ecognizing the need to build reliable industry-wide capacity for systematic patient engagement, several multi-stakeholder initiatives have introduced patient engagement toolkits, training programs, and individual guidance over the past few years. This article describes key organizations, initiatives, and resources driving the convergence towards establishing systemic patient engagement capacity and operational practices. Stakeholders can access resources to pursue patient engagement credentials independently and to implement functions and practices within their organizations.

Key Takeaways

• Individuals involved in medicines development now can receive professional credentials in patient engagement.
• Organizations can transform culture towards patient-centeredness by leading the adoption of co-created patient engagement training, toolkits, and tools that value and reflect input from patients, caregivers, and advocates in operational activities, including compensation and contracting, protocol design, and quality measurements.
• Many of the trainings and toolkits are available now for free or at low cost to individuals and organizations to facilitate adoption, influence standard operating procedures, build capacity, and drive the culture shift towards a common view of patient engagement throughout medical product development.

Where to Find Comprehensive Patient Engagement Training for Industry, Patients, and Other Stakeholders

1. Educating Industry: DIA Patient Engagement Certificate Program

DIA began offering its first eLearning patient engagement training in 2018 and has continued to build its patient engagement online curriculum since that time. The program is designed for industry, regulatory agency, and Contract Research Organization (CRO) professionals working in, or new to, the medical product development process. DIA’s Patient Engagement Certificate Program provides the foundational knowledge and considerations needed to implement a successful patient engagement program, including the fundamentals about why and how to incorporate patient focus and build organization-wide capabilities.

This comprehensive training program is based on the DIA Patient Engagement Competency Framework developed with patient engagement experts from a cross-section of stakeholders, including representatives from large and small biopharmaceutical companies, CROs, and patient advocacy organizations. The Competency Framework outlines the functional knowledge and skills needed to incorporate meaningful patient engagement throughout the product lifecycle and embed patient focus into the culture of an organization.

Participants in the program earn digital credentials as they continue through the program’s six modules and certificate exam, culminating in the DIA Patient Engagement Certificate and corresponding digital credential. Enrollment in the Patient Engagement Certificate Program is free. Participants pay registration fees for the online courses and the comprehensive exam to complete the program.

2. Educating Patients: European Patients’ Academy on Therapeutic Innovation (EUPATI)

Funded by the Innovative Medicines Initiative in 2012, EUPATI aims to build capacity among patient experts and advocates to be effective partners with “relevant authorities, healthcare professionals, and industry to influence the medicines development process for the benefit of patients.” EUPATI offers a portfolio of online and face-to-face training interventions for individuals, teams, and organizations based on the Patient Engagement Roadmap. The Roadmap illustrates the areas to engage patients in producing deliverables from the start of the medicines development process, such as setting research priorities, designing meaningful protocols, ensuring informed consent, and reporting study results.

Training geared for patient expert and advocate audiences focuses on the overall processes of medicines research and development, and then individual “National Platform” training that localizes the content for language and individual country context. National Platform training for patient representatives is available for countries throughout Europe, and in development beyond Europe.

EUPATI’s Open Classroom is an extension of the EUPATI Patient Expert Training Program, which certifies patients and advocates as EUPATI Fellows, patient expert advisors for medicines development. The Open Classroom content is self-paced and available on demand for learners who register and pay modest course assessment fees. Participants earn digital badges and certificates with each course towards the ultimate certification as a EUPATI Patient Fellow.

3. Educating Industry, Patient Advocates, and Others: PFMD E-Learning Platform | Making Systematic Patient Engagement Happen

Patient-Focused Medicines Development (PFMD) is a global multi-stakeholder collaboration based in Europe and established in 2015 to “transform the way in which we understand, engage, and partner with patients globally in the design and development of research and medicines by focusing on unmet patient needs.” PFMD introduced its Patient Engagement E-learning platform in 2019 as part of its Patient Engagement Management (PEM) Suite of resources to help build capacity for systemic patient engagement. Sponsored originally by six industry partners and co-created with multiple stakeholders, including patient advocates, the PFMD curriculum is designed for a global audience of industry, advocacy, and regulatory professionals working across the drug development continuum, from early- stage research to post-marketing approvals. The collaboration was a finalist in the Reuters Pharma Awards in June, 2020.

PFMD’s online training program is free but requires registration. The program consists of three parts: an introduction, Level 1, and Level 2. The Level 1 training describes patient engagement and what it means to “get it right,” while Level 2 delves into practical next steps and strategies for practitioners. Learners earn certificates with completion of Levels 1 and 2.

Putting Patient Engagement Principles Into Practice with Toolkits and Tools

• contracting and establishing fair market value for patient interaction,
• calculating Return on Investment for patient engagement interventions,
• patient engagement in establishing quality measures, and
• clinical outcomes assessments.

DIA has maintained an active research program in partnership with patients and industry stakeholders since the launch of its first Patient Fellows program in 2006. DIA shares outcomes via publications and provides other tangible tools, including the DIA Considerations Guide for industry organizations. The Guide first describes the objectives of each process stage relative to building or advancing patient-centric initiatives in organizations, then provides questions to guide decision-making and resources to consult as organizations design and implement patient-centric initiatives.

