Patient and Patient Group Engagement in Cancer Clinical Trials: A Stakeholder Charter.
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ABSTRACT:
SUBMITTER: Michaud S
PROVIDER: S-EPMC8167642 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:For the past two decades, the National Cancer Institute (NCI) has supported the involvement of patient advocates in both internal advisory activities and funded research projects to provide a patient perspective. Implementation of the inclusion of patient advocates has varied considerably, with inconsistent involvement of patient advocates in key phases of research such as concept development. Despite this, there is agreement that patient advocates have improved the patient focus of many cancer research studies. This commentary describes our experience designing and pilot testing a new framework for patient engagement at SWOG, one of the largest cancer clinical trial network groups in the United States and one of the four adult groups in the NCI's National Clinical Trials Network (NCTN). Our goal is to provide a roadmap for other clinical trial groups that are interested in bringing the patient voice more directly into clinical trial conception and development. We developed a structured process to engage patient advocates more effectively in the development of cancer clinical trials and piloted the process in four SWOG research committees, including implementation of a new Patient Advocate Executive Review Form that systematically captures patient advocates' input at the concept stage. Based on the positive feedback to our approach, we are now developing training and evaluation metrics to support meaningful and consistent patient engagement across the SWOG clinical trial life cycle. Ultimately, the benefits of more patient-centered cancer trials will be measured in the usefulness, relevance, and speed of study results to patients, caregivers, and clinicians.
| S-EPMC6005117 | biostudies-literature
Project description:IntroductionStakeholder engagement is an essential component of HIV clinical trials. We define stakeholder engagement as an input by individuals or groups with an interest in HIV clinical trials to inform the design or conduct of said trials. Despite its value, stakeholder engagement to inform HIV clinical trials has not been rigorously examined. The purpose of our systematic review is to examine stakeholder engagement for HIV clinical trials and compare it to the recommendations of the UNAIDS/AVAC Good Participatory Practice (GPP) guidelines.MethodsWe used the PRISMA checklist and identified English language studies describing stakeholder engagement to inform HIV clinical trials. Four databases (PubMed, Ovid, CINAHL and Web of Science) and six journals were searched, with additional studies identified using handsearching and expert input. Two independent reviewers examined citations, abstracts and full texts. Data were extracted on country, engagement methods, stakeholder types and purpose of stakeholder engagement. Based on the GPP guidelines, we examined how frequently stakeholder engagement was conducted to inform clinical trial research question development, protocol development, recruitment, enrolment, follow-up, results and dissemination.Results and discussionOf the 917 citations identified, 108 studies were included in the analysis. Forty-eight studies (44.4%) described stakeholder engagement in high-income countries, thirty (27.8%) in middle-income countries and nine (8.3%) in low-income countries. Fourteen methods for stakeholder engagement were identified, including individual (e.g. interviews) and group (e.g. community advisory boards) strategies. Thirty-five types of stakeholders were engaged, with approximately half of the studies (60; 55.6%) engaging HIV-affected community stakeholders (e.g. people living with HIV, at-risk or related populations of interest). We observed greater frequency of stakeholder engagement to inform protocol development (49 studies; 45.4%) and trial recruitment (47 studies; 43.5%). Fewer studies described stakeholder engagement to inform post-trial processes related to trial results (3; 2.8%) and dissemination (11; 10.2%).ConclusionsOur findings identify important directions for future stakeholder engagement research and suggestions for policy. Most notably, we found that stakeholder engagement was more frequently conducted to inform early stages of HIV clinical trials compared to later stages. In order to meet recommendations established in the GPP guidelines, greater stakeholder engagement across all clinical trial stages is needed.
