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Improving Design, Evaluation and Analysis of early drug development Studies

Total Cost €


EC-Contrib. €






Project "IDEAS" data sheet

The following table provides information about the project.


Organization address
address: BAILRIGG
postcode: LA1 4YW

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country United Kingdom [UK]
 Project website
 Total cost 3˙108˙939 €
 EC max contribution 3˙108˙939 € (100%)
 Programme 1. H2020-EU.1.3.1. (Fostering new skills by means of excellent initial training of researchers)
 Code Call H2020-MSCA-ITN-2014
 Funding Scheme MSCA-ITN-ETN
 Starting year 2015
 Duration (year-month-day) from 2015-01-01   to  2018-12-31


Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    UNIVERSITY OF LANCASTER UK (LANCASTER) coordinator 819˙863.00
2    POLITECNICO DI TORINO IT (TORINO) participant 516˙122.00
3    MEDIZINISCHE UNIVERSITAET WIEN AT (WIEN) participant 511˙868.00
4    UNIVERSITAET BREMEN DE (BREMEN) participant 498˙432.00
6    JANSSEN PHARMACEUTICA NV BE (BEERSE) participant 250˙560.00
7    Bayer Pharma AG DE (Berlin) participant 249˙216.00
8    INSTITUT CURIE FR (PARIS) participant 0.00
9    Aptiv Solutions DE (Köln) partner 0.00
10    Clinical Trials Consulting & Training Limited UK (North Marston) partner 0.00


 Project objective

Drug development is a long and costly process which suffers from the major shortcoming that frequently failure is often only determined during the final stage. Recently, it has been recognised that more care needs to be taken during the early stages of development to avoid going into lengthy and costly confirmatory studies with ineffective or harmful treatments. To achieve this goal it is essential to implement efficient methods for the design and analysis of such early development studies. The expertise in this area is, however, limited at the moment and adequate methodology is only partially available. Using a cross-sectorial, transnational approach, the IDEAS network brings together leading public and private sector researchers in the field with ample experience in training to educate, promote and support the future leaders in medical statistics in general and in the design and analysis of early developmental studies in particular.

Within the network, cross-sectorial, transnational teams will support young researchers with individual methodological projects and devise an individually tailored training programme for them. Clinical advisors supplement the input of the supervisory team and ensure practical relevance and uptake of the methods devised. The training activities are comprised of a well-rounded mix of specialist, methodological components and generic, transferable skills. A mandatory set of networkwide training activities is supplemented by individual training components and cross-sectorial secondments, and particular attention is given to interaction and collaboration between researchers and supervisors across public and private sector partners. At the end of their training the researchers will be uniquely qualified with expertise in the field, benefit from experience in both public and private sector and can rely on a wide network of experts in the field in the future.


List of deliverables.
Award of PhDs Other 2019-12-17 15:41:24
Release of non-technical summary reports for clinical colleagues Documents, reports 2019-12-17 15:41:24
Final report Documents, reports 2019-12-17 15:41:24
e-learning course 2 Websites, patent fillings, videos etc. 2019-12-17 15:41:24
Peer-reviewed publications Other 2019-12-17 15:41:24
Presentation at scientific events Other 2019-12-17 15:41:24
Release of summary videos Other 2019-12-17 15:41:24
e-learning course 3 Other 2019-12-17 15:41:24
Dissemination workshop Other 2019-12-17 15:41:24
Review papers submitted Documents, reports 2019-12-17 15:41:22
e-learning course 1 Other 2019-12-17 15:41:22
Launch of Website Websites, patent fillings, videos etc. 2019-12-17 15:41:22

Take a look to the deliverables list in detail:  detailed list of IDEAS deliverables.


