Improving Design, Evaluation and Analysis of early drug development Studies

Informacje na temat projektu

IDEAS

Identyfikator umowy o grant: 633567

DOI

10.3030/633567

Projekt został zamknięty

Data podpisania przez KE 16 Grudnia 2014

Data rozpoczęcia 1 Stycznia 2015

Data zakończenia 31 Grudnia 2018

Finansowanie w ramach

• EXCELLENT SCIENCE - Marie Skłodowska-Curie Actions

Koszt całkowity

€ 3 108 939,48

Wkład UE

€ 3 108 939,48

Koordynowany przez

UNIVERSITY OF LANCASTER
United Kingdom

CORDIS oferuje możliwość skorzystania z odnośników do publicznie dostępnych publikacji i rezultatów projektów realizowanych w ramach programów ramowych HORYZONT.

Odnośniki do rezultatów i publikacji związanych z poszczególnymi projektami 7PR, a także odnośniki do niektórych konkretnych kategorii wyników, takich jak zbiory danych i oprogramowanie, są dynamicznie pobierane z systemu OpenAIRE .

Rezultaty

Other (7)

Presentation at scientific events

Each research will have presented at least once at a scientific conference or meeting.

e-learning course 3

"The third e-learning course on ""Multiple Testing"" has been completed by all researchers"

Award of PhDs
e-learning course 1

"The first e-learning course on ""Computational skills in statistics"" has been completed by all researchers"

Release of summary videos
Dissemination workshop
Peer-reviewed publications

The first peer-reviewed publication has been submitted by every researcher

Websites, patent fillings, videos etc. (2)

Launch of Website
e-learning course 2

"The second e-learning course on ""Genomics: Technologies and data analyses"" has been completed by all researchers"

Documents, reports (3)

Final report
Review papers submitted

At least one paper by each researcher discussing state of the art statistical methods relevant in medical statistics and drug development for a non-statistical audience and has been submitted to a substantive journals.

Release of non-technical summary reports for clinical colleagues

Publikacje

Peer reviewed articles (33)

Sample size for multiple hypothesis testing in biosimilar development

Autorzy: Johanna Mielke, Byron Jones, Bernd Jilma, Franz König
Opublikowane w: Statistics in Biopharmaceutical Research, 2017, Strona(/y) 0-0, ISSN 1946-6315
Wydawca: Taylor & Francis
DOI: 10.1080/19466315.2017.1371071

Model selection based on combined penalties for biomarker identification

Autorzy: Eleni Vradi, Werner Brannath, Thomas Jaki, Richardus Vonk
Opublikowane w: Journal of Biopharmaceutical Statistics, 2017, Strona(/y) 1-15, ISSN 1054-3406
Wydawca: Marcel Dekker Inc.
DOI: 10.1080/10543406.2017.1378662

Longitudinal assessment of the impact of multiple switches between a biosimilar and its reference product on efficacy parameters

Autorzy: Johanna Mielke, Heike Woehling, Byron Jones
Opublikowane w: Pharmaceutical Statistics, 2018, ISSN 1539-1604
Wydawca: John Wiley & Sons Inc.
DOI: 10.1002/pst.1849

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

Autorzy: Marius Thomas, Björn Bornkamp, Heidi Seibold
Opublikowane w: Statistics in Medicine, 2018, ISSN 0277-6715
Wydawca: John Wiley & Sons Inc.
DOI: 10.1002/sim.7594

A review of the deterministic and diffusion approximations for stochastic chemical reaction networks

Autorzy: Pavel Mozgunov, Marco Beccuti, Andras Horvath, Thomas Jaki, Roberta Sirovich, Enrico Bibbona
Opublikowane w: Reaction Kinetics, Mechanisms and Catalysis, 2018, ISSN 1878-5190
Wydawca: Akademiai Kiado
DOI: 10.1007/s11144-018-1351-y

Incorporating historical information in biosimilar trials: Challenges and a hybrid Bayesian-frequentist approach

Autorzy: Mielke, Johanna, Schmidli, Heinz, Jones, Byron.
Opublikowane w: Biometrical Journal, 2018, ISSN 1521-4036
Wydawca: Wiley
DOI: 10.1002/bimj.201700152

Clinical trials for authorized biosimilars in the European Union: a systematic review

Autorzy: Johanna Mielke, Bernd Jilma, Franz Koenig, Byron Jones
Opublikowane w: British Journal of Clinical Pharmacology, Numer 82(6), 2016, Strona(/y) 1444-1457, ISSN 0306-5251
Wydawca: Blackwell Publishing Inc.
DOI: 10.1111/bcp.13076

A proposal for a new PhD level curriculum on quantitative methods for drug development

