• 1996: INVOLVEINVOLVE was established 1996 and is funded by the National Institute for Health Research (NIHR) to support active public involvement in National Health Services (NHS) public health and social care research. As a national advisory group the role of INVOLVE is to bring together expertise, insight, and experience in the field of public involvement in research (PIR), with the aim of advancing it as an essential part of the process by which research is identified, prioritized, designed, conducted and disseminated.
  www.invo.org.uk was established as part of the National Institute for Health Research (NIHR) NIHR was established in 2006 under the government’s health research strategy Best Research for Best Health to “create a health research system in which the NHS supports outstanding individuals, working in world-class facilities, conducting leading-edge research focused on the needs of patients and the public”. Since that time, we have transformed research in and for the NHS and helped to shape the health research landscape more broadly. Our mission is unchanged: to improve the health and wealth of the nation through research. We deliver against this mission through five core workstreams.
  www.nihr.ac.uk, to support active public involvement in National Health Services (NHS), public health, and social care research. As a national advisory group, the role of INVOLVE has been to bring together expertise, insight, and experience in the field of public involvement in research (PIR) Patient Involvement in Research is defined as research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them, with the aim of advancing it as an essential part of the process by which research is identified, prioritized, designed, conducted, and disseminated. United Kingdom

NOTE: “PIR” is also referred to as Patient and Public Involvement (PPI) or Consumer Involvement.

INVOLVE later incorporated into the new NIHR Centre for Engagement and Dissemination, 2020.

CoPI: Public Involvement in Research (PIR)/Patient and Public Involvement (PPI), advisory panels

Context: Dissemination/knowledge translation

While not specific to rheumatology, including patients in the regulatory process paves the way for advances in therapeutic outcomes.

• 2000: The European Medicines Agency (EMA) EMA is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU www.ema.europa.eu invites patients as committee members and the Food and Drug Administration (FDA)Food and Drug Administration’s (FDA) evaluation of new medicines (United States). During clinical trials, researchers study whether new medicines are safe and effective for patients and whether the medicine’s benefits outweigh the risks.
  www.fda.gov expands the Patient Representative role to serve as consultants to scientific and regulatory reviewers.
• 2003: EMA expands to patient inclusion in working groups.
• 2005: EMA establishes their first collaboration framework for regulatory practices between EMA and patients and consumers and their organizations, which was revised in 2014. 
• 2006: The EMA establishes the Patients’ and Consumers’ Working Party (PCWP) EMA is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. The Patients’ and Consumers’ Working Party (PCWP) provides a platform for exchange of information and discussion of issues of common interest between EMA and patients and consumers. www.ema.europa.eu, which provides a platform for the exchange of information and discussion of issues of common interest between EMA and patients and consumers. The PCWP provides recommendations to EMA and its human scientific committees on all matters of interest in relation to medicines.

CoPI: Working groups, regulatory reviewers, consumer reviewers

Context: Regulatory process

Databanks and registries in the rheumatology community began actively collecting relevant data from patients that can be used in both non-pharmaceutical and drug development research efforts. However, most registries – while rheumatology in nature – typically only include patients as respondents.

CoPI: Co-production of stakeholder groups

Context: Registries

• 2005: Cochrane Musculoskeletal (CM)Cochrane Musculoskeletal (CM) is made up of health care professionals, researchers and consumer representatives that belong to Cochrane, an international, non-profit organization that aims to help people make well-informed decisions about health care by preparing, maintaining and promoting reviews on the effects of health care treatments. They produce reliable, up-to-date reviews of interventions for the prevention, treatment or rehabilitation of musculoskeletal disorders in the form of systematic reviews. CM is also dedicated to making our systematic reviews available to those interested in treatments for musculoskeletal diseases (dissemination). In 1993, they formed a Consumer Group (CMSG), enlisting patient systematic reviewers to join health care professionals and researchers belonging to Cochrane. Canada musculoskeletal.cochrane.org develops guidance for systemic review authors and for building partnerships in research.Consumer‐driven health care: Building partnerships in research, 2005. Shea B, Santesso N, Qualman A, Heiberg T, Leong A, Judd M, et al. Consumer-driven health care: building partnerships in research. Health Expectations 2005;8(4):352-9.
  musculoskeletal.cochrane.org
  Download PDF
• 2006: Cochrane Musculoskeletal Consumer Group (CMSG)The CMSG formed in 1993, enlisting patient systematic reviewers to join health care professionals and researchers belonging to Cochrane. “The feedback provides a layperson’s perspective to complement the feedback provided by our clinical experts.”musculoskeletal.cochrane.org develops initial recommendations to aid knowledge translation and exchange between clinicians and consumersSantesso N, Maxwell L, Tugwell PS, Wells GA, O’connor AM, Judd M, Buchbinder R. Knowledge transfer to clinicians and consumers by the Cochrane Musculoskeletal Group. J Rheumatol. 2006 Nov;33(11):2312-8. PMID: 17086612.. These were updated in 2014.
• 2008: Assessment of SpondyloArthritis International SocietyAssessment of SpondyloArthritis International Society is an international group of experts in the field of spondyloarthritis.
  asas-group.org/European Alliance of Associations for Rheumatology European League Against Rheumatism (EULAR) aims to reduce the burden of rheumatic diseases on the individual and society and to improve the treatment, prevention, and rehabilitation of musculoskeletal diseases.
  eular.org (ASAS/EULAR) collaborated with patients to translate recommendations for the management of ankylosing spondylitis for the first time into a language easily understood by patients.

