Participation In Clinical Research Research Articles

Investigator Participation in Clinical Research: An Examination of Barriers and Facilitators in the Indian Clinical Trials Settings

Background: This study aims to improve clinical research by identifying the barriers and facilitators for investigators conducting trials. We explore investigator demographics, challenges faced, and factors promoting engagement. Additionally, we examine how investigators’ background influences their experiences with both barriers and facilitators, ultimately aiming to foster a patient-centric clinical trial ecosystem. Methods: A quantitative, exploratory study investigated barriers and facilitators in clinical trials among 132 investigators in India. A self-designed questionnaire captured experiences with challenges, strategies, and facilitators. Pilot testing ensured tool validity and reliability. Ethical considerations were addressed, and data analysis will identify key factors impacting investigator engagement. This study aims to improve the clinical research ecosystem in India. Results: The study aims to identify the facilitators and barriers experienced by the research investigators. An online questionnaire survey was used in this cross-sectional investigation. The study's population consists of 132 respondents, with 68 (51.5%) males and 64 (48.5%) females. Clinical Research Coordinators (CRCs) (41.7%), Research Associates (RA’s) (27.3%), Supporting staff (19.7%), Co-Investigators (Co-I) (6.8%), and Principal Investigators (PIs) (4.5%) which were the majority of respondents. The most common barriers found among the principal investigators regarding the limited resources (p=0.014) towards the clinical trials. Inadequate training (p=0.461), Complex regulations (p=0.625), and Communication barriers (p=0.853) did not seem like barriers to the clinical research staff. Whereas some of the staff faced barriers (p=0.118) with the complex regulations and Inadequate training on the other hand most of the respondents considered the same statements as facilitators (p=0.963) with their daily working activities. Conclusion: The Barriers and Facilitators experienced by the clinical investigators, It was found that there is no difference in viewpoint. As per the results, Research associates agreed more with the facilitators and the principal investigators faced barriers.

Addressing Barriers and Facilitators to African Americans' and Hispanics' Participation in Clinical and Genomic Research Through a Bioethical Sensitive Video.

Research advances on effective methods to prevent, diagnose, and treat cancer continue to emerge through clinical and genomic research. Most clinical trial and genomic research participants identify as White which limits the generalizability of research findings to non-White populations. With the development and access to technology, digital delivery of salient and tailored health education may provide innovative pathways to increase representation of African Americans (AA) and Hispanics in research. This project focused on the creation of a bioethical sensitive education video aimed at increasing participation in clinical trials and genomic research by bringing together experts from the community, healthcare, biomedical research, and public health. The goal was to utilize existing educational resources to create a tailored message to address AA/Hispanics' beliefs, values, and bioethical concerns related to participation in clinical and genomic research. Models of behavior change and communication theories were leveraged to frame key components of the message, which then informed the framework for the animated video. Development of the video consisted of six iterative phases: 1) writing sessions; 2) storyboarding; 3) animating; 4) screening/revisions; 5) acceptability testing; 6) finalization. The final animated video is approximately 5min in length and covers several topics including the goal of clinical research, disparities in research participation, bioethical concerns, and genomic research regulations. Increasing AA and Hispanic participation in clinical and genomic research is imperative to achieving health equity. Tailored messages via short videos may assist in addressing the barriers and facilitators towards research participation and increase intentions to enroll in trials.

Equitable Representation of Pregnant and Lactating Women in Clinical Research: A Historical Review and Critical Analysis of Proposed Legislation.

A long history of policymaking and regulation constructed for the purpose of ensuring adequate fetal and infant protections has inadvertently sanctioned the widespread exclusion of pregnant and lactating patients from biomedical research, leaving a paucity of high quality data necessary for clinical decision-making. Although well-intended, the regulatory classification of pregnant women as "vulnerable", in conjunction with burdensome enrollment criteria and other factors weighing against broad inclusion, have ultimately placed the health and safety of these women and their babies in jeopardy. Robust measures are urgently needed to overcome patient and physician reluctance, address substantial evidence gaps and rectify longstanding disparities which precipitate disproportionately poor health outcomes among this population. In February 2023, the Advancing Safe Medications for Moms and Babies Act of 2023 (the Act) was introduced in the United States House of Representatives with the overarching goal of enabling pregnant and lactating women to achieve equitable participation in clinical research and contribute to developing important biomedical knowledge to guide and improve healthcare delivered to these patients. This review discusses the historical influence of federal human subject protection regulations on the health and clinical treatment of pregnant and lactating women, outlines and critically analyzes the provisions incorporated into the Act, and reflects on the potential long-term impact the Act would have should it be successful in becoming law.

Household income and health-related quality of life in children receiving treatment for acute myeloid leukemia: Potential impact of selection bias in health equity research.