Autorzy: T. Jaki, A. Gordon, P. Forster, L. Bijnens, B. Bornkamp, W. Brannath, R. Fontana, M. Gasparini, L.V. Hampson, T. Jacobs, B. Jones, X. Paoletti, M. Posch, A. Titman, R. Vonk, F. Koenig
Opublikowane w: Pharmaceutical Statistics, 2018, ISSN 1539-1604
Wydawca: John Wiley & Sons Inc.
DOI: 10.1002/pst.1873

Interval and point estimation in adaptive Phase II trials with binary endpoint

Autorzy: Arsénio Nhacolo, Werner Brannath
Opublikowane w: Statistical Methods in Medical Research, 2018, Strona(/y) 096228021878141, ISSN 0962-2802
Wydawca: SAGE Publications
DOI: 10.1177/0962280218781411

Between-Batch Pharmacokinetic Variability Inflates Type I Error Rate in Conventional Bioequivalence Trials: A Randomized Advair Diskus® Clinical Trial

Autorzy: E. Burmeister Getz, K.J. Carroll, J. Mielke, L.Z. Benet, B. Jones
Opublikowane w: Clinical Pharmacology & Therapeutics, 2016, ISSN 0009-9236
Wydawca: Nature Publishing Group
DOI: 10.1002/cpt.535

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

Autorzy: Eleni Vradi, Thomas Jaki, Richardus Vonk, Werner Brannath
Opublikowane w: Statistical Methods in Medical Research, 2018, Strona(/y) 096228021878477, ISSN 0962-2802
Wydawca: SAGE Publications
DOI: 10.1177/0962280218784778

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

Autorzy: Pavel Mozgunov, Thomas Jaki
Opublikowane w: Journal of the Royal Statistical Society: Series C (Applied Statistics), 2018, Strona(/y) 68(2):347-367, ISSN 0035-9254
Wydawca: Blackwell Publishing Inc.
DOI: 10.1111/rssc.12293

Generalization of Cramér-Rao and Bhattacharyya inequalities for the weighted covariance matrix

Autorzy: Kelbert, Mark; Mozgunov, Pavel
Opublikowane w: Mathematical Communications, Numer 8, 2017, ISSN 1848-8013
Wydawca: University of Osijek

An update on the clinical evidence that supports biosimilar approvals in Europe

Autorzy: Johanna Mielke, Bernd Jilma, Byron Jones, Franz Koenig
Opublikowane w: British Journal of Clinical Pharmacology, Numer 84/7, 2018, Strona(/y) 1415-1431, ISSN 0306-5251
Wydawca: Blackwell Publishing Inc.
DOI: 10.1111/bcp.13586

A benchmark for dose finding studies with continuous outcomes

Autorzy: Pavel Mozgunov, Thomas Jaki, Xavier Paoletti
Opublikowane w: Biostatistics, 2018, ISSN 1465-4644
Wydawca: Oxford University Press
DOI: 10.1093/biostatistics/kxy045

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

Autorzy: Elvira M. Erhardt, Moreno Ursino, Jeike Biewenga, Tom Jacobs, Mauro Gasparini
Opublikowane w: Biometrical Journal, 2018, ISSN 0323-3847
Wydawca: John Wiley & Sons Ltd.
DOI: 10.1002/bimj.201700263

Comparing Approaches to Treatment Effect Estimation for Subgroups in Clinical Trials

Autorzy: Marius Thomas, Björn Bornkamp
Opublikowane w: Statistics in Biopharmaceutical Research, 2016, Strona(/y) 0-0, ISSN 1946-6315
Wydawca: Taylor & Francis
DOI: 10.1080/19466315.2016.1251490

Quantifying the association between progression-free survival and overall survival in oncology trials using Kendall's τ

Autorzy: Enya M. Weber, Andrew C. Titman
Opublikowane w: Statistics in Medicine, 2018, ISSN 0277-6715
Wydawca: John Wiley & Sons Inc.
DOI: 10.1002/sim.8001

Cancer phase I trial design using drug combinations when a fraction of dose limiting toxicities is attributable to one or more agents

Autorzy: Jose L. Jimenez, Mourad Tighiouart, Mauro Gasparini
Opublikowane w: Biometrical Journal, 2018, ISSN 0323-3847
Wydawca: John Wiley & Sons Ltd.
DOI: 10.1002/bimj.201700166

Subgroup identification in clinical trials via the predicted individual treatment effect

Autorzy: Nicolás M. Ballarini, Gerd K. Rosenkranz, Thomas Jaki, Franz König, Martin Posch
Opublikowane w: PLOS ONE, Numer 13/10, 2018, Strona(/y) e0205971, ISSN 1932-6203
Wydawca: Public Library of Science
DOI: 10.1371/journal.pone.0205971

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

Autorzy: Pavel Mozgunov, Thomas Jaki, Xavier Paoletti
Opublikowane w: Journal of Biopharmaceutical Statistics, 2018, Strona(/y) 1-19, ISSN 1054-3406
Wydawca: Marcel Dekker Inc.
DOI: 10.1080/10543406.2018.1535503