CoPI: Advisory panels, consumer reviewers

Tools: Guidance documents – patient-researcher engagement; Recommendations – dissemination

Context: Systemic literature reviews, lay summaries, guideline development, dissemination (knowledge translation)

“Can I have a few moments of your time?”

Around 2009, pharmaceutical companies began realizing the benefits of patient involvement in research, but legal barriers minimized engagement. At this time, pharmaceutical companies did not have official patient-engagement branches, so outreach was often limited to patients they could access online (bloggers, social media influencers).

Since the immunology sectors of pharmaceutical companies had not yet formed patient engagement departments, conversations typically were not structured, casual phone conversations where patient advocates happily shared their opinions for no fee. By 2012, several companies began enlisting patient advocates to participate in advisory panels, in exchange for payment, but developed departments specializing in patient engagement in rheumatology did not become standard practice until a few years later.

CoPI: Advisory panels

Context: Research & Development

• 2011: Strategy for Patient Oriented Research (SPOR): Canadian Institutes of Health Research (CIHR) Canadian Institutes of Health Research played a prominent role in the launch, implementation, and oversight of SPOR, but represents only one in a multitude of partners.cihr-irsc.gc.ca.html establishes a Strategy for Patient-Oriented Research SPOR is a collaboration of researchers, patients, provinces and territories, health care professionals, and others – all working in partnership to integrate research into patient care, ultimately improving the health of Canadians. cihr-irsc.gc.ca (SPOR) to integrate evidence in all levels of the health care system.
• 2012: Patient Research Partner (PRP): Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) GRAPPA is organized exclusively for non-profit, educational, and scientific purposes, specifically to facilitate the sharing of information related to psoriasis and psoriatic arthritis, networking among different medical disciplines that see psoriasis and psoriatic arthritis patients, and to enhance research, diagnosis, and treatment of psoriasis and psoriatic arthritis.
  grappanetwork.org invites Patient Research Partners for the first time. In 2015, a team of Patient Research Partners was permanently added to round out their perspective first report from Patient Research Partner perspective:
  De Wit M, Campbell W, FitzGerald O, Gladman DD, Helliwell PS, James J, et al. Patient Participation in Psoriasis and Psoriatic Arthritis Outcome Research: A Report from the GRAPPA 2013 Annual Meeting. The Journal of Rheumatology 2014;41(6):1206-11.
• 2013: Core Outcome Measures in Effectiveness Trials (COMET)COMET brings together people interested in the development and application of agreed standardized sets of outcomes, known as ‘Core Outcome Sets’ (COS). These sets represent the minimum that should be measured and reported in all clinical trials of a specific condition, but COS are also suitable for use in routine care, clinical audit, and research other than randomized trials.
  comet-initiative.org & the International Dermatology Outcome Measures (IDEOM)(IDEOM) is a non-profit organization seeking to develop and validate measures throughout dermatology with an initial focus on psoriatic disease. They strive for the establishment of patient-centric outcomes to enhance the research and treatment of dermatological conditions. Launched in 2013, IDEOM seeks to bring together physicians, researchers, government agencies, pharmaceutical companies, payers, and patients from around the globe to develop and validate measures throughout the field of dermatology with an initial focus on psoriasis.
  dermoutcomes.org collaborate with Outcome Measures in Rheumatology OMERACTOMERACT is a global community for the development of Core Outcome Sets in the field of rheumatology. Patients participate as research partners in all phases of the research and are equal members in any OMERACT working group.
  omeract.org to adopt the patient-centered approach of developing core outcome sets with full involvement of patients.

CoPI: Patient Research Partner (PRP), Patient-Centered Outcomes Research (PCOR), Strategy for Patient-Oriented Research (SPOR), conference participant

Context: Clinical trials, assessing grant applications, Core Outcome Set (COS)

As the decade progresses, international efforts to expand the patient voice in rheumatology research continues. As a result, more programs that focus on patient-reported needs, guidance for involving patients in research, and reports that assess patient involvement emerge.