Examine the influence of household income on health-related quality of life (HRQOL) among children with newly diagnosed acute myeloid leukemia (AML). Secondary analysis of data prospectively collected from pediatric patients receiving treatment for AML at 14 hospitals across the United States. Household income was self-reported on a demographic survey. The examined mediators included the acuity of presentation and treatment toxicity. Caregiver proxy reported assessment of patient HRQOL from the Peds QL 4.0 survey. Children with AML (n = 131) and caregivers were prospectively enrolled to complete PedsQL assessments. HRQOL scores were better for patients in the lowest versus highest income category (mean ± SD: 76.0 ± 14 household income <$25,000 vs. 59.9 ± 17 income ≥$75,000; adjusted mean difference: 11.2, 95% CI: 2.2-20.2). Seven percent of enrolled patients presented with high acuity (ICU-level care in the first 72 h), and 16% had high toxicity (any ICU-level care); there were no identifiable differences by income, refuting mediating roles in the association between income and HRQOL. Enrolled patients were less likely to be Black/African American (9.9% vs. 22.2%), more likely to be privately insured (50.4% vs. 40.7%), and more likely to have been treated on a clinical trial (26.7% vs. 18.5%) compared to eligible unenrolled patients not enrolled. Evaluations of potential selection bias on the association between income and HRQOL suggested differences in HRQOL may be smaller than observed or even in the opposing direction. While primary analyses suggested lower household income was associated with superior HRQOL, differential participation may have biased these results. Future studies should partner with patients/families to identify strategies for equitable participation in clinical research.

110 Answering the Call for Greater LGBTQ+ Research Inclusivity by Co-Developing A Workshop for Researchers

OBJECTIVES/GOALS: The objectives of this workshop were to: (1) provide learners with a space to become aware of and discuss the history of the LGBTQ+ community in medical and public health research; (2) apply frameworks for LGBTQ+ inclusivity in research, inspired by lived experience and multimedia; and (3) assess LGBTQ+ research inclusivity best practices. METHODS/STUDY POPULATION: The CTSC provided the LGBT Community Center of Greater Cleveland (Center) with access to academic resources via an affiliate account and insights on the clinical and translational science research process. Members of the CTSC Research Equity, Accessibility, Diversity, and Inclusion team met regularly with the education and programming team at the Center to review research findings for workshop segments, ideate and provide feedback on activities, and strategize to ensure a psychologically safe virtual environment for learners. Zoom registration was used for workshop registration. An evaluation survey, created by the LGBT Community Center of Greater Cleveland (Center), was deployed by the CTSC to learners after the workshop. Respondents reported that the LGBTQ+ terminology focus was most valuable. RESULTS/ANTICIPATED RESULTS: To maximize investment in and scale theLGBTQ+ Inclusivity For Researchers workshop, the LGBT Community Center of Greater Cleveland offered a shortened version to their Youth Participatory Action Research group and will continue to offer the workshop in their suite of program/educational offerings. The CTSC plans to offer opportunities to co-host the workshop at its hospital system partner institutions, with room to tailor content based on internal LGBT resources (e.g., gender care offered at the institution). We hope to see a remarkable increase in LGBTQ+ identifying researchers, LGBTQ+ participation in research studies and clinical trials, and LGBTQ+ research topics/ideas/questions in response to CTSC pilots, local, national, and global funding opportunities. DISCUSSION/SIGNIFICANCE: LGBTQ+ people are less likely to have a regular health care provider—impeding screening, diagnosis, and treatment. This is reflected in health research where clinical research participation may follow a diagnosis. By providing tools for LGBTQ+ research inclusion, we will catalyze more research with LGBTQ+ people—as researchers and participants.

Using digital tools in clinical, health and social care research: a mixed-methods study of UK stakeholders

ObjectiveThe COVID-19 pandemic accelerated changes to clinical research methodology, with clinical studies being carried out via online/remote means. This mixed-methods study aimed to identify which digital tools are currently used...

Abstract 810: Assessing human papillomavirus (HPV) awareness and intentions to participate in HPV vaccination and clinical trials (CT) among Latinos/as in Los Angeles (LA) County: A multicomponent intervention

