All Stories

  1. The Elusiveness of the Win Ratio Parameter in the Presence of Missing Data

    Article • Therapeutic Innovation & Regulatory Science, March 2024, Springer Science + Business Media

    Heng Li

  2. The Finkelstein–Schoenfeld Test: A Note on Some Overlooked Issues Concerning Power

    Article • Therapeutic Innovation & Regulatory Science, February 2024, Springer Science + Business Media

    Heng Li

  3. Propensity score‐incorporated adaptive design approaches when incorporating real‐world data

    Article • Pharmaceutical Statistics, November 2023, Wiley

    Heng Li

  4. A Non-parametric Test Based on Local Pairwise Comparisons of Patients for Single and Composite Endpoints

    Article • Statistics in Biosciences, April 2023, Springer Science + Business Media

    Heng Li

  5. Principled leveraging of external data in the evaluation of diagnostic devices via the propensity score‐integrated composite likelihood approach

    Article • Pharmaceutical Statistics, March 2023, Wiley

    Heng Li

  6. Propensity score‐based methods for causal inference and external data leveraging in regulatory settings: From basic ideas to implementation

    Article • Pharmaceutical Statistics, February 2023, Wiley

    Heng Li

  7. Some Thoughts on the Use of Predictive Probability in Clinical Trials

    Article • Therapeutic Innovation & Regulatory Science, January 2023, Springer Science + Business Media

    Heng Li

  8. Clinical Studies Leveraging Real-World Data Using Propensity Score-based Methods

    Article • January 2023, Springer Science + Business Media

    Heng Li

  9. Propensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies

    Article • Journal of Biopharmaceutical Statistics, May 2022, Taylor & Francis

    Heng Li

  10. Estimands in observational studies: Some considerations beyond ICH E9 ( R1 )

    Article • Pharmaceutical Statistics, February 2022, Wiley

    Heng Li

  11. Propensity score-integrated power prior approach for augmenting the control arm of a randomized controlled trial by incorporating multiple external data sources

    Article • Journal of Biopharmaceutical Statistics, November 2021, Taylor & Francis

    Heng Li

  12. Leveraging real‐world evidence for determining performance goals for medical device studies

    Article • Statistics in Medicine, September 2021, Wiley

    Heng Li

  13. Augmenting Both Arms of a Randomized Controlled Trial Using External Data: An Application of the Propensity Score-Integrated Approaches

    Article • Statistics in Biosciences, June 2021, Springer Science + Business Media

    Heng Li

  14. Leverage multiple real-world data sources in single-arm medical device clinical studies

    Article • Journal of Biopharmaceutical Statistics, April 2021, Taylor & Francis

    Heng Li

  15. Evaluation of diagnostic tests for low prevalence diseases: a statistical approach for leveraging real-world data to accelerate the study

    Article • Journal of Biopharmaceutical Statistics, February 2021, Taylor & Francis

    Heng Li

  16. Mitigating Study Power Loss Caused by Clinical Trial Disruptions Due to the COVID-19 Pandemic: Leveraging External Data via Propensity Score-Integrated Approaches

    Article • Statistics in Biopharmaceutical Research, December 2020, Taylor & Francis

    Heng Li

  17. Novel statistical approaches and applications in leveraging real-world data in regulatory clinical studies

    Article • Health Services and Outcomes Research Methodology, September 2020, Springer Science + Business Media

    Heng Li

  18. Use of Weighted Performance Goals in Prospective Single-Arm Clinical Studies Designed to Assess the Safety and Effectiveness of Medical Devices

    Article • Statistics in Biopharmaceutical Research, August 2020, Taylor & Francis

    Heng Li

  19. Propensity score-integrated composite likelihood approach for augmenting the control arm of a randomized controlled trial by incorporating real-world data

