Participation In Clinical Research Research Articles

Using provocative design to foster electronic informed consent innovation

BackgroundThe development of technological applications in clinical research, such as electronic informed consent (eIC), is on the rise. The involvement of end users throughout the design process of eIC is of utmost importance to improve the current informed consent process.MethodsUsing a provocative design, we conducted interviews with 30 clinical research participants. Provotypes were used as a starting base to discuss various aspects relevant to eIC. By providing a medium to encourage divergent thinking, participants’ views and concerns were solicited. Thematic analysis was undertaken using NVivo.ResultsThe majority of participants placed trust in the principal investigator or the hospital to perform the role of eIC hosting party. Differing opinions were reported on the amount of information required related to stakeholders’ access to an eIC system, and thus, to participants’ personal data, to enable trust in an eIC system. Nevertheless, this study indicates a general willingness of participants to share personal data with physicians and pharmaceutical companies on an international level, and to receive requests for new research studies via an eIC system. Participants suggested to tailor an eIC system based upon their preferences, for example, regarding whom they want to share their personal data with. Moreover, they expressed a desire to choose how they can contact the research team, and to indicate which study-related information they would like to receive electronically. In addition, positive opinions were voiced on the integration of a test to assess participants’ understanding before providing their eIC.ConclusionsFollowing a research through design approach, insights have been generated which inform the design of eIC. Provotypes were designed to help participants think beyond what is familiar to them. Study findings revealed that not all situations were perceived as provocative, because of participants’ motivation to advance scientific research and the trust they place in the research team. Nevertheless, the use of provocative design resulted in additional insights, generated by clinical research participants, which could be considered in the further design of eIC.

Supported decision-making can advance clinical research participation for people with disabilities.

Supported decision-making can advance clinical research participation for people with disabilities.

Training needs of health researchers in research ethics in Cameroon: a cross-sectional study

BackgroundResearchers are responsible for the protection of health research participants. The purpose of this study was to identify and prioritize the training needs of researchers involved in human health research in Cameroon.MethodsIt was a cross-sectional study conducted in all the Cameroon regions in the last quarter of 2020. It targeted researchers involved in human health research selected by systematic stratified sampling from health and training institutions, and health facilities. Data were collected using a face-to-face administered questionnaire deployed in Smartphones via the ODK-collect. The distribution of participants’ exposure to research ethics training was described as well as their knowledge on the related regulatory texts. A score was used to rank the training needs identified by the participants.ResultsOf 168 reached participants, 134 (79.76%) participated in the study. A total of 103 (76.87%) researchers reported having received training in human health research ethics and 98 (73.13%) perceived need of training in research ethics. Of those involved in clinical, vaccine, and field trials, 63.64, 33.33, 52.53% have been exposed respectively to related training regarding participants’ protection. Having received at least one training in research ethics significantly increase the proportion of researchers systematically submitting application for ethical evaluation prior to implementation (OR = 3.20 (1.31–7.78)). Training priorities identified by researchers include: guidelines and regulations on health research ethics and research participant’s protection in Cameroon, procedures for evaluating research protocols, protection of research participants in clinical trials, and fundamental ethics principles.ConclusionThe coverage of researchers in training regarding research participant protection remains limited in a number of areas including those related to clinical trial participant protection and research participant protection in Cameroon. Improving this coverage and addressing perceived needs of researchers are expected to contribute in improving their ability in playing their role in research participant protection.

Lived experience with sickle cell disease: Predictors of altruistic participation in clinical research

Researchers have found that research altruism motivates research participation, but little is known about what aspects of lived experience motivate this socially focused altruistic participation when participation emerges at the intersection of illness, identity, and injustice. This study examines adults living with sickle cell disease (n = 235) in the United States enrolled in the INSIGHTS clinical research study to investigate what aspects of the sickle cell disease lived experience, understood here as pain and illness perception, are associated with reporting subsidiary and primary altruistic motivations for participating in clinical research. Results from two binary logistic regressions indicate that pain frequency is positively associated with greater odds of reporting subsidiary altruistic motivations, and pain frequency and pain severity are positively associated with greater odds of citing primary altruistic motivations. Conversely, pain interference and illness perception are associated with lower odds of reporting primary altruistic motivations. These results reveal that for this racialized population, participation, although overwhelmingly altruistic, is rooted in an experience of persistent pain. Researchers must disentangle measures of lived experience in order to better understand what factors underlie and prevent participation.

