Tech. Report No. 2026-01 Berry Consultants · Austin, TX Rev. 3 · 2026

PERSONAL HOMEPAGE

Nicholas S. Berry

Senior Statistical Scientist at Berry Consultants, developing the FACTS trial simulation software.

DISTRIBUTION
UNLIMITED
open access · 2026
AUTHOR
Nicholas S. Berry, PhD
AFFILIATION
Berry Consultants, LLC · Austin, TX
KEYWORDS
trial simulation software; FACTS; Bayesian adaptive design

ABSTRACT · Rev. 3

Biostatistician now working mostly on the software side of Berry Consultants, developing FACTS, our software for designing and simulating adaptive clinical trials. I still design and implement trials as well, especially Bayesian adaptive trials including platform trials. Results from trials I’ve designed appear in NEJM, JAMA, The Lancet, and Clinical Trials, and more.

Nick Berry, current headshot
Fig. 1. Current Nick.

2.0  RESEARCH

2.1  Platform trials in infectious disease

Statistical design and analysis for the PRINCIPLE and PANORAMIC COVID-19 platform trials in the UK, which tested community treatments from azithromycin and inhaled budesonide to molnupiravir and nirmatrelvir–ritonavir. Results appeared in The Lancet and the New England Journal of Medicine.

2.2  Oncology and critical care

Bayesian adaptive designs for GBM AGILE, the global phase 2/3 platform trial in glioblastoma, as well as I-SPY2, the CHIPS cold-stored platelet trial in cardiac surgery, and RESCUE-3 in ventilator weaning.

2.3  Methods and simulation

Modelling time trends in multi-arm platform trials, using early and longitudinal endpoint data to make adaptive decisions sooner, and simulation-guided trial design. Developer of the FACTS clinical trial simulation software.

3.0  SELECTED PUBLICATIONS

  1. [1]Butler CC, …, Berry NS, … Little P. “Oral nirmatrelvir–ritonavir for Covid-19 in higher-risk outpatients.” New England Journal of Medicine 394(16):1583–1594, 2026. doi
  2. [2]Spinella PC, …, Berry NS, … Steiner ME. “Cold and room-temperature platelets in cardiac surgery: the CHIPS randomized clinical trial.” JAMA, 2026. doi
  3. [3]Wen PY, Berry DA, …; GBM AGILE Regorafenib Study Group (incl. Berry NS). “Evaluation of regorafenib in newly diagnosed and recurrent glioblastoma.” Journal of Clinical Oncology 44(18):1676–1686, 2026. doi
  4. [4]Butler CC, …, Berry NS, … Little P. “Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 (PANORAMIC).” The Lancet 401(10373):281–293, 2023. doi
  5. [5]Saville BR, Berry DA, Berry NS, Viele K, Berry SM. “The Bayesian time machine: accounting for temporal drift in multi-arm platform trials.” Clinical Trials 19(5):490–501, 2022. doi
  6. [6]Berry LR, Lorenzi E, Berry NS, Crawford AM, Jacko P, Viele K. “Effects of allocation method and time trends on identification of the best arm in multi-arm trials.” Statistics in Biopharmaceutical Research 16(4):512–525, 2024. doi

6 of 22 peer-reviewed papers shown. Full list in Appendix A — CV.

4.0  INVITED PRESENTATIONS

YEARVENUETITLE
2026ASA Biopharm. Section RISW“Design, Simulate, Refine: Simulation-Guided Clinical Trial Design in the Age of ICH E20”
2026Medtronic Biostatistics Grand Rounds“From Concept to Approval: The Statistical Journey of the INFUSE TLIF Trial”
2025ASA Biopharm. Section RISW“Statistical Efficiency in Adaptive Trials from Incorporating Early Endpoint Data”
2025University of Bath“Getting the Most Out of Patient Data: Improving Efficiency in Adaptive Trials Through Longitudinal Models”
2024Medical University of Vienna“Modelling Time Trends in COVID-19 Platform Trials: An Example from PRINCIPLE”
2023ASA Biopharm. Section RISW“Modelling Time Trends in COVID-19 Platform Trials: An Example from PRINCIPLE”