Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice
Ratitch, Bohdana, Bell, James, Mallinckrodt, Craig, Bartlett, Jonathan W., Goel, Niti, Molenberghs, Geert, O’Kelly, Michael, Singh, Pritibha, Lipkovich, Ilya
Published in Therapeutic innovation & regulatory science (01.03.2020)
Published in Therapeutic innovation & regulatory science (01.03.2020)
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Journal Article
Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines
Ratitch, Bohdana, Goel, Niti, Mallinckrodt, Craig, Bell, James, Bartlett, Jonathan W., Molenberghs, Geert, Singh, Pritibha, Lipkovich, Ilya, O’Kelly, Michael
Published in Therapeutic innovation & regulatory science (01.03.2020)
Published in Therapeutic innovation & regulatory science (01.03.2020)
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Journal Article
Considerations for Analyzing and Interpreting Data from Biometric Monitoring Technologies in Clinical Trials
Ratitch, Bohdana, Rodriguez-Chavez, Isaac R., Dabral, Abhishek, Fontanari, Adriano, Vega, Julio, Onorati, Francesco, Vandendriessche, Benjamin, Morton, Stuart, Damestani, Yasaman
Published in Digital biomarkers (01.09.2022)
Published in Digital biomarkers (01.09.2022)
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Journal Article
Causal Inference and Estimands in Clinical Trials
Lipkovich, Ilya, Ratitch, Bohdana, Mallinckrodt, Craig H.
Published in Statistics in biopharmaceutical research (02.01.2020)
Published in Statistics in biopharmaceutical research (02.01.2020)
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Journal Article
Using principal stratification in analysis of clinical trials
Lipkovich, Ilya, Ratitch, Bohdana, Qu, Yongming, Zhang, Xiang, Shan, Mingyang, Mallinckrodt, Craig
Published in Statistics in medicine (30.08.2022)
Published in Statistics in medicine (30.08.2022)
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Journal Article
Correction to “Using principal stratification in analysis of clinical trials”
Lipkovich, Ilya, Ratitch, Bohdana, Qu, Yongming, Zhang, Xiang, Shan, Mingyang, Mallinckrodt, Craig
Published in Statistics in medicine (15.04.2024)
Published in Statistics in medicine (15.04.2024)
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Journal Article
Multiplicity issues in exploratory subgroup analysis
Lipkovich, Ilya, Dmitrienko, Alex, Muysers, Christoph, Ratitch, Bohdana
Published in Journal of biopharmaceutical statistics (01.01.2018)
Published in Journal of biopharmaceutical statistics (01.01.2018)
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Journal Article
Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic
Meyer, R. Daniel, Ratitch, Bohdana, Wolbers, Marcel, Marchenko, Olga, Quan, Hui, Li, Daniel, Fletcher, Christine, Li, Xin, Wright, David, Shentu, Yue, Englert, Stefan, Shen, Wei, Dey, Jyotirmoy, Liu, Thomas, Zhou, Ming, Bohidar, Norman, Zhao, Peng-Liang, Hale, Michael
Published in Statistics in biopharmaceutical research (01.10.2020)
Published in Statistics in biopharmaceutical research (01.10.2020)
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Journal Article
Clinical and Statistical Perspectives on the ICH E9(R1) Estimand Framework Implementation
Ionan, Alexei C., Paterniti, Miya, Mehrotra, Devan V., Scott, John, Ratitch, Bohdana, Collins, Sylva, Gomatam, Shanti, Nie, Lei, Rufibach, Kaspar, Bretz, Frank
Published in Statistics in biopharmaceutical research (03.07.2023)
Published in Statistics in biopharmaceutical research (03.07.2023)
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Journal Article
Subgroup Identification in Clinical Trials by Stochastic SIDEScreen Methods
Lipkovich, Ilya, Dmitrienko, Alex, Patra, Kaushik, Ratitch, Bohdana, Pulkstenis, Erik
Published in Statistics in biopharmaceutical research (02.10.2017)
Published in Statistics in biopharmaceutical research (02.10.2017)
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Journal Article
Impact of enzalutamide (ENZA) vs. bicalutamide (BIC) on health-related quality of life (HRQoL) of patients (pts) with castration-resistant prostate cancer (CRPC): STRIVE study
Concepcion, Raoul, Armstrong, Andrew J., Karsh, Lawrence Ivan, Holmstrom, Stefan, Ivanescu, Cristina, Dunshee, Curtis, Agarwal, Neeraj, O'Kelly, Michael, Naidoo, Shevani, Olsson, Carl A., Phung, De, Ratitch, Bohdana, Wang, Fong, Kral, Pavol, Penson, David F.
Published in Journal of clinical oncology (20.02.2018)
Published in Journal of clinical oncology (20.02.2018)
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Journal Article
A Time-response Measure to Assess Clinical Equivalence in Rheumatoid Arthritis: an Assessment Using Data From Clinical Trials of Biosimilars
O'Kelly, Michael, Zhang, Aijing, Lipkovich, Ilya, Song, Guochen, Reeve, Russell, Ratitch, Bohdana, Li, Siying, Behnke, Martha, Kay, Jonathan, Chow, Shein-Chung, Baek, Inyoung
Published in Statistics in biopharmaceutical research (03.04.2022)
Published in Statistics in biopharmaceutical research (03.04.2022)
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Journal Article
Points to consider for analyzing efficacy outcomes in long‐term extension clinical trials
Ratitch, Bohdana, Lipkovich, Ilya, Erickson, Janelle Shannon, Zhang, Lu, Mallinckrodt, Craig H.
Published in Pharmaceutical statistics : the journal of the pharmaceutical industry (01.11.2018)
Published in Pharmaceutical statistics : the journal of the pharmaceutical industry (01.11.2018)
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Journal Article