• 2013: Patient-Centered Outcomes Research Institute (PCORI)PCORI is an independent nonprofit, nongovernmental organization and was authorized by Congress in 2010. PCORI is the largest funder of comparative effectiveness research (CER) in the United States with the mandate to improve the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policymakers make better-informed health decisions. In addition to requiring patient and stakeholder engagement in PCORI funded research, PCORI also engages the public through its own institutional activities, such as Merit Review, which includes patients and stakeholders as reviewers of research applications, ensuring dollars spent are aligned with research outcomes that are meaningful to the patient population. www.pcori.org began the novel funding opportunity, Eugene Washington Engagement Awards ProgramThe Eugene Washington PCORI Engagement Award program, named in honor of the first chair of PCORI’s Board of Governors, is intended to bring more patients, caregivers, clinicians, and other healthcare stakeholders into the research process. The goal is to support projects that will build a community better able to participate in patient-centered outcomes research (PCOR) and comparative clinical effectiveness research (CER) and serve as channels to disseminate study results. www.pcori.org/engagement , which supports projects that will build a community better able to participate in patient-centered outcomes research (PCOR) and comparative clinical effectiveness research (CER) and serve as channels to disseminate study results. Example of award: Matching Actions to Needs: What Matters Most to the Arthritis Community? – Arthritis Foundation, United States
• 2014: Canada’s Strategy for Patient-Oriented Research (SPOR)Endorses the active partnership of patients, researchers, health professionals and decision-makers in research so as to build a sustainable and accessible health care system that optimizes the health of Canadian citizens. cihr-irsc.gc.ca publishes A Resource Guide for Research Teams and Networks , a living guide to support researchers, decision-makers and other relevant stakeholders involved in a wide range of SPOR-related activitiesThis resource aims to:
  1) Clarify key concepts and terms relevant to involving patients in health research such as what we mean by patients, the public and stakeholders, and the different levels and types of involvement, and the rationales and perceived benefits of patient involvement
  2) Describe, at a very high level, the current state of the evidence about patient engagement with respect to the effectiveness of different methods in relation
  to process and outcome measures
  3) Assemble in one place, a selection of resource documents collected from leading patient engagement organizations around the world to provide basic guidance for researchers about principles and methods for involving patients
  in health research. 
• 2014: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) is organized exclusively for non-profit, educational, and scientific purposes, specifically to facilitate the sharing of information related to psoriasis and psoriatic arthritis, networking among different medical disciplines that see psoriasis and psoriatic arthritis patients, and to enhance research, diagnosis, and treatment of psoriasis and psoriatic arthritis.
  www.grappanetwork.org publishes Patient Participation in Psoriasis and Psoriatic Arthritis Outcome Research report , co-authored by Patient Research Partners (PRPs)Patient Research Partner (PRP) is defined as a person with a relevant disease who participates or has participated as an active research team member on an equal basis with professional researchers, thus adding the value of experiential knowledge to a research project. After this publication, GRAPPA publishes annual patient reports through 2018.
• 2014: Cochrane Musculoskeletal Consumer Group (CMSG)Formed in 1993, enlisting patient systematic reviewers to join health care professionals and researchers belonging to Cochrane. “The feedback provides a layperson’s perspective to complement the feedback provided by our clinical experts.” musculoskeletal.cochrane.org updates recommendations to aid knowledge translation and exchange between clinicians and consumers .

CoPI: Patient Research Partners (PRPs), Patient-Oriented Research (POR), Patient-Centered Outcomes Research (PCOR)

Tools: Guidance – patient-researcher engagement;  Reports – patient researcher engagement, patient engagement, and dissemination; Instruments – patient engagement

Context: Patient-reported outcomes (PROs), Clinical Effectiveness Research (CER)/decision science, dissemination/knowledge translation

• 2013: PCORnet PCORnet is a national resource that offers the kind of research ecosystem that has long been pursued: a fully integrated network where vast, highly representative health data, research expertise, and patient insights are built-in and accessible from the very start. The infrastructure of PCORnet is well established, meaning that the community knows how to maximize the value of these connections to deliver fast, trustworthy answers that advance public health. pcornet.org –  The era of big data, loosely defined as the development and analysis of large or complex data sets, the Patient-Centered Outcomes Research Institute (PCORI) The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit, nongovernmental organization and was authorized by Congress in 2010. PCORI is the largest funder of comparative effectiveness research (CER) in the United States with the mandate to improve the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policymakers make better-informed health decisions.
  www.pcori.org establishes PCORnet, bringing new opportunities to empower patients and their families to generate, collect, and use their health information for both clinical and research purposes. Through PCORnet, a “network of networks” was established– Patient-Powered Research Networks (PPRNs), built and governed by stakeholder groups focused on specific conditions and community interests. Learn more about PPRN’s .

