Publications of the group

Published

December 1, 2024

Here we list the publications that the group has written or contributed to:

2024

  • H. Lynggaard, S. McKendrick, M. Baird, E. Kerwash, V. Lanius, F. Lasch, D. Wright. Applying the estimand framework to clinical pharmacology trials with a case study in bioequivalence. Br J Clin Pharmacol (2024) https://doi.org/10.1111/bcp.16347
  • T. Mütze, J. Bell, S. Englert, P. Hougaard, D. Jackson, V. Lanius, H. Ravn. Principles for Defining Estimands in Clinical Trials — A Proposal. Pharmaceutical Statistics (2024) https://doi.org/10.1002/pst.2432
  • H. Lynggaard, O. Keene, T. Mütze and S. Rehal. Applying the Estimand Framework to Non-Inferiority Trials. Pharmaceutical Statistics (2024) https://doi.org/10.1002/pst.2433
  • B. C. Kahan, J. Hindley, M. Edwards, S. Cro, T. P. Morris. The estimands framework: a primer on the ICH E9(R1) addendum. BMJ. 384:e076316 (2024) https://doi.org/10.1136/bmj-2023-076316

2023

  • O. N. Keene. Adherence, per‐protocol effects, and the estimands framework. Pharmaceutical Statistics. 22(6):1141-4 (2023). https://doi.org/10.1002/pst.2326
  • O. N. Keene, H. Lynggaard , S. Englert, V. Lanius, D. Wright. Why Estimands are Needed to Define Treatment Effects in Clinical Trials. BMC Medicine. 21:276 (2023) https://doi.org/10.1186/s12916-023-02969-6
  • B. C. Kahan, I. R. White, M. Edwards, M. O. Harhay. Using modified intention-to-treat as a principal stratum estimator for failure to initiate treatment. Clinical Trials 20(3):269-275 (2023) https://doi.org/10.1177/17407745231160074

2022

  • A. Morga, NR. Latimer, M. Scott, N. Hawkins, M. Schlichting, J. Wang. Is Intention to Treat Still the Gold Standard or Should Health Technology Assessment Agencies Embrace a Broader Estimands Framework?: Insights and Perspectives From NICE and IQWiG on the ICH E9(R1) Addendum. Value Health. 2022 Sep 20:S1098-3015(22)02148-9. https://doi.org/10.1016/j.jval.2022.08.008
  • H. Lynggaard, J. Bell, C. Lösch, A. Besseghir, K. Rantell, V. Schoder, V. Lanius. Principles and Recommendations for Incorporating Estimands into Clinical Study Protocol Templates. Trials (2022) https://doi.org/10.1186/s13063-022-06515-2
  • C. Fletcher, N. Hefting, M. Wright, J. Bell, J. Anzures-Cabrera, D Wright, H. Lynggaard, A. Schueler. Marking 2-years of new thinking in clinical trials - the estimand journey. Ther Innov Regul Sci 56, 637–650 (2022). https://doi.org/10.1007/s43441-022-00402-3

2021

  • O. N. Keene, D. Wright, A. Phillips, M. Wright. Why ITT analysis is not always the answer for estimating treatment effects in clinical trials. Contemporary Clinical Trials. (2021) https://doi.org/10.1016/j.cct.2021.106494