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IDEAS

Improving Design, Evaluation and Analysis of early drug development Studies

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

IDEAS project word cloud

Explore the words cloud of the IDEAS project. It provides you a very rough idea of what is the project "IDEAS" about.

confirmatory ineffective clinical recognised teams skills stages supervisory ample individual private practical lengthy secondments input uniquely care rely determined methodology comprised shortcoming educate transferable efficient network area devised team qualified ideas benefit statistics devise frequently medical interaction supervisors mix mandatory supplemented harmful treatments young rounded supplement brings expertise cross limited experts sectorial individually moment stage drug transnational training relevance final leaders costly advisors methodological components suffers specialist public developmental networkwide

Project "IDEAS" data sheet

The following table provides information about the project.

Coordinator	UNIVERSITY OF LANCASTER Organization address address: BAILRIGG city: LANCASTER postcode: LA1 4YW website: www.lancaster.ac.uk 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	http://www.ideas-itn.eu/
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

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	UNIVERSITY OF LANCASTER UNIVERSITY OF LANCASTER Organization address address: BAILRIGG city: LANCASTER postcode: LA1 4YW website: www.lancaster.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LANCASTER)	coordinator	819˙863.00
2	POLITECNICO DI TORINO POLITECNICO DI TORINO Organization address address: CORSO DUCA DEGLI ABRUZZI 24 city: TORINO postcode: 10129 website: www.polito.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (TORINO)	participant	516˙122.00
3	MEDIZINISCHE UNIVERSITAET WIEN MEDIZINISCHE UNIVERSITAET WIEN Organization address address: SPITALGASSE 23 city: WIEN postcode: 1090 website: www.meduniwien.ac.at contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	AT (WIEN)	participant	511˙868.00
4	UNIVERSITAET BREMEN UNIVERSITAET BREMEN Organization address address: Bibliothekstrasse 1 city: BREMEN postcode: 28359 website: www.uni-bremen.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (BREMEN)	participant	498˙432.00
5	INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE Organization address address: RUE DE TOLBIAC 101 city: PARIS postcode: 75654 website: www.inserm.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	262˙875.00
6	JANSSEN PHARMACEUTICA NV JANSSEN PHARMACEUTICA NV Organization address address: TURNHOUTSEWEG 30 city: BEERSE postcode: 2340 website: www.janssenpharmaceutica.be contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (BEERSE)	participant	250˙560.00
7	Bayer Pharma AG Bayer Pharma AG Organization address address: Muellerstrasse 178 city: Berlin postcode: 13353 website: www.bayerpharma.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (Berlin)	participant	249˙216.00
8	INSTITUT CURIE INSTITUT CURIE Organization address address: rue d'Ulm 26 city: PARIS postcode: 75231 website: www.curie.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	0.00
9	Aptiv Solutions Aptiv Solutions Organization address address: Robert Perthel Str. 77a city: Köln postcode: 50739 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (Köln)	partner	0.00
10	Clinical Trials Consulting & Training Limited Clinical Trials Consulting & Training Limited Organization address address: Portway 53 city: North Marston postcode: MK18 3PL website: www.CTCT-Ltd.co.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (North Marston)	partner	0.00

Map

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.

Deliverables

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.

Publications

List of publications.
year	authors and title	journal	last update
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 CramÃ©r-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	JosÃ© L. JimÃ©nez, 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 Dâ€™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	NicolÃ¡s M. Ballarini, Gerd K. Rosenkranz, Thomas Jaki, Franz KÃ¶nig, 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 benefitâ€“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 KÃ¶nig 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, BjÃ¶rn 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 DiskusÂ® 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 KÃ¶nig 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, BjÃ¶rn 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	ArsÃ©nio 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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The information about "IDEAS" are provided by the European Opendata Portal: CORDIS opendata.