| S-EPMC6192899 | biostudies-literature
Project description:Stakeholder engagement is increasingly recognised and institutionalised as an essential component of HIV-related biomedical research. However, we know little about stakeholder engagement's social outcomes, such as its influence on the community it engages with, in authoritarian regimes and beyond high-income countries. This study evaluates a multi-site structured stakeholder engagement programme conducted in parallel with two HIV prevention studies among men who have sex with men in China. We conducted a one-month ethnographic study and 41 semi-structured interviews with participants of a structured stakeholder engagement programme in six Chinese cities. We found that the structured stakeholder engagement programme offered community stakeholders additional and flexible funding, networking opportunities, increased clinical research literacy, and strengthened their connections with the community. However, the structured stakeholder programme generated unintended consequences in some cases. It caused community stakeholders to expend their social capital, introduced moral conflicts and created tension between stakeholders' 'community representative' and 'research assistant' identities. Our findings suggest that despite these unintended consequences, structured stakeholder engagement could effectively mitigate negative outcomes generated by such engagement if such programmes are more sensitive and responsive to the broader socio-political structure in which trials are embedded.
| S-EPMC7205565 | biostudies-literature
Project description:The conduct of clinical trials is increasingly challenging due to greater complexity and governance requirements as well as difficulties with recruitment and retention. Electronic Health Records for Clinical Research (EHR4CR) aims at improving the conduct of trials by using existing routinely collected data, but little is known about stakeholder views on data availability, information governance, and acceptable working practices.Senior figures in healthcare organisations across Europe were provided with a description of the project and structured interviews were subsequently conducted to elicit their views.37 structured interviewees in Germany, UK, Switzerland, and France indicated strong support for the proposed EHR4CR platform. All interviewees reported that using the platform for assessing feasibility would enhance the conduct of clinical trials and the majority also felt it would reduce workloads. Interviewees felt the platform could enhance trial recruitment and adverse event reporting but also felt it could raise either ethical or information governance concerns in their country.There was clear support for EHR4CR and a belief that it could reduce workloads and improve the conduct and quality of trials. However data security, privacy, and information governance issues would need to be carefully managed in the development of the platform.
| S-EPMC4619877 | biostudies-literature
Project description:IntroductionEngaging patients, caregivers, and other stakeholders to help guide the research process is a cornerstone of patient-centered research. Lived expertise may help ensure the relevance of research questions, promote practices that are satisfactory to research participants, improve transparency, and assist with disseminating findings.MethodsTraditionally engagement has been conducted face-to-face in the local communities in which research operates. Decentralized platform trials pose new challenges for the practice of engagement. We used a remote model for stakeholder engagement, relying on Zoom meetings and blog communications.ResultsHere we describe the approach used for research partnership with patients, caregivers, and clinicians in the planning and oversight of the ACTIV-6 trial and the impact of this work. We also present suggestions for future remote engagement.ConclusionsThe ACTIV-6 experience may inform proposed strategies for future engagement in decentralized trials.
| S-EPMC10789984 | biostudies-literature
Project description:BackgroundMultinational clinical trials are logistically complex and require close coordination between various stakeholders. They must comply with global clinical standards and are accountable to multiple regulatory and ethical bodies. In resource-limited settings, it is challenging to understand how to apply global clinical standards to international, national, and local factors in clinical trials, making multiple-level stakeholder engagement an important element in the successful conduct of these clinical trials.Main bodyDuring the planning and implementation of a large multinational clinical trial for intermittent preventive treatment of malaria in pregnancy in resource-limited areas of sub-Saharan Africa, we encountered numerous challenges, which required implementation of a range of engagement measures to ensure compliance with global clinical and regulatory standards. These challenges included coordination with ongoing global malaria efforts, heterogeneity in national regulatory structures, sub-optimal healthcare infrastructure, local practices and beliefs, and perspectives that view healthcare providers with undue trust or suspicion. In addition to engagement with international bodies, such as the World Health Organization, the Malaria in Pregnancy Consortium, the Steve Biko Centre for Bioethics, and the London School of Hygiene and Tropical Medicine, in order to address the challenges just described, Pfizer Inc. and Medicines for Malaria Venture (the "Sponsoring Entities" for these studies) and investigators liaised with national- and district-level stakeholders such as health ministers and regional/local community health workers. Community engagement measures undertaken by investigators included local meetings with community leaders to explain the research aims and answer questions and concerns voiced by the community. The investigators also engaged with family members of prospective trial participants in order to be sensitive to local practices and beliefs.ConclusionEngagement with key stakeholders at international and national levels enabled the Sponsoring Entities to address challenges by aligning the study design with the requirements of health and regulatory agencies and to understand and address healthcare infrastructure needs prior to trial initiation. Local stakeholder engagement, including community members, study participants, and family enabled the investigators to address challenges by ensuring that study design and conduct were adapted to local considerations and ensuring accurate information about the study aims was shared with the public.Trial registrationClinicalTrials.gov, ID: NCT01103063 . Registered on 7 April 2010.
