s the call for meaningful and impactful patient engagement grows stronger, so does the push for an increasingly empirical approach to address the topic. In 2018, we continued to drive the movement towards evidence-based patient centricity and engagement across the entire healthcare ecosystem.

• We released new findings of our 2016 multi-phase research study on patient-centric initiatives in drug development conducted in partnership with Tufts University. Published in DIA’s peer-reviewed journal Therapeutic Innovation & Regulatory Science (TIRS), the article Measuring the Impact of Patient Engagement and Patient Centricity in Clinical Research and Development describes patient engagement metrics and their use in determining return on engagement.
• Kick-off of Phase II of the study, called “Assessing Patient Centricity Preparedness, Capability, Experience, and Impact.”
• Five key DIA events provided a platform for patients and other stakeholders to share fresh, multi-faceted insights on meaningful patient engagement.
• We incorporated patient engagement concepts for industry into the DIA Learning portfolio with the release of the new eLearning module Introduction to Patient Engagement in Drug Development. Also this year, two new drug safety courses were released and included specific concepts on incorporating patient perspectives into these aspects of drug development and lifecycle management: Benefit-Risk Assessment and Management Across the Lifecycle, and Safety Risk Communication for Medical Products.
• The DIA Patient Engagement Community (PEC) continued to expand its membership as well as its global presence with the start-up of a new chapter in Japan.

Why we care: At DIA we have long recognized the important role patients play in shaping the care they need. Involving patients in therapeutic product R&D and developing methods to characterize the impact of patient feedback and return on engagement helps drive the development of better healthcare products and therapies that deliver meaningful health outcomes.

Together with Tufts University we spearheaded a collaborative, multi-phase research project in 2016 to gain insights into patient-centric initiatives in drug development and their impact on health outcomes.

• The recently published article in TIRS presented a comprehensive list of metrics derived from the analysis of nearly 125 use cases assessing overall return on engagement of patient centric initiatives (PCIs) to both the organization and the patients. Advocacy group support and involvement, conducting patient advisory panels, and focus groups were examples of PCIs with lowest cost and largest impact with respect to quality, speed, and impact on the patient compared to other PCIs. The initial set of standardized return-on-engagement metrics resulting from Phase I of the study have been compiled within a toolkit that can serve as a reference and starting point for building additional measures.
• Phase II of the study includes about 20 biopharmaceutical companies ranging from small, specialized to large multi-nationals organizations that are headquartered predominantly in the US, Europe, and Japan. Through a collaborative, consensus-based process, the study group developed a comprehensive assessment tool that was pilot-tested and validated in a subset of the study companies. The assessment process will examine preparedness, capabilities, experience, and use of impact measures in five broad areas within participating companies. Aggregated results will be used to establish preliminary benchmarks for biopharmaceutical companies striving to develop and strengthen their patient centric efforts.

In 2018, five key DIA events brought patients together with other stakeholders to determine steps necessary for meaningful patient engagement:

• In a panel discussion at the DIA Europe 2018 Meeting in Basel, patient, industry, regulatory, and HTA representatives discussed recent successes for collaboration among these stakeholders throughout the medicines lifecycle and sticking points to overcome as their partnerships continue to evolve (Patient Centricity: Beyond the Talk).
• The patient engagement DIAmond session at the DIA 2018 Global Annual Meeting in Boston convened patient, regulatory, and industry experts from Asia, Europe, Latin America, and the US to discuss the current state of patient engagement in their respective regions and ways to encourage advancement in Global Perspectives on Patient Engagement.
• For the first time in 2018, we built a patient engagement theme into the 10th DIA China Annual Meeting in Beijing, featuring a DIAmond session on “Patient Initiatives – Global Perspective” as well as two forums on the role of patient groups in rare disease therapy development.
• Throughout the year we addressed the issue of unmet medical need, beginning with an examination of the definitions of unmet need and its role in regulatory and pricing decision making at the DIA Europe 2018 Meeting. A 4-part workshop at the DIA 2018 Global Annual Meeting further explored this topic. Its findings are summarized in a peer-reviewed article that is currently in preparation.

• Building on the 2017 fall workshop, the “Patient Included”-accredited two-day workshop on Measuring Impact in Patient-Centered Drug Development was the second offering on metrics for patient-centered efforts in medical product development. For those newer to the field, we also offered a pre-conference short course to provide a foundation for building evaluation measures early into patient engagement initiatives.
• The 15th DIA Japan Annual Meeting in Tokyo offered in-depth content from the perspective of multiple stakeholders on topics such as empowered patient involvement in clinical trials, patients’ communication needs in clinical trials, and strategies to improve drug literacy of Japanese citizens.

In recent years, patient partnerships in healthcare product development have flourished as a direct result of the confidence and sense of autonomy patients have gained. To drive this positive movement forward, we are now collaborating with more than 30 patient-focused organizations via the International Leadership Group (PILG) of the new Innovative Medicine Initiative (IMI) PARADIGM (Patients Active in Research and Dialogues for an Improved Generation of Medicines). Our goal is to provide a framework for meaningful, impactful, and ethical patient engagement throughout three key decision-making points in the life cycle medicinal products: research priority setting, clinical trial design, and early dialogues with regulators and HTA bodies.

Starting with the DIA 2018 Global Annual Meeting in Boston, we continued to offer “Patients Included” conferences in 2018. Meeting all five clauses of the Patients Included Conference Charter, patients are involved as active contributors to the conference program. The Global Annual Meeting, for example, featured a dedicated Patient Engagement track with 14 sessions, and in the remaining 11 tracks of the conference we included patient-focused content as part of numerous sessions, content hubs, and roundtable discussions.

Membership in the DIA Patient Engagement Community (PEC) has also grown in 2018. Today, over 250 DIA members representing patients and patient groups, industry, academic, and regulatory agencies participate in the activities of the PEC. Ten of these members are part of DIA Japan’s new regional branch of PEC founded in 2018.