A national platform for Covid-19 vaccine studies recruitment in France: Covireivac volunteer’s characteristics

ABSTRACT During the Covid-19 pandemic, the urgent need for safe and effective vaccines has led to many vaccine trials, implying fast and extensive recruitment of volunteers. In France, until 2020, vaccine clinical research participants were usually recruited locally, through center-based pools of volunteers, and local communication plans. Covireivac is a French public online platform launched on 10/01/2020 that enables national, large-scale recruitment of volunteers for Covid-19 vaccine studies. On the Covireivac website, all adult participants registered online, gave their informed consent, and filled out two online forms with information on their identity, health status (comorbidities, treatments), and known exposure to SARS-CoV-2. Since July 2021, volunteers could mention if their children are interested in participating in a Covid-19 vaccine trial. The objective of this work is to describe Covireivac’s volunteer characteristics registered from 10/01/2020 to 11/02/2022. To identify independent volunteer characteristics associated with a period of registration we performed a multivariate logistic regression. Among 54,424 registrations, 52,391 (96%) were analysed; 61% were male (n = 31,893), median age was 50 y; 13% (n = 6586) were healthcare workers. At registration, 15,879 volunteers (33%) reported at least one comorbidity, among whom 16% (n = 7349) were obese and 17% (n = 8346) had hypertension. Most volunteers registered during the first month (n = 35,876, 66%). The Covireivac platform allowed quick and large recruitment of potential volunteers for Covid-19 vaccine trials and could be used on a larger scale for vaccine trials in France. It could facilitate recruitment in vaccine trials and provide sponsors with better visibility of the recruitment capacities of clinical research centers.

Beyond race: Recruitment of diverse participants in clinical genomics research for rare disease.

Purpose: Despite recent attention to increasing diversity in clinical genomics research, researchers still struggle to recruit participants from varied sociodemographic backgrounds. We examined the experiences of parents from diverse backgrounds with enrolling their children in clinical genomics research on rare diseases. We explored the barriers and facilitators parents encountered and possible impacts of sociodemographic factors on their access to research. Methods: We utilized semi-structured interviews with parents of children participating in the Undiagnosed Diseases Network. Interview data were analyzed using comparative content analysis. Results: We interviewed 13 Hispanic, 11 non-Hispanic White, four Asian, and two biracial parents. Participants discussed different pathways to clinical genomics research for rare disease as well as how sociodemographic factors shaped families’ access. Themes focused on variation in: 1) reliance on providers to access research; 2) cultural norms around health communication; 3) the role of social capital in streamlining access; and 4) the importance of language-concordant research engagement. Conclusion: Our findings suggest that variables beyond race/ethnicity may influence access in clinical genomics research. Future efforts to diversify research participation should consider utilizing varied recruitment strategies to reach participants with diverse sociodemographic characteristics.

Perceptions and attitudes toward participation in clinical research in the Eastern Mediterranean Region: A systematic review.

Introduction:Successful recruitment of participants into clinical research has always been challenging and is affected by many factors. This systematic review aimed to explore the perceptions and attitudes as well as identify the factors affecting the participation in clinical research among the Eastern Mediterranean Regional Office countries’ population.Methods:A systematic search of the literature was conducted to explore attitudes or perceptions of the general public or patients towards participation in clinical research. PubMed, Pro-Quest Central, World Health Organizations Index Medicus for the Eastern Mediterranean Region, and Google Scholar were searched. Studies were considered eligible for inclusion if they presented primary data and were conducted in one of the Eastern Mediterranean Regional Office countries. A data extraction sheet was used to record the following: year, country, aim, population, sample size, study design, data collection, and setting. The identified factors from the included studies were categorized into motivators and barriers.Results:In total, 23 original research articles were identified that addressed perceptions or attitudes towards clinical research participation. Six main motivators and barriers of research participation among patients, the general public, and patient family members were identified. The most common cited motivators included personal benefits to the individual, altruism and the desire to help others, the research process, the influence of the physician, family encouragement, and religion. Concerns regarding safety, confidentiality, and other factors in addition to the research process, lack of trust in healthcare providers or healthcare system, lack of interest in research and no perceived personal benefit, religious concerns, and family/cultural concerns were the most cited barriers to participation.Conclusion:The identified motivators and barriers are essential to tackle during clinical research planning among the population of Eastern Mediterranean Regional Office countries. Further research is needed to assess the attitudes and perceptions of individuals approached to participate in trials.

