Description
Pre-Congress event:
This one-day multi-stakeholder consensus conference will take place the day before EASL Congress 2025.
This event organised with patronage from the main scientific societies in hepatology aims to integrate the current knowledge in endpoints for therapy management in PBC, the role of real world evidence, and provide a new framework for ongoing and future clinical trials.
The primary goals of this consensus conference are:
- to identify the key scientific, clinical, and regulatory needs to advance the development of reliable surrogate endpoints;
- to reach a clear consensus on how to use real world evidence to design confirmatory clinical trials in PBC.
Date and time: 6 May, 9:00-17:30 CEST
Steering Committee: Marco Carbone, Christophe Corpechot, Claudia Couto, Bettina E. Hansen, Gideon Hirschfield, David Jones, Cynthia Levy, Ana Lleo, Alejandra Villamil, and José Willemse.
Registration:
Registration is required to attend the pre-congress event “Consensus conference: surrogate end-points and real world evidence in PBC”. Please note that the pre-conference event is only accessible for onsite participants. There will be no live-stream available and online delegates will not be able to attend.
Registration fee:
EUR 102.85 (EUR 85 plus 21% Dutch VAT)
Registration process:
- Go to the EASL Congress 2025 registration platform.
- Login with your account or create a new account.
- Select “Individual Registration”
- Click “Next” to accept the Terms & Conditions.
- Select “Register or book tickets for yourself” or “Register or book ticket for someone else” to proceed.
- Select “Participant type”. Add your EASL Membership number if appropriate, and click “Choose tickets” to proceed.
- Add “discount code” if applicable, and click “Next” to proceed.
- Select tickets:
- If you wish to register for both EASL Congress 2025 and the pre-congress event “Consensus conference: surrogate end-points and real world evidence in PBC” please select both tickets.
- If you have already register for EASL Congress 2025 or wish to only register for the pre-congress event “Consensus conference: surrogate end-points and real world evidence in PBC” please only select the applicable ticket.
- Complete all other required fields and proceed to payment to confirm your registration.
Questions:
For registration queries, please contact: EASLcongress.registration@easloffice.eu
Learning objectives
- Review current trial design and end points, and the need for agreement on best study designs.
- Review the role of real world evidence in PBC and how to design and use prospective data collection. Analyse the possibility of collaborative data sets; how can they be used agnostic to a specific drug.
- Understand the views of providers, regulatory agencies and patients about criteria for defining clinical benefit and potential regulatory approval.
- Develop a consensus statement based on multi-stakeholder input about best approaches to ensuring a diverse range of therapies for patients.
Methodology
Pre-conference: Define working groups and leads for each group; define literature review for each group and summary of data with voting questions.
During the Conference: present findings of groups and allow for open discussion.
In principle, the panel would explore achieving a community consensus agreement, although in special circumstances a majority decision might prevail. In these cases, a minority report will be included in the document.
A final document capturing potential changes will be prepared for submission to Journal of Hepatology by the end of 2025.
Target Audience
- Health care providers (physicians, nurses, physician associates
- Statisticians
- Real world data experts
- Patients and patient representatives
- Government/Regulatory Representatives
- Industry
- Pharmacists
- Fellows/Trainee