year authors and title journal last update
List of publications.
2018 Johanna Mielke, Bernd Jilma, Byron Jones, Franz Koenig
An update on the clinical evidence that supports biosimilar approvals in Europe
published pages: 1415-1431, ISSN: 0306-5251, DOI: 10.1111/bcp.13586
British Journal of Clinical Pharmacology 84/7 2019-12-17
2018 Pavel Mozgunov, Thomas Jaki, Xavier Paoletti
A benchmark for dose finding studies with continuous outcomes
published pages: , ISSN: 1465-4644, DOI: 10.1093/biostatistics/kxy045
Biostatistics 2019-12-17
2018 Elvira M. Erhardt, Moreno Ursino, Jeike Biewenga, Tom Jacobs, Mauro Gasparini
Bayesian knowledge integration for an in vitro-in vivo correlation model
published pages: , ISSN: 0323-3847, DOI: 10.1002/bimj.201700263
Biometrical Journal 2019-12-17
2017 Kelbert, Mark; Mozgunov, Pavel
Generalization of Cramér-Rao and Bhattacharyya inequalities for the weighted covariance matrix
published pages: , ISSN: 1848-8013, DOI:
Mathematical Communications 8 2019-12-17
2019 Fabiola La Gamba, Tom Jacobs, Helena Geys, Thomas Jaki, Jan Serroyen, Moreno Ursino, Alberto Russu, Christel Faes
Bayesian sequential integration within a preclinical PK-PD modeling framework: Lessons learned
published pages: , ISSN: 1539-1604, DOI: 10.1002/pst.1941
Pharmaceutical Statistics 2019-12-17
2019 José L. Jiménez, Viktoriya Stalbovskaya, Byron Jones
Properties of the weighted log-rank test in the design of confirmatory studies with delayed effects
published pages: , ISSN: 1539-1604, DOI: 10.1002/pst.1923
Pharmaceutical Statistics 2019-12-17
2018 Pavel Mozgunov, Thomas Jaki, Xavier Paoletti
Randomized dose-escalation designs for drug combination cancer trials with immunotherapy
published pages: 1-19, ISSN: 1054-3406, DOI: 10.1080/10543406.2018.1535503
Journal of Biopharmaceutical Statistics 2019-12-17
2018 Jacopo Burrello, Elvira M. Erhardt, Gaelle Saint-Hilary, Franco Veglio, Franco Rabbia, Paolo Mulatero, Silvia Monticone, Fabrizio D’Ascenzo
Pharmacological Treatment of Arterial Hypertension in Children and Adolescents
published pages: 306-313, ISSN: 0194-911X, DOI: 10.1161/hypertensionaha.118.10862
Hypertension 72/2 2019-12-17
2018 Jose L. Jimenez, Mourad Tighiouart, Mauro Gasparini
Cancer phase I trial design using drug combinations when a fraction of dose limiting toxicities is attributable to one or more agents
published pages: , ISSN: 0323-3847, DOI: 10.1002/bimj.201700166
Biometrical Journal 2019-12-17
2018 Nicolás M. Ballarini, Gerd K. Rosenkranz, Thomas Jaki, Franz König, Martin Posch
Subgroup identification in clinical trials via the predicted individual treatment effect
published pages: e0205971, ISSN: 1932-6203, DOI: 10.1371/journal.pone.0205971
PLOS ONE 13/10 2019-12-17
2019 Johanna Mielke, Franz Innerbichler, Martin Schiestl, Nicolas M. Ballarini, Byron Jones
The Assessment of Quality Attributes for Biosimilars: a Statistical Perspective on Current Practice and a Proposal
published pages: , ISSN: 1550-7416, DOI: 10.1208/s12248-018-0275-9
The AAPS Journal 21/1 2019-12-17
2017 Xavier Paoletti, Damien Drubay, Laurence Collette
Dose-Finding Methods: Moving Away from the 3 + 3 to Include Richer Outcomes
published pages: 3977-3979, ISSN: 1078-0432, DOI: 10.1158/1078-0432.ccr-17-1306
Clinical Cancer Research 23/15 2019-12-17
2019 Saswati Saha, Werner Brannath
Comparison of different approaches for dose response analysis
published pages: 83-100, ISSN: 0323-3847, DOI: 10.1002/bimj.201700276
Biometrical Journal 61/1 2019-12-17
2018 Gaelle Saint-Hilary, Veronique Robert, Mauro Gasparini, Thomas Jaki, Pavel Mozgunov
A novel measure of drug benefit–risk assessment based on Scale Loss Score
published pages: 96228021878652, ISSN: 0962-2802, DOI: 10.1177/0962280218786526
Statistical Methods in Medical Research 2019-12-17
2019 Julia Niewczas, Cornelia U. Kunz, Franz König
Interim analysis incorporating short- and long-term binary endpoints
published pages: , ISSN: 0323-3847, DOI: 10.1002/bimj.201700281
Biometrical Journal 2019-12-17
2019 Haiyan Zheng, Lisa V Hampson, Simon Wandel
A robust Bayesian meta-analytic approach to incorporate animal data into phase I oncology trials
published pages: 96228021882004, ISSN: 0962-2802, DOI: 10.1177/0962280218820040
Statistical Methods in Medical Research 2019-12-17
2017 Jun Yin, Xavier Paoletti, Daniel J Sargent, Sumithra J Mandrekar