Abstract Background: The incidence of HPV-related cancers continues to disproportionately affect women and men of Latino origin. In LA, a total of 20,868 individuals have been diagnosed with HPV-related cancers from 2009 to 2019. HPV infection knowledge and interpersonal barriers contribute to HPV vaccine delay and refusal. Similarly, Latinos/as continue to also have low participation in clinical trials research. To address the low knowledge, attitudes, and intentions towards HPV vaccination and participation in clinical trials (CT), we have adopted the NCI National Outreach Network framework and have used community health educators to deliver bilingual-culturally appropriate workshops on HPV and CT. Methods: Individuals, 18 and over and parents with eligible age children (in respect to the HPV initiative) were recruited through community outreach and local community partnerships to participate in the bilingual (English and Spanish) health education workshops. A baseline assessment was administered before each educational workshop and a follow-up assessment was administered after to evaluate change in HPV and CT knowledge, intentions to vaccinate, and likelihood to participate in CT. Descriptive statistics were calculated to assess distribution of demographic variables of interest and a paired T-test was used to explore matched pre-post differences in knowledge scores and intentions. Results: 290 (HPV) 272 (CT) individuals participated in the workshops. The mean age of participants was 41.13yrs with a (SD=11.63). More than half of participants were women 453 (81.7%), men 94 (16.9%) and other 7 (1.26%). Comparing HPV knowledge scores of matched pre-and post-surveys, showed that for baseline (n=182) (M=72.9%, SD=13.3) was statistically different from post-scores (n=182) (M=81%, SD=9.85) where p&amp;lt;0.05. Intentions were measured using a Likert scale, baseline (M=4.1), agree to get HPV vaccine, post (M=4.5) strongly agree to get HPV vaccine. In respect to CT baseline knowledge (n=174) (M=75.3%, SD=0.15), following a Likert scale response of (M=3.4), unsure to join a clinic trial. In assessing post-CT scores (N=174) (M=78%, SD:0.14), mean scores were significant where p&amp;lt;0.05 and an increase to (M=3.7) agree to join a clinical trial. After workshops attendance, not only was knowledge increased, but intentions to vaccinate against HPV and to participate in a clinical trial was strengthen. Conclusions: Strengthening community-based education and providing the necessary tools, can help reframe misconceptions about HPV and HPV vaccination and promote willingness to vaccinate and participate in clinical trials. Citation Format: Alejandra Ramos, Carolina Aristizabal, Lourdes A. Baezconde-Garbanati. Assessing human papillomavirus (HPV) awareness and intentions to participate in HPV vaccination and clinical trials (CT) among Latinos/as in Los Angeles (LA) County: A multicomponent intervention [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 810.

Primary care involvement in clinical research – prerequisites, motivators, and barriers: results from a study series

BackgroundLong-term reinforcement in the role of primary care and improvement the healthcare system as a whole requires the involvement of GPs in clinical research processes. However, many clinical studies fail due to failure to achieve sample population targets amongst GPs and their patients. This issue has been identified and discussed, but effective strategies to overcome it are still lacking. One of the reasons is that the positions, requirements, and experiences of GPs on participating in clinical research have hardly been examined up to now.MethodsThe years 2021 and 2022 saw three quantitative and qualitative surveys amongst GPs in Germany with the aim of shedding light on the attitudes, experiences, and potential issues regarding the involvement of primary care in clinical research projects and participation in cluster-randomised controlled trials (cRCTs) in a general sense. This overview summarises and abstracts conclusions gained from the exploratory series of studies and compares the results with the current research situation. From here, this contribution will then develop an approach towards optimising the integration of GPs into clinical research.ResultsMost of the GPs asked associated clinical research with opportunities and potential such as closing gaps in healthcare, using evidence-based instruments, optimising diagnostic and therapeutic management, and reinforcement of multiprofessional healthcare. Even so, many GPs unsure as to how far primary care in particular would stand to benefit from studies of this type in the long term. Respondents were also divided on willingness to participate in clinical research. GPs having already participated in Innovation Fund projects generally saw a benefit regarding intervention and cost–benefit relationship. However, some also reported major hurdles and stress factors such as excessive documentation and enrolment requirements, greater interference in practice routines, and sometimes poor integration into project processes such as in communication and opportunities to play an active role in the project.ConclusionsResults from the studies presented provide indications as to how GPs perceive clinical research projects and cRCTs as a whole and from their existing project experience, and on the requirements that studies would have to meet for GPs to be willing to participate. In particular, making sure that clinical studies fully conform with GPs would play a major role; this especially applies to freedom to make medical decisions, limitation of documentation obligations, interference in regular practice routine, greater involvement in research planning, and long-term reinforcement in the role of primary care. Clinical research projects and cRCTs should be planned, designed, and communicated for clear and visible relevance to everyday primary care.

Public perception of participation in low-risk clinical trials in critical care using waived consent: a Canadian national survey.