Underrepresentation of ethnic minorities in hypertension research—a survey of enablers and barriers among South Asian and African communities in Glasgow

BackgroundHypertension is the biggest contributor to the global cardiovascular burden with evidence for ethnic differences in treatment response and outcomes. Under-representation of ethnic minorities in clinical research is well known, and despite wide-ranging public engagement events by the Glasgow Blood Pressure Clinic team, there was a lack of participation of ethnic minorities in both engagement activities and clinical trials conducted by them. This study aims to explore the awareness and knowledge of hypertension and the facilitators and barriers to participation in hypertension clinical research among South Asian (SA) and African (AFR) communities in Glasgow.MethodsA survey questionnaire was co-developed with representatives from South Asian (SA) and African (AFR) patients and community members in Glasgow to understand awareness and knowledge of hypertension and enablers and barriers to participation in clinical research. The survey was distributed to adults (aged > 18) years of SA or AFR ancestry at public engagement events at venues that were frequently visited by these two communities in Glasgow.ResultsThe survey response rate was 337 (67.4%) consisting of 242 (71.8%) South Asian (SA) and 56 (16.9%) African (AFR) respondents. Thirty-nine questionnaires were excluded because of incompletion. Most of the respondents were not born in the UK and were in the 35–53-year group (AFR 29 (51%), SA 113 (47%)). The proportion living in the most deprived (SIMD 1) and least deprived (SIMD 5) was respectively 26 (12.4%) and 34 (16.2%) for SA and 20 (42.6%) and 2 (4.3%) for AFR. There was a considerable recognition that treatment needs to be ethnicity-specific (SA/AFR = 107 (48%)/23 (45.1%)) and that current cardiovascular disease treatment guidelines were not tailored for different ethnicities 84 (38.5%)/23 (45.1%). The key enablers encouraging research participation are enhanced health information, conducting aspects of their clinical research visits/appointments at a location they frequently visited and allowing a family member to accompany them. Barriers included concerns about the use of personal information and side effects of the new treatment.ConclusionOur survey confirmed enablers and barriers to ethnic minority participation in research. We find improving and evolving awareness and beliefs among the ethnic minority population including community leaders. Thus, continual review of researchers’ beliefs and attitudes is also essential to ensure engagement activities keep up with these changing perceptions.

Barriers to Enrollment in Rheumatology Research: Who, What, Where, When, and Why?

Despite the evidence that complicated rheumatic diseases are more prevalent and severe in ethnic minorities, rheumatology research is afflicted with inadequate patient representation. It is lacking in ethnic and socioeconomic diversity. The objective of this study is to identify barriers to enrollment in rheumatology research and propose possible solutions to overcome these barriers.In this study, 184 patients from two rheumatology clinics (Safety Net clinic, a university-based clinic) were surveyed for concerns regarding participation in clinical research. Patients were asked to rank their top five of eight concerns. Data were then stratified by self-reported ethnicity and clinic site to determine ranking differences in both groups.Fear of risks associated with clinical research was ranked as the primary barrier in all ethnicities. More non-Hispanic Whites (NHW) (24.4%) ranked work responsibilities as a primary barrier compared to Hispanics (10%). Fear of discovering a serious illness as a primary barrier was more frequent at the Safety Net clinic (25%) compared to the university-based clinic (6.3%) and ranked more frequently in the top five in Hispanics compared to NHW.Fears associated with research risks, work responsibilities, and fear of discovering a serious illness were the top-ranked barriers to enrollment in research among patients. However, differences in rankings between ethnicities and clinic sites were identified. This sheds light on the importance of health literacy and the responsibility of researchers in addressing gaps in communication while acknowledging potential cultural components that warrant further investigation.