| S-EPMC5863846 | biostudies-literature
Project description:Few studies have explored the problem of engagement in relation to group psychoeducation from a multi-site and multi-stakeholder perspective. The aim of the study was to explore the factors influencing service user and family engagement with group psychoeducation programmes. The study design was qualitative descriptive. Data were collected through individual and focus group interviews with key stakeholders (n = 75) involved with the programme within 14 mental health sites in the Republic of Ireland. Enablers and barriers to engagement were identified at participant, provider, programme and organization level. Motivated participants and engaged clinicians, peer co-facilitation and support, and skilled and responsive facilitators were some of the factors which enhanced engagement. Barriers to engagement included readiness among participants, concerns related to stigma and confidentiality, desire to distance oneself from mental health services, a lack of support for programme participation within families, group discomfort, the time and length of the programme, issues with transport, visibility of the programme, and structural supports for clinicians. Findings from the study illustrate the multifaceted nature of engagement as well as provide a greater understanding of the multifactorial influences on engagement. Strategies to enhance engagement should therefore reflect a multipronged approach. At the outset of programme implementation, organizations should address their readiness to engage, conduct local needs assessments to anticipate individuals' needs and plan accordingly in order to maximize engagement, and bolster facilitators' engagement skills through the provision of training and mentoring opportunities.
| S-EPMC9233715 | biostudies-literature
Project description:Introduction/objectivesThe engagement of patients and other stakeholders is a critical element in the design of patient-centered outcomes research studies. However, methodology for scalable engagement in research management particularly activities such as operationalization of principles and setting of priorities is not well-developed. The objective of this study is to describe a novel approach for scalable stakeholder engagement in research aligned with the Patient-Centered Outcomes Research Institute (PCORI) engagement principles, which was evaluated in a national clinical data research network.Materials and methodsPatient, patient advocate, clinician, and researcher stakeholders were recruited from clinical sites, as well as social media sites related to the 3 conditions of focus, heart failure, obesity, and Kawasaki disease. The engagement strategy was designed, implemented, and mapped to the PCORI engagement principles. Evaluation included internal assessment and quantitative measures of online engagement.ResultsWe operationalized the PCORI principles with 12 stakeholder engagement strategies and convened stakeholder advisory boards and online research prioritization panels to determine research priorities in a rigorous, deliberative process. A total of 46 advisors (20 patients) and 339 panelists (159 patients) actively participated. There were not significant differences between patients and clinicians in level of online engagement. Nonetheless, while patients reported a slightly greater challenge with following online discussion, they overall had a more favorable opinion about use of the online format.Discussion/conclusionAn efficient way to engage large numbers of representative stakeholders in research is a necessary first step to assure the public of trustworthy use of data networks for health research. This paper describes a comprehensive approach to engagement in patient-centered outcomes research management that informs ongoing development of rigorous methodologies in this area.