The acceptability of waiver of consent for participation in clinical research in intensive care unit (ICU) settings is uncertain. We sought to survey the Canadian public to assess levels of support, comfort, and acceptability for waived consent for low-risk clinical trials. We performed a prospective cross-sectional survey of the Canadian public aged 18yr or older. The survey was conducted by Ipsos between 19 and 23 November 2020. The survey content was derived from a literature review and in consultation with a patient and family partnership committee. The survey focused on attitudes and beliefs on waived consent for participation in low-risk clinical trials in ICU settings. The survey contained 35 items focused on sociodemographics, general health status, participation in medical research, and levels of support and comfort with research and with waived consent. The survey used a case study of a low-risk clinical trial intervention in ICU patients. Analysis was descriptive. We included 2,000 participants, 38% of whom reported experience with ICU and 16% with medical research. Participation in medical research was more common among those with postsecondary education, those with chronic disease, and those who were employed in health care. Most (80%) would support a model of waived consent for low-risk clinical trials, citing medical benefits (36%) and low perceived risk (34%). Most (77%) were comfortable with personally participating in a low-risk clinical trial. Most (80%) believed waived consent approaches were acceptable. Half (52%) believed the waived consent process should provide information about the research and include the option of opting out. When asked whether participants should always give full informed consent, regardless of the practicality or level of risk, 74% and 72% agreed, respectively. There is public support for models of waived consent for participation in low-risk pragmatic clinical trials in ICU settings in Canada; however, this is not universal. This information can inform and guide education, ethics, policy, and legal discussion on consent models.

Nurses' views on the presence of family members during invasive procedures in hospitalised children: A questionnaire survey.

(I) To identify the opinion and practices of nursing professionals regarding the presence of family members during invasive procedures in hospitalised children; (II) to determine the knowledge of nursing professionals about the patient-and family-centred care model. Family presence in invasive procedures benefits the patient and their relatives, but varied attitudes exist among healthcare personnel, with some being favourable and others unfavourable toward family presence. Observational, descriptive, cross-sectional study. Study population: Nurses from paediatric critical care services, emergency services, hospital wards, day hospitals and outpatient clinics at a Catalan tertiary hospital who participated voluntarily between September 2021 and July 2022. Data collection instrument: A questionnaire prepared by the researchers, based on the literature and reviewed by experts. REDCap link with access to the questionnaire was sent out to potential respondents through the institutional email. Bivariate analysis was performed with the R 4.2 program. The study was approved by the hospital's Clinical Research Committee and participants gave informed consent before responding to the questionnaire. A total of 172 nurses participated, and 155 valid responses were obtained. All respondents consider the family as a key element in paediatric care and report inviting family members to participate in the care given to their child. However, 12.0% of nurses do not invite the family to be present in invasive procedures. Almost all respondents note the need for training to acquire communication skills and improve the management of emotions. The results show a favourable opinion towards the presence of family members and highlight the need to train nurses to develop communication skills. The data provided can favour the design of measures to improve and promote the presence of parents during invasive procedures, reinforcing the patient-and family-centred care model and improving the quality of care provided. One example is the creation of family care protocols where the inclusion of parents and the roles of each individual involved in the care process appears.

Determinatori kliničkih ishoda kod obolelih od hroničnih artritisa i sistemskih bolesti vezivnog tkiva - fokus pandemija COVID-19

Introduction. Early diagnosis and treatment improve clinical outcomes, especially in chronic arthritis (CA) and systemic connective tissue disorders (SCTD). Thanks to clinical research from the 1990s on and innovative drugs, 55 million life-years have been saved. The COVID-19 pandemic brought on medical challenges in rheumathology. Objective. The study objective was to research early diagnosis, time of the introduction of innovative therapy, participation in clinical research, influence of gender, age, and corticosteroid treatment on hospitalization rate due to COVID-19 infection in CA and SCTD patients. Method. In November 2022 we performed the crosssectional study in CA and/or SCTD patients using an online questionnaire. The first part of the analyzed questions referred to sociodemographic characteristics and data concerning rheumatic disease - rheumatoid arthritis (RA) and other rheumatic diseases. The second part referred to COVID-19. Data were analyzed by descriptive statistics and Pearson's Chi-square test using SPSS 29. Results. Out of the total of 176 participants, RA was present in 60,8%. The time from the symptom onset to diagnosis was longer than two years. RA was more frequently diagnosed in the first six months (p &lt; 0,05 - males). The innovative therapy was used by 59,7% of the participants. The majority of RA patients got innovative therapy after five years from disease onset, which is later than in other CAs (p &lt; 0,05 - females). There were 23,3% of the participants who took part in clinical research, more those with RA (p &lt; 0,05 - females). Corticosteroid therapy influenced a higher rate of hospitalization during COVID-19 infection (p &lt; 0,05 - females). Conclusion. Males suffering from RA were diagnosed sooner, while females with RA participated more in clinical research but were later introduced to innovative therapy. The use of glucocorticoid therapy in the treatment of CA and SCTD increased the risk of hospitalization due to COVID-19 infection.

Evidence-based recruitment strategies for clinical research: Study personnel's and research participants' perceptions about successful methods of outreach for a U.S. Autism-Research Cohort.

