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The need for reporting guidelines for early phase dose-finding trials: Dose-Finding CONSORT Extension

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Acknowledgements

This work is funded by a Medical Research Council and National Institute for Health Research (MRC–NIHR) Methodology Research Programme grant: ‘Early Phase Dose-finding Trials: Development of reporting guidance to improve knowledge transfer’ (grant no. MR/T044934/1). C.J.W. was supported in this work by NHS Lothian via Edinburgh Clinical Trials Unit. S.L. was funded through the National Center for Advancing Translational Sciences, National Institutes of Health (grant no. UL1TR001873). T.J. received funding from UK MRC (MC UU 00002/14). This reporting guideline under development is registered on the Enhancing Quality and Transparency of Health Research (EQUATOR) Network database. All the named authors are part of the Dose-Finding CONSORT Extension Executive Committee.

The authors acknowledge the support of E. Garrett-Mayer, D. Ashby, and J. Isaacs, members of the Independent Expert Panel in contributing their expertise and support to this initiative. The authors also thank the late D. Altman for his enthusiasm, inspiration and significant contribution to the initial conception of this work.

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Authors and Affiliations

  1. Clinical Trials and Statistics Unit, Institute of Cancer Research, Sutton, UK

    Christina Yap, Johann de Bono, Aude Espinasse & Olga Solovyeva

  2. Roche, Welwyn Garden City, UK

    Alun Bedding

  3. School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK

    Munyaradzi Dimairo

  4. University of Glasgow, Glasgow, UK

    Jeffry Evans

  5. University of Oxford, Oxford, UK

    Sally Hopewell

  6. Lancaster University, Lancaster, UK

    Thomas Jaki

  7. University of Cambridge, Cambridge, UK

    Thomas Jaki

  8. Patient and Public involvement partner, Lichfield, Staffordshire, UK

    Andrew Kightley

  9. Columbia University, New York, NY, USA

    Shing Lee

  10. Bristol Meyers Squibb, Berkeley Heights, New Jersey, USA

    Rong Liu

  11. Centre for Trials Research, Cardiff University, Cardiff, UK

    Adrian Mander

  12. Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK

    Christopher J. Weir

Authors
  1. Christina Yap
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  2. Alun Bedding
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  3. Johann de Bono
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  4. Munyaradzi Dimairo
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  5. Aude Espinasse
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  6. Jeffry Evans
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  7. Sally Hopewell
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  8. Thomas Jaki
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  9. Andrew Kightley
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  10. Shing Lee
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  11. Rong Liu
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  12. Adrian Mander
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  13. Olga Solovyeva
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  14. Christopher J. Weir
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Contributions

C.Y., J.d.B., M.D., J.E., S.H., T.J., A.K., S.L., A.M. and C.J.W. were responsible for conception and funding; A.E. and C.Y. drafted the manuscript; all authors critically revised the manuscript for important intellectual content and approved the final version.

Corresponding author

Correspondence to Christina Yap.

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The authors declare no competing interests.

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Yap, C., Bedding, A., de Bono, J. et al. The need for reporting guidelines for early phase dose-finding trials: Dose-Finding CONSORT Extension. Nat Med 28, 6–7 (2022). https://doi.org/10.1038/s41591-021-01594-1

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