    Article  Google Scholar 

  6. Esteva, A. et al. Nature 542, 115–118 (2017).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  7. Keane, P. & Topol, E. NPJ Digit. Med. 1, 40 (2018).

    Article  PubMed  PubMed Central  Google Scholar 

  8. Topol, E. J. Nat. Med. 25, 44–56 (2019).

    Article  CAS  PubMed  Google Scholar 

  9. Perez, M. V. et al. N. Engl. J. Med. 381, 1909–1917 (2019).

    Article  PubMed  PubMed Central  Google Scholar 

  10. Abràmoff, M. D., Lavin, P. T. & Birch, M. et al. NPJ Digit. Med. 1, 39 (2018).

    Article  PubMed  PubMed Central  Google Scholar 

  11. Gulshan, V. et al. JAMA Ophthalmol. 137, 987–993 (2019).

    Article  PubMed Central  PubMed  Google Scholar 

  12. Kanagasingam, Y. et al. JAMA Netw. Open. 1, e182665 (2018).

    Article  PubMed  PubMed Central  Google Scholar 

  13. Long, E., Lin, H. & Liu, Z. et al. Nat. Biomed. Eng. 1, 0024 (2017).

    Article  Google Scholar 

  14. Steiner, D. F. et al. Am. J. Surg. Pathol. 42, 1636–1646 (2018).

    Article  PubMed  PubMed Central  Google Scholar 

  15. Lee, H. et al. Nat. Biomed. Eng. 3, 173–182 (2019).

    Article  PubMed  Google Scholar 

  16. Mori, Y. et al. Ann. Intern. Med. 169, 357–366 (2018).

    Article  PubMed  Google Scholar 

  17. Li, C. et al. Cancer Commun. 38, 59 (2018).

    Article  Google Scholar 

  18. Dascalu, A. & David, E. O. EBioMedicine 43, 107–113 (2019).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  19. Phillips, M. et al. JAMA Netw. Open 2, e1913436 (2019).

    Article  PubMed  PubMed Central  Google Scholar 

  20. Hollon, T. C. et al. Nat. Med. 26, 52–58 (2020).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  21. Wang, Pu. et al. Lancet Gastroenterol. Hepatol. 5, 343–351 (2020).

    Article  PubMed  Google Scholar 

  22. Gong, Dexin et al. Lancet Gastroenterol. Hepatol. 5, 352–361 (2020).

    Article  PubMed  Google Scholar 

  23. Su, J.-R. et al. Gastrointest. Endosc. 91, 415–424.e4 (2020).

    Article  PubMed  Google Scholar 

  24. Wu, L. et al. Gut 68, 2161–2169 (2019).

    Article  PubMed  Google Scholar 

  25. Wang, P. et al. Gut 68, 1813–1819 (2019).

    Article  PubMed  Google Scholar 

  26. Lin, H. et al. EClinicalMedicine 9, 5–59 (2019).

    Article  Google Scholar 

  27. Wijnberge, M. et al. J. Am. Med. Assoc. 323, 1052–1060 (2020).

    Article  Google Scholar 

Download references

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  1. Scripps Research Translational Institute, Scripps Research, La Jolla, CA, USA

    Eric J. Topol

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Topol, E.J. Welcoming new guidelines for AI clinical research. Nat Med 26, 1318–1320 (2020). https://doi.org/10.1038/s41591-020-1042-x

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