Under enrollment of participants in clinical research is costly and delays study completion to impact public health. Given that research personnel make decisions about which strategies to pursue and participants are the recipients of these efforts, we surveyed research staff (n = 52) and participants (n = 4,144) affiliated with SPARK (Simons Foundation Powering Autism for Knowledge) - the largest study of autism in the U.S. - to understand their perceptions of effective recruitment strategies. In Study 1, research personnel were asked to report recruitment strategies that they tried for SPARK and to indicate which ones they would and would not repeat/recommend. In Study 2, SPARK participants were asked to indicate all the ways they heard about the study prior to enrollment and which one was most influential in their decisions to enroll. Staff rated speaking with a SPARK-study-team member (36.5%), speaking with a medical provider (19.2%), word of mouth (11.5%), and a live TV news story (11.5%) as the most successful strategies. Participants most often heard about SPARK via social media (47.0%), speaking with a medical provider (23.1%), and an online search (20.1%). Research personnel's and participants' views on effective recruitment strategies often differed, with the exception of speaking with a medical provider. Results suggest that a combination of strategies is likely to be most effective in reaching diverse audiences. Findings have implications for the selection of strategies that meet a study's specific needs, as well as recruitment-strategy "combinations" that may enhance the influence of outreach efforts.

FAITH-BASED COMMUNITY OUTREACH TO INCREASE ALZHEIMER’S CLINICAL RESEARCH PARTICIPATION IN THE BLACK COMMUNITY

Abstract Issues: Despite the fact that African Americans are twice more likely to develop Alzheimer’s disease (AD) compared to non-Hispanic whites, they are under-represented in AD clinical research. Lower representation exists in the AHEAD Study as well, which is an AD prevention clinical trial evaluating the efficacy and safety of Lecanemab in 1400 study participants. We sought to raise awareness about AD and increase clinical research participation of African Americans in the AHEAD Study, through a community-based education and recruitment program (CERP). Description: Our diverse team from Eastern Virginia Medical School and Hampton University, a Historically Black College University (HBCU), established a Community Advisory Board and Ministerial Alliance with representation from faith-based, long-standing civic and fraternal organizations within the Greater Hampton Roads Black community. The alliance guided us to identify prioritization areas for addressing sociocultural barriers and increasing clinical research awareness and participation in traditional African American events, key historic community sites, and non-traditional community centers (i.e., YMCA, independent-living, assisted-living centers, Annual Juneteenth Celebration, Black fraternity, and sorority events.) Community health workers, embedded within the community, of the same cultural background and ethnicity, drove our CERP. Lessons Learned: As of July 2023, we offered our program at 45 community events, including community health fairs, civics events, and Purple Sunday luncheons and talks at Black churches in urban and localities in Hampton Roads, in partnership with fraternal and civic community organizations. Out of over 1700 participants, 177 community members have been prescreened for the AHEAD Study.

Abstract A005: The development of a bioethically sensitive education video: Addressing the barriers to African Americans’ and Hispanics’ participation in clinical and genomic research through digital animation

Abstract Introduction: Research advances on effective methods to prevent, diagnose and treat cancer continue to emerge through clinical and genomic research. To ensure the results from these research studies help those who need it most, a diverse population needs to enroll. Despite guidance from authorities, such as the National Institutes of Health, most clinical trial and genomic research participants identify as White. At the participant level, mistrust of research, unawareness of research opportunities and gaps in bioethical knowledge about clinical trials and genomic research remain proven barriers to participating, especially among African Americans (AA) and Hispanics. With the development and access to technology, digital delivery of salient and tailored health education may provide innovative pathways to increase representation of AA and Hispanics in research. Methods: Members from the NCI-funded Partnerships to Advance Cancer Health Equity (PACHE) including experts from the community, healthcare, biomedical research and public health, such as oncologists, cancer geneticists, behavioral scientists and bioethicists collaborated on all phases. A design lab with experience synthesizing complex health messages into brief animations was contracted. The goal was to utilize existing educational resources from the National Cancer Institute and the National Human Genome Research Institute to create a tailored message to address AA's and Hispanics’ beliefs, values and bioethical concerns related to participation in clinical and genomic research. Models of behavior change and communication theories were leveraged to frame key components of the message, which then informed the animated video. Results: Development of the video consisted of six iterative phases: 1) writing sessions; 2) storyboarding; 3) animating; 4) screening/revisions; 5) acceptability testing; 6) finalization. In the last two steps, the video was presented to family members of cancer patients, cancer survivors and community members who provided quantitative and qualitative feedback which informed further edits. The final animated video is approximately five minutes in length and covers several topics including the goal of clinical research, disparities in clinical trials and genomic research participation, genomic research regulations and the purpose of a biobank. Supporting imagery to emphasize specific concepts, such as racial disparities in research, was dispersed throughout the video. A voiceover emphasized key bioethical concepts, including how research participation is safe and voluntary. When possible, characters were designed to resemble the targeted viewing audience. Discussion: Increasing AA and Hispanic participation in clinical and genomic research is imperative to achieving health equity. Tailored messages via short videos may assist in addressing the barriers and facilitators towards research participation and increase intentions to enroll in trials. Future research will evaluate the efficacy of the video through a multi-level framework in real-world settings. Citation Format: Victoria Churchill, Yu-Mei Schoenberger, Vivian L Carter, Windy Dean-Colomb, Roland Matthews, Desiree Rivers, Stephen O Sodeke, Jamirah Chevrin, Brian Rivers. The development of a bioethically sensitive education video: Addressing the barriers to African Americans’ and Hispanics’ participation in clinical and genomic research through digital animation [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A005.

