Just like Rome, PARADIGM wasn’t built in a day. Rather it was borne out of a desire to systematise the many patient engagement efforts that had begun to proliferate in this new era of patient-centredness within medicine R&D and healthcare delivery.

The PARADIGM consortium and its mission is the most recent manifestation of the work being done in the patient engagement arena. All partners have a proven track record in the area, and have been willing to bring their individual knowledge and expertise to the project.

Magda Chlebus, Executive Director of Science Policy & Regulatory Affairs at EFPIA, explains that PARADIGM came about in a spirit of true collaboration.

“There are many people who had been doing a lot of exciting things around patient engagement, we cannot do that in isolation, we have to share. We need to ensure that people do not have to go through the ‘trial and error’ stage, reinventing the wheel or making mistakes.”

This will also aid in making patient engagement within the medicines development process the norm, rather than the exception throughout the entire ecosystem, she adds.

“It is not yet in people’s DNA and we have to make sure that we facilitate upscaling and implementation of these good practices in companies and in our partner’s research such as academia or non-pharmaceutical companies. If we have good practices that work we need to ensure people know about them, and make them available to anybody who is embarking on that journey.”

Chlebus adds that the Eurordis Black Pearl Award that EFPIA and the three co-leading companies (MSD, UCB and Bayer) received in February 2018 for setting up the foundations of PARADIGM, set the bar for the project extremely high before its formal beginning.

“Were we nervous? Yes, we were: we’ve designed a very ambitious programme of work for just 30 months, that implied co-creation with many stakeholders and communities, and in full knowledge that in all large consortia the start up phases tend to be slow. The expectations from the patient community are also very high: after EUPATI, which empowers patients, PARADIGM is facilitating access to tools which would make patient engagement to happen in practice.”

Yet the path for success was paved during preparation of the original joint proposal, she explains. “We established open dialogue between all partners, culture of challenge and care. And we started very early to walk the walk; co-creation and engagement are not empty words: the website is running, the foundational survey is available in several languages allowing all stakeholders to give their insights and we opened up to other international initiatives with similar focus.”

According to Nicola Bedlington, Secretary General of the European Patients’ Forum (EPF), the Forum chose strategically to co-lead this initiative, partly because of the success of EUPATI.

“EUPATI was another IMI project in 2011 that was due to last five years but it became so successful and so crucial that we actually integrated it as an EPF programme.”

She explains that EUPATI is all about patient education; understanding the therapeutic innovation process, and how medicines development actually happens.

“This enables patients to be engaged in the most effective way possible due to that backdrop of knowledge – so they can come to the table with their own expertise in a confident and assertive way,” she says.

Yet while EUPATI focused solely on education, education without engagement is “meaningless” and vice versa, Bedlington notes.

“It was clear there was this logical gap for more structured and systematic engagement. There were very good examples of this work being done, but very much in an ad hoc, piecemeal fashion. There was a real need for more conversations between the stakeholders, more  joint working and more reflection on the metrics of patient engagement.”

PARADIGM has sought to formalise this. “This is what PARADIGM is all about, joining the dots and co-creating with other stakeholders,” she explains. “We are building a framework that we can all identify with, but also the tools and resources that will make patient engagement easier and more effective. I really believe that PARADIGM is filling a major gap for all the players concerned – it is important for the regulators, it is important for the HTA community, it is important for industry and obviously for patients and their voice coming through the entire process.”

EPF’s Mathieu Boudes, coordinator of PARADIGM, agrees with Bedlington and Chlebus with respect to PARADIGM’s mission to build on the good work being done in patient engagement. “We want to make it systematic and efficient and sustainable.” He explains that the first step of the project is to garner a deeper understanding of what the current state of patient engagement is, as well as the aspirations of all the stakeholders.  

“From this we can derive criteria to assess guidance tools that already exist and assess those against the aspirations of the stakeholders. We know that by doing this we are going to identify gaps, and we need to fill those gaps.”

PARADIGM will provide actionable templates on patient engagement that can help those active in the field, whilst developing metrics to measure the return on engagement, from the perspectives of all the different stakeholders – not just pharma, Boudes outlines.

“Nobody has those tools as of yet. We are trying to effect a cultural change and a shifting mindset. This is a key milestone because we are moving from the early adopters and believers to the mass implementation of PE practices, and we need to be able to measure them.”

While the 30-month timeframe of the project is relatively tight, the goal is to make PARADIGM’s outcomes as sustainable as possible, he adds.

“We want to develop a sustainability model – not just the tools, but also the concept. The overall goal is to move from a system of one-to-one interactions towards something more integrated and coherent and provide that roadmap for sustainability.”

Moving from advocacy to implementation is always a challenge, and Boudes admits that tight management is a key success factor for this kind of project involving 34 partners with different cultures and backgrounds.

“It will have a long term impact because what we develop should have the buy-in from most of the stakeholders involved, and that’s not something the rest of the initiatives in this space have. This reinforces the credibility and durability  of the tools we will develop.”

Yet Boudes is also keen to stress that there is a lighter side to the consortium – despite the varied backgrounds and focus of the different stakeholders, they are working together well. “Even though what we are trying to do is serious, we are doing so in a fun spirit.”