Two rheumatology specific PPRN’s were developed, including:

• 2015: ArthritisPowerVisit the ArthritisPower.org website for products and/or info about how to get involved. led by CreakyJointsCreakyJoints is a digital community for millions of arthritis patients and caregivers worldwide who seek education, support, advocacy, and patient-centered research. CreakyJoints is a part of the non-profit Global Healthy Living Foundation, which receives funding from grants and sponsorships from pharmaceutical manufacturers, private foundations, and government-sponsored research grants. They frequently collaborate on research with major research institutions and universities.
  creakyjoints.org. ArthritisPower is a non-profit, patient-inspired, and patient-managed research initiative that helps patients make a difference in the fight against arthritis and related conditions. View ArthritisPower overview, includes links to publications .
• 2015: Patients, Advocates and Rheumatology Teams Network for Research and Service (PARTNERS) PARTNERS is a PPRN linking patients, family members, caregivers, researchers, healthcare providers, and other people interested in pediatric rheumatic diseases. Through PARTNERS, patients, family members, and other caregivers are able to share research ideas, work on proposals, and join study teams. www.arthritis.org/science ) – led by healthcare providers, Childhood Arthritis and Rheumatology Research Alliance (CARRA)Childhood Arthritis and Rheumatology Research Alliance (CARRA) was founded by a small group of pediatric rheumatologists who aimed to create an investigator-led collaborative research network by establishing a registry. The information is provided by the medical team and by patients and their families. The registry was created to monitor the long-term safety of the medications used to treat pediatric rheumatic diseases.
  carragroup.org/, the US Arthritis FoundationThe Arthritis Foundation boldly pursues a cure for America’s #1 cause of disability while championing the fight against arthritis with life-changing resources, science, advocacy, and community connections. https://www.arthritis.org/, Friends of CARRA, the Lupus Foundation of AmericaLupus Foundation of America’s mission is to improve the quality of life for all people affected by lupus through programs of research, education, support, and advocacy.
  www.lupus.org/, and a quality-improvement learning network (Pediatric Rheumatology Care and Outcomes Improvement Network, or PR-COIN)Pediatric Rheumatology Care and Outcomes Improvement Network (PR-COIN) works to improve outcomes and provide safe, effective, efficient, timely, patient-centered, and equitable care for all children with rheumatic conditions. Our goals are to increase remission and clinically inactive disease rates among children with JIA, improve quality of life including optimal physical function and pain, and support families in managing their child’s condition.
  https://pr-coin.org/. View summary overview of PARTNERS .
• 2015 PCORnet Assessment:  Report evaluating the strengths and weaknesses of the initial phase dedicated to building its governance, technical, and research infrastructure. View report .

CoPI: Patient-Centered Outcomes Research (PCOR), co-production of stakeholder groups, patient-powered networks

Tools: Reports – patient research engagement

Context: Registries, patient-powered registries, children

Patient-focused drug development (PFDD) is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation. The primary goal of patient-focused drug development is to better incorporate the patient’s voice in drug development and evaluation