Plasma Alzheimer’s Disease Biomarkers and Brain Amyloid in a Multi‐Ethnic Aging Cohort

AbstractBackgroundDementia diagnoses are more common among Hispanic (HW) than non‐Hispanic white (NHW) older adults. Alzheimer’s disease (AD) is the most common neuropathological finding in patients with dementia. Plasma AD biomarkers have accelerated efforts towards increasing access to timely diagnosis, but existing data often come from cohorts lacking ethnic diversity. Clinical translation of plasma AD biomarkers requires continued evaluation in study cohorts that reflect the growing ethnic diversity of the population.MethodWe studied 379 older adults (age 71.9±7.8 years old, 60.2% female) from the 1Florida Alzheimer’s Disease Research Center who underwent blood draw and analysis for P‐tau181 (Quanterix). Of these, 240 completed Aβ‐PET (converted to Centiloids). Over half (57%) self‐identified as HW (32% Cuba, 18% South American, 7% other). Analyses included 1) comparing plasma biomarker concentrations between clinically normal (CN), amnestic MCI (amnMCI), amnestic dementia (amnDEM), and nonamnestic MCI/dementia (ANCOVA controlling for age), 2) evaluating P‐tau181 correlations with Aβ burden (Spearman’s rho), and 3) determining discriminability (AUC) of Aβ‐PET[+] from Aβ‐PET[‐]. Interactions between independent variables and ethnicity were evaluated to inform whether observed relationships differed between HW and non‐Hispanic white (NHW). Lastly, using a cutoff derived from the PET sub‐cohort, we investigated rates of P‐tau181‐defined “AD positivity” (plasmaAD[+]) between HW and NHW diagnosed with amnMCI. Additional data for plasma GFAP and NfL will also be presented.ResultsPlasma P‐tau181 was higher in amnMCI (p = .004, d = 0.53) and amnDEM (p&lt;.001, d = 0.97) than CN. Higher P‐tau181 related to greater Aβ burden (ρ = .59 [.50‐.67], p&lt;.001) and had good discriminability between Aβ‐PET[+] and Aβ‐PET[‐] (AUC = 0.86 [0.81‐0.91], Youden’s Index = 2.39 pg/mL). There were no significant interactions with ethnicity. Applying the P‐tau181 cutoff (2.39 pg/mL) to all amnMCI participants, HW diagnosed with amnMCI had lower odds of being plasmaAD[+] than NHW (36.5% vs. 58.5%; OR = 0.41 [0.21‐0.78], p = .006).ConclusionPlasma P‐tau181 may aid etiological diagnosis of cognitively impaired older adults from Hispanic and non‐Hispanic ethnic origins. Hispanic ethnicity alone does not significantly influence the interpretation of how plasma P‐tau181 relates to Aβ‐PET, but may be linked to greater likelihood of non‐AD causes of memory loss. Blood‐based biomarkers could help reduce barriers to clinical diagnosis and research participation that disproportionately impact underrepresented groups.

Development of a Real-Time Dashboard Characterizing Acute Leukemia Clinical Trial Enrollment Diversity at the Practice, Investigator, and Individual Clinician Level

