Patient Engagement In Clinical Research Research Articles

Abstract 714: Using empathy-driven instructional design to reimagine cancer research

Abstract Following the advent of groups like PCORI, patient engagement in clinical research is no longer a novel concept. However, involvement of lay stakeholders in areas such as artificial intelligence or biomedical informatics can pose challenges. Community stakeholder involvement in cancer research can prove especially challenging as cancer has personally impacted nearly everyone. The purpose of this study was to assess whether addressing needs outlined in the Self-Determination Theory (SDT) helped community stakeholders feel prepared for this role. The University of Florida (UF) health science center employs Citizen Scientists (CSs) as partners in the research process to offer insight otherwise unavailable to researchers. To prepare for this role, CSs complete an online curriculum, co-created by their peers and UF researchers, to educate them about clinical research. The UF Health Cancer Center created the CS Cancer Curriculum (CSCC) as a companion piece to the clinical research course. To create the CSCC, researchers, administrators, and CSs and participated in a needs assessment to identify common interests. Through this needs assessment, the research team found that each CS had personal connections to cancer and the team felt an empathic approach to the course design was necessary to respect these experiences. The SDT and reflective questions were applied throughout the course. Storytelling was used to present a multipart case study series with a patient, family members, and physician. Those videos were accompanied by a note that the story may cause the viewer to recall their own painful experiences. The note then prompted viewers to review resources from the National Cancer Institute support services page if needed. All but two of the nine CSs scored a 95% or higher across all questions in the CSCC. Overall course assessments included a pre/posttest and a case study assessment based on the SDT. Relatedness (100%) and autonomy (83%) were the highest construct scores of the case study assessment, indicating that CSs felt most empowered in their role once they had more of an emotional connection to the subject matter. For the pre/posttests, confidence in their ability to learn and apply the content to their work grew slightly (79% to 80%). However, scores for the “Capable” construct rose by several percentage points. At the pretest, 81% felt they were capable of learning the content and, at the posttest, 86% felt that they were capable of applying the content. Taking the time to ensure that the psychological needs of learners are met can result in committed, engaged research partners who can provide pragmatic feedback and have long-lasting effects on cancer research. The CSs in this study were passionate about this work, despite the intimidating jargon and dense concepts used in this field. They are an excellent example of how impactful community stakeholders can be if researchers can meet them where they are. Citation Format: Janet Brishke, Zachary Jones, Elizabeth A. Shenkman. Using empathy-driven instructional design to reimagine cancer research [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 714.

Using Patient Perspectives to Inform Better Clinical Trial Design and Conduct: Current Trends and Future Directions.

The approach to patient engagement (PE) in drug development has changed rapidly due to many factors, including the complexity of innovative drugs and the need to demonstrate outcomes of relevance to patients, the desire to show 'value add' of PE, and the pandemic-related changes to how clinical trials are run, e.g., decentralised studies. In parallel, there have been changes in technology-assisted ways of running clinical trials, capturing patient health outcomes and preferences, an increasing societal demand for diversity and inclusion, and efforts to improve clinical trial efficiency, transparency, and accountability. Organisations are beginning to monitor PE activities and outcomes more effectively to learn and inform future PE strategies. As a result, these factors are facilitating the incorporation of patients' lived experience, preferences and needs into the design and running of clinical trials more than ever before. In this paper, the authors reflect upon these last few years, the emerging trends and their drivers, and where we may expect PE in clinical research to progress in the near future.

Patient engagement in clinical research: Geneva University Hospitals’ model

While the concept of patients as partners in clinical research is becoming increasingly prevalent, there is still room for improvement. The development and validation of partnership models to engage patients in the design and governance of clinical research programmes are still in the early stages, and approaches that can ensure substantial and effective patient contributions to research are needed. In this article, we describe the patient partnership model being developed at Geneva University Hospitals (HUG) to engage patients and their caregivers in the design of clinical research studies and to encourage research groups in their efforts to involve patients within their teams.

Engaging Those Living With Moderate to Severe TBI and Their Caregivers in Research.

