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1

Sensitivity to censored-at-random assumption in the analysis of time-to-event endpoints

Lipkovich, Ilya, Ratitch, Bohdana, O'Kelly, Michael

Journal:

Pharmaceutical Statistics

Year:

2016

Language:

english

File:

PDF, 963 KB

english, 2016

2

Causal inference and estimands in clinical trials

Lipkovich, Ilya, Ratitch, Bohdana, Mallinckrodt, Craig H

Journal:

Statistics in Biopharmaceutical Research

Year:

2019

File:

PDF, 785 KB

2019

3

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

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2019

Language:

english

File:

PDF, 317 KB

english, 2019

4

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

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2020

File:

PDF, 407 KB

2020

5

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, Chrissie, Li, Xin, Wright, David, Shentu, Yue, Englert, Stefan, Shen, Wei, Dey, Jyotirmoy, Liu, T

Journal:

Statistics in Biopharmaceutical Research

Year:

2020

File:

PDF, 716 KB

2020

6

Missing data in clinical trials: from clinical assumptions to statistical analysis using pattern mixture models

Ratitch, Bohdana, O'Kelly, Michael, Tosiello, Robert

Journal:

Pharmaceutical Statistics

Year:

2013

Language:

english

File:

PDF, 270 KB

english, 2013

7

Missing Data: Turning Guidance Into Action

Mallinckrodt, Craig, Roger, James, Chuang-stein, Christy, Molenberghs, Geert, Lane, Peter W., O’kelly, Michael, Ratitch, Bohdana, Xu, Lei, Gilbert, Steve, Mehrotra, Devan V., Wolfinger, Russ, Thijs, H

Journal:

Statistics in Biopharmaceutical Research

Year:

2013

Language:

english

File:

PDF, 316 KB

english, 2013

8

Clinical Trials with Missing Data (A Guide for Practitioners) || Mixed Models for Repeated Measures using Categorical time Effects (MMRM)

O'Kelly, Michael, Ratitch, Bohdana

Year:

2014

Language:

english

File:

PDF, 892 KB

english, 2014

9

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.

Journal:

Pharmaceutical Statistics

Year:

2018

Language:

english

File:

PDF, 586 KB

english, 2018

10

Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into Practice

Mallinckrodt, C. H., Bell, J., Liu, G., Ratitch, B., O’Kelly, M., Lipkovich, I., Singh, P., Xu, L., Molenberghs, G.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2019

File:

PDF, 334 KB

2019

11

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

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2019

File:

PDF, 317 KB

2019

12

Clinical Trials with Missing Data (A Guide for Practitioners) || Front Matter

O'Kelly, Michael, Ratitch, Bohdana

Year:

2014

Language:

english

File:

PDF, 122 KB

english, 2014

13

Recent Developments in the Prevention and Treatment of Missing Data

Mallinckrodt, C., Roger, J., Chuang-Stein, C., Molenberghs, G., O'Kelly, M., Ratitch, B., Janssens, M., Bunouf, P.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2014

Language:

english

File:

PDF, 320 KB

english, 2014

14

Clinical Trials with Missing Data (A Guide for Practitioners) || Analyses under Missing-not-at-random Assumptions

O'Kelly, Michael, Ratitch, Bohdana

Year:

2014

Language:

english

File:

PDF, 1.17 MB

english, 2014

15

Clinical Trials with Missing Data (A Guide for Practitioners) || Doubly Robust Estimation

O'Kelly, Michael, Ratitch, Bohdana

Year:

2014

Language:

english

File:

PDF, 171 KB

english, 2014

16

Clinical Trials with Missing Data (A Guide for Practitioners) || A Guide to Planning for Missing Data

O'Kelly, Michael, Ratitch, Bohdana

Year:

2014

Language:

english

File:

PDF, 600 KB

english, 2014

17

Subgroup identification in clinical trials by Stochastic SIDEScreen methods

Lipkovich, Ilya, Dmitrienko, Alex, Patra, Kaushik, Ratitch, Bohdana, Pulkstenis, Erik