Introduction Adult acute leukemia clinical trials in the United States under-enroll persons from historically marginalized groups. Practices, investigators, and individual clinicians have identified the lack of multidimensional, real-time enrollment data as a barrier to remediating participation inequities. We sought to overcome this by developing a visual data interface (“dashboard”) for assessing enrollment diversity across an institution in real-time. Methods Real-time dashboard data sources were the electronic health record (EPIC) and the trial registration system (OnCore); Tableau software was used for data visualization. The primary objective was to create an integrated data source that accurately assigned individuals as patients of the correct clinical group, primary oncologist, and research protocol(s). The primary endpoint was an accurate assignment algorithm, defined as an area under the receiver operator curve (AUROC) of &amp;gt;=0.90, as compared to manual review. Trial enrollment was assigned via OnCore and was itself the reference standard, so algorithm classification was considered accurate if individuals were assigned correctly to the clinical group and primary oncologist. The AUROC of a basic assignment algorithm was 0.78, requiring a sample size of 528 to show improvement to 0.90 or above. Interim testing was performed to assess potential improvements in logic accuracy. Exploratory objectives were to assess associations between exposures (e.g., age, race, ethnicity, sex) and outcomes (treatment trial and biobank enrollment) among a one-year cohort of patients followed by the clinical group, as determined by the final algorithm. Due to small numbers in some race and ethnicity categories, a People of Color aggregate variable was generated and included those listed as Hispanic Black, Other, Unknown, White, and Non-Hispanic Asian, Black, and Other. Associations were determined using parametric or non-parametric bivariate tests, as appropriate; multiplicity was not considered. Results Interim testing was used to revise diagnostic criteria assignment and inpatient encounter algorithms. This improved classification AUROCs to 0.80 and then 0.85, after which the physician assignment algorithm was further revised and finalized. Final testing of 528 patients seen on randomly chosen dates resulted in an AUROC of 0.98 for the assignment algorithm against manual classification. Real-time data visualizations were then developed to display multidimensional enrollment diversity data grouped by patient panels for individual clinicians (Figure 1) and by trial for primary investigators, with additional views showing trends over time and enrollment process metrics (i.e., who is consented, eligible, on study). From 6/22/2022-6/21/2023 there were 432 unique patients followed by the clinical group, of which 124 (28.7%) participated in a treatment trial and 287 (66.4%) in a biobanking study. Patient characteristics and bivariate comparisons of participation by study type are shown in Table 1. Characteristics associated with treatment trial participation included lower Social Deprivation Index score (20 vs 27, p=0.05), residing outside Massachusetts (36.2% vs 25.5%, p=0.03), and having ALL (33.8% vs 25.8%, p=0.02). Characteristics associated with biobank study participation included lower Social Deprivation Index score (21 vs 25, p=0.01) and having ALL (33.8% vs 25.8%, p=0.02). While Persons of Color participated in treatment trials (22.4% vs 29.7%) and biobanks (62.1% vs 66.7%) numerically less than NHW, but differences were not significant (p&amp;gt;0.05). Conclusions An enrollment diversity dashboard can accurately provide real-time data on acute leukemia clinical research participation at a large referral center. In this cohort, enrollment rates were relatively high and associated with socioeconomic status, place of residence, and disease type but not race-ethnicity. The dashboard is now being revised to incorporate trial eligibility metrics and will be piloted as performance feedback for practices, investigators, and individual clinicians.

886. Impact of Race on the Early Diagnosis and Treatment of Lyme Disease

Abstract Background Previous studies using single-state and Medicare surveillance data found that Black patients with Lyme Disease (LD) are more likely to present outside of the typical summer months and have higher rates of disseminated disease at diagnosis. We further explored differences in clinical presentation and early treatment of Lyme Disease by self-reported race among a large cohort of patients at an academic research clinic. Methods We abstracted data from all patients with untreated or post-treatment LD seen at the Johns Hopkins Lyme Disease Research Center (LDRC)—either for clinical care or research participation. Patients self-reported their demographics, and clinical information regarding their initial Lyme presentation was either recorded at the time of diagnosis or was abstracted from prior, external medical records. We examined the distribution of race across initial LD clinical presentations—categorized as 1) erythema migrans (EM) rash only, 2) disseminated disease, or 3) non-specific symptoms only—using chi-squared or Fisher’s exact test and fit logistic regression models. We compared racial differences in time to appropriate treatment using a one-sided Mann-Whitney test. Results Of 1363 individuals seen at the LDRC, 93% were white, 3% were Black, 2% were Asian, and 3% self-identified as either ‘other’ or more than one race. Compared to white patients, Black patients were less likely to present with erythema migrans (EM) rash (p &amp;lt; 0.0001) and more likely to present with disseminated disease or non-specific symptoms (p=0.009, p=0.019, respectively). Black patients were more likely to have received a course of inappropriate antibiotic therapy ( 16.7% vs 8.0 %, p= 0.058). Also, Black patients with EM rash experienced longer time to appropriate treatment (16.3 days vs 4.0, p=0.062). Number of asterisks indicates degree of statistical significance. N/S means "non-significant" Conclusion We identified several racial disparities in the early detection and treatment of Lyme Disease, highlighting the need for increased awareness of Lyme and its early manifestations among patients of color and the front-line clinicians who care for them. Because darker skin tones are generally under-represented in medical textbooks and patient education materials, we include several examples of EM rashes from Black patients seen at the LDRC (Figure 2). Disclosures John Aucott, MD, Pfizer, Inc.: Advisor/Consultant

