Recent Selected Peer-Reviewed Publications

Berry Consultants has a thriving research program in Bayesian and adaptive clinical trials with many accomplished scholars on staff. These include a member of the National Academy of Medicine, 4 fellows of the American Statistical Association, 2 fellows of the Society for Clinical Trials, and current or formers editors of JAMA and Bayesian Analysis, as well as many Associate Editors for various journals. Our work is routinely published in high-impact medical journals such as the New England Journal of Medicine, JAMA, and The Lancet, as well as methodological outlets such as Statistics in Medicine and Clinical Trials. Over 90% of Berry Consultants scientists have published in the past year, many producing several highly cited and pioneering works on adaptive, Bayesian, and platform trials. Berry provides uniquely complete knowledge, having a combination of expertise in the theoretical and methodology underpinnings of this work, real-world experience discussing these trials with regulators, practical implementation experience, and the development of software products and packages to support their use. Berry Consultants routinely travel to professional conferences to present their work, and to conduct short courses or other training activities on clinical trial design. A sample of our recent publications is below.


Please feel free to contact the authors of any publication below directly, or for general inquiries on research at Berry Consultants, contact Kert Viele ().

(Click each publication’s hyperlink to be directed to the publication)

1. Khanna S, …, Berry SM, Marion J, …, Feuerstadt P (2022) Efficacy and Safety of RBX2660 in PUNCH CD3, a Phase III, Randomized, Double-Blind, Placebo-Controlled Trial with a Bayesian Primary Analysis for the Prevention of Recurrent Clostridioides difficile Infection. 2022;82(15):1527-38.

2. Berry DA, Dhadda S, Kanekiyo M, Li D, Swanson CJ, Irizarry M, Kramer LD, Berry SM (2023) Lecanemab for Patients With Early Alzheimer Disease: Bayesian Analysis of a Phase 2b Dose-Finding Randomized Clinical Trial. JAMA Netw Open. 2023;6(4):e237230.

3. Quintana M, Saville BR, Vestrucci M, Detry MA, Chibnik L, …, Macklin EA (2023) Design and Statistical Innovations in a Platform Trial for Amyotrophic Lateral Sclerosis. Ann Neurol. 2023 doi: 10.1002/ana.26714. Epub ahead of print. PMID: 37245090.

4. McCreary EK, …, Berry LR, Berry S, Crawford AM, McGlothlin A, …, Kip KE (2022) Association of Subcutaneous or Intravenous Administration of Casirivimab and Imdevimab Monoclonal Antibodies With Clinical Outcomes in Adults With COVID-19. JAMA Netw Open 2022;5(4):e226920.

5. Godolphin PJ, …, Berry LR, …, Lorenzi E, …, Vale CL (2022) Association between tocilizumab, sarilumab and all-cause mortality at 28 days in hospitalised patients with COVID-19: A network meta-analysis. PLoS One. 2022;17(7):e0270668.

6. Bruce P, …, Berry LR, Fitzgerald M, …, Berry S, …, Nichol A (2022) Prophylaxis in healthcare workers during a pandemic: a model for a multi-centre international randomised controlled trial using Bayesian analyses. Trials 2022;23(1):534

7. Goligher EC, …, Jensen TP, …, Berry LR, Lorenzi E, …, Berry S, Angus DC; REMAP-CAP, ATTACC, and ACTIV-4a Investigators (2023) Heterogeneous Treatment Effects of Therapeutic-Dose Heparin in Patients Hospitalized for COVID-19. JAMA 2023;329(13):1066-77.

8. Writing Committee for the REMAP-CAP Investigators (includes Berry LR, Lorenzi E, Detry MA, Fitzgerald M, McGlothlin A, Saunders CT, Lewis RJ, Berry S) (2023) Long-term (180-Day) Outcomes in Critically Ill Patients With COVID-19 in the REMAP-CAP Randomized Clinical Trial. JAMA 2023;329(1):39-51

9. Butler CC, …, Saville BR, Marion J, …, Detry MA, Saunders CT, Fitzgerald M, Berry NS, …, Little P (2023) Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial. Lancet 2023;401(10373):281-93.

10. Malinoski D, Saunders C, …, Niemann CU (2023) Hypothermia or Machine Perfusion in Kidney Donors. N Engl J Med 2023;388(5):418-26

11. Writing Committee for the REMAP-CAP Investigators (includes Berry LR, Lorenzi E, Detry MA, Fitzgerald M, McGlothlin A, Saunders CT, Lewis RJ, Berry S) (2023) Effect of Angiotensin-Converting Enzyme Inhibitor and Angiotensin Receptor Blocker Initiation on Organ Support-Free Days in Patients Hospitalized With COVID-19: A Randomized Clinical Trial. JAMA. 2023;329(14):1183-96.

