An editorial written by Mathieu Boudes, EPF, coordinator PARADIGM and Alexandra Moutet, UCB, member of the PARADIGM Steering Committee

PARADIGM is a public-private adventure of 30 months, to advance patient engagement in medicines R&D. Due to years of advocacy and successes from patient organisations and others, the topic of patient engagement, especially in R&D and clinical development, is a trendy topic that is being addressed around the world. It is clear that PARADIGM does not operate in a vacuum, and that there is a strong willingness from many actors to make patient engagement a greater reality. Due to its focus, nature and lifespan, PARADIGM cannot afford to duplicate the work of others and needs to trigger as many operational collaborations as possible. This is not about collaborating for the sake of it, it is a genuine interest to engage within a coalition of the willing. It was with this in mind that the PARADIGM International Liaison Group (PILG) was devised, created, and rolled out.

In short, the PILG is an exchange and, when appropriate, a co-creation hub acting as an operational platform to connect PARADIGM with like-minded initiatives. These include key Innovative Medicine Initiatives and other international efforts focused on the co-development and implementation of patient engagement practices in medicines development.

The PILG enables synergies – such as the identification of existing practices – aligned with PARADIGM’s scope. It helps to reduce fragmentation and duplication while ensuring that PARADIGM outputs are aligned with the mission and vision of members. This will enhance their uptake and future implementation. Where appropriate, the PILG also provides external guidance on the relevance of PARADIGM strategic objectives and deliverables (see the PILG Charter here).

The PILG supports the members of the PARADIGM consortium to create a well-defined roadmap addressing the strategic and operational needs and resources for patient engagement, focusing on the three phases targeted by PARADIGM:

  1. research priority settings
  2. design of clinical trials
  3. early dialogue with regulatory and HTA bodies

This will help to align patient engagement initiatives across the entire PILG membership, create synergies to make patient engagement happen, and support PARADIGM in elaborating and evolving existing guidance for patient engagement with the pharmaceutical industry and others. For example, several members of the PILG are engaging with a specific task of PARADIGM, aiming to build a consensus around priorities on criteria needed to make patient engagement practices more actionable for all.

On a more strategic level, the PILG is instrumental in providing advice to PARADIGM in developing relationships with key international players relevant to patient engagement in R&D. It establishes an international vision on patient engagement, on the global relevance of PARADIGM results and on the uptake and implementation of PARADIGM outcomes in an international setting.

So as not to overburden any member, the operation and governance of the PILG is meant to be informal, agile and as lean as possible to focus on the content and not bureaucracy. The overarching theme is to make patient engagement a greater reality, not add to the paper trail!

The PILG is composed of senior representatives of the following organisations and initiatives:

  • International Children’s Advisory Network (iCAN)
  • DIA
  • European Patient Academy (EUPATI)
  • National Health Council (NHC)
  • International Society For Pharmacoeconomics and Outcomes Research (ISPOR)
  • Patient Focused Medicines Development (PFMD)
  • TransCelerate BioPharma Inc.
  • PREFER (IMI project)
  • BD4BO PROGRAMME (IMI) – represented by the WP4 of DO-IT
  • NICE
  • Clinical Trials Transformation Initiative (CTTI)
  • FasterCures
  • Children Tumor’s Foundation (CTF)
  • International Consortium for Health Outcomes (ICHOM)
  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • External experts such as Dr Violeta Stoyanova-Beninska from the Medicine Evaluation Board and chair of the Committee for Orphan Medicinal Product at the EMA and representatives from PCORI.

It goes without saying that all members of the PARADIGM consortium acknowledge the contribution of the PILG members, working pro-bono in the context of PARADIGM and thank all the members.