Living with Advanced Breast Cancer: A Descriptive Analysis of Survivorship Strategies.

Survivors of advanced breast cancer (ABC), also known as metavivors, are often left with fewer treatment options in the landscape of a cure culture. Metavivors have unique psychosocial and physical needs distinct from patients with early-stage breast cancer. This analysis delves into side effects commonly experienced by patients with ABC, such as fatigue, anxiety, and cardiotoxicity; how these side effects impact caregiver support, financial toxicity, emotional strain, and spiritual and emotional distress; as well as current strategies for mitigation, including nutrition, exercise, and participation in clinical research. Overall, this analysis is a mandate for additional research to explore novel treatments and implement strategies to maintain and improve patients’ quality of life.

Using Technology to Enhance Cancer Clinical Trial Participation.

The COVID-19 pandemic presented many challenges to health care systems, including oncology clinical research programs. There were substantial negative effects on oncology clinical trial screening, enrollment, and study activities that forced institutions and regulatory bodies to develop innovative solutions to maintain robust and equitable participation in these trials. Digital pathology innovations at Memorial Sloan Kettering Cancer Center have streamlined the diagnostic life cycle for patients with cancer, and the seamless integration of digital pathology services with next-generation sequencing and other molecular pathology services have accelerated the time to diagnosis and receipt of molecular results. Timely access to these results, coupled with Memorial Sloan Kettering Cancer Center's knowledge engine OncoKB, enhances patient clinical trial coordination precisely and efficiently. At the Sarah Cannon Research Institute, centralized remote clinical trial matching and screening, virtual molecular tumor boards, and centralized molecular interpretation support services have empowered clinic staff to identify more efficiently potential participants in clinical research, despite the COVID-19 pandemic. In addition, the U.S. Food and Drug Administration Oncology Center of Excellence has been involved in several efforts to address challenges for patients with cancer during the COVID-19 pandemic, including writing guidance documents and participating in efforts to modernize clinical trials. The enclosed personal experience of a patient with cancer currently participating in an oncology clinical trial emphasizes the need for continued decreasing of barriers to study participation. Clinical trial advances that were accelerated by the pandemic will ultimately help patients with cancer and the greater oncology health care community.

Motivators and barriers towards clinical research participation: A population-based survey from an Arab MENA country.

Jordan was the first Arab country to enact clinical research regulations. The country has a well-flourished pharmaceutical industry that leans heavily on clinical research (CR) for drug development and post-marketing surveillance. In this cross-sectional study, we sought to assess the public’s awareness and attitude towards CR as well as their perceived motivators and barriers to CR participation. A population-based, self-administered questionnaire was distributed to the general public in Jordan. Among the 1061 participants in this survey, 74% reported being aware of CR. The majority (70%) agreed to the role of CR in health promotion. Online information and healthcare staff were the two main sources of CR information for the participants. About 25% of the participants received prior invitations to participate in CR with 21% agreeing to participate. However, most participants of the current study (63%) were willing to participate in future CR. Contributing to science, benefiting others, and promoting one’s own health were the top motivating factors for participating in CR; while time constraints, fear of research procedure, and lack of interest were the most cited reasons for rejecting participation. Filling out questionnaire surveys, donating blood samples, and participating in physical examinations were the main CR contributions of the participants. Nearly 31% of the participants believed that CR is conducted in a responsible and ethical manner, while 57% did not have an opinion regarding the same matter. In addition, 49% and 44% were neutral with regards to the degree of harm and confidentiality posed by CR. While only 27% disagreed that CR exposes participants to some form of harm, 48% either strongly agreed (15%) or agreed (33%) that it maintains high level of confidentiality for participants. The current study provides insight into the public’s perception of CR in Jordan as well as its motivating factors and perceived barriers towards participating in CR. We envisage to utilize this insight as an aid in the design of vigilant future awareness campaigns and recruitment strategies.

A New Tool to Enhance Physicians' Participation in Clinical Research.

A New Tool to Enhance Physicians' Participation in Clinical Research.