• 2012: The Food and Drug Administration (FDA)Food and Drug Administration’s (FDA) evaluation of new medicines (United States). During clinical trials, researchers study whether new medicines are safe and effective for patients and whether the medicine’s benefits outweigh the risks.
  www.fda.gov/ established the PFDD initiative under the Prescription Drug User Fee Act (PDUFA V)2012, the US President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) to include the reauthorization of the Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products.
  www.fda.gov.
•  2016: The National Psoriasis FoundationNational Psoriasis Foundation (NPF) drives efforts to cure psoriatic disease and to improve the lives of those affected.
  www.psoriasis.org a public meeting to hear perspectives from psoriasis patients, caregivers, and other patient representatives on the most significant dermal or skin-related effects of the disease. Publishes Voice of the Patient report . While attendees were not asked to focus on the arthritic component, a large percentage of comments and concerns included those with Psoriatic Arthritis.
•  2017: The Arthritis Foundation
  The Arthritis Foundation boldly pursues a cure for America’s #1 cause of disability while championing the fight against arthritis with life-changing resources, science, advocacy, and community connections. www.arthritis.org hosts the first externally ledExternally-led means it was not commissioned by the FDA so nonprofit organization(s) raise funds to host a meeting offsite. Patient-Focused Drug Development (PFDD) meeting for Osteoarthritis and, as a result, publishes OA Voice of the Patient ReportVisit www.arthritis.org to view videos and more information about this PFDD. You can also download the Report HERE .
•  2017: Lupus and Allied Diseases AssociationThe Lupus and Allied Diseases Association, Inc., is an all-volunteer national non-profit dedicated to enhancing quality of life for those impacted by lupus and allied diseases and other conditions of unmet needs by fostering collaboration among stakeholders, promoting unity in the community, and participating in innovative advocacy, awareness and biomedical research initiatives www.ladainc.org , the Lupus Research AllianceThe Lupus Research Alliance is the largest nongovernmental, nonprofit funder of lupus research worldwide. The organization aims to transform treatment while advancing toward a cure by funding the most innovative lupus research; fostering diverse scientific talent; stimulating collaborations; and driving discovery toward better diagnostics, improved treatments and, ultimately, a cure for lupus. www.lupusresearch.org , and the Lupus Foundation of America unite to host an externally-led PFDD meeting for lupus. Publishes Lupus: Patient Voices reportVisit www.lupuspfdd.org to learn more about this PFDD. The full report can be downloaded HERE .
• 2018 – 2019: FDA develops PFDD guidance materialsInformation and documents related to FDA’s development of the methodological PFDD guidance, including public workshops, draft guidance, and hypothetical scenarios, which are all intended to serve as a basis for dialogue.
  View guidance materials at:
  www.fda.gov to improve efforts to gain patient input and assessing outcomes in regulatory engagement.
• 2019: FasterCuresFasterCures, a center of the Milken Institute works to build a system that is effective, efficient, and driven by a clear vision: working with our partners to build a patient-centric system where science is accelerated, unnecessary barriers are overcome, and lifesaving and life-enhancing treatments get to those who need them as rapidly as possible.
  https://milkeninstitute.org publishes a guide for patient advocacy organizations interested in hosting, or are currently planning, an externally led PFDD meeting. The guide includes links to other tools for planning PFDD meetings, including the PFDD Meeting Tracker, the PFDD Readiness Assessment, and the PFDD Community Toolbox.

CoPI: Patient-Focused Drug Development (PFDD), regulatory reviewers

Tools: Guidance Documents – patient-focused drug development (PFDD); Reports – patient-focused drug development (PFDD)

Context: Regulatory process, clinical trials, Research & Development, guideline development

Patient testimony in the regulatory process expands in the second half of this decade and the Food and Drug Administration (FDA)Food and Drug Administration’s (FDA) evaluation of new medicines (United States). During clinical trials, researchers study whether new medicines are safe and effective for patients and whether the medicine’s benefits outweigh the risks.
www.fda.gov and the European Medicines Agency (EMA) EMA is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU www.ema.europa.eu join forces!

In addition to the European Medicines Agency EMA recently revising their original framework for interaction between the agency and patients and consumers and their organizations (2014) :

• 2015: The FDA launches the Patient Engagement Advisory Committee (PEAC)Patient Engagement Advisory Committee (PEAC) – Food and Drug Administration (FDA) committee providing advice to the Commissioner or designee on complex issues relating to medical devices, the regulation of devices, and their use by patients.
  www.fda.gov/patients to provide advice relating to medical devices . CoPI: Patient Preference Information (PPI)PPI: Qualitative or quantitative assessments of the relative desirability or acceptability to patients of specified alternatives or choices among outcomes or other attributes that differ among alternative health interventions. is established to describe this patient engagement. PPI framework and guidance released for the Center for Devices and Radiological Health (CDRH)(CDRH) recognizes that scientists, clinicians, device developers, and regulators play critical roles in evaluating and communicating the benefits and risks of medical devices. However, only patients live with their medical conditions and make daily choices regarding their health care. Their voice and perspective are critical to understanding the impact of medical devices.
  www.fda.gov/about-fda/fda-organization medical device decision-making.
• 2016: FDA and the EMA create a new workgroup on patient engagement called the FDA/EMA Patient Engagement ClusterWork group that allows FDA and EMA to share best practices involving patients along drug and biologic regulatory lifecycles. Information that is discussed is covered by confidentiality agreements signed by the FDA and EMA.
  www.fda.gov/patients to share best practices involving patients along with drug and biologic regulatory lifecycles.
• 2017: FDA launches Patient Engagement Collaborative The Patient Engagement Collaborative (PEC) is a group of patient organizations and individual representatives who discuss how to achieve more meaningful patient engagement in medical product development and other regulatory discussions at the FDA. The PEC was established by the FDA and the Clinical Trials Transformation Initiative (CTTI), a public-private partnership that brings together organizations and individuals representing academia, clinical investigators, government and regulatory agencies, industry, institutional review boards, patient advocacy groups and others to develop evidence-based solutions to clinical research challenges. www.fda.gov/patients with the Clinical Trials Transformation Initiative (CTTI)The FDA, together with the Clinical Trials Transformation Initiative, established a group of patient organization and individual representatives to discuss topics focusing on enhancing patient engagement in medical product development and regulatory discussions at FDA.
  www.ctti-clinicaltrials.org/ to develop guidance materials for including patients in the R & D continuum. This collaborative was modeled after the European Medicines Agency (EMA)’s Patients’ and Consumers’ Working PartyEMA is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. The Patients’ and Consumers’ Working Party (PCWP) provides a platform for exchange of information and discussion of issues of common interest between EMA and patients and consumers. www.ema.europa.eu/en/committees.
• 2017: EMA involves young people in their activities and establishes the principles for the involvement of young patients, consumers, and their carers, in the Agency’s scientific committees and working parties in a consistent and efficient manner .
• 2017: EMA begins holding public hearings to give European citizens a voice in the evaluation of the safety of medicines and empower them to express their views on issues related to the safety of certain medicines and the management of risks.
• 2017: EMA expands opportunities to acquire patients’ perspectives on benefit/risk considerations within the Committee for Medicinal Products for Human Use (CHMP)(CHMP) is the European Medicines Agency’s (EMA) committee responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.www.ema.europa.eu/en/committees meetings.

