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Background: To explore the association between ethnicity, as a proxy for language, and participation in clinical trials (CT) conducted by Principal Investigators (PI) who speak one or more language in addition to English. Methods: This retrospective, descriptive study utilized CT participant demographic data extracted from the largest Midwestern non-profit healthcare system between January 1, 2019 and 12/31/2021. The CT participant sample (N = 4308) was divided for comparison: CT Participants of Hispanic or Latino Origin (N = 254; 5.90 %) and CT Participants of Non-Hispanic or Latino Origin (N = 4054; 94.10 %). Logistic regressions were performed to generate the crude and adjusted odds of patients of Hispanic or Latino origin participating in CTs conducted by PIs who speak another language in addition to English. Results: Crude analysis revealed that patients of Hispanic or Latino ethnicity had 2.04 (1.58, 2.64) times greater odds of participating in CTs conducted by PIs who speak another language than English (<0.0001), which increased to 2.67 (1.97, 3.62) times greater odds after adjusting for sex, race, age and insurance (p < 0.0001). Conclusions: Overall findings indicate that patients of Hispanic or Latino ethnicity, who are more likely to speak Spanish, have greater odds of participating in CTs conducted by PIs who speak another language beyond English. This may imply that cultural sensitivity at the top of a CT study team, as likely to be demonstrated by PIs who speak another language beyond English, may be an important contributor to reducing ethnicity- and language-based barriers to diversity in CTs and a relationship worth exploring further.

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Objectives: Rural patients have poor cancer outcomes and clinical trial (CT) enrollment compared to urban patients due to attitudinal, awareness, and healthcare access differential. Knowledge of cancer survival disparities and CT enrollment is important for designing interventions and innovative approaches to address the stated barriers. The study explores the potential disparities in cancer survival rates and clinical trial enrollments in rural and urban breast and lung cancer patients. Our hypotheses are that for both cancer types, urban cancer patients will have longer 5-year survival rates and higher enrollment rates in clinical trials than those in rural counties. Methods: We compared breast and lung cancer patients' survival rates and enrollment ratios in clinical trials between rural (RUCC 4-9) and urban counties in Georgia at a Comprehensive Cancer Center (CCC). To assess these differences, we carried out a series of independent samples t-tests and Chi-Square tests. Results: The outcomes indicate comparable 5-year survival rates across rural and urban counties for breast and lung cancer patients, failing to substantiate our hypothesis. While clinical trial enrollment rates demonstrated a significant difference between breast and lung cancer patients at CCC, no significant variation was observed based on rural or urban classification. Conclusion: These findings underscore the need for further research into the representation of rural patients with diverse cancer types at CCC and other cancer centers. Further, the findings have considerable implications for the initiation of positive social change to improve CT participation and reduce cancer survival disparities.

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BACKGROUND: This study aimed to investigate the association between index trial participation status and 30-day unplanned readmission rates, causes, and outcomes in acute coronary syndrome (ACS) patients. METHODS: The National Readmission Database was analysed for all index hospitalizations with a principal diagnosis of ACS between October 2015 to November 2019, stratified by index trial participation status (International Classification of Diseases - 10th edition code: Z00.6). The 30-day unplanned readmission rates, causes and outcomes were analysed, including the assessment of factors associated with readmission. Multivariable regression analyses were reported as adjusted odds ratios (aOR) with 95 % confidence intervals (95 % CI). All analyses were weighted and utilized hierarchical multi-level organization. RESULTS: A total of 2,066,328 cases with a principal diagnosis of ACS were included in the study, of which there were 4061 trial participants (0.2 %) and 189,240 (9.2 %) cases experienced unplanned 30-day readmission. Rates of unplanned 30-day readmission were similar between trial participants and non-participants (9.8 % vs. 9.2 %, p = 0.16). Consistently, after multivariable adjustment, there was no significant association between trial participation and unplanned 30-day readmissions (aOR 0.96, 95 % CI 0.86-1.07, p = 0.45). Compared with trial participants, the majority of readmissions in non-participants were related to cardiovascular conditions (55.2 % vs. 46.7 %, p = 0.005, respectively). There was no significant difference in all-cause mortality (5.5 % vs. 4.6 %, p = 0.368, respectively), but trial participants were more likely to develop major bleeding (3.5 % vs. 2.1 %, p = 0.044), ischemic stroke (4.0 % vs. 2.1 %, p = 0.008) and haemorrhagic stroke (2.0 % vs. 0.6 %, p < 0.001) at readmissions. CONCLUSION: Overall rates of unplanned 30-day readmissions after ACS are similar between trial participants and non-participants, but non-participation in trials was associated with a higher likelihood of cardiovascular readmission.