Abstract 5930: Identifying effective communication for recruitment of minority women to a breast cancer prevention study: A novel focus group approach

Abstract Ensuring that minoritized women are involved in breast cancer research is important to address well-documented current disparities in cancer incidence, stages of diagnosis, and mortality rates. This study used a novel interactive focus group method to identify innovative communication strategies for recruiting women from two minority groups—Latinas and Asian Americans—into the Komen Tissue Bank, a specific breast cancer biobank clinical trial. Through activities that employed visual interactive tools to facilitate group discussion and self-reflection, the authors examined perspectives and motivations for Asian American women (N=17) and Latinas (N=14) toward donating their healthy breast tissue. Findings included three themes that, while common to both groups, were unique in how they were expressed: lack of knowledge concerning breast cancer risks and participation in clinical research, cultural influences in breast cancer risk thinking, and how altruism relates to perceived personal connection to breast cancer. More significantly, this study illuminated the importance of using innovative methods to encourage deeper, more enlightened participation among underrepresented populations that may not arise in a traditional focus group format. The findings from this study will inform future health communication efforts to recruit women from these groups into clinical research projects like the Komen Tissue Bank. These findings also illustrate the importance of applying rigorous qualitative work to supplement quantitative research to increase the inclusion of minoritized populations in clinical trials. Citation Format: Katherine E. Ridley-Merriweather, Stephanie M. Younker, Madeline D. Evans, Cynthia Y. Wu. Identifying effective communication for recruitment of minority women to a breast cancer prevention study: A novel focus group approach [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 5930.

Abstract LB173: AACR President's initiative - 2020 by 2020: Democratizing precision cancer medicine and advancing health equity in the black belt

Abstract African Americans (AA) have higher incidence and mortality rates for several cancer types in comparison to their European American (EA) counterparts. Increasing participation in clinical research and patient registries, related to precision cancer medicine, will significantly improve cancer health equity. Many AA cancer patients are treated in community oncology clinics. Unfortunately, these health systems have limited access to Clinical Laboratory Improvement Amendments (CLIA) next generation sequence (NGS) germline and somatic DNA and RNA testing that are used to inform oncologists on the best treatment and/or clinical trial options for cancer patients. Indeed, AA CLIA NGS sample sets are poorly represented, which could presumably result in incomplete knowledge of genomic variants that could affect their treatment and overall outcomes. Hence, it is crucial to implement CLIA NGS efforts for all cancer patients. To address these disparities, Morehouse School of Medicine has formed the Comprehensive Approach to Reimagine health Equity Solutions (CARhES) consortium with Tuskegee University that has engaged community oncology practices in Alabama and Georgia - two of five Black Belt states. The CARhES consortium aims to implement precision cancer medicine to underserved and underrepresented communities that will improve the standard of cancer care by providing access to CLIA NGS testing, clinical trials, and personalized cancer care. Here we describe the first proof of concept of this approach with community oncology partners, i.e., Grady Health System, Wellstar Health System, Georgia Urology, Midtown Urology, and Maui Memorial Medical Center. At the time of consent, saliva, buccal, and tumor samples were collected from participants. Germline and somatic CLIA NGS was performed, and medical reports were returned to practitioners within 14 days. Prior to the COVID pandemic, the study enrolled over 880 patients with a 88% consent rate (n = 1000) in the first 11months of the program. At the start of the COVID pandemic, recruitment efforts were suspended for four months with a slow restart by June 2020. A decrease in the number of staff, office visits (67% reduction), and increase in COVID cases significantly limited recruitment efforts. During this slowdown, we established and improved eConsenting capabilities, which exist today. Community anxiety, due to the pandemic and SARS-CoV-19 vaccine efforts, resulted in a significant reduction in consent rates (88% to 60%). Nevertheless, this study began in April of 2019 and consented 1,750 participants in less than 2 years. Taken together, our study shows that a community-focused precision medicine approach requires meeting people where they are and providing them with access and understanding the benefit of clinical trial participation. The approximate 2,000 clinically annotated genomic AA datasets will greatly contribute to our understanding of cancer health disparities and among the first steps to democratize precision medicine. This study was funded by the American Association for Cancer Research, The Pelotonia Foundation, the M2Gen Foundation, and the National Cancer Institute (U54CA118638). Citation Format: Latrisha L. Horne, Gabriella M. Oprea-Ilies, Eddie R. Stanley, Carla M. Holloway, Margaret P. Hooker, Amina Isom, Derrick J. Beech, Ana Gaonkar, Shavette Harden, Jeffrey F. Hines, LaTonya Randolph, James K. Bennett, Daniel Canter, Darrell J. Carmen, Pooja Mishra, Giuseppe Del Priore, Roland Matthews, Brian M. Rivers, James W. Lillard. AACR President's initiative - 2020 by 2020: Democratizing precision cancer medicine and advancing health equity in the black belt [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr LB173.