CoPI: Regulatory reviewers, working groups, advisory panels, Patient Preference Information (PPI)

Tools: Frameworks – regulatory; Guidance Documents – patient engagement

Context: Regulatory process, clinical trials, Research & Development, health technology assessment (HTA), decision aids, young adults

While the European League Against Rheumatism (EULAR)EULAR is the organization that represents people with arthritis/rheumatism, health professionals (HPR), and scientific societies of rheumatology of all the European nations. The aims of EULAR are to reduce the burden of rheumatic diseases on the individual and society and to improve the treatment, prevention, and rehabilitation of musculoskeletal diseases. To this end, EULAR fosters excellence in education and research in the field of rheumatology. It promotes the translation of research advances into daily care and fights for the recognition of the needs of people with musculoskeletal diseases by the governing bodies in Europe. As such, they have always had their own educational program at the annual EULAR Congress meeting, but in the earlier years, the symposia they organized was mostly independent of the other congress sessions. eular.org has always involved patients at their annual Congress, the American College of Rheumatology (ACR)American College of Rheumatology (ACR) is a professional membership organization whose mission is to empower rheumatology professionals to excel in their specialty. They are committed to improving the care of patients with rheumatic disease and advancing the rheumatology subspecialty.
www.rheumatology.org had a slower start.

• 2016: 1st patient-centered research study group is held at the American College of Rheumatology (ACR) annual meeting.
• 2017: EULAR Standing Committee of People with Arthritis/Rheumatism in Europe (PARE)(EULAR PARE) is the Committee within EULAR comprised of representatives and musculoskeletal user groups around Europe to work together towards improving the quality of life for people in Europe living with these conditions, with the vision to empower and help them lead full and independent lives.
  www.eular.org/pare initiate the EULAR study group for collaborative research. The EULAR study group meets annually during the EULAR congress and reports progress and activities through an electronic poster. The study group for collaborative research is meant to bring together physicians/researchers and PRPs. It provides a great opportunity to exchange new experiences and developments and discuss trendy topics. View meeting overview .
• 2017: The ACR invites patients, for the first time, to present research posters.

CoPI: Patient-Centered Outcomes Research (PCOR), Patient Research Partners (PRP), conference participant