| S-EPMC6143220 | biostudies-literature
Project description:BackgroundA 2017 systematic review suggested patient engagement in clinical trials has been limited, with little active engagement in trial design or data analysis, interpretation or dissemination. Additionally, there remains limited sex/gender reporting in clinical trial research.ObjectivesThe overall goal of this project was to disseminate sex/gender knowledge and build capacity for patient engagement in clinical trials. Specific objectives were to (1) create capacity and identify opportunities for patient engagement in clinical trials and sponsor- or investigator-led activities (e.g. clinical trial design and conduct); and (2) enhance new/early investigator sex/gender knowledge and skills related to patient-oriented research (POR).MethodsWe used the Canadian Institutes of Health Research Strategy for Patient-Oriented Research (SPOR) Capacity Development Framework and the SPOR Patient Engagement Framework to guide three phases of this project: (1) conduct a scoping review using methods described by the Evidence for Policy and Practice Information (EPPI) and the Coordinating Centre at the Institute of Education (Phase 1); (2) host a 1-day POR consultation workshop (Phase 2); and (3) deliver a new/early investigator POR training day (Phase 3). Six electronic databases (CINAHL, MEDLINE, EMBASE, PsychInfo, the Cochrane Library, and AMED) were searched from 1996 using keywords and Medical Subject Heading (MeSH) terms in accordance with the International Association for Public Participation (IAP2) and the search criteria in the bibliographic databases. Standard approaches were used to search the grey literature.ResultsA total of 79 studies and over 150 websites were subject to data abstraction by team members, capturing information on sex/gender and SPOR's patient engagement guiding principles of inclusiveness, support, mutual respect, and co-building. Results were presented to 32 key stakeholders at the consultation workshop and input was sought on next steps using nominal group techniques. Based on the plethora of existing POR resources, relevant POR information from the scoping review was collated into two decision aids (patient and investigator) to determine readiness to engage with/as a patient partner in a clinical trial. The decision aids were presented at a POR training day with 88 new/early investigators, clinicians, patient partners and decision makers. The decision aids showed 'good' usability, assessed using the System Usability Scale (SUS). Attendees thought the decision aids were engaging, they increased their understanding of sex/gender, patient engagement and POR, and they would recommend them to others. POR principles and practices were integrated across all phases of the project. Patient partners (1) identified research priorities/search terms; (2) collected/analyzed data; (3) designed the patient partner decision aid; and (4) disseminated the results through presentation.ConclusionOur digital patient partner and investigator decision aids are the first to provide information technology to deliver sex/gender, POR knowledge, and decision support beyond the traditional decision aids used for health screening and/or treatment decisions. The decision aids have the potential to make a significant contribution to Canada's Strategy for POR and support the collaborative efforts of patients and investigators to build a sustainable, accessible and equitable health care system.
| S-EPMC7655585 | biostudies-literature
Project description:BackgroundMusculoskeletal (MSK) pain is a global public health problem with increased societal burden. Increased attention has focused toward patient and other stakeholder perspectives when determining future MSK pain research priorities, however infrastructure and capacity building within the community are needed for individuals and organizations to participate in patient-centered outcomes research. The purpose of this manuscript is to describe our collaborative experiences with several MSK pain stakeholders and processes to identify a top priority research topic.MethodsLunch meetings and formalized workshops were used to develop infrastructure for engaging patients and other stakeholders with early capacity building for partners to identify MSK pain research ideas based on their personal experiences. Additional capacity building and engagement through literature searching further prepared partners to contribute informed decisions about MSK pain research topics and subsequent selection of an important research question.ResultsSeveral key deliverables (e.g., Governance Document, Communication Plan) were developed and completed over the course of this project to provide partnership structure. Other key deliverables included a list of preliminary comparative effectiveness research ideas (n?=?8) and selection of shared decision making for MSK pain as the top priority research topic with patient partners identifying pain self-efficacy as an important outcome domain.ConclusionsOur patient partners provided the catalyst for identifying shared decision making as a high priority research topic based on a wide spectrum of stakeholder perspectives and unique experiences. Patient partners were primarily identified using a single rehabilitation health system and clinician partners were heavily weighted by physical therapists which may have introduced selection bias.
| S-EPMC7268422 | biostudies-literature