Livrables
Online communications Updated website and repository
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 therapiesDefinition 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 consultation and participation of the SPOF in the definition of COS (WP2) for the new HMsReport 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 researchReport 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 analysisReport 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 PLUSReport on the set up of the trans BD4BO Ethical and Legal Working Group
HARMONY PLUS Communication Strategy
HARMONY PLUS Communication Strategy detailing communication targets
Guidance document on the application of optimal outcome measures in HARMONY PLUS HMs (white paper)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 planStakeholder 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)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
Publications
Auteurs:
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
Publié dans:
Blood Cancer Journal, Numéro 11/2, 2021, ISSN 2044-5385
Éditeur:
Nature Publishing Group
DOI:
10.1038/s41408-021-00417-3
Auteurs:
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
Publié dans:
Journal of Clinical Oncology, Numéro Volume 40, Number 29, 2022, Page(s) 3406-3418, ISSN 0732-183X
Éditeur:
American Society of Clinical Oncology
DOI:
10.1200/jco.21.02614
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