Repeated measures dose-finding design with time-trend detection in the presence of correlated toxicity data
published pages: 611-620, ISSN: 1740-7745, DOI: 10.1177/1740774517723829
Clinical Trials 14/6 2019-12-17
2019 Mozgunov P, Jaki T, Gasparini M
Loss Functions in Restricted Parameter Spaces and Their Bayesian Applications
published pages: , ISSN: 0266-4763, DOI: 10.1080/02664763.2019.1586848
Journal of Applied Statistics 2019-12-17
2018 Jimenez, Jose L; Stalbovskaya, Viktoriya; Jones, Byron
Properties of the weighted log-rank test under delayed effects assumption in the design of confirmatory studies with delayed effects
published pages: , ISSN: 1539-1612, DOI:
Pharmaceutical Statistics 1 2019-12-17
2016 Marius Thomas, Björn Bornkamp
Comparing Approaches to Treatment Effect Estimation for Subgroups in Clinical Trials
published pages: 0-0, ISSN: 1946-6315, DOI: 10.1080/19466315.2016.1251490
Statistics in Biopharmaceutical Research 2019-12-17
2016 E. Burmeister Getz, K.J. Carroll, J. Mielke, L.Z. Benet, B. Jones
Between-Batch Pharmacokinetic Variability Inflates Type I Error Rate in Conventional Bioequivalence Trials: A Randomized Advair Diskus® Clinical Trial
published pages: , ISSN: 0009-9236, DOI: 10.1002/cpt.535
Clinical Pharmacology & Therapeutics 2019-12-17
2016 Johanna Mielke, Bernd Jilma, Franz Koenig, Byron Jones
Clinical trials for authorized biosimilars in the European Union: a systematic review
published pages: 1444-1457, ISSN: 0306-5251, DOI: 10.1111/bcp.13076
British Journal of Clinical Pharmacology 82(6) 2019-12-17
2017 Johanna Mielke, Byron Jones, Bernd Jilma, Franz König
Sample size for multiple hypothesis testing in biosimilar development
published pages: 0-0, ISSN: 1946-6315, DOI: 10.1080/19466315.2017.1371071
Statistics in Biopharmaceutical Research 2019-12-17
2018 Pavel Mozgunov, Thomas Jaki
An information theoretic phase I-II design for molecularly targeted agents that does not require an assumption of monotonicity
published pages: 68(2):347-367, ISSN: 0035-9254, DOI: 10.1111/rssc.12293
Journal of the Royal Statistical Society: Series C (Applied Statistics) 2019-12-17
2018 Eleni Vradi, Thomas Jaki, Richardus Vonk, Werner Brannath
A Bayesian model to estimate the cutoff and the clinical utility of a biomarker assay
published pages: 96228021878477, ISSN: 0962-2802, DOI: 10.1177/0962280218784778
Statistical Methods in Medical Research 2019-12-17
2018 Mielke, Johanna, Schmidli, Heinz, Jones, Byron.
Incorporating historical information in biosimilar trials: Challenges and a hybrid Bayesian-frequentist approach
published pages: , ISSN: 1521-4036, DOI: 10.1002/bimj.201700152
Biometrical Journal 2019-12-17
2018 Marius Thomas, Björn Bornkamp, Heidi Seibold
Subgroup identification in dose-finding trials via model-based recursive partitioning
published pages: , ISSN: 0277-6715, DOI: 10.1002/sim.7594
Statistics in Medicine 2019-12-17
2018 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
A proposal for a new PhD level curriculum on quantitative methods for drug development
published pages: , ISSN: 1539-1604, DOI: 10.1002/pst.1873
Pharmaceutical Statistics 2019-12-17
2017 Eleni Vradi, Werner Brannath, Thomas Jaki, Richardus Vonk
Model selection based on combined penalties for biomarker identification
published pages: 1-15, ISSN: 1054-3406, DOI: 10.1080/10543406.2017.1378662
Journal of Biopharmaceutical Statistics 2019-12-17
2018 Johanna Mielke, Heike Woehling, Byron Jones
Longitudinal assessment of the impact of multiple switches between a biosimilar and its reference product on efficacy parameters
published pages: , ISSN: 1539-1604, DOI: 10.1002/pst.1849
Pharmaceutical Statistics 2019-12-17
2018 Pavel Mozgunov, Marco Beccuti, Andras Horvath, Thomas Jaki, Roberta Sirovich, Enrico Bibbona
A review of the deterministic and diffusion approximations for stochastic chemical reaction networks
published pages: , ISSN: 1878-5190, DOI: 10.1007/s11144-018-1351-y
Reaction Kinetics, Mechanisms and Catalysis 2019-12-17
2018 Arsénio Nhacolo, Werner Brannath
Interval and point estimation in adaptive Phase II trials with binary endpoint
published pages: 96228021878141, ISSN: 0962-2802, DOI: 10.1177/0962280218781411
Statistical Methods in Medical Research 2019-12-17

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