Tools: Report – patient engagement

Context: Poster presentations, study groups

• 2018: INVOLVEINVOLVE was established in 1996 and funded by the National Institute for Health Research (NIHR) to support active public involvement in National Health Services (NHS) public health and social care research.As a national advisory group, the role of INVOLVE is to bring together expertise, insight, and experience in the field of public involvement in research (PIR), with the aim of advancing it as an essential part of the process by which research is identified, prioritized, designed, conducted and disseminated.www.invo.org.uk
  produces a set of six draft Standards for Patient Engagement that are currently piloted and evaluated in different areas of health research. United Kingdom
• 2018: Canadian Institute of Health Research (CIHR)The Canadian Institutes of Health Research (CIHR) is Canada’s federal funding agency for health research. Composed of 13 Institutes. It collaborates with partners and researchers to support the discoveries and innovations that improve our health and strengthen our health care system.https://cihr-irsc.gc.ca publishes draft Ethics Guidance for Developing Research Partnerships with PatientsThe proposed ethics guidance builds on the SPOR Patient Engagement Framework and, once finalized, could be adapted in various formats by SPOR leads and other initiatives, organizations, and institutions to serve as an educational resource for all those involved in research partnerships with patients.
  http://www.cihr-irsc.gc.ca, in support of Canada’s Strategy for Patient-Oriented Research (SPOR)Endorses the active partnership of patients, researchers, health professionals and decision-makers in research so as to build a sustainable and accessible health care system that optimizes the health of Canadian citizens.https:cihr-irsc.gc.ca. The project is a response to ethical issues that were initially identified by the SPOR SUPPORT Unit Patient Engagement Working GroupPatient engagement means fostering a climate in which researchers, health care providers, decision-makers and policy-makers understand the value of patient involvement and patients see the value of these interactions.Engaging patients is an integral component in the development and implementation of all elements of SPOR https://cihr-irsc.gc.ca and reiterated at various conferences and workshops.
• 2019: ESCEO (European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases)ESCEO is a not-for-profit organization, dedicated to a close interaction between clinical scientists dealing with bone, joint, and muscle disorder, pharmaceutical industry developing new compounds in this field, regulators responsible for the registration of such drugs and health policymakers, to integrate the management of Osteoporosis and Osteoarthritis within the comprehensive perspective of health resources utilization.
  The objective of ESCEO is to provide practitioners with the latest clinical and economic information, allowing them to organize their daily practice, in an evidence-based medicine perspective, with a cost-conscious perception.
  www.esceo.org & World Health Organisation (WHO) publish “Best practice principles for engaging patients in health research, treatment guidelines, and regulatory processesM. de Wit e.a., Principles for engaging with patients in health research, treatment guidelines and regulatory processes: Results of an expert group meeting organized by the World Health Organization (WHO)WHO is the United Nations agency that connects nations, partners and people to promote health, keep the world safe and serve the vulnerable – so everyone, everywhere can attain the highest level of health.www.who.int and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis, and Musculoskeletal Diseases (ESCEO), Lancet, April 2019”.

CoPI: Strategy for Patient-Oriented Research (SPOR), Patient Involvement in Research (PIR)/Patient and Public Involvement (PPI), working groups

Tools:  Guidance documents – ethics

Context: Ethical review, regulatory process, clinical research, guideline development

2018: Arthritis Research Canada (ARC)ARC was created in 2000 in recognition of the tremendous potential that research can bring to arthritis treatment in Canada, and indeed, the world. Arthritis Research Canada has earned international attention as a leading arthritis research environment. We have built a strong multi-disciplinary research team of outstanding medical doctors and research scientists, and we willingly collaborate with medical professionals around the world. www.arthritisresearch.ca introduces the Patient Engagement in Research Scale (PEIRS)Learn more about the PEIRS tool at:
www.arthritisresearch.ca/peirs/, the first tool of its kind to evaluate the effectiveness of patient engagement in all areas of research. ARC scientists and Patient Research Partners (PRPs) worked together to create this tool.

The tool is designed to measure the degree of meaningful patient engagement in research projects from a patient perspective.

CoPI: Patient Research Partners (PRPs)

Tools: Instruments –patient engagement

Context: Measuring impact

2019: International Consortium for Health Outcome Measurement (ICHOM)International Consortium for Health Outcomes Measurement (ICHOM) aims to unlock the potential of value-based healthcare by defining global Standard Sets of outcome measures that matter most to patients and driving adoption and reporting of these measures worldwide to create better value for all stakeholders.
https://ichom.org unites an international working group – including patients – to develop the Inflammatory Arthritis Standard Set to enable health care providers to implement the value-based health care framework and compare outcomes that are important to patients with inflammatory arthritis.  (Covers patients with rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, and juvenile idiopathic arthritis.)

CoPI: Working groups

Tools: Guidance Documents – value-based healthcare

Context: Patient-Reported Outcomes (PROs), value-based health care, core outcome sets (COS)

Patients are increasingly co-authoring peer-reviewed publications at all stages of the medicines development life cycle. Their unique insights enhance the body of evidence across numerous therapy areas. Practical guidance can support patient authors to publish successfully and collaborate with non-patient authors.

• 2020: Researchers and patient partners from the Strategy for Patient-Oriented Research Chronic Pain NetworkThe Chronic Pain Network is one of five networks to receive funding through the Canadian Institutes of Health Research’s Strategy for Patient-Oriented Research (SPOR) and represents an unprecedented level of collaboration amongst national stakeholders. Working with patients as partners, the Network supports, coordinates and synchronizes leading innovative and high-impact research with the ultimate goal of removing barriers to better chronic pain management. cpn.mcmaster.ca co-wrote guidance to help others talk about authorship and acknowledgement for the research projects they are working on together.Guidance on authorship with and acknowledgement of patient partners in patient-oriented research
• 2022: The Patient Author Candidate Framework was developed by Envision Pharma GroupWe are a global leader in medical affairs and healthcare communications. Our purpose-built software, scientific solutions, and behavior change expertise make us a unique partner to the pharmaceutical industry. envisionpharmagroup.com as a Patient Authorship Resource for industry sponsors. It is designed to guide assessment of potential patient author candidates, based on a set of transparent, relevant, and pre specified criteria.

