WATCH: A Workflow to Assess Treatment Effect Heterogeneity in Drug Development for Clinical Trial Sponsors

Authors: Sechidis, Konstantinos, Sun, Sophie, Chen, Yao, Lu, Jiarui, Zhang, Cong, Baillie, Mark, Ohlssen, David, Vandemeulebroecke, Marc, Hemmings, Rob, Ruberg, Stephen, Bornkamp, Björn

Source: Pharmaceutical Statistics 2025

Subject Terms: Statistics - Applications

Access URL: http://arxiv.org/abs/2405.00859

TorchSurv: A Lightweight Package for Deep Survival Analysis

Authors: Monod, Mélodie, Krusche, Peter, Cao, Qian, Sahiner, Berkman, Petrick, Nicholas, Ohlssen, David, Coroller, Thibaud

Subject Terms: Computer Science - Machine Learning

Access URL: http://arxiv.org/abs/2404.10761

Predicting subgroup treatment effects for a new study: Motivations, results and learnings from running a data challenge in a pharmaceutical corporation

Authors: Bornkamp, Björn, Zaoli, Silvia, Azzarito, Michela, Martin, Ruvie, Müller, Carsten Philipp, Moloney, Conor, Capestro, Giulia, Ohlssen, David, Baillie, Mark

Source: Pharmaceutical Statistics 23, 495-510 (2024)

Subject Terms: Statistics - Applications

Access URL: http://arxiv.org/abs/2304.05658

Principled Drug-Drug Interaction Terms for Bayesian Logistic Regression Models of Drug Safety in Oncology Phase I Combination Trials

Authors: Widmer, Lukas A., Bean, Andrew, Ohlssen, David, Weber, Sebastian

Subject Terms: Statistics - Applications, Statistics - Methodology

Access URL: http://arxiv.org/abs/2302.11437

A Deep Learning Approach to Private Data Sharing of Medical Images Using Conditional GANs

Authors: Sun, Hanxi, Plawinski, Jason, Subramaniam, Sajanth, Jamaludin, Amir, Kadir, Timor, Readie, Aimee, Ligozio, Gregory, Ohlssen, David, Baillie, Mark, Coroller, Thibaud

Subject Terms: Computer Science - Machine Learning

Access URL: http://arxiv.org/abs/2106.13199

A framework for longitudinal latent factor modelling of treatment response in clinical trials with applications to Psoriatic Arthritis and Rheumatoid Arthritis

Authors: Falck, Fabian, Zhu, Xuan, Ghalebikesabi, Sahra, Kormaksson, Matthias, Vandemeulebroecke, Marc, Zhang, Cong, Martin, Ruvie, Gardiner, Stephen, Kwok, Chun Hei, West, Dominique M., Santos, Luis, Tian, Chengeng, Pang, Yu, Readie, Aimee, Ligozio, Gregory, Gandhi, Kunal K., Nichols, Thomas E., Mallon, Ann-Marie, Kelly, Luke, Ohlssen, David, Nicholson, George

Source: In Journal of Biomedical Informatics June 2024 154

Sequential knockoffs for continuous and categorical predictors: with application to a large Psoriatic Arthritis clinical trial pool

Authors: Kormaksson, Matthias, Kelly, Luke J., Zhu, Xuan, Haemmerle, Sibylle, Pricop, Luminita, Ohlssen, David

Subject Terms: Statistics - Methodology, Statistics - Applications

Access URL: http://arxiv.org/abs/2010.14026

Good Data Science Practice: Moving Toward a Code of Practice for Drug Development

Authors: Baillie, Mark, Moloney, Conor, Mueller, Carsten Philipp, Dorn, Jonas, Branson, Janice, Ohlssen, David

Source: Statistics in biopharmaceutical research. 15(1):74-85

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100173248702.0x000001&indx=1&recIds=ETOCvdc_100173248702.0x000001

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Conflict diagnostics for evidence synthesis in a multiple testing framework

Authors: Presanis, Anne M., Ohlssen, David, Cui, Kai, Rosinska, Magdalena, De Angelis, Daniela

