Author: Teresa Finlay, Postdoctoral Researcher, IRIHS Research Group

DIA Europe, a member of the PARADIGM International Liaison Group, held its annual conference in Vienna in early February. I quickly forgot the sun glinting on the Danube and biting cold when the impressive programme commenced. Structured around seven tracks concerning medicines research and development, the overarching theme that prevailed at conference sessions was change, its realities, its impact and management. I was fortunate to be able to attend the conference courtesy of one of PARADIGM’s industry partners, MSD, and with the IMI-PARADIGM project in mind, I focused on sessions related to patient engagement.

Informed patients and patient engagement:

A powerful opening keynote set the scene for conference with the patient engagement theme as Dave de Bronkhart shared his experience as cancer patient and survivor. He described how conventional assumptions about patients are “broken” as people now have access to information and support from numerous sources via the internet. Coupled with their motivation and focus on their condition and its treatment options, access to information has changed patients forever; they are now co-producers in healthcare research and delivery and need to be welcomed as equal players.

Dave’s key note set the stage for sessions with a patient engagement focus; this came most emphatically from patients themselves and patient advocacy groups. There were repeated calls for patients to be included in collaborations across the entire span of R&D, from early discussions about research ideas through to regulatory approval. Vivid illustrations of the challenges patients face included those from Dimitrios Athanaiou of the World Duchene Organisation and Rocco Falchetto of the International Porphyria Patient Network. Along with Richard Stevens from the National Cancer Research Institute in the UK, they highlighted the importance of patient advisors being suitably trained for engagement. As Dimitris put it, “drugs are not approved by emotions, drugs are approved by data”. This point was supported by the sessions involving EUPATI at which their patient training programmes were outlined; Jan Geissler of EUPATI took this further suggesting that all stakeholders involved in medicines R&D should be trained for patient engagement.

Disruptive digital technology

Much was promised for the future in presentations about technological advances. Currently, these mostly relate to digital technologies such as Roche’s chatbots, which are being developed to provide product information for patients and health care professionals. Artificial Intelligence (AI) and real-world datasets were also described as having significant capability for next steps in medicines R&D because “we need health data like we need blood”. However, the tensions inherent in data collection and use were acknowledged; the need to develop trust in AI and machine learning is crucial. Patients may be eager to share data (whether individually online or in research studies) but they are uncomfortable with commercialisation of it as the care.data incident in the UK’s NHS showed.

Tensions and change

This point is an example of the tensions that were also evident at DIA Europe this year. There was palpable frustration from some for whom innovation is the norm and regulatory processes are seen as obstructing development. Whilst safety and ethical conduct are the gold standard, others interpret the need for consensus and the process-driven nature of pharma R&D and regulatory bodies as hindering technological developments that are already available in other (non-health) sectors.

There were also tensions between the need for change in terms of patient engagement that numerous speakers called for and the perception of limitations imposed by industry and regulatory processes. Many industry speakers referred to ‘patient-centricity’ but it was also observed that “everyone is more patient centric than others but where’s the beef?” implying that patient engagement is still tokenistic in many areas. It appeared clear that patient centricity and patient engagement are two different concepts, though probably too often used interchangeably. The degree of engagement implied by talking to patients did not always match the “super-patient”/co-producer that de Bronkhart embodies.

Everyone recognised change as being necessary in order to develop drugs and interventions that patients need. Different groups’ views of change may need to be reconciled for the potential scientific discoveries of the future to be acceptable and accessible by patients. Some expressed the view that inertia and the need for consensus slow down change whilst conversely the need for collaboration and asking “the right” questions were repeatedly highlighted, particularly in relation to Patient Engagement.

The impact of Patient Engagement was stated by Matt Cooper of the UK’s National Institute for Health Research as “the holy grail” hinting at the potential for the IMI-PARADIGM project outputs to come. Our poster demonstrating the findings of our literature review on metrics and evaluation of patient engagement was on display at the exhibitor stands and outlines the first step in our project to develop a framework for evaluating patient engagement to show the “return on engagement”.

With increasing emphasis on engaging patients in medicines R&D set in stark contrast to AI technologies that mine online content for pharmacovigilance because “it’s fair game”, the future will be interesting.

PARADIGM Poster presented in the conference on the subject of “Monitoring and Evaluating Patient Engagement in Medicines Development: How literature informed a draft evaluation framework.” Click to find out more.