Output

Here we make available publications and presentations generated by the IDEAS projects.

 

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A benchmark for dose finding studies with continuous outcomes

Mozgunov, P., Jaki, T. & Paoletti, X (2018) Biostatistics

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Vradi, E., Jaki, T., Vonk, R. & Brannath, W. (2018) A Bayesian model to estimate the cutoff and the clinical utility of a biomarker assay. Statistical Methods in Medical Research

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Mozgunov, P. & Jaki, T. (2018) An information-theoretic Phase I/II design for molecularly targeted agents that does not require an assumption of monotonicity. Journal of the Royal Statistical Society: Series C (Applied Statistics)

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Nhacolo, A. & Brananth, W. (2018) Interval and point estimation in adaptive Phase II trials with binary endpoint. Statistical Methods in Medical Research

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Saint-Hilary, G., Robert, V., Gasparini, M., Jaki, T & Mozgunov, P. (2018) A novel measure of drug benefit–risk assessment based on Scale Loss Score. Statistical Methods in Medical Research

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La Gamba, F., Jacobs, T., Geys, H., Ver Donck, L. & Faes, C. (2018) A Bayesian K‐PD model for synergy: A case study

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Pharmacological Treatment of Arterial Hypertension in Children and Adolescents: A network meta-analysis

Burello, J., Erhardt, E., Saint-Hilary, G., Veglio, F., Rabbia, F., Mulatero, P., Monticone, S & D’Ascenzo, F. (2018), Hypertension

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Jaki, T., Gordon, A., Forster, P., Bijnens, L., Bornkamp, B., Brannath, W., Fontana, R., Gasparini, M., Hampson, L.V., Jacobs, T., Jones, B., Paoletti, X., Posch, M., Titman, A., Vonk, R., Koenig, F. (2018 ) A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharmaceutical Statistics, 1-14.

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Jimenez JL, Tighiouart M, Gasparini M (2018) Cancer phase I trial design using drug combinations when a fraction of dose limiting toxicities is attributable to one or more agents, Biometrical Journal

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Mielke, J., Jilma, B., Jones, B. & Koenig, F (2018) An update on the clinical evidence that supports biosimilar approvals in Europe, British Journal of Pharmacomology

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Mielke, J., Schmidli, H., Jones, B. Incorporating historical information in biosimilar trials: Challenges and a hybrid Bayesian-frequentist approach

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La Gamba, F., Corrao, G., Romio, S., Sturkenboom, M., Trifirò, G., Schink, T., de Ridder, M (2017) Combining evidence from multiple electronic health care databases: performances of one-stage and two-stage meta-analysis in matched case-control studies, Pharmacoepidemiology and Drug Safety

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Thomas, M., Bornkamnp, B, Seibold, H. (2018) Subgroup identification in dose-finding trials via model-based recursive partitioning, Statistics in Medicine (E-Publication in advance of print)

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Burmeister, G.E., Carroll K.J., Mielke J., Jones B., Benet L.Z (2017) Pharmacokinetic Behavior of Fluticasone Propionate and Salmeterol from Advair Diskus: The Consequences of Batch Variability, RDD Europe 2017. Volume 1, 2017: 25-34.

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Mielke J, Woehling H, Jones B. Longitudinal assessment of the impact of multiple switches between a biosimilar and its reference product on efficacy parameters. Pharmaceutical Statistics. 2018;1–17. https://doi.org/10.1002/pst.1849

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Mozgunov, P., Beccuti, M., Horvath, A., Jaki, T., Sirovich, R., & Bibbona, E. (2018) A review of the deterministic and diffusion approximations for stochastic chemical reaction networks. Reaction Kinetics, Mechanisms and Catalysis

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Vradi, E., Brannath, W., Jaki, T. & Vonk, R. Model selection based on combined penalties for biomarker identification

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Mielke, J., Jones, B., Jilma. & König, F. (2017) ‘Sample size for multiple hypothesis testing in biosimilar development’, Statistics in Biopharmaceutical Research

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Kelbert M, Mozgunov P. (2017) Generalization of Cramer-Rao and Bhattacharyya inequalities for the weighted covariance matrix. Mathematical Communications, 22:25-40.

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Bornkamp B, Thomas M (2016) Comparing Approaches to Treatment Effect Estimation for Subgroups in Clinical Trials. Statistics in Biopharmaceutical Research. Published online ahead of print.

