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original article |
Date |
Title |
Authors All Authors |
1 |
[GO] |
2023―May―10 |
Vaccine development during a pandemic: General lessons for clinical trial design |
Benjamin Hofner, Elina Asikanius, Wolfgang Jacquet, Theodor Framke, Katrien Oude Rengerink, Lukas Aguirre Dávila, et al. (+8) Maria Grünewald, Florian Klinglmüller, Martin Posch, Finbarr P. Leacy, Thomas Lang, Armin Koch, Jörg Zinserling, Kit Roes |
2 |
[GO] |
2023―Feb―07 |
Rejoinder: Estimands and their Estimators for Clinical Trials Impacted by the COVID-19 Pandemic: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions |
Kelly Van Lancker, Sergey Tarima, Jonathan Bartlett, Madeline Bauer, Bharani Bharani-Dharan, Frank Bretz, et al. (+5) Nancy Flournoy, Hege Michiels, Camila Olarte Parra, James L Rosenberger, Suzie Cro |
3 |
[GO] |
2023―Feb―07 |
Comment on “Estimands and Their Estimators for Clinical Trials Impacted by the COVID-19 Pandemic: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions” |
Mouna Akacha, Tianmeng Lyu |
4 |
[GO] |
2023―Feb―07 |
Comment on” Estimands and their Estimators for Clinical Trials Impacted by the COVID-19 Pandemic: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions” |
Stijn Vansteelandt |
5 |
[GO] |
2022―Jul―25 |
Cancer Clinical Trials Beyond Pandemic: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion |
Rajeshwari Sridhara, Elizabeth Barksdale, Olga Marchenko, Qi Jiang, Yuki Ando, Erick Bloomquist, et al. (+26) Michael Coory, Melissa Crouse, Evgeny Degtyarev, Theodor Framke, Boris Freidlin, David E. Gerber, Thomas Gwise, Filip Josephson, Lorenzo Hess, Paul Kluetz, Daniel Li, Sumithra Mandrekar, Martin Posch, Khadija Rantell, Bohdana Ratitch, Andrew Raven, Kit Roes, Kaspar Rufibach, Sinan B Sarac, Richard Simon, Harpreet Singh, Marc Theoret, Andrew Thomson, Emmanuel Zuber, Yuan Li Shen, Richard Pazdur |
6 |
[GO] |
2022―Jul―05 |
Leveraging Real-World Data in COVID-19 Response |
Freda Cooner, Ran Liao, Junjing Lin, Sophie Barthel, Yodit Seifu, Shiling Ruan |
7 |
[GO] |
2022―Jun―27 |
Estimands and their Estimators for Clinical Trials Impacted by the COVID-19 Pandemic: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions |
Kelly Van Lancker, Sergey Tarima, Jonathan Bartlett, Madeline Bauer, Bharani Bharani-Dharan, Frank Bretz, et al. (+5) Nancy Flournoy, Hege Michiels, Camila Olarte Parra, James L Rosenberger, Suzie Cro |
8 |
[GO] |
2021―Nov―08 |
Statistical Issues and Challenges in Clinical Trials for COVID-19 Treatments, Vaccines, Medical Devices and Diagnostics |
Freda Cooner, Toshimitsu Hamasaki, Frank Bretz, Gene Pennello, Martin Posch |
9 |
[GO] |
2021―Nov―05 |
Predicting the COVID-19 Pandemic Impact on Clinical Trial Recruitment |
Nicky Best, Inna Perevozskaya, Dave Lunn, Graeme Archer, Jack Euesden, Christina Fillmore, et al. (+3) Valeriia Sherina, Doug Thompson, Magdalena Zwierzyna |
10 |
[GO] |
2021―Jun―11 |
Quantifying efficiency gains of innovative designs of two-arm vaccine trials for COVID-19 using an epidemic simulation model |
Rob Johnson, Chris Jackson, Anne Presanis, Sofia S. Villar, Daniela De Angelis |
11 |
[GO] |
2021―Apr―22 |
Statistical Observations on Vaccine Clinical Development for Pandemic Diseases |
Scott Patterson, Bo Fu, Ya Meng, Fabrice Bailleux, Josh Chen |
12 |
[GO] |
2021―Apr―19 |
Planning for the Next Pandemic: Ethics and Innovation Today for Improved Clinical Trials Tomorrow |
Gianna McMillan, Cristiana Mayer, Rui Tang, Yi Liu, Lisa LaVange, Zoran Antonijevic, Robert A. Beckman |
13 |
[GO] |
2021―Mar―18 |
A Phase 3 trial analysis proposal for mitigating the impact of the COVID-19 pandemic |
Eva Hua, Reinhold Janocha, Thomas Severin, Jiawei Wei, Marc Vandemeulebroecke |
14 |
[GO] |
2021―Jan―29 |
Discrete Time Multi-State Model with Regime Switching for Modelling COVID-19 Disease Progression and Clinical Outcomes |
Sujatro Chakladar, Ran Liao, Will Landau, Margaret Gamalo, Yanping Wang |
15 |
[GO] |
2020―Dec―17 |