12. McCreary EK, …, Berry LR, Berry S, Crawford AM, McGlothlin A, …, Huang DT (2022) The comparative effectiveness of COVID-19 monoclonal antibodies: A learning health system randomized clinical trial. Contemp Clin Trials 2022;119:106822.

13. Huang DT, …, Berry LR, Berry S, Crawford AM, McGlothlin A, …, Seymour CW (2022) Effectiveness of Casirivimab-Imdevimab and Sotrovimab During a SARS-CoV-2 Delta Variant Surge: A Cohort Study and Randomized Comparative Effectiveness Trial. JAMA Netw Open 2022;5(7):e2220957.

14. Tong SYC, …, Lewis RJ, …, McGlothlin A, …, Davis JS (2022) Staphylococcus aureus Network Adaptive Platform (SNAP) Study Group. The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe. Clin Infect Dis. 2022;75(11):2027-34.

15. Paulon G, Müller P, Sal y Rosas VG (2022). Bayesian nonparametric bivariate survival regression for current status data. Bayesian Analysis, Advance Publication 1-27;BA1346

16. Broglio K,…,McGlothlin A, Elliott CF,…, Wendelberger B,…, Berry DA (2022) PET-CR as a potential surrogate endpoint in untreated DLBCL: meta-analysis and implications for clinical trial design. Leuk Lymphoma. 2022 Dec;63(12):2816-2831.

17. Staffaroni AM, Quintana M, Wendelberger B,…,Boxer AL (2022) Frontotemporal Dementia Prevention Initiative (FPI) Investigators. Temporal order of clinical and biomarker changes in familial frontotemporal dementia. Nat Med. 2022;28(10):2194-2206.

18. Wang G, …,Wendelberger B,…, Bateman R (2022). Evaluation of dose-dependent treatment effects after mid-trial dose escalation in biomarker, clinical, and cognitive outcomes for gantenerumab or solanezumab in dominantly inherited Alzheimer's disease. Alzheimer's Dement. 2022; 14:e12367.

19. Williamson SF, Jacko P, Jaki T (2022) Generalisations of a Bayesian decision-theoretic randomisation procedure and the impact of delayed responses. Computational Statistics and Data Analysis 174, 107407.

20. Villar SS, Jacko P (2022) Bandit Procedures for Designing Patient-Centric Clinical Trials. In The Elements of Joint Learning and Optimization in Operations Management, 365-389, Springer.

21. Krotka P, Hees K, Jacko P, Magirr D, Posch M, Bofill Roig M (2023): NCC: An R-package for analysis and simulation of platform trials with non-concurrent controls. arXiv preprint arXiv:2302.12634.

22. Meyer EL, Mesenbrink P, Dunger‐Baldauf C, Glimm E, Li Y, König F, & EU‐PEARL (EU Patient‐cEntric clinicAl tRial pLatforms) Consortium (2022). Decision rules for identifying combination therapies in open‐entry, randomized controlled platform trials. Pharml Stat, 21(3), 671-690.

23. Bofill Roig M, König F, Meyer E, Posch M (2022). Commentary: Two approaches to analyze platform trials incorporating non-concurrent controls with a common assumption. Clinical Trials, 19(5), 502-503.

24. Meyer EL, Mesenbrink P, DiProspero NA, Pericàs JM, Glimm E, Ratziu V (2023) Designing an exploratory phase 2b platform trial in NASH with correlated, co-primary binary endpoints. Plos one, 18(3), e0281674

25. Saville BR, Berry DA, Berry NS, Viele K, Berry SM (2022) The Bayesian Time Machine: Accounting for temporal drift in multi-arm platform trials. Clinical Trials 2022;19(5):490-501.

26. Roig MB, Krotka P, Burman CF, Glimm E, Gold SM, Hees K, Jacko P, Koenig F, Magirr D, Mesenbrink P, Viele K, Posch M (2022). On model-based time trend adjustments in platform trials with non-concurrent controls. BMC Med Res Methodol 22, 228 (2022).

27. Zantek ND, Steiner ME, VanBuren JM, Lewis RJ, Berry NS, Viele K, Krachey E, Dean JM, Nelson S, Spinella PC (2023). Design and logistical considerations for the randomized adaptive non-inferiority storage-duration-ranging CHIlled Platelet Study. Clin Trials 2023;20(1):36-46.

28. Saville BR, Detry MA, Viele K (2023) Conditional Power: How Likely Is Trial Success? JAMA 2023;329(6):508-9.

29. Berry SM, Viele K (2023) Response Adaptive Randomization in Practice. Comment on Robertson et al. Statistical Science 2023;38(2);229-33.

30. Viele K (2023) Allocation in Platform Trials to Maintain Comparability Across Time and Eligibility. Statistics in Medicine 2023;42(16);2811-18.

31. Lewis RJ, Viele K (2023) Revisiting the Analogy Between Clinical Trials and Diagnostic Tests by Interpreting a Negative Trial as a Negative Test for Efficacy. JAMA 2023;329(23):2023-25.