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      Co-creation of practical “how-to guides” for patient engagement in key phases of medicines development—from theory to implementation

      research-article
      1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 10 , , on behalf of Patient Focused Medicines Development Working Groups 1, on behalf of Patient Focused Medicines Development Working Groups 2A, on behalf of Patient Focused Medicines Development Working Groups 2B
      Research Involvement and Engagement
      BioMed Central
      Practical guidance patient engagement medicines development

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          Abstract

          Background

          The effective impact of patient engagement (PE) across the medicines development continuum is widely acknowledged across diverse health stakeholder groups, including health authorities; however, the practical applications of how to implement meaningful and consistent PE are not always addressed. Guidance for the practical implementation of PE requires granularity, and the need for such guidance has been identified as a priority. We describe the co-production and summarize the content of how-to guides that focus on PE in the early stages of medicines development.

          Methods

          Multi-stakeholder working groups (WGs) were established by Patient Focused Medicines Development (PFMD) for how-to guide development. How-to guides were co-produced with patients for PE activities identified as priorities through public consultation and by WGs. Guides were developed by applying PE quality guidance and associated quality criteria in an iterative process. How-to guides underwent internal review and validation by experts (ie, those with relevant experience in the particular PE activity or focus area) in specific focus groups and external review and validation through appropriate events and public consultation.

          Results

          Overall, 103 individual contributors from 38 organizations (representing eight stakeholder groups, including patients/patient organizations) and from 14 countries were organized into WGs and workstreams. Each WG comprised 15–30 contributors with PE experience relevant to the specific how-to guide. How-to guides were developed for PE in the early discovery and preclinical phases; PE in the development of a clinical outcomes assessment strategy; and PE in clinical trial protocol design. The how-to guides have a standardized format and structure to promote user familiarity. They provide detailed guidance and examples that are relevant to the individual PE activity and aim to facilitate the practical implementation of PE.

          Conclusions

          The how-to guides form a comprehensive series of actionable and stepwise resources that build from and integrate the PE quality criteria across the medicines continuum. They will be made freely available through PFMD’s Patient Engagement Management Suite ( pemsuite.org) and shared widely to a variety of audiences in different settings, ensuring access to diverse patient populations. Implementation of these guides should advance the field of PE in bringing new medicines to the market and ultimately will benefit patients.

          Plain English summary

          Medicines are developed to help patients improve their health and lives. Many organizations and individuals want to ensure that medicines are developed to meet real patient needs and to address what is most important to patients. Finding out what patients need and what patients want requires good patient engagement, but knowing how to do patient engagement is not always clear. This is because medicines development is complicated, and a lot of different steps, people, and organizations are involved. Patient Focused Medicines Development (PFMD) was established in 2015 to connect individuals and organizations that are committed to making medicines not just for patients but with patients. To do this, PFMD brought together patients and other groups of people with relevant experience and good ideas on how to achieve patient engagement in the real-world setting. Together, PFMD has developed “how-to guides” for patient engagement that cover the main activities along the medicines development process. The guides are free to use and provide practical advice and examples that anyone can use in their patient engagement activities. The how-to guides will also help patients to understand medicines development and how best they can participate in this process to address their needs.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s40900-021-00294-x.

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          Most cited references39

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          The PCORI Engagement Rubric: Promising Practices for Partnering in Research

          Engaging patients, caregivers, and other health care stakeholders as partners in planning, conducting, and disseminating research is a promising way to improve clinical decision making and outcomes. Many researchers, patients, and other stakeholders, however, lack clarity about when and how to engage as partners within the clinical research process. To address the need for guidance on creating meaningful stakeholder partnerships in patient-centered clinical comparative effectiveness research, the Patient-Centered Outcomes Research Institute (PCORI) developed the PCORI Engagement Rubric (Rubric).
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            Patient and public engagement in research and health system decision making: A systematic review of evaluation tools

            Abstract Background Patient and public engagement is growing, but evaluative efforts remain limited. Reviews looking at evaluation tools for patient engagement in individual decision making do exist, but no similar articles in research and health systems have been published. Objective Systematically review and appraise evaluation tools for patient and public engagement in research and health system decision making. Methods We searched literature published between January 1980 and February 2016. Electronic databases (Ovid MEDLINE, Embase, Cochrane Database of Systematic Reviews, CINAHL and PsycINFO) were consulted, as well as grey literature obtained through Google, subject‐matter experts, social media and engagement organization websites. Two independent reviewers appraised the evaluation tools based on 4 assessment criteria: scientific rigour, patient and public perspective, comprehensiveness and usability. Results In total, 10 663 unique references were identified, 27 were included. Most of these tools were developed in the last decade and were designed to support improvement of engagement activities. Only 11% of tools were explicitly based on a literature review, and just 7% were tested for reliability. Patients and members of the public were involved in designing 56% of the tools, mainly in the piloting stage, and 18.5% of tools were designed to report evaluation results to patients and the public. Conclusion A growing number of evaluation tools are available to support patient and public engagement in research and health system decision making. However, the scientific rigour with which such evaluation tools are developed could be improved, as well as the level of patient and public engagement in their design and reporting.
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              Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative

              Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach recruitment goals-a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist. To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies. We describe our multi-stakeholder effort to develop a framework that delineates three areas essential to strategic recruitment planning efforts: (1) trial design and protocol development, (2) trial feasibility and site selection, and (3) communication. Our recommendations propose an upstream approach to recruitment planning that has the potential to produce greater impact and reduce downstream barriers. Additionally, we offer tools to help facilitate adoption of the recommendations. We hope that our framework and recommendations will serve as a guide for initial efforts in clinical trial recruitment planning irrespective of disease or intervention focus, provide a common basis for discussions in this area and generate targets for further analysis and continual improvement.
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                Author and article information

                Contributors
                am.hamoir@thesynergist.org
                Journal
                Res Involv Engagem
                Res Involv Engagem
                Research Involvement and Engagement
                BioMed Central (London )
                2056-7529
                23 August 2021
                23 August 2021
                2021
                : 7
                : 57
                Affiliations
                [1 ]GRID grid.419687.5, ISNI 0000 0001 1958 7479, National Kidney Foundation, ; New York, NY USA
                [2 ]REPE—Rete Pazienti Esperti, Roma, Italy
                [3 ]Eli Lilly Benelux N.V, Brussels, Belgium
                [4 ]Evidera, London, UK
                [5 ]GRID grid.418301.f, ISNI 0000 0001 2163 3905, Institut de Recherches Internationales Servier, ; Suresnes, France
                [6 ]GRID grid.417570.0, ISNI 0000 0004 0374 1269, F. Hoffmann-LaRoche, ; Basel, Switzerland
                [7 ]Commutateur Advocacy Communications, Paris, France
                [8 ]GRID grid.478379.6, ISNI 0000 0004 5899 1740, National Kidney Foundation, , Alport Syndrome Foundation, ; New York, NY USA
                [9 ]Twist Medical, Burlingame, CA USA
                [10 ]The Synergist, Brussels, Belgium
                Author information
                http://orcid.org/0000-0002-9898-5703
                Article
                294
                10.1186/s40900-021-00294-x
                8383358
                34425911
                44425eaf-c281-448f-8ffd-b1b4c373e68d
                © The Author(s) 2021

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 26 February 2021
                : 25 June 2021
                Categories
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                © The Author(s) 2021

                practical guidance patient engagement medicines development

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