Accelerated Development of Appropriate Patient Therapies: a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes - Sofia ref.: 115890

Projektinformationen

ADAPT-SMART

ID Finanzhilfevereinbarung: 115890

DOI

10.3030/115890

Projekt abgeschlossen

EK-Unterschriftsdatum 2 September 2015

Startdatum 1 Juli 2015

Enddatum 30 April 2018

Finanziert unter

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Gesamtkosten

€ 4 064 146,00

EU-Beitrag

€ 1 130 000,00

Koordiniert durch

STICHTING LYGATURE
Netherlands

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

Other (8)

List of relevant stakeholders (and updated)

Migration

Operational portal to allow for internal team information

Migration

Press releases (various releases during project)

Migration

Project meetings scheduled and organized

Migration

Organisation of closing event

Migration

Create ADAPT SMART infographic

Migration

Management of IP

Migration

Project templates and materials for communication

Migration

Documents, reports (26)

Identification of legal constraints for MAPPs

Migration

Position paper on the impact of adaptive licencing and adaptive access on IP and regulatory data protection periods and recommendations

Migration

Update D1.02 – Document- analysis of already completed IMI and non-IMI projects and their outputs

Migration

Short report-horizon scanning of future IMI and non-IMI projects with release of a summary of the findings

Migration

Document-analysis of already completed IMI and non-IMI projects and their outputs

Migration

Select methods, toolset (such as the Janus program) and datasets to perform scenario studies in order to facilitate stakeholder’s engagement

Migration

Detailed work plan for each deliverable including staffing 3

Migration

Detailed work plan for each deliverable including staffing 2

Migration

Collaborative research proposals based on gap analysis

Migration

Matrix that contrasts decision points in current vs. future processes by stakeholder groups and implications for a roadmap for implementation. (workshop in M7)

Migration

Inventory/Paper on the available managed entry agreements, including pricing models and their experiences as judged by the different stakeholders

Migration

Proposal for pragmatic operational criteria for the respective decision(s) to use the MAPPs pathway, the timing and the stakeholders needed for this decision. (workshop in M6, briefing document M4)

Migration

Map of the different transition/engagement moments with stakeholders, and identify the information and data needs of these stakeholders at each of these moments

Migration

Gap analysis and where appropriate recommendations for projects addressing enablers of decision making in an adaptive environment (e.g. managing uncertainties at HTA level). (interim: M6, M18)

Migration

Six-monthly reports on project progress and completion (first in M6, then every 6 months)

Migration

Briefing documents during project about EMA pilots to relevant leads of the working groups in the project

Migration

Detailed work plan for each deliverable including staffing 1

Migration

External communications plan (and updated)

Migration

Report with recommendations on current tools and systems to guide the appropriate use by the targeted patient groups, both at the European and national level (also input for D3.09). (workshop in M16)

Migration

Recommendations on applicability of managed entry agreements and pricing arrangements to possible adaptive scenarios

Migration

Review/paper on the ethical and legal aspects of prescribing and use by target populations

Migration

Points to consider document on ethical and legal aspects of adaptive decision-making and recommendations on how these can be addressed

Migration

Glossary with agreed operational definitions of the terms used in international literature

Migration

Inventory and analysis of increased uncertainties for patients and other stakeholders and the issues these raise

Migration

Reports to IMI (first in M18, then M30)

Migration

Detailed project plans/tools for use by the consortium

Migration

Websites, patent fillings, videos etc. (1)

Project website

Migration

Veröffentlichungen

Peer reviewed articles (3)

Medicines Adaptive Pathways to Patients: Why, when and how to engage?

Autoren: Hans-Georg Eichler, Nicola Bedlington, Mathieu Boudes, Jacoline C. Bouvy, André W. Broekmans, Francesca Cerreta, Stuart D. Faulkner, Sue Forda, Angelika Joos, Yann Le Cam, Mark Mayer, Vinciane Pirard, Solange Corriol-Rohou
Veröffentlicht in: Clinical Pharmacology & Therapeutics, 2018, ISSN 0009-9236
Herausgeber: Nature Publishing Group
DOI: 10.1002/cpt.1121

Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe

Autoren: Jacoline C. Bouvy, Claudine Sapede, Sarah Garner
Veröffentlicht in: Frontiers in Pharmacology, Ausgabe 9, 2018, ISSN 1663-9812
Herausgeber: Frontiers Media S.A.
DOI: 10.3389/fphar.2018.00280

The evolution of adaptiveness: balancing speed and evidence

Autoren: Hans-Georg Eichler, Richard Barker, Nicola Bedlington, Jacoline C. Bouvy, André W. Broekmans, Anna Bucsics, Francesca Cerreta, Solange Corriol-Rohou, Alicia Granados, Yann Le Cam, Ad Schuurman
Veröffentlicht in: Nature Reviews Drug Discovery, 2018, ISSN 1474-1776
Herausgeber: Nature Publishing Group
DOI: 10.1038/nrd.2018.90

Other (1)

Patient Access in the Context of Adaptive Pathways for Medicines: What Could Make It Work?

Autoren: C. Sapede
Veröffentlicht in: Value and Outcomes Spotlight, 2017, Seite(n) 11-13
Herausgeber: Ispor