The National Health Council (NHC) is a US-based patient advocacy organization made up of more than 140 national health-related organizations and businesses, whose mission is to “provide a united voice for the 160 million people living with chronic diseases and disabilities and their family caregivers.” NHC has organized, managed, and participated in several sponsored multi-stakeholder activities and collaborations to build consensus around patient engagement and to help standardize patient engagement operational practices across healthcare enterprises.

NHC’s Patient Engagement Toolbox consists of tools for Patient Compensation and Patient Contracting. It includes a Fair Market Value Calculator to help establish compensation to patients, caregivers, and/or advocates for their time and expertise in pharmaceutical and medical device development.

NHC has also convened multi-stakeholder working groups to create individual rubrics to guide the implementation and evaluation of patient engagement activities, such as:

• Patient Engagement Rubric: defines meaningful patient engagement processes and explains the domains for evaluating patient-centeredness.
• Patient Representativeness: offers a definition for “representativeness” and explores approaches for building representative sample populations.
• Patient Engagement in Quality Measurement Rubric: guides the integration of individual, family, and caregiver participation in the development of healthcare quality measures.

Similar to NHC in the US, EUPATI in Europe promotes a toolbox for patient engagement led by expert patients and advocates and co-created with diverse stakeholders. The EUPATI toolbox includes guidance documents and tools for industry-advocacy collaborations, including the use of Community Advisory Boards, managing conflicts of interest, establishing legal agreements, and monitoring and evaluating the success of patient engagement efforts.

Integrating Patient Engagement Specifically in Clinical Trial Activities

There are several organizations providing resources offering guidance and tools for patient engagement in clinical trial activities, from clinical trial awareness through protocol development and diverse patient recruitment.

The Clinical Trials Transformation Initiative (CTTI) is a consortium of more than 80 patient advocacy, industry, regulatory, and other organizations across the clinical trials enterprise with a mission to “transform clinical trials by 2030” toward a vision of patient-centeredness. Patient engagement is integrated throughout CTTI’s recommendations. Specifically, CTTI offers a prioritization tool to help patient groups and clinical research sponsors identify high-value opportunities to work together. In 2019, CTTI published recommendations for patient engagement in mobile clinical trials and has since compiled resources for adapting patient engagement in clinical trials during the COVID-19 pandemic.

The Center for Information and Study on Clinical Research Participation (CISCRP) is a nonprofit organization providing education, information resources, and events to inform the public, patients, medical/research communities, the media, and policy makers about clinical research and stakeholder roles in the process. CISCRP’s patient engagement resources include webinars, videos, brochures, surveys and research publications.

TransCelerate, a pharmaceutical industry consortium, published the Patient Protocol Engagement Toolkit (P-PET) Resource Guide to help clinical teams engage patients in the study design and execution stages of clinical development so that clinical trial protocols and operational plans produce meaningful and feasible patient experiences. The Resource Guide includes sample questions and visual aids that clinical teams can use to plan and conduct patient advisory boards and other interactions.

The Multi-Regional Clinical Trials Center (MRCT) of Brigham and Women’s Hospital and Harvard is an independent convening group that brings together multiple stakeholders to “deliver ethical, actionable, and practical solutions for the global clinical trial enterprise, with a focus on emerging economies.” MRCT has published tools related to Plain Language Summaries, Health Literacy, and a Community Resources site with brochures to support patient-provider conversations and shared decision-making about clinical trial participation. MRCT also produced “Achieving Diversity, Inclusion, and Equity in Clinical Research,” a free toolkit to improve representation in clinical research. The Toolkit offers logic models, key performance indicators, strategies, and initiatives to promote patient and community engagement.

Coming Together

Some co-created tools, such as the National Health Council’s (NHC) Fair Market Value Calculator described below, appear in multiple toolboxes. This is an indication of the drive towards consensus and standardization of patient engagement in global medical products development.

Those interested in operationalizing patient engagement in medical product development can find many of the tools and organizations mentioned throughout this article in the PFMD’s Patient Engagement Management (PEM) Suite. The PEM Suite is a “global hub” of co-created tools, resources, and practices that enable stakeholders to adopt patient engagement in a systematic, efficient, and meaningful way and to plan, assess, and execute patient engagement activities. In addition to the PFMD training described above, the PEM Suite provides links to how-to guidance and real-world examples of patient engagement activities across pharmaceutical development functions and phases. Topics include Patient Engagement in Early Discovery and Preclinical Phases, Clinical Outcomes Assessment, Protocol Design, Plain Language Summaries, Regulatory and Post-launch phases.

The suite also includes links to NHC’s Fair Market Value calculator and sample legal agreements for patient engagement, as well as to the Patient Engagement Network (Synapse). Synapse encourages patient engagement practitioners to document initiatives, resources and people across companies and countries in order to facilitate interaction and consensus-building among fellow patient engagement professionals. Practitioners are invited to comment on new resources prior to launch.

Finally, DIA’s Patient Engagement Community invites industry professionals, patients, and patient advocates and others interested in patient engagement to join monthly conversations around issues and strategies for advancing patient-centric practices in medical product development.

Conclusion