Properties of the weighted log-rank test in the design of confirmatory studies with delayed effects

Autorzy: José L. Jiménez, Viktoriya Stalbovskaya, Byron Jones
Opublikowane w: Pharmaceutical Statistics, 2019, ISSN 1539-1604
Wydawca: John Wiley & Sons Inc.
DOI: 10.1002/pst.1923

Pharmacological Treatment of Arterial Hypertension in Children and Adolescents

Autorzy: Jacopo Burrello, Elvira M. Erhardt, Gaelle Saint-Hilary, Franco Veglio, Franco Rabbia, Paolo Mulatero, Silvia Monticone, Fabrizio D’Ascenzo
Opublikowane w: Hypertension, Numer 72/2, 2018, Strona(/y) 306-313, ISSN 0194-911X
Wydawca: Lippincott Williams & Wilkins Ltd.
DOI: 10.1161/hypertensionaha.118.10862

A Bayesian K-PD model for synergy: A case study

Autorzy: Fabiola La Gamba, Tom Jacobs, Helena Geys, Luc Ver Donck, Christel Faes
Opublikowane w: Pharmaceutical Statistics, Numer 17/6, 2018, Strona(/y) 674-684, ISSN 1539-1604
Wydawca: John Wiley & Sons Inc.
DOI: 10.1002/pst.1887

The Assessment of Quality Attributes for Biosimilars: a Statistical Perspective on Current Practice and a Proposal

Autorzy: Johanna Mielke, Franz Innerbichler, Martin Schiestl, Nicolas M. Ballarini, Byron Jones
Opublikowane w: The AAPS Journal, Numer 21/1, 2019, ISSN 1550-7416
Wydawca: Springer New York
DOI: 10.1208/s12248-018-0275-9

A novel measure of drug benefit–risk assessment based on Scale Loss Score

Autorzy: Gaelle Saint-Hilary, Veronique Robert, Mauro Gasparini, Thomas Jaki, Pavel Mozgunov
Opublikowane w: Statistical Methods in Medical Research, 2018, Strona(/y) 096228021878652, ISSN 0962-2802
Wydawca: SAGE Publications
DOI: 10.1177/0962280218786526

Dose-Finding Methods: Moving Away from the 3 + 3 to Include Richer Outcomes

Autorzy: Xavier Paoletti, Damien Drubay, Laurence Collette
Opublikowane w: Clinical Cancer Research, Numer 23/15, 2017, Strona(/y) 3977-3979, ISSN 1078-0432
Wydawca: American Association for Cancer Research
DOI: 10.1158/1078-0432.ccr-17-1306

Comparison of different approaches for dose response analysis

Autorzy: Saswati Saha, Werner Brannath
Opublikowane w: Biometrical Journal, Numer 61/1, 2019, Strona(/y) 83-100, ISSN 0323-3847
Wydawca: John Wiley & Sons Ltd.
DOI: 10.1002/bimj.201700276

A robust Bayesian meta-analytic approach to incorporate animal data into phase I oncology trials

Autorzy: Haiyan Zheng, Lisa V Hampson, Simon Wandel
Opublikowane w: Statistical Methods in Medical Research, 2019, Strona(/y) 096228021882004, ISSN 0962-2802
Wydawca: SAGE Publications
DOI: 10.1177/0962280218820040

Repeated measures dose-finding design with time-trend detection in the presence of correlated toxicity data

Autorzy: Jun Yin, Xavier Paoletti, Daniel J Sargent, Sumithra J Mandrekar
Opublikowane w: Clinical Trials, Numer 14/6, 2017, Strona(/y) 611-620, ISSN 1740-7745
Wydawca: SAGE Publications
DOI: 10.1177/1740774517723829

Interim analysis incorporating short- and long-term binary endpoints

Autorzy: Julia Niewczas, Cornelia U. Kunz, Franz König
Opublikowane w: Biometrical Journal, 2019, ISSN 0323-3847
Wydawca: John Wiley & Sons Ltd.
DOI: 10.1002/bimj.201700281

Loss Functions in Restricted Parameter Spaces and Their Bayesian Applications

Autorzy: Mozgunov P, Jaki T, Gasparini M
Opublikowane w: Journal of Applied Statistics, 2019, ISSN 0266-4763
Wydawca: Routledge
DOI: 10.1080/02664763.2019.1586848

Bayesian sequential integration within a preclinical PK-PD modeling framework: Lessons learned

Autorzy: Fabiola La Gamba, Tom Jacobs, Helena Geys, Thomas Jaki, Jan Serroyen, Moreno Ursino, Alberto Russu, Christel Faes
Opublikowane w: Pharmaceutical Statistics, 2019, ISSN 1539-1604
Wydawca: John Wiley & Sons Inc.
DOI: 10.1002/pst.1941