STAKEHOLDER WORKSHOP

08, 22, 26 & 29 October 2020

Join us in shaping the future of clinical trials

The EU-PEARL project and the IRP regulatory, methodological and operational framework

The initiative ‘EU Patient centric clinical trial platforms (EU-PEARL) aims to enable a transformation of drug development through multi-sponsor, multi-compound Integrated Research Platforms (IRPs). An IRP is a novel clinical development concept centered around a master protocol trial that can accommodate multi-sourced interventions, using an existing infrastructure of hospitals and federated patient data, and an agreed, optimized regulatory pathway. EU-PEARL will design platform studies in four diseases areas: Major Depressive Disorder, Tuberculosis, Non-Alcoholic Steatohepatitis and Neurofibromatosis. It will also provide the framework for designing and executing IPRs in other disease areas.

 

The EU-PEARL 1st Stakeholder Workshop

Creating a collaborative environment integrated by a diversity of stakeholders is vital to move forward on this innovative paradigm of IRPs. In this sense, EU-PEARL represents a unique opportunity for pharmaceutical companies, researchers, patients, and regulators to both be adaptive and work together effectively in a highly regulated context. EU-PEARL’s first Stakeholder Workshop has been designed to foster dialogue between the most relevant actors in drug development.

The Workshop aims to:

  • Introduce the EU-PEARL project, and IRP concept
  • Share learnings from prior and on-going platform trials
  • Obtain Stakeholder feedback regarding opportunities and challenges in conducting IRPs to advance the project, and begin shaping the future environment
The Workshop is organized along different sessions, in virtual format:

October 8th, 2020
2-6 PM CET/ 8AM-12 PM EST

EU-PEARL SWS introduction session

This general session will focus on the current and future states of platform trials and the related regulatory guidance. The concept of an IRP will be introduced. The EU-PEARL project along with other relevant case studies will be presented, followed by a panel discussion on current opportunities and challenges

October 22nd, 2020
3-6 PM CET/9 AM-12 PM EST

Breakout session ‘Multiplicity Framework for IRPs’

When and how to adjust for multiplicity in platform trials: What are the main sources of multiplicity in complex trial designs? Which error rates and methods are suitable for which study objectives & designs (and which methods are not)?

October 26th, 2020
3-6 PM CET/10 AM-1 PM EST

Breakout session ’Regulatory and Ethic Committee Considerations for IRPs’

Main issues to overcome for alignment on submission principles at various stages of an IRP (Initial submission, during trial execution and end of trial) and other relevant regulatory and ethical aspects of IRPs.

October 29th, 2020
3-6 PM CET/10 AM-1 PM EST

Breakout session ‘Patient engagement for IRPs’

Incorporating perspectives of patients and patient advocates on platform trials and IRP design, and understanding potential opportunities and hurdles.

The sessions will be hold in Zoom, it is recommended to install the Zoom client up front.

Please note, that the sessions will be recorded and used to write a public report.

Agenda

Please check the details of each session in the SWS agenda available here

Briefing material

Comming soon

For further information, do not hesitate to contact Anne Kaminski (AKamins2@ITS.JNJ.com) or Esther Arévalo (esther.arevalo@vhir.org).