The following 2 abstracts (outlines) were sent for review by RWE Collaborative SIG members Feb 8th, 2023 (via email) and have been endorsed by the RWE Collaborative SIG for submission at ICPE 2023. Abstract proposers have received comments provided by SIG members:
1) Title: Many minds spring many ideas – the power of collaboration (final title to be confirmed)
Authors, speakers:
Donna Rivera, Christina Mack, Hu Li, Montse Soriano Gabarro and ISPE liaisons from the following organizations: Duke-Margolis RWE Collaborative, ASCO/FOCR, ENCePP, DIA, Get Real, CIOMS, ICH
Background:
The ISPE RWE Collaborative Special Interest Group (SIG) promotes global knowledge exchange of scientific ideas focused on real world data (RWD) collected in routine clinical practice from a variety of sources, and on its use to generate real world evidence (RWE) regarding the use, benefits, and risks of medical products. The RWE Collaborative SIG provides an interactive forum, in collaboration with other external initiatives, to discuss RWD and RWE including study designs and methodologies needed to conduct and interpret these studies appropriately through pharmacoepidemiology. This session is intended to meet the SIG objectives as an interactive global forum to discuss RWE to enhance knowledge sharing between members across academia, government, regulators, payers, service providers and the pharmaceutical industry.
Objectives:
- Introduce the role and activities of the new ISPE RWE Collaborative SIG, encourage discussion, and engage members in initiatives and deliverables
- Highlight how the work of the RWE Task Force and RWE Collaborative SIG is enriched and enabled through strategic collaborations with other external organizations through each ISPE Liaison
- Illustrate through case examples the criticality of identifying synergies between groups and facilitating communication and crossover
2) Title: Scaling-up real world evidence generation for regulators in Europe: DARWIN EU
Authors, speakers: Daniel Prieto-Alhambra, Katia Verhamme, Edward Burn, Juan Jose Abellan, Daniel Morales, Andrej Segec, Montse Soriano Gabarro, Patrick Ryan, Robert Platt, and Peter Rijnbeek
Background:
The Data Analysis and Real World Interrogation Network (DARWIN EU®) was initiated in February 2022 as a federated data network generating reliable, reproducible and fast evidence to inform regulatory decision-making on the safety and effectiveness of medicines in Europe. DARWIN EU will also serve as pathfinder to the development of the European Health Data Space.
Objectives:
- Describe the aims, methods, and principles behind the setup of DARWIN EU® after its first year
- Learn about the logistics, first onboarded data partners, the approved catalogue of standardised analytics, practices underpinning the programming of analytical pipelines, and first completed studies
- Describe how DARWIN EU® aims to become transformational for the evaluation of medicines in Europe
- Provide perspectives on the utility and future challenges and opportunities of DARWIN EU when fully operational