An editorial by Nicola Bedlington, EPF Secretary-General and Magda Chlebus, EFPIA Executive Director, Science Policy and Regulatory Affairs 

Nicola Bedlington

The patient engagement (PE) landscape is changing – fast. Momentum has gathered behind the concept of PE in recent years, demanding new processes and tools to ensure ‘structured, effective, meaningful, ethical, innovative and sustainable’ collaborations.

Magda Chlebus

You may recognise the quoted phrase above as the mission of the IMI-PARADIGM project. 2018 saw the launch of this 34-member consortium dedicated to delivering what stakeholders need in several key areas – research priority setting, the design of clinical trials, and early dialogue. As we reflect on our work so far, we are grateful for the tremendous contributions of our active partners, without whom the work would not have been done so efficiently and with such high quality – all in collaboration and co-creation. The amount of work completed is prodigious and provides a strong foundation for the work we will continue in 2019.

Many of the key building blocks are in place. Workstreams within PARADIGM are now up and running with concrete goals and deadlines coming over the horizon. We are particularly grateful for the input of the PARADIGM International Liaison Group (PILG) that acts as advisors but also co-creators of the PARADIGM outputs. We appreciate greatly the work of the Ethics Expert Panel which participates in the daily work, the external experts that are currently taking part in the Delphi process, the respondents to our online survey, the patient advisors, as well as the wider community following our journey via social media channels like Twitter and LinkedIn.

2019 will be an even bigger year. As we look ahead to the next steps in our shared adventure, we see a year punctuated with many outcomes, milestones, webinars and workshops. With 20 months remaining, this is the year for PARADIGM to rise to the challenges PE is facing today.

In 2019, we will have the first versions of the tools that we are developing, minimum criteria for PE, recommendations for capacity and capabilities in PE, the assessment and monitoring framework, the sustainability roadmap and more. In the spirit of engagement, the most relevant documents will be opened for consultation to the wider community.

The 2nd Open Forum on Patient Engagement, our flagship event with the objective of providing a holistic perspective on patient engagement, will be organised in September 2019. This fits our vision of bringing together the pieces of the PE puzzle that have, for too long, been scattered across the medicines development landscape. Stay tuned for more information later this spring on how to join us at the Open PE Forum!

Our responsibility, as co-leaders of this project, is to drive the PARADIGM consortium members to be agents of change for patient engagement in medicine R&D. The field cannot wait any longer, and it will take every ounce of our collective energy to deliver for the PE community in the year ahead. We are ready – are you?

We needed you all in 2018 – and you were there. We will count on you again in 2019.

Magda and Nicola