Journal:

Statistics in Biopharmaceutical Research

Year:

2017

Language:

english

File:

PDF, 865 KB

english, 2017

18

Multiplicity issues in exploratory subgroup analysis

Lipkovich, Ilya, Dmitrienko, Alex, Muysers, Christoph, Ratitch, Bohdana

Journal:

Journal of Biopharmaceutical Statistics

Year:

2017

Language:

english

File:

PDF, 1.60 MB

english, 2017

19

Clinical Trials with Missing Data (A Guide for Practitioners) || Multiple Imputation

O'Kelly, Michael, Ratitch, Bohdana

Year:

2014

Language:

english

File:

PDF, 593 KB

english, 2014

20

Clinical Trials with Missing Data (A Guide for Practitioners) || What's the Problem with Missing Data?

O'Kelly, Michael, Ratitch, Bohdana

Year:

2014

Language:

english

File:

PDF, 1.19 MB

english, 2014

21

Clinical Trials with Missing Data (A Guide for Practitioners) || Statistics in Practice

O'Kelly, Michael, Ratitch, Bohdana

Year:

2014

Language:

english

File:

PDF, 35 KB

english, 2014

22

Clinical Trials with Missing Data (A Guide for Practitioners) || Regulatory Guidance - a Quick Tour

O'Kelly, Michael, Ratitch, Bohdana

Year:

2014

Language:

english

File:

PDF, 84 KB

english, 2014

23

Clinical Trials with Missing Data (A Guide for Practitioners) || The Prevention of Missing Data

O'Kelly, Michael, Ratitch, Bohdana

Year:

2014

Language:

english

File:

PDF, 256 KB

english, 2014

24

Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into Practice

Mallinckrodt, C. H., Bell, J., Liu, G., Ratitch, B., O’Kelly, M., Lipkovich, I., Singh, P., Xu, L., Molenberghs, G.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2019

Language:

english

File:

PDF, 334 KB

english, 2019

25

Clinical Trials with Missing Data (A Guide for Practitioners) ||

O'Kelly, Michael, Ratitch, Bohdana

Year:

2014

Language:

english

File:

PDF, 5.15 MB

english, 2014

26

Clinical Trials with Missing Data (A Guide for Practitioners) || Index

O'Kelly, Michael, Ratitch, Bohdana

Year:

2014

Language:

english

File:

PDF, 64 KB

english, 2014

27

Clinical Trials with Missing Data (A Guide for Practitioners) || Bibliography

O'Kelly, Michael, Ratitch, Bohdana

Year:

2014

Language:

english

File:

PDF, 75 KB

english, 2014

28

PNS294 REVIEW OF ANALYTICAL METHODS FOR ANALYSIS OF PATIENT REPORTED OUTCOME (PRO) DATA IN THE PRESENCE OF CENSORING DUE TO DEATH

O'Kelly, M., Kráľ, P., Ratitch, B., Niklasson, A., Ivanescu, C.

Journal:

Value in Health

Year:

2019

File:

PDF, 321 KB

2019

29

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

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2020

Language:

english

File:

PDF, 377 KB

english, 2020

30

Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into Practice

Mallinckrodt, C. H., Bell, J., Liu, G., Ratitch, B., OâKelly, M., Lipkovich, I., Singh, P., Xu, L., Molenberghs, G.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2020

Language:

english

File:

PDF, 417 KB

english, 2020

31

A Time-response Measure to Assess Clinical Equivalence in Rheumatoid Arthritis: an Assessment Using Data From Clinical Trials of Biosimilars

OâKelly, Michael, Zhang, Aijing, Lipkovich, Ilya, Song, Guochen, Reeve, Russell, Ratitch, Bohdana, Li, Siying, Behnke, Martha, Kay, Jonathan, Chow, Shein-Chung, Baek, Inyoung

Journal:

Statistics in Biopharmaceutical Research

Year:

2020

File:

PDF, 1.40 MB

2020