Tags

CoPI: Patient-Oriented Research, Co-production of stakeholder groups

Tools: Guidance documents – Authorship, Frameworks – Authorship

Context: Authorship

With the onset of the global pandemic of COVID-19COVID-19 is the disease caused by SARS-CoV-2, the coronavirus that emerged in December 2019. www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus , rheumatology registries – come existing and some forming solely for this reason – began focusing strongly on tracking cases in rheumatology patients. Some of these registries included the patient voice in various phases of data collection.

• 2020: COVID-19 Global Rheumatology Alliance (GRA)The mission of the GRA is to collect, analyze and disseminate information about COVID-19 and rheumatology to patients, physicians, and other relevant groups to improve the care of patients with rheumatic disease.
  rheum-covid.org/ was developed to collect, analyze, and disseminate information about COVID-19 and rheumatology to patients, physicians, and other relevant groups to improve the care of patients with rheumatic disease. In addition to establishing a Patient Board, patients were invited to submit and review questions as part of the Patient Experience Survey and help develop lay summaries. International
• 2020: The Arthritis & Rheumatic Disease COVID-19 Project From conception to development and launch, the Arthritis and Rheumatic Disease COVID-19 project included patients during all phases of the project, which began by learning about the impact of COVID-19 on people who are living with underlying chronic disease through multiple conversations. Patients also collaborated with researchers and clinicians to help develop and refine the survey, prioritize survey questions, provide input on the study timeline, and strategize on dissemination efforts.
  rheumcovid19project.org/ – A patient-powered study of the Autoimmune Research Collaborative, from conception to development and launch, the Arthritis and Rheumatic Disease COVID-19 project included patients during all phases of the project. Respondents are asked to participate at multiple time points to better understand concerns, behaviors, and the pandemic’s overall impact on them over time. The study will also inform the preparedness of patients and clinicians for future pandemics and provide a better understanding of concerns with infection in general among patients with autoimmune disease. Led by Global Healthy Living Foundation/CreakyJoints. United States, Canada

CoPI: Advisory panel, working group, co-production of stakeholder groups

Context: Registries, lay summaries, dissemination (knowledge translation)

While patient inclusion in rheumatology research has advanced considerably over the last decade, engagement in the basic science phase of research is lacking. However, efforts are underway to explore opportunities for patient-researcher collaboration at the laboratory setting.

• 2022: A study by the department of rheumatic diseases of the Radboud University Medical CenterRadboud university medical center specializes in patient care, scientific research, teaching and training. Our mission is to have a significant impact on health care. We aim to be pioneers in shaping the health care of the future. We do this in a person-centered and innovative way. https://www.radboudumc.nl/en/research/, which included thirteen Patient Research Partners (PRPs)Patient Research Partner (PRP) EULAR defines a Patient Research Partner (PRP) as a person with a relevant disease who participates or has participated as an active research team member on an equal basis with professional researchers, thus adding the value of experiential knowledge to a research project. explored good working models and impact of patient involvement in basic rheumatology research and to identify barriers and facilitators (report) . Associated road map for patient involvement in basic research also provided .
• 2022: With the emergence of precision medicine in rheumatology, basic scientists are exploring potential biomarkers that may be associated with diagnosis and potential worsened disease outcomes or harmful side effects. Patient groups have been collecting this research for use in efforts to influence public policy (Research AdvocacyConducting research and collecting data that can be used to influence legislation or public policy.), particularly advocating for access to biomarker testing in the future.

Tags

CoPIs: Patient Research Partners, Patient and Public Involvement in Research, Research Advocacy

Tools: Reports – Patient-researcher engagement, Guidance documents – patient-researcher engagement

Context: Basic research, precision medicine

While patient engagement as partners in rheumatology research has been a staple at scientific conferences in both Europe and Canada for years, until 2022, the topic has had little focus at US-based scientific research conferences.

• 2022: The ACR Convergence meeting features the 1st scientific session of its kind to help attendees improve patient involvement as partners in their research projects. Presentation of this Pathway of Patient Engagement in Rheumatology Research Tool designed by the ACTion Council.
• Attendees – including researchers, rheumatologists, patient research partners, and representatives from scientific societies, patient organizations, and industry – worked together post session to build out the tool to create the most robust repository of patient included rheumatology research to date. (TBD)

Tags

CoPI: Patient Research Partner, conference participant, Co-production of stakeholder groups

Tools: Instruments – Patient-Researcher Engagement

Context: Research & Development