Publications

Publications 2017-06-20T11:17:44+00:00

General

Report – ADAPT SMART General Assembly, 18th of January 2017

Location: European Medicines Agency, London 9:30 AM –1 PM

This report highlights the main outcomes of the General Assembly of the IMI ADAPT SMART consortium.

Webinar Report: Status Updates from ADAPT SMART Work Package Leads 

On 8th January 2016, the ADAPT SMART work package leads participated in a webinar to share status updates, and compare notes on progress made and hurdles to overcome. ADAPT SMART Consortia members were invited to [...]

ADAPT SMART Project Overview

The project overview of ADAPT SMART (Accelerated Development of Appropriate Patient Therapies: a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes) provides information regarding participants, objectives, expected impact, and a work plan, among other details.

Work Package 1

Initial Review Report On Imi Projects – WP1 Final Report

Initial Review Report On Imi Projects - WP1 Final Report D1.02 aimed to analyse and monitor IMI and non IMI project outputs, and to perform a gap analysis of the wealth of evidence generation [...]

Discussion paper on Engagement Criteria for MAPPs

On the 29th of February, ADAPT SMART hosted an invitation-only multi-stakeholder workshop around selection criteria for MAPPs in Amsterdam, The Netherlands.

Work Package 2

Seamless Process and Decision Points of an Adaptive Pathway

This report proposes a framework with pictographic representation of an adaptive pathway containing key moments, events and involved stakeholders, in each phase. This model is purposefully presented rather simplistically in this first evolution, acknowledging that there remain several questions to be answered – both unique to each individual potential medicine as well as to full implementation of an integrated adaptive pathway approach.

Discussion paper on Engagement Criteria for MAPPs

An issue of divergent views became apparent early in the course of the ADAPT SMART project, namely; to what kind of novel medicines and clinical scenarios/conditions should a MAPPs approach be applied? The ADAPT SMART consortium convened discussion fora with stakeholders to elaborate MAPPs engagement criteria that may be acceptable to all concerned within the existing legislation. In this paper, we summarize viewpoints from these discussions.

ADAPT SMART Glossary

The ADAPT SMART glossary provides working definitions for common terms relevant for the consortium and includes references. The glossary is based on the input from members of the ADAPT SMART consortium representing different stakeholder groups. The [...]

Blog From D2.03 Leaders: Takeaways From the ADAPT SMART Workshop on Selection Criteria for MAPPs

On the 29th of February, ADAPT SMART hosted an invitation-only multi-stakeholder workshop around selection criteria for MAPPs in Amsterdam, The Netherlands. Angelika Joos of MSD and Mathieu Boudes of EURORDIS attended the workshop in their capacity [...]

Work Package 3

Seamless Process and Decision Points of an Adaptive Pathway

This report proposes a framework with pictographic representation of an adaptive pathway containing key moments, events and involved stakeholders, in each phase. This model is purposefully presented rather simplistically in this first evolution, acknowledging that there remain several questions to be answered – both unique to each individual potential medicine as well as to full implementation of an integrated adaptive pathway approach.

Blogpost: “Putting Patients at the Centre – The Ethical and Legal Considerations of MAPPs”

Putting Patients at the Centre – The Ethical and Legal Considerations of MAPPs
By Paul Robinson of Merck Sharp & Dohme

One of the key factors in the future success of any MAPPs implementation will be the need for continuous monitoring, in health data registries, of how patients respond to new therapies. On January 17th, 2017, the ADAPT SMART consortia hosted a multi-stakeholder workshop to explore the ethical and legal considerations of MAPPs and the uncertainties of patients. The workshop covered several topics including the use of patient data in registries.