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E Burmeister Getz, KJ Carroll, J Mielke, LZ Benet, B Jones (2017) Between-Batch Pharmacokinetic Variability Inflates Type I Error Rate in Conventional Bioequivalence Trials: A Randomized Advair Diskus Clinical Trial. Clinical Pharmacology & Therapeutics. 101:331-340.

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Mielke J, Jilma B, Koenig F, Jones B (2016) Clinical trials for authorized biosimilars in the European Union: a systematic review. British Journal of Clinical Pharmacology. 82:1444-1457

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An ethical non-parametric design for selecting arms in a multi-arm clinical trial

Thomas Jaki & Pavel Mozgunov, International Society for Clinical Biostatistics (ISCB) 2018, Melbourne, Australia

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A Bayesian model to estimate the cutoff and the clinical utility of a biomarker assay

Eleni Vradi, Werner Brannath, Thomas Jaki & Richard Vonk. IBC (2018), Barcelona.

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Incorporating historical information in biosimilar trials

Johanna Miekle, Heidi Schmidli & Byron Jones. IBC 2018 (Barcelona, Spain).

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An information-theoretic Phase I/II design for molecularly targeted agents that does not require an assumption of monotonicity

Pavel Mozgunov & Thomas Jaki. IBC 2018, Barcelona, Spain

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A Bayesian hierarchical model to incorporate pre-clinical data from multiple species into a phase I first-in-man trial

Haiyan Zheng, Lisa Hampson & Simon Wandel. IBC (2018), Barcelona

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About IDEAS: What’s the Big Idea?

An overview of the objectives and training of the IDEAS Network. Presented at IBC 2018 (Barcelona) and ISCB 2018 (Melbourne)

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A Bayesian model to estimate the cutoff and the clinical utility of a biomarker assay

Eleni Vradi, Thomas Jaki, Werner Brannath & Ricahard Vonk. PSI, 4th June 2018 (Amsterdam)

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Scale Loss Score (SLoS): a novel measure of drug benefit-risk assessment

Gaëlle Saint-Hilary, Veronique Robert, Mauro Gasparini & Pavel Mozgunov. PSI Conference 2018, Amsterdam and IBC 2018, Barcelona

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Presentation by Nicolas Ballarini to the 14th YSA PhD Symposium (June 2018)

“Graphical displays for subgroup analysis in clinical trails”

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Graphical displays for subgroup analysis in clinical trials

N. Ballarini, Y.D.Chiu, F. Koenig, M. Posch, T. Jaki. Best Poster Award, PSI 2018, Amsterdam

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Improving Design, Evaluation and Analysis of early drug development Studies

Julia Niewczas, N. Ballarini, M. Posch, F. Koenig, T. Jaki. The 14th Young Scientist Association Symposium, 7th & 8th June 2018, Vienna

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Challenges and opportunities for sequential knowledge integration within a Bayesian PK/PD modeling framework

Fabiola La Gamba, Tom Jacobs, Jan Serroyen, Helen Geys & Christel Faes. PSI Annual Conference, Amsterdam (4th June 2018)

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Improving a safety of the Continual Reassessment Method via a modifi ed allocation rule

Pavel Mozgunov, Thomas Jaki. PSI Annual Conference, Amsterdam (4th June 2018)

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A Bayesian information theoretic design for Phase I dose finding trials without monotonicity assumption

Pavel Mozgunov & Thomas Jaki. PSI One-Day Meeting on Bayesian Methods for Dose Finding and Biomarkers (28th February 2018)

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Randomized dose-escalation design for drug combination cancer trials with immunotherapy

Pavel Mozgunov, Thomas Jaki & Xavier Paoletti. PSI Conference, 2017

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Subgroup identification in dose-finding trials via model-based recursive partitioning

Marius Thomas. ZeSOB Kolloquium, November 2017, Oldenburg, Germany

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How much evidence is provided prior to approval? An updated systematic review of biosimilar applications in Europe.