Abstract 5967: ROSA: An ambassador program facilitating bidirectional partnerships between communities and basic scientists

Abstract Background: Community Outreach and Engagement (COE) is integral in NCI-designated Cancer Centers. COEs work with community stakeholders identifying community needs, communicating research, and catalyzing significant activities to Cancer Center’s catchment areas. To facilitate this, the University of Arizona Cancer Center (UACC) Office of COE established the Research Outreach for Southern Arizona (ROSA) program, supporting bidirectional partnerships between basic scientists and underrepresented communities in catchment areas. Objective: To describe a community and student ambassador program developed as ROSA, bridging gaps between basic science programs and community needs in UACC catchment areas. Methods: The UACC catchment areas include five southern Arizona counties where 40% of residents are Hispanic, compared to 18.3% in the US. Moreover, ambassadors were bilingual/bicultural Hispanic undergraduate students (n=4) and Hispanic community members (n=4). The ambassador program held weekly cancer educational discussions, research methods, monthly Meet the Scientist events, and presentations on experiences. Evaluations for ROSA were completed by all affiliates. Results: Overall, ROSA ambassadors reported increased knowledge of research and increased confidence sharing cancer information. Facilitators of ROSA community members included a bilingual/bicultural team, outreach collaborations, and participant compensation. Barriers included payments for undocumented members, lack of Spanish-speaking scientists, and reduced in-person activities. As a result of ROSA partnerships, scientists, healthcare professionals, and stakeholders is developing Scientific Cafes where scientists present research proposals for community feedback. The workgroup will select a community-driven project to implement in the future. Discussion: Based on positive ambassador evaluations and working group collaborations, ROSA is successful in growing authentic partnerships between scientists and communities. Recently, a community-based survey was developed by members to examine perceptions of cancer and willingness of clinical research participation. This survey will inform how basic scientists align research within community needs. ROSA will continue to be valuable in providing bidirectional engagement from basic scientists and community members in cancer research. Citation Format: Gabriela Ruiz, MEd., Amanda Lee. ROSA: An ambassador program facilitating bidirectional partnerships between communities and basic scientists [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 5967.

Clinical perspectives and strategies for confronting disparities in social determinants of health for Hispanic bilinguals with aphasia

Disparities in social determinants of health (SDOH) such as socioeconomic status and access to quality healthcare present serious barriers to enrollment in clinical rehabilitation programs for individuals who have experienced a stroke, especially for those who identify with a racial-ethnic minority group. Hispanic bilinguals with aphasia (HBWA) are one marginalized group who face even greater enrollment challenges since post-stroke language impairment and limited English proficiency make it difficult to advocate for one's needs and identify appropriate rehabilitation programs. Given the increasing representation of Hispanic individuals in the U.S. (projected to be 30% of the population in 2050), it is imperative that clinicians counter disparities in stroke care by facilitating access to clinical services for HBWA. However, the Hispanic population remains largely understudied in the stroke and aphasia literature, due in part to reduced opportunities to enroll in large-scale clinical research studies. In this paper we highlight how our team at Boston University has designed and implemented a variety of recruitment practices, assessment modifications, and treatment accommodations to circumvent the known barriers to participation in clinical research experienced by HBWA. Furthermore, we discuss the importance of cultural responsiveness and demonstrate how including principles of sensitivity and humility in clinical trial protocols improves participant enrollment and retention. Although clinical adjustments in this study were developed for use with HBWA, the effectiveness of the procedures suggests they may be useful blueprints for expanding access to research opportunities for various marginalized groups.