    Article • Journal of Biopharmaceutical Statistics, May 2020, Taylor & Francis

    Heng Li

  20. Subgroups in Design and Analysis of Clinical Trials, General Considerations

    Article • January 2020, Springer Science + Business Media

    Heng Li

  21. Propensity score-integrated composite likelihood approach for incorporating real-world evidence in single-arm clinical studies

    Article • Journal of Biopharmaceutical Statistics, November 2019, Taylor & Francis

    Heng Li

  22. Homogeneity assessment for pivotal medical device clinical studies

    Article • Journal of Biopharmaceutical Statistics, September 2019, Taylor & Francis

    Heng Li, Li Ming Dong

  23. Propensity score-integrated power prior approach for incorporating real-world evidence in single-arm clinical studies

    Article • Journal of Biopharmaceutical Statistics, September 2019, Taylor & Francis

    Heng Li

  24. A Note on Good Practice of Objective Propensity Score Design for Premarket Nonrandomized Medical Device Studies with an Example

    Article • Statistics in Biopharmaceutical Research, July 2016, Taylor & Francis

    Heng Li

  25. Medical Devices

    Article • December 2014, Wiley

    Heng Li

  26. Wilcoxon's signed-rank statistic: what null hypothesis and why it matters

    Article • Pharmaceutical Statistics, June 2014, Wiley

    Heng Li

  27. Statistical and Regulatory Issues in Nonrandomized Medical Device Clinical Studies

    Article • Journal of Biopharmaceutical Statistics, December 2007, Taylor & Francis

    Heng Li

  28. The covariance structure and likelihood function for multivariate dyadic data

    Article • Journal of Multivariate Analysis, July 2006, Elsevier

    Heng Li

  29. Medical Devices

    Article • July 2005, Wiley

    Heng Li

  30. A widely applicable extension of the random effects two-way layout: Its definition and statistical analysis based on group invariance

    Article • Psychometrika, March 2004, Springer Science + Business Media

    Heng Li

  31. The Resolution of Some Paradoxes Related to Reliability and Validity

    Article • Journal of Educational and Behavioral Statistics, January 2003, American Educational Research Association (AERA)

    Heng Li

  32. The fundamental theorem of least squares: its relevance to experimental design and Bayesian inference

    Article • January 2003, Institute of Mathematical Statistics

    Heng Li

  33. Modeling through group invariance: an interesting example with potential applications

    Article • August 2002, Institute of Mathematical Statistics

    Heng Li

  34. Likelihood-based quadratic analyses for diallel cross and other experiments involving data collected on ordered pairs of sampling units

    Article • Statistics & Probability Letters, May 2002, Elsevier

    Heng Li

  35. TOWARD A COHERENT VIEW OF RELIABILITY IN TEST THEORY

    Article • ETS Research Report Series, June 1998, Wiley

    Heng Li

  36. Bayesian Inference for Nested Designs Based on Jeffreys's Prior

    Article • The American Statistician, August 1997, JSTOR

    Heng Li

  37. Bayesian Inference for Nested Designs Based on Jeffreys's Prior

    Article • The American Statistician, August 1997, Taylor & Francis

    Heng Li

  38. A unifying expression for the maximal reliability of a linear composite

    Article • Psychometrika, June 1997, Springer Science + Business Media

    Heng Li

  39. Toward a Coherent View of Reliability in Test Theory

    Article • Journal of Educational and Behavioral Statistics, January 1997, American Educational Research Association (AERA)

    Heng Li

  40. Teacher's Corner: Toward a Coherent View of Reliability in Test Theory

    Article • Journal of Educational and Behavioral Statistics, January 1997, American Educational Research Association (AERA)

    Heng Li

  41. Reliability of measurement in psychology: From Spearman-Brown to maximal reliability.

    Article • Psychological Methods, January 1996, American Psychological Association (APA)

    Heng Li

  42. Reliability of measurement in psychology: From Spearman-Brown to maximal reliability.

    Article • Psychological Methods, January 1996, American Psychological Association (APA)

    Heng Li