Initiatives

Thought-leadership, innovation & collaboration in Real-World Evidence based decision making in healthcare

knowledge exchange

Shared Learning Forum

The shared learning forum is a neutral space where diverse stakeholder perspectives can explore transformative outcomes, shaping the future of evidence-based decision-making in healthcare.

We took the initiative to begin a dialogue with stakeholders to explore the need, design and proposed outputs for a multi-stakeholder shared learning forum for RWE. We engaged with regulatory and HTA experts, held discussions with the European Federation of Pharmaceutical Industries and Associations (EFPIA), convened a workshop with stakeholders and presented at conferences to solicit feedback.  These activities are a precursor to planning and implementing a shared learning forum concept.

Rationale

Preparatory Workshop – RWE Case Studies for HTA Decision-Making

Recommendations
Registry Design
  • Emphasise strategic design considerations for crafting registries for Health Technology Assessment (HTA) excellence and underscore the importance of early engagement with diverse stakeholders for improved decision-making in healthcare interventions
  • Prioritise data source agnosticism, good data provenance, and effective governance. Engage patients and clinicians in dataset design to ensure relevance and fitness for purpose
Registry Adoption
  • Promote widespread understanding of registry data as valuable evidence for health outcomes and healthcare decisions
  • Utilise registries for historical data collection, ensuring meaningful insights into treatment effectiveness and facilitating regulatory and reimbursement decisions
Multi-Stakeholder Collaboration
  • Facilitate multi-stakeholder collaborations to address challenges related to data quality, implementation, and ethical considerations
  • Address perceptions and misconceptions regarding registry data utilisation
Guidance & Standards
  • Champion the adoption of international guidelines and standards, leveraging comprehensive frameworks, to ensure transparent and globally aligned regulatory and HTA decision-making
  • Identify challenges and provide support towards implementing and adhering to standards
Funding & Sustainability
  • Support early investment in patient registries and their development to address evidence gaps in healthcare, and advocate for incentives to streamline data collection processes
  • Recognise the dynamic nature of registry implementation and address challenges related to data quality, consent for secondary data use, and ensure adaptability to evolving healthcare landscapes

Attendees

We had participation from 27 members from academia, HTA bodies, industry, patient organisations and regulatory bodies
University of Bordeaux
UMC Groningen/More-EUROPA
University of Oslo Faculty of Medicine
ALTEMS Universita Cattolica del Sacro Curore
Erasmus School of Health Policy & Management
Duke-Margolis Centre for Health Policy
NICE
TLV
CADTH
GenMab
Lane Clark & Peacock
IQVIA
Verily Life Sciences
Astellas Europe
AstraZeneca
BMS
Bayer
GSK
Takeda
EFPIA
EURORDIS
Cystic Fibrosis Europe
EMA

Outputs

Click on the images or the links below to download copies of the GetReal Shared Learning Forum Reports on RWE Case Studies for HTA Decision-Making.

The reports include:

GetReal Institute Shared Learning Forum | Report | Workshop Deep Dive
GetReal Institute Shared Learning Forum | Report | Workshop Summary
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