Subject Terms: Statistics - Methodology

Access URL: http://arxiv.org/abs/1702.07304

Using knockoffs for controlled predictive biomarker identification

Authors: Sechidis, Konstantinos, Kormaksson, Matthias, Ohlssen, David

Source: Statistics in medicine. 40(25):5453-5473

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100132316116.0x000001&indx=1&recIds=ETOCvdc_100132316116.0x000001

Sequential knockoffs for continuous and categorical predictors: With application to a large psoriatic arthritis clinical trial pool

Authors: Kormaksson, Matthias, Kelly, Luke J., Zhu, Xuan, Haemmerle, Sibylle, Pricop, Luminita, Ohlssen, David

Source: Statistics in medicine. 40(14):3313-3328

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100122986581.0x000001&indx=1&recIds=ETOCvdc_100122986581.0x000001

Conflict Diagnostics in Directed Acyclic Graphs, with Applications in Bayesian Evidence Synthesis

Authors: Presanis, Anne M., Ohlssen, David, Spiegelhalter, David J., De Angelis, Daniela

Source: Statistical Science 2013, Vol. 28, No. 3, 376-397

Subject Terms: Statistics - Methodology

Access URL: http://arxiv.org/abs/1310.0628

Bayesian Extrapolation in Pediatric Clinical Trials
Joint statistical meetings

Authors: Aregay, Mehreteab F., Ohlssen, David, Schmidli, Heinz

Source: JSM proceedings (CD-ROM edition). 2018:631-7

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCCN605188975&indx=1&recIds=ETOCCN605188975

Predicting subgroup treatment effects for a new study: Motivations, results and learnings from running a data challenge in a pharmaceutical corporation.

Authors: Bornkamp, Björn, Zaoli, Silvia, Azzarito, Michela, Martin, Ruvie, Müller, Carsten Philipp, Moloney, Conor, Capestro, Giulia, Ohlssen, David, Baillie, Mark

Source: Pharmaceutical Statistics; Jul/Aug2024, Vol. 23 Issue 4, p495-510, 16p

Subject Terms: TREATMENT effect heterogeneity, CLINICAL trials, TREATMENT effectiveness, MOTIVATION (Psychology)

All that Glitters Is not Gold: Type‐I Error Controlled Variable Selection from Clinical Trial Data.

Authors: Zimmermann, Manuela R., Baillie, Mark, Kormaksson, Matthias, Ohlssen, David, Sechidis, Konstantinos

Source: Clinical Pharmacology & Therapeutics; Apr2024, Vol. 115 Issue 4, p774-785, 12p

Subject Terms: CLINICAL trials, MACHINE learning, FALSE positive error, PSORIATIC arthritis, C-reactive protein, PROGNOSIS, MULTIPLE comparisons (Statistics)

Functional Mixed Effects Model for the Analysis of Dose-Titration Studies

Authors: Chen, Ji, Ohlssen, David, Zhou, Yingchun

Source: Statistics in biopharmaceutical research. 10(3):176-184

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100068011451.0x000001&indx=1&recIds=ETOCvdc_100068011451.0x000001

Bayesian two-stage dose finding for cytostatic agents via model adaptation

Authors: Xu, Jiajing, Yin, Guosheng, Ohlssen, David, Bretz, Frank

Source: Journal of the Royal Statistical Society. Series C (Applied Statistics), 2016 Apr 01. 65(3), 465-482.

Access URL: http://www.jstor.org/stable/24773032

Challenges When Applying Advanced Analytics to Multiple Data Sources
Joint statistical meetings

Authors: Ohlssen, David

Source: JSM proceedings (CD-ROM edition). 2019:273-2

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCCN606200521&indx=1&recIds=ETOCCN606200521

Estimands and Their Role in Clinical Trials

Authors: Akacha, Mouna, Bretz, Frank, Ohlssen, David, Rosenkranz, Gerd, Schmidli, Heinz

Source: Statistics in biopharmaceutical research. 9(3):268-271

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100056855128.0x000001&indx=1&recIds=ETOCvdc_100056855128.0x000001