51 Feasibility of Remote Administration of a Modified UDSv3 Cognitive Battery

Objective:Face-to-face administration is the “gold standard” for both research and clinical cognitive assessments. However, many factors may impede or prevent face-to-face assessments, including distance to clinic, limited mobility, eyesight, or transportation. The COVID19 pandemic further widened gaps in access to care and clinical research participation. Alternatives to face-to-face assessments may provide an opportunity to alleviate the burden caused by both the COVID-19 pandemic and longer standing social inequities. The objectives of this study were to develop and assess the feasibility of a telephone- and video-administered version of the Uniform Data Set (UDS) v3 cognitive batteries for use by NIH-funded Alzheimer’s Disease Research Centers (ADRCs) and other research programs.Participants and Methods:Ninety-three individuals (M age: 72.8 years; education: 15.6 years; 72% female; 84% White) enrolled in our ADRC were included. Their most recent adjudicated cognitive status was normal cognition (N=44), MCI (N=35), mild dementia (N=11) or other (N=3). They completed portions of the UDSv3 cognitive battery, plus the RAVLT, either by telephone or video-format within approximately 6 months (M:151 days) of their annual in-person visit, where they completed the same in-person cognitive assessments. Some measures were substituted (Oral Trails for TMT; Blind MoCA for MoCA) to allow for phone administration. Participants also answered questions about the pleasantness, difficulty level, and preference for administration mode. Cognitive testers provided ratings of perceived validity of the assessment. Participants’ cognitive status was adjudicated by a group of cognitive experts blinded to most recent inperson cognitive status.Results:When results from video and phone modalities were combined, the remote assessments were rated as pleasant as the inperson assessment by 74% of participants. 75% rated the level of difficulty completing the remote cognitive assessment the same as the in-person testing. Overall perceived validity of the testing session, determined by cognitive assessors (video = 92%; phone = 87.5%), was good. There was generally good concordance between test scores obtained remotely and in-person (r = .3 -.8; p &lt; .05), regardless of whether they were administered by phone or video, though individual test correlations differed slightly by mode. Substituted measures also generally correlated well, with the exception of TMT-A and OTMT-A (p &gt; .05). Agreement between adjudicated cognitive status obtained remotely and cognitive status based on in-person data was generally high (78%), with slightly better concordance between video/in-person (82%) vs phone/in-person (76%).Conclusions:This pilot study provided support for the use of telephone- and video-administered cognitive assessments using the UDSv3 among individuals with normal cognitive function and some degree of cognitive impairment. Participants found the experience similarly pleasant and no more difficult than inperson assessment. Test scores obtained remotely correlated well with those obtained in person, with some variability across individual tests. Adjudication of cognitive status did not differ significantly whether it was based on data obtained remotely or in-person. The study was limited by its’ small sample size, large test-retest window, and lack of randomization to test-modality order. Current efforts are underway to more fully validate this battery of tests for remote assessment. Funded by: P30 AG072947 &amp; P30 AG049638-05S1

Adopting human factors in early phase and experimental medicine research: A nested pilot study observing controlled human infection with SARS-CoV-2.

The influence of human factors on safety in healthcare settings is well established, with targeted interventions reducing risk and enhancing team performance. In experimental and early phase clinical research participant safety is paramount and safeguarded by guidelines, protocolized care and staff training; however, the real-world interaction and implementation of these risk-mitigating measures has never been subjected to formal system-based assessment. Independent structured observations, systematic review of study documents, and interviews and focus groups were used to collate data on three key tasks undertaken in a clinical research facility (CRF) during a SARS CoV-2 controlled human infection model (CHIM) study. The Systems Engineering Initiative for Patient Safety (SEIPS) was employed to analyse and categorize findings, and develop recommendations for safety interventions. High levels of team functioning and a clear focus on participant safety were evident throughout the study. Despite this, latent risks in both study-specific and CRF work systems were identified in all four SEIPS domains (people, environment, tasks and tools). Fourteen actionable recommendations were generated collaboratively. These included inter-organization and inter-study standardization, optimized checklists for safety critical tasks, and use of simulation for team training and exploration of work systems. This pioneering application of human factors techniques to analyse work systems during the conduct of research in a CRF revealed risks unidentified by routine review and appraisal, and despite international guideline adherence. SEIPS may aid categorization of system problems and the formulation of recommendations that reduce risk and mitigate potential harm applicable across a trials portfolio.

Evaluating ethnically diverse patients' perspectives of considering participation in renal clinical research.

Clinical trial cohorts do not often reflect target patient populations because minority ethnic groups are underrepresented in clinical trials. To increase minority ethnic groups' opportunities to participate in clinical trials, by evaluating ethnically diverse patients' perspectives of considering participation in renal clinical research. The authors gave patients participating in at least one research study the opportunity to take part in a structured survey. The survey explored preferences, barriers and opportunities that patients considered when deciding whether to take part in a clinical trial. The authors included participants from multiple ethnic groups so they could compare data for different ethnicities. Participation was a positive experience for most patients, mostly because of the research team's flexibility and professionalism. Researchers' gender and ethnicity did not affect the participants' decision to participate. Cultural preferences were not obvious from the data as 80% of the participants were white. Patients preferred a face-to-face approach and the expertise of the research team affected participation more than any other characteristics did. However, respondents were already research-engaged and conducting a similar study with those who have declined to participate in research may show different results.