The DIA (Drug Information Association) 2018 Global Annual Meeting took place recently in Boston. This unique event gathered together over 6,000 professionals in the pharmaceutical, biotechnology, and medical device communities from more than 50 countries.

DIA has provided a global yet neutral stage for collaboration to address healthcare challenges for more than 50 years. The Global Annual Meeting gathered stakeholders from across the world to openly knowledge share, generating insights beyond boundaries to advance innovation in healthcare product development and lifecycle management globally.

The event was designated ‘Patients Included’ and ‘patient engagement’ was one of the 12 themes of the meeting. Indeed, PE was the theme of 15 sessions during the meeting, including a DIAMOND session on Global Perspectives on Patient Engagement that I had the honour of chairing.

The most directly relevant sessions to PARADIGM were about (i) Patient-Focused Medicines Development (PFMD): where it has led us to today, what challenges remain, and what do we still need to do to achieve success?, (ii) beyond adult patients, untapped advisors in clinical development: adolescents, parents, siblings, and spouses and (iii) measuring the impact of patient engagement, what to ask depends on who you ask. There was much of interest with discussions focusing on the nature of the relations between patient organisations and sponsors, the role of patient organisations in benefice-risk assessments and patient-relevant outcomes; and incorporating the perspectives of patient representatives in the US Food and Drug Administration’s (FDA) Medical Product Development and Regulatory Decision. The later session mentioned the draft guidance document on the FDA flagship initiative PFFD for ‘Patient-Focused Drug Development’: Collecting Comprehensive and Representative Input Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders. This includes recommendations for sponsors that look to incorporate patient experience data and other patient-focused information into their drug development programs. The guidance also provides recommendations for both qualitative and quantitative research methods for analysing patient experience data. The next guidances in the series will focus on what questions to ask patients and caregivers and how to ask them, how to decide what patient-focused outcomes to measure in a clinical trial, and how to determine an appropriate clinical trial endpoint using a patient-focused clinical outcome assessment.

The DIAMOND session on the Global perspectives on Patient Engagement was a great moment to hear about the current state of patient engagement, to shine lights on the drivers and denounce its barriers from regions of the world that are less present on the patient engagement map. The panellists included:

  • Dr Junko Sato, PhD, office director of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
  • Young Jack Lee, CEO of LSK Global PS from Korea
  • Ji-eun Lee, assistant Director of the Ministry of Food and Drugs Safety in Korea.
  • Durhane Wong-Rieger from the Canadian Organization for Rare Disorders, Rare Diseases International and Chair of Consumer Advocate Network; and Past-Chair, International Alliance of Patient Organizations (IAPO); Co-Chair, HTAi Patient / Citizen Involvement Interest Group.
  • Jan Nissen, acting VP, Patient Innovation and Engagement at Merck & Co, Inc.

This very dedicated pool of panellists explored the drivers of patient engagement in medicines R&D, finding that unsurprisingly there are commonalities as to how to provide the best medicines to the patients who need them. The panel agreed this goes through the understanding of the needs and aspirations of the patient communities. Interestingly, due to differences in the  maturity of patient engagement in some regions of the world, the focus sometimes differs from more political advocacy actions, to patient experience to, for the more experienced, co-design of clinical trials and strong involvement in medicines development.

The panellists also discussed the cultural barriers for not engaging patients. In Japan and Korea, the strongest barrier is the  respect and deference from the patients to the medical community, which often hampers their ability to take a stance and speak louder about their own needs. This is reflected in a less-structured patient engagement world.

At the end of the discussion, our Asian colleagues touched on and regretted the persistence of the feeling of shame of being a patient preventing engagement with other stakeholders. The representatives from North America and Europe echoed these concerns, despite acknowledging that significant progress has been made in the last decades in overcoming this ostracization of the patient community thanks to the continuous and ongoing efforts of patient organisations.

In summary, this lively and productive discussion illustrated that while progress still needs to be made, efforts by the patient community and the recognition from stakeholders have helped to significantly move the needle towards sustainable, meaningful, ethical and systematic patient engagement in patient engagement.

PARADIGM is playing its part with all initiatives that are active in this field or instance, DIA and PFMD are members of the PARADIGM International Liaison Group (PILG), an informal group of initiatives that support the work of PARADIGM aiming to avoid non-affordable duplication and seek synergies. The PILG is composed of volunteering organisations carrying activities in the field of patient engagement and is an advisory and engagement element of and for PARADIGM.

The next meeting organised by the DIA of great interest to PARADIGM will be the European Meeting in Vienna next year; one of the DIAMOND sessions will be about “Patient engagement as a strategic imperative in therapeutic innovation- let’s look at current thinking on ‘return on engagement’”. The European Patients’ Forum, through its Secretary General Nicola Bedlington is working with the DIA as part of the Programme Committee to make it THE session to the meeting to not miss! Stay tuned.