| Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine FP Polack, SJ Thomas, N Kitchin, J Absalon, A Gurtman, S Lockhart, ... New England journal of medicine 383 (27), 2603-2615, 2020 | 15456 | 2020 |
| Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine through 6 months SJ Thomas, ED Moreira Jr, N Kitchin, J Absalon, A Gurtman, S Lockhart, ... New England Journal of Medicine 385 (19), 1761-1773, 2021 | 1457 | 2021 |
| Use of historical control data for assessing treatment effects in clinical trials K Viele, S Berry, B Neuenschwander, B Amzal, F Chen, N Enas, B Hobbs, ... Pharmaceutical statistics 13 (1), 41-54, 2014 | 492 | 2014 |
| Robust meta-analytic-predictive priors in clinical trials with historical control information H Schmidli, S Gsteiger, S Roychoudhury, A O'Hagan, D Spiegelhalter, ... Biometrics 70 (4), 1023-1032, 2014 | 426 | 2014 |
| Robust exchangeability designs for early phase clinical trials with multiple strata B Neuenschwander, S Wandel, S Roychoudhury, S Bailey Pharmaceutical statistics 15 (2), 123-134, 2016 | 165 | 2016 |
| Six Month safety and efficacy of the BNT162b2 Mrna Covid-19 vaccine SJ Thomas, ED Moreira Jr, N Kitchin, J Absalon, A Gurtman, S Lockhart, ... MedRxiv, 2021.07. 28.21261159, 2021 | 138 | 2021 |
| Alternative analysis methods for time to event endpoints under nonproportional hazards: a comparative analysis RS Lin, J Lin, S Roychoudhury, KM Anderson, T Hu, B Huang, LF Leon, ... Statistics in Biopharmaceutical Research 12 (2), 187-198, 2020 | 96 | 2020 |
| Robust design and analysis of clinical trials with nonproportional hazards: a straw man guidance from a cross-pharma working group S Roychoudhury, KM Anderson, J Ye, P Mukhopadhyay Statistics in Biopharmaceutical Research 15 (2), 280-294, 2023 | 62 | 2023 |
| On the use of co-data in clinical trials B Neuenschwander, S Roychoudhury, H Schmidli Statistics in Biopharmaceutical Research 8 (3), 345-354, 2016 | 62 | 2016 |
| Principal stratum strategy: potential role in drug development B Bornkamp, K Rufibach, J Lin, Y Liu, DV Mehrotra, S Roychoudhury, ... Pharmaceutical Statistics 20 (4), 737-751, 2021 | 59 | 2021 |
| Natural history and real‐world data in rare diseases: applications, limitations, and future perspectives J Liu, JS Barrett, ET Leonardi, L Lee, S Roychoudhury, Y Chen, P Trifillis The Journal of Clinical Pharmacology 62, S38-S55, 2022 | 51 | 2022 |
| Bayesian industry approach to phase I combination trials in oncology B Neuenschwander, A Matano, Z Tang, S Roychoudhury, S Wandel, ... Statistical methods in drug combination studies 2015, 95-135, 2015 | 51 | 2015 |
| Türeci ü, Nell H, Schaefer A, Ãnal S, Tresnan DB, Mather S, Dormitzer PR, Åahin U, Jansen KU, Gruber WC FP Polack, SJ Thomas, N Kitchin, J Absalon, A Gurtman, S Lockhart, ... N Engl J Med 383 (27), 2603, 2020 | 49 | 2020 |
| C4591001 Clinical Trial Group FP Polack, SJ Thomas, N Kitchin, J Absalon, A Gurtman, S Lockhart, ... Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine 2603, //doi, 2020 | 42 | 2020 |
| Basket designs: statistical considerations for oncology trials AM Kaizer, JS Koopmeiners, MJ Kane, S Roychoudhury, DS Hong, ... JCO Precision Oncology 3, 1-9, 2019 | 34 | 2019 |
| Bayesian leveraging of historical control data for a clinical trial with time‐to‐event endpoint S Roychoudhury, B Neuenschwander Statistics in medicine 39 (7), 984-995, 2020 | 30 | 2020 |
| Perspectives on virtual (remote) clinical trials as the “new normal” to accelerate drug development D Alemayehu, R Hemmings, K Natarajan, S Roychoudhury Clinical Pharmacology & Therapeutics 111 (2), 373-381, 2022 | 29 | 2022 |
| Log-rank test vs MaxCombo and difference in restricted mean survival time tests for comparing survival under nonproportional hazards in immuno-oncology trials: a systematic … P Mukhopadhyay, J Ye, KM Anderson, S Roychoudhury, EH Rubin, ... JAMA oncology 8 (9), 1294-1300, 2022 | 26 | 2022 |
| Application of Bayesian methods to accelerate rare disease drug development: scopes and hurdles KM Kidwell, S Roychoudhury, B Wendelberger, J Scott, T Moroz, S Yin, ... Orphanet Journal of Rare Diseases 17 (1), 186, 2022 | 23 | 2022 |
| Beyond p-values: A phase II dual-criterion design with statistical significance and clinical relevance S Roychoudhury, N Scheuer, B Neuenschwander Clinical Trials 15 (5), 452-461, 2018 | 23 | 2018 |