EPCT-08. Disease-specific working groups within the Pacific Pediatric Neuro-Oncology Consortium (PNOC) and Children’s Brain Tumor Network (CBTN) facilitate multi-disciplinary collaboration and translation of innovative strategies in pediatric neuro-oncology

Abstract BACKGROUND: In Summer 2019, PNOC leadership developed working groups to align basic scientists, clinical researchers, and foundations for rapid translation of novel therapies for children and young adults with central nervous system tumors. Soon after, PNOC partnered with the Children’s Brain Tumor Network (CBTN) to grow collaborations and augment preclinical resources. Since their inception, working groups have advanced translation of new therapies and biomarkers, developed pipelines for preclinical and clinical research, and expanded global collaborations. DESIGN: Each working group is led by 2 to 3 experts in a disease, such as medulloblastoma, diffuse midline glioma, or craniopharyngioma, or subject matter, like imaging, nursing, or diversity, equity, and inclusion. A project manager coordinates regular multidisciplinary meetings to share new findings from research laboratories, provide updates on clinical trial development (with real-time feedback and incorporation of trial endpoints and biomarkers), and invite speakers to share advancements in the disease or subject of interest. RESULTS: Eleven working groups have been created with over 200 members across the United States, Europe, Australia. More than 20 foundations, led predominantly by families, provide support and insight to guide working group efforts. Working groups have developed 4 clinical trials (n=2, diffuse midline glioma; n=1, craniopharyngioma; n=1, medulloblastoma) and completed 3 international surveys, investigating experiences of patients/families affected by craniopharyngioma, evaluating diversity and inclusion throughout the consortia, and assessing nursing and advanced practice provider needs. Additional accomplishments include a registry for atypical teratoid rhabdoid tumors, a population dataset evaluating diversity in clinical research participation across consortia, incorporation of nursing members for review and refinement of clinical trial protocols, and updated imaging case report forms for application across clinical trials. CONCLUSION: Multidisciplinary working groups within international consortia facilitate efficient translation of multi-pronged strategies to improve the care of children and young adults with central nervous system tumors.

Health concerns and attitudes towards research participation in a community of rural Black Americans

ABSTRACT Objectives Describe health concerns of Black Americans as they age and what influences their participation in aging and clinical research. Methods Fifty participants attended focus groups and completed questionnaires to identify barriers to research participation and attitudes toward dementia screening. Bivariate correlations explored associations between barriers to research participation and attitudes toward dementia screening. Results Cancer, hereditary conditions, vascular conditions, memory disorders, and psychological disorders were the greatest health concerns. Time demands, mistrust, lack of knowledge about potential research, and stigma were identified as barriers for research participation. Incentives, better understanding of how proposed research will benefit the community, lifestyle modification studies, active presence of principal researchers/clinicians, and community investment were identified as factors to improve participation. Questionnaires revealed mistrust and religious beliefs to be among the primary barriers. Attitudes toward dementia screening reflected perceived stigma, suffering, and subsequent loss of independence. Higher barriers to participation were associated with perceived stigma and loss of independence related to dementia screening. Conclusions Successfully recruiting Black Americans for aging and clinical research remains a challenge. This study identifies barriers to participation and offers suggestions for planning and recruitment.

176 Clinical research participation in neurology

The benefits of clinical research for patients are well recognised. The Royal College of Physicians’ recent strategy document ‘Benefiting from the research effect’ highlights the role of NHS trusts in supporting research activity. Anecdotal evidence suggests that higher recruitment of patients to research studies in oncology compared to neurology is partly driven by a more pro-active approach by oncologists in dis- cussing clinical research participation with their patients. In an ongoing evaluation across NHS neurology and oncology services in a large teaching hospital, we are gathering views from clinical staff regarding their experience, attitudes, training, and barriers in recruiting patients to clinical studies, comparing the two specialities. To gather the patient perspective, hospital attenders from the neurology research setting (specifically the multiple sclerosis Phase III trial MS-STAT2), and from the multiple sclerosis clinical service in the same hospital are being surveyed. Preliminary results suggest that in 23/40 trial neurology patients (57.5%), there was at least one occasion where additional clinical care unrelated to the study was delivered as a result of engagement with research pathway. Comparing neurology to oncology, and neurology research with service settings, will deliver objective data to inform improvements in clinical research participation in neurology.carmen.jacob@uhs.nhs.uk