Statistical Opportunities to Accelerate Development for COVID-19 Therapeutics |
Fanni Natanegara, Névine Zariffa, Joan Buenconsejo, Ran Liao, Freda Cooner, Divya Lakshminarayanan, et al. (+3) Samiran Ghosh, Jerald S. Schindler, Margaret Gamalo |
16 |
[GO] |
2020―Dec―14 |
Mitigating Study Power Loss Caused by Clinical Trial Disruptions Due to the COVID-19 Pandemic: Leveraging External Data via Propensity Score-Integrated Approaches |
Heng Li, Wei-Chen Chen, Nelson Lu, Changhong Song, Chenguang Wang, Ram Tiwari, et al. (+2) Yunling Xu, Lilly Q. Yue |
17 |
[GO] |
2020―Nov―05 |
The Role of FDA CDER Statisticians in Response Efforts to the COVID-19 Pandemic |
Sylva H. Collins, Dionne Price, Laura Lee Johnson |
18 |
[GO] |
2020―Oct―28 |
Statistical Challenges in the Conduct and Management of Ongoing Clinical Trials During the COVID-19 Pandemic |
Toshimitsu Hamasaki, Frank Bretz, Freda Cooner, Lisa M. LaVange, Martin Posch |
19 |
[GO] |
2020―Aug―20 |
Assessing via Simulation the Operating Characteristics of the WHO Scale for COVID-19 Endpoints |
Michael O’Kelly, Siying Li |
20 |
[GO] |
2020―Aug―05 |
Clinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-19 |
Mary Nilsson, Brenda Crowe, Greg Anglin, Greg Ball, Melvin Munsaka, Seta Shahin, Wei Wang |
21 |
[GO] |
2020―Jul―23 |
Embedding a COVID-19 group sequential clinical trial within an ongoing trial: lessons from an unusual experience |
Pierre-François Dequin, Amélie Le Gouge, Elsa Tavernier, Bruno Giraudeau, Sarah Zohar |
22 |
[GO] |
2020―Jul―22 |
Clinical trials impacted by the COVID-19 pandemic: Adaptive designs to the rescue? |
Cornelia Ursula Kunz, Silke Jörgens, Frank Bretz, Nigel Stallard, Kelly Van Lancker, Dong Xi, et al. (+3) Sarah Zohar, Christoph Gerlinger, Tim Friede |
23 |
[GO] |
2020―Jul―20 |
Machine learning for clinical trials in the era of COVID-19 |
William R. Zame, Ioana Bica, Cong Shen, Alicia Curth, Hyun-Suk Lee, Stuart Bailey, et al. (+4) James Weatherall, David Wright, Frank Bretz, Mihaela van der Schaar |
24 |
[GO] |
2020―Jul―20 |
Operational Experiences in China and Statistical Issues on the Conduct of Clinical Trials During the COVID-19 Pandemic |
Tong Guo, Chian Chen, Chieh Chiang, Chi-Tian Chen, Chin-Fu Hsiao |
25 |
[GO] |
2020―Jul―02 |
Efficient adaptive designs for clinical trials of interventions for COVID-19 |
Nigel Stallard, Lisa Hampson, Norbert Benda, Werner Brannath, Thomas Burnett, Tim Friede, et al. (+11) Peter K. Kimani, Franz Koenig, Johannes Krisam, Pavel Mozgunov, Martin Posch, James Wason, Gernot Wassmer, John Whitehead, S. Faye Williamson, Sarah Zohar, Thomas Jaki |
26 |
[GO] |
2020―Jul―01 |
The Impact of Major Events on Ongoing Non-inferiority Trials, With Application to COVID-19 |
Brian L. Wiens, Ilya Lipkovich |
27 |
[GO] |
2020―Jul―01 |
Challenges in assessing the impact of the COVID-19 pandemic on the integrity and interpretability of clinical trials |
Mouna Akacha, Janice Branson, Frank Bretz, Bharani Dharan, Paul Gallo, Insa Gathmann, et al. (+4) Robert Hemmings, Julie Jones, Dong Xi, Emmanuel Zuber |
28 |
[GO] |
2020―Jun―25 |
Assessing the Impact of COVID-19 on the Objective and Analysis of Oncology Clinical Trials - Application of the Estimand Framework |
Evgeny Degtyarev, Kaspar Rufibach, Yue Shentu, Godwin Yung, Michelle Casey, Stefan Englert, et al. (+7) Feng Liu, Yi Liu, Oliver Sailer, Jonathan Siegel, Steven Sun, Rui Tang, Jiangxiu Zhou |
29 |
[GO] |
2020―Jun―25 |
Under a black cloud glimpsing a silver lining: Comment on Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic |
Rob Hemmings |
30 |
[GO] |
2020―Jun―08 |
Comment on: Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic |
Sylva H. Collins, Mark S. Levenson |
31 |
[GO] |
2020―Jun―08 |
Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic |
R. Daniel Meyer, Bohdana Ratitch, Marcel Wolbers, Olga Marchenko, Hui Quan, Daniel Li, et al. (+12) Chrissie Fletcher, Xin Li, David Wright, Yue Shentu, Stefan Englert, Wei Shen, Jyotirmoy Dey, Thomas Liu, Ming Zhou, Norman Bohidar, Peng-Liang Zhao, Michael Hale |