CORDIS bietet Links zu öffentlichen Ergebnissen und Veröffentlichungen von HORIZONT-Projekten.
Links zu Ergebnissen und Veröffentlichungen von RP7-Projekten sowie Links zu einigen Typen spezifischer Ergebnisse wie Datensätzen und Software werden dynamisch von OpenAIRE abgerufen.
Leistungen
Online communications Updated website and repository
Report detailing lessons learnt and summarised advice given (dependant on confidentiality requirements of HARMONY). In case the EUnetHTA and/or EMA don’t have capacity to accept the Task 4.4 Parallel Early Scientific Advice, then the consortium agree that this project can be complete by NICE Scientific Advice alone. (M34) (contingent upon EM/HTA agencies availabilities / speed in completing the process).
Regulatory/HTA/payer interaction guidance (öffnet in neuem Fenster)RegulatoryHTApayer interaction guidance Decision tool and guidance to support the individual HARMONY PLUS projects in identifying the most appropriate way of interacting with regulators HTA bodies M18 for first report and M36 for finalized report
Definition of a COS for disease overarching therapies such as ATMPs or targeted therapies (öffnet in neuem Fenster)Definition of a COS for disease overarching therapies such as ATMPs or targeted therapies a focus will be provided on a COS for novel CD19 CAR T cell products as well as one novel targeted approach eg ibrutinib or venetoclax M18 outcome measures for these COS will include deep omic data
Report on the dissemination of results of the studies and research questions through publications (öffnet in neuem Fenster)Report on the dissemination of results of the studies and research questions through publications. The aim will be to publish results from first “Proof-of-Principle” joint studies and new HMs specific projects.
Report on consultation and participation of the SPOF in the definition of COS (WP2) for the new HMs (öffnet in neuem Fenster)Report on consultation and participation of the SPOF in the definition of COS WP2 for the new HMs contingent upon requests from WP2 Deliverable dates contingent upon WP2 requests for consultation of the SPOF and deliverables of the COS for each indication
Report on scenarios for governing international health data research (öffnet in neuem Fenster)Report on scenarios for governing international health data research M24M362 reports will be provided to IMI at month 24 and 36
Report on costs-effectiveness and societal value analysis (öffnet in neuem Fenster)Report on costseffectiveness and societal value analysis including healthrelated QoL and disease burden For societal value analysis data from HRQL instruments will be analysed in order to identify an HM profile in terms of physical function emotional wellbeing treatment satisfaction and disease burden The Strategic Plan will contain a report about different sustainability options that could be adopted and that will be used to define the business models considering the results of this task
SOP for engaging participation of consulting and informing the POs and patients in research projects of WP2 and HARMONY PLUS (öffnet in neuem Fenster)Report on the set up of the trans BD4BO Ethical and Legal Working Group (öffnet in neuem Fenster)
Updated and final version of D4.3 Regulatory/HTA/payer interaction guidance (öffnet in neuem Fenster)
Finalized report on Regulatory/HTA/payer interaction guidance. Decision tool and guidance to support the individual HARMONY PLUS projects in identifying the most appropriate way of interacting with regulators, HTA bodies.
Report on the advice on ethics and governance issues (öffnet in neuem Fenster)Report on the advice on ethics and governance issues (M18/M36).2 reports will be provided to IMI, at month 18 and 36
HARMONY PLUS Communication Strategy (öffnet in neuem Fenster)HARMONY PLUS Communication Strategy detailing communication targets
Guidance document on the application of optimal outcome measures in HARMONY PLUS HMs (white paper) (öffnet in neuem Fenster)Guidance document on the application of optimal outcome measures in HARMONY PLUS HMs white paper This report will complement the comprehensive information to all stakeholders already provided on HARMONYs seven pillars and refine the previous information
Stakeholder engagement plan (öffnet in neuem Fenster)Stakeholder engagement plan M12M24M363 reports will be provided to IMI at month 12 24 and 36
Definition of a COS for individual HMs (MPD, CML and HL) (öffnet in neuem Fenster)Definition of a COS for individual HMs MPD CML and HL and individual HMspecific questions that will consider clinical outcome measures patientrelated factors for patients and caregivers and payers surrogate endpoints
Updated and final version of D5.3 Stakeholder engagement plan (öffnet in neuem Fenster)Final version of the Stakeholder engagement plan.
Veröffentlichungen
Autoren:
Tiziano Barbui, Valerio De Stefano, Alberto Alvarez-Larran, Alessandra Iurlo, Arianna Masciulli, Alessandra Carobbio, Arianna Ghirardi, Alberto Ferrari, Valeria Cancelli, Elena Maria Elli, Marcio Miguel Andrade-Campos, Mercedes Gasior Kabat, Jean-Jaques Kiladjian, Francesca Palandri, Giulia Benevolo, Valentin Garcia-Gutierrez, Maria Laura Fox, Maria Angeles Foncillas, Carmen Montoya Morcillo, Elis
Veröffentlicht in:
Blood Cancer Journal, Ausgabe 11/2, 2021, ISSN 2044-5385
Herausgeber:
Nature Publishing Group
DOI:
10.1038/s41408-021-00417-3
Autoren:
D'Agostino, Mattia; Cairns, David A.; Lahuerta, Juan José; Wester, Ruth; Bertsch, Uta; Waage, Anders; Zamagni, Elena; Mateos, María-Victoria; Dall'Olio, Daniele; van de Donk, Niels W.C.J.; Jackson, Graham; Rocchi, Serena; Salwender, Hans; Bladé Creixenti, Joan; van der Holt, Bronno; Castellani, Gastone; Bonello, Francesca; Capra, Andrea; Mai, Elias K.; Dürig, Jan; Gay, Francesca; Zweegman, Son
Veröffentlicht in:
Journal of Clinical Oncology, Ausgabe Volume 40, Number 29, 2022, Seite(n) 3406-3418, ISSN 0732-183X
Herausgeber:
American Society of Clinical Oncology
DOI:
10.1200/jco.21.02614
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