Despite the fact that millions of individuals living in the United States are coping with disabilities associated with traumatic brain injury (TBI), limited work has explored strategies for patient engagement in research among those with such injuries. The Coalition for Recovery and Innovation in Traumatic Brain Injury Care Across the Lifespan (CRITICAL) brought together those living with TBI, caregivers, clinicians, researchers, and advocates with the goal of developing a new patient-centered research agenda. This platform was also used to explore strategies to engage those with moderate to severe TBI in the research process. The CRITICAL was formed of 6 survivors of moderate to severe TBI, 2 caregivers of survivors of moderate to severe TBI, and 8 TBI professionals. The CRITICAL identified 3 priority topic areas: Relationship Quality, Caregiver Needs, and Thriving. Furthermore, strategies associated with Communication, Preparation, and the Environment facilitated research engagement. Employing the strategies outlined in this article is expected to promote patient engagement in clinical research, which can improve patient-centered interventions and outcomes for individuals living with TBI.

Challenges of Patient Engagement in an HIV Clinical Research Program: A Qualitative Analysis of Stakeholder Accounts.

Patient engagement (PE) promotes collaboration between stakeholders (researchers, patients, clinicians, etc). It often faces challenges due to tensions between its ethical/political and scientific underpinnings. This article explores how stakeholders applied the guiding principles of a PE project (“co-build,” “support and mutual respect,” and “inclusiveness”) for an HIV clinical research program initiated in January 2016. Three researchers/clinicians, a PE agent, and 2 patients held 3 meetings (June-October 2018) to discuss challenges faced and how these impacted their approach to PE. Regular stakeholder discussions about PE in clinical research could be documented and help guide PE to better meet stakeholder needs.

Restructuring Clinical Trials in Type 1 Diabetes and Exercise in the Context of Adult Patient-Oriented Research: An Intervention Codevelopment Protocol

Patient engagement in health research is a methodological approach whereby individuals living with a health condition are actively engaged throughout the research process. Engaging patient partners in research enhances participant recruitment, and reduces attrition rates once participants are enrolled (1,2), thereby reducing research “waste” (3). Qualitatively, patient engagement in clinical research cultivates trust between end-users and the scientific community, incorporating a broader diversity of perspectives and facilitating access to research findings (4,5).

Partnering with patients to get better outcomes with chimeric antigen receptor T-cell therapy: towards engagement of patients in early phase trials

AimThough patient engagement in clinical research is growing, recent reports suggest few clinical trials report on such activities. To address this gap, we describe our approach to patient engagement in the development of a clinical trial protocol to assess a new immunotherapy for blood cancer (chimeric antigen receptor T-cell therapy, CAR-T cell therapy).MethodsOur team developed a clinical trial protocol by working with patient partners from inception. Two patient partners with lived blood cancer experience were identified through referrals from our team’s professional network and patient organization contacts. Our patient partners were onboarded to the team and engaged in several studies conducted to develop the clinical trial protocol, including a systematic review of the existing literature on the therapy, patient interviews and a survey to obtain perspectives on barriers and enablers to participating in the trial, an early economic analysis, and a retrospective cohort study.ResultsEngaging patient partners enhanced our research in ways that would not have otherwise occurred. By selecting patient important outcomes for data collection, our partners helped flag that quality of life and health utility measures have not been reported in previous CAR-T cell therapy trials for blood cancer. Our partners also co-developed a non-technical summary of the systematic review that summarized results in an accessible manner. Our patient partners reviewed interview and survey questions, to improve the language and appropriateness; provided recruitment suggestions; and provided a patient perspective on the results, thereby confirming the importance of findings. Input was also obtained on costs for the early economic analysis. Our patient partners identified costs that may be a burden to both patients and caregivers during a trial and helped to confirm that the overall structure of the economic model reflected the patient care pathway. Our patient partners also shared their diagnosis and treatment stories, which helped to provide the research team with insight into this experience.ConclusionsContributions by our patient partners were invaluable to each component study, as well as the overall development of the trial protocol. We plan to use this approach in the future in order to meaningfully engage patients in the development of other clinical trials; we also hope that by reporting our methods this will help other research teams to do the same.Trial registrationAffiliated with the development of NCT03765177.

Real World Survey of Patient Engagement Status in Clinical Research: The First Input from Japan.