Joahnna Mielke, Byron Jones, Franz Koenig, Bernd Jilma. 2nd Annual Biosmiliars Forum, October 2017, Budapest

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Subgroup identification for dose-finding trials via model-based recursive partitioning

Marius Thomas, Bjoern Bornkamp, Heidi Seibold, Torsten Hothorn. CEN ISBS, 2017, Vienna

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Subgroup identification for dose-finding trials via model-based recursive partitioning

Marius Thomas, Bjoern Bornkamp, Heidi Seibold, Torsten Hothorn. ISBS, July 2017, Vigo

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A flexible non-parametric dose-fi nding design for Phase II clinical trials

Pavel Mozgunov & Thomas Jaki. PSI Conference 2017, London

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PSI translational day, 30. 03. 2017 (Haiyan Zheng, Lancaster)

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PSI translational day, 30. 03. 2017 (Thomas Jaki, Lancaster)

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PSI translational day, 30. 03. 2017 (Richardus Vonk, Bayer)

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Marius Thomas, Comparing Novel Approaches to Subgroup Analyses in Clinical Trials, JSM 2016

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Thomas Jaki, A weighted differential entropy based approach for dose-escalation trials, 5th Early Phase Adaptive Trials Workshop

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Haiyan Zheng, A Bayesian decision-theoretic approach to incorporating pre-clinical information into phase I clinical trials, ISCB 2016

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Fabiola La Gamba, A Bayesian PK/PD model for synergy, NCS2016 Conference, Corpus Christi College – 4th – 6th October 2016

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T Jaki “Improving Design, Evaluation and Analysis of Early Drug Development Studies (IDEAS)” at the PSI conference on the 24th May 2016

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Interval estimation for dose-finding studies

A summary of our ESR Saswati Saha’s work with IDEAS

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Subgroup analyses in early-phase clinical trials

A summary of our ESR Marius Thomas’s work with IDEAS

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Statistical methods for phase I/II trials of molecularly targeted agents in oncology

A summary of our ESR Maria-Athina Altzerinakou’s work with IDEAS

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Innovative designs for combination of therapies

A summary of our ESR Jose Luis Jimenez’s work with IDEAS

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Detecting pharmacodynamic drug-drug interactions

A summary of our ESR Fabiola La Gamba’s work with IDEAS

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Bayesian knowledge integration for an in vitro–in vivo correlation model

A summary of our ESR Elvira Erhardt’s work with IDEAS

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Statistical aspects of animal to human translation

A summary of our ESR Eleni Vradi’s work with IDEAS

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Bias and precision in early phase adaptive studies and its consequences for the decisions about conducting and designing confirmatory studies”

A summary of our ESR Arsenio Nhacolo’s work with IDEAS

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Switchability assessment of biosimilars

A summary of our ESR Johanna Mielke’s research with IDEAS.

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Development of a biomarker score to identify a subgroup of treatment responders

A summary of our ESR Nicolas Ballarini’s research with IDEAS.

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Monitoring clinical trials using short-term information when long-term information is missing

A summary of our ESR Julia Niewczas’ research with IDEAS

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Investigation of the gain in efficiency from using a Gamma threshold model for joint modelling of PFS and OS in oncology trials

A summary of our ESR Enya Weber’s research with IDEAS

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Incorporating preclinical information into phase I first-in-man trials

A summary of our ESR Haiyan Zheng’s research with IDEAS

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Dose finding for combination trials with many treatments

A summary of our ESR Pavel Mozgunov’s research with IDEAS

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A novel PK/PD for synergy in a Bayesian setting

Fabiola La Gamba, Janssen, Belgium.

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Innovative designs for combination of existing therapies

Jose Jimenez, Politecnico di Torino, Italy

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Dose response estimation and why it is important to find the right dose

Saswati Saha
University of Bremen, Germany

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Using preclinical information in a first-in-man trial

Haiyan Zheng
Lancaster University, UK

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Bias and imprecision in early stage adaptive studies

Arsénio Nhacolo, University of Bremen, Germany.

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The role of biomarkers in drug development

Eleni Vradi
Bayer, Germany

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Impact of interim decisions of Data and Safety Monitoring Boards

Julia Niewczas
Medical University of Vienna, Austria

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Existing challenges of improving the efficiency in the analysis of treatment effects on overall survival

Enya Weber
Lancaster University, UK

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Modelling and simulation for the early development of a modified administration route

Elvira Erhadt
Politecnico di Torino, Italy

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Developing a Biomarker score to identify a subgroup of treatment responders

Nicolas Ballarini
Medical University of Vienna, Austria

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Challenges of early phase oncology dose-finding clinical trials

Pavel Mozgunov, Lancaster University, UK.

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Subgroup analyses in early-phase clinical trials

Marius Thomas, Novartis, Switzerland

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Optimal Designs and Analysis Methods for the Development of Biosimilars

Johanna Mielke, Novartis, Switzerland.

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Statistical methods for Phase I/II trials of molecularly targeted agents in oncology

Maria-Athina Altzerinakou, INSERM, France