The updated international draft guidelines, the "General Considerations for Clinical Studies, ICH E8 (R1)", state that patient engagement ensures that all perspectives are captured in the research process; however, this is not well understood, specifically in Japan. This study examined the current status and perceptions of patient engagement in clinical research from the perspectives of patient groups, pharmaceutical corporations, and researchers in Japan, using anonymous self-administered questionnaires. Three online surveys were conducted with patient groups (n = 100), pharmaceutical corporations (n = 66), and researchers (n = 300) in May and June 2019. The main variables were the current status and the current perception of patient engagement in clinical research. The response rate was 71% for patient groups and 85% for pharmaceutical corporations, and there were 300 valid responses (emergence rate: 4.9%) from researchers. Experiences with clinical research involving patient engagement were reported by 76.5% of the patients, 21.4% of the pharmaceutical corporations, and 51.7% of the researchers. Patient groups reported three major factors that negatively impacted their relationship with pharmaceutical corporations and researchers: (1) 'lack of understanding of the benefits of partnering'; (2) 'lack of transparency or openness'; and (3) 'unclear or ill-defined processes'. Pharmaceutical corporations in Japan have less experience with patient engagement in clinical research than other stakeholders. A neutral connecting system among the stakeholders with a constructive co-learning system will allow effective involvement/engagement of patient groups for enhancing the effectiveness of clinical research.

A proposed framework for patient engagement throughout the broader research enterprise.

Patient engagement in clinical research refers to the involvement of patients beyond the role of research subject. To date, the goals of patient engagement have not been clearly defined for each stage of the research enterprise, which, when viewed broadly, encompasses stages such as setting research priorities, interpreting and incorporating research results in clinical guidance, and translating study results into insurance coverage policies. This article presents a new framework for patient engagement by first describing the goals of patient engagement at each stage of the research enterprise and then establishing how to prioritize the types of patient expertise that are needed to achieve these goals.

Assessing Biopharmaceutical Company Experience with Patient-centric Initiatives

PurposeA growing number of biopharmaceutical companies have been implementing patient-centric initiatives (PCIs). The Drug Information Association (DIA) and the Tufts Center for the Study of Drug Development (CSDD) collaborated on a study to gather data on the usage and impact of these PCIs to characterize company experience and impact. MethodsDIA and Tufts CSDD collaborated with 17 organizations to define PCIs used in clinical research and development and to quantify their use, and to define metrics in use to document impact and return on engagement (ROE) for these PCIs. The study used a mixed methods approach that consisted of an online survey, in-depth interviews, and literature review. FindingsTwenty-two unique companies responded to an on-line survey on the use of 23 PCIs identified by the study working group. PCIs most frequently implemented included patient organization landscape analysis, support of patient advocacy groups, use of patient advisory boards, and use of home nursing networks. Seven additional PCIs were found through a literature search and included in the group of PCIs for which impact measures were assessed. A total of 121 cases of use of the 30 PCIs and associated impact measures and impact data were gathered through literature review, in-depth interviews with the study companies, and in-depth interviews with organizations identified in the literature as having experience with patient engagement in clinical research as well as with patients who had participated in clinical trials. Analysis of the 121 case studies resulted in a list of 666 measures of impact (metrics) in use for 13 of the PCIs. Assessment of overall ROE for these PCIs found that PCIs such as support of patient advocacy groups and use of patient advisory boards indicated the greatest ROE, whereas costlier, more complex PCIs such as digital medicine and gaming indicated relatively low ROE. ImplicationsActivity around PCIs among the companies studied was widespread, with initiatives more frequently planned and piloted than implemented at the time of this study. Measures of impact have been identified and can be used to assess ROE, providing insights to facilitate the adoption of PCIs of highest impact for patients and biopharmaceutical research organizations.

Evaluation of 3 approaches for increasing patient engagement in clinical research: Feedback from a community engagement advisory board.

The purpose of this study was to obtain feedback from a diverse group of community advisory board members about different clinic or hospital-based approaches to increasing research participation. Members of an established community engagement advisory board (n=16) provided qualitative and survey data regarding attitudes and preferences for 3 hospital and clinic system strategies to recruit patients into clinical research including universal consent for research, patient registries, and patient portals. Overall, there was moderate support for each of the 3 approaches discussed. Board members described advantages and disadvantages of each method. Based on the qualitative data, universal consent was viewed as the best strategy for consenting high volumes of patients for research. However, patient registries and portals were seen as more acceptable, less-intrusive and more likely to result in higher participation rates. Survey data were consistent with qualitative findings. Input from community stakeholders is needed to identify strategies to enhance participation and increase diversity in clinical research. Members of our CEAB identified patient registries and portals as feasible and nonintrusive approaches to increasing research participation. Additional research is needed to confirm these findings and to establish best practices for supporting patients in using registry approaches.

Patient engagement in clinical research through mobile technology

Patient engagement in clinical research through mobile technology