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AIMS: This study aimed to explore how incorporating shared decision-making (SDM) can address recruitment challenges in clinical trials. Specifically, it examines how SDM can align the trial process with patient preferences, enhance patient autonomy and increase active patient participation. Additionally, it identifies potential conflicts between SDM and certain clinical trial aspects, such as randomization or blinding, and proposes solutions to mitigate these issues. MATERIALS AND METHODS: We conducted a comprehensive review of existing literature on patient recruitment challenges in clinical trials and the role of SDM in addressing these challenges. We analysed case studies and trial reports to identify common obstacles and assess the effectiveness of SDM in improving patient accrual. Additionally, we evaluated three proposed solutions: adequate trial design, communication skill training and patient decision aids. RESULTS: Our review indicates that incorporating SDM can significantly enhance patient recruitment by promoting patient autonomy and engagement. SDM encourages physicians to adopt a more open and informative approach, which aligns the trial process with patient preferences and reduces psychological barriers such as fear and mental stress. However, implementing SDM can conflict with elements such as randomization and blinding, potentially complicating trial design and execution. DISCUSSION: The desire for patient autonomy and active engagement through SDM may clash with traditional clinical trial methodologies. To address these conflicts, we propose three solutions: redesigning trials to better accommodate SDM principles, providing communication skill training for physicians and developing patient decision aids. By focussing on patient wishes and emotions, these solutions can integrate SDM into clinical trials effectively. CONCLUSION: Shared decision-making provides a framework that can promote patient recruitment and trial participation by enhancing patient autonomy and engagement. With proper implementation of trial design modifications, communication skill training and patient decision aids, SDM can support rather than hinder clinical trial execution, ultimately contributing to the advancement of evidence-based medicine.

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Background: The participation of patients in clinical trials is crucial for the development of healthcare. There are several challenges in the recruitment of trial participants with acute medical conditions. The registry-based randomized DAPA-MI clinical trial recruited patients during hospitalization for myocardial infarction and provided study drugs in bottles with smart caps that used wireless technology to transmit monitoring data. This interview study aimed to investigate patients' experience of participation in a clinical trial and their attitude to the new bottle cap technology. Methods: A subset of patients participating in the DAPA-MI trial were recruited from four hospitals in Sweden. Semi-structured interviews were conducted and analysed using manifest content analysis. Results: Video interviews were performed including 21 patients (four women and 17 men). The median age was 59 years (range 44-80). Four categories of patients' experiences were identified. A willingness to contribute consisted of patients' positive attitudes to participation and to be a part of development and research. The perception of information emphasized the value of the oral information as well as the importance of time for reflection. Be in a vulnerable condition highlighted the impaired ability to perceive and remember in the acute medical condition. Adaptation to a new technology described the overall positive experiences of the smart bottle cap to evaluate adherence. Conclusions: Patients' experiences of trial participation were in general positive but some challenges in the acute setting of a myocardial infarction were revealed. The smart bottle cap was well accepted, despite some handling difficulties.

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BACKGROUND: The Coronavirus Disease 2019 (COVID-19) pandemic precipitated an urgent need for clinical trials to discover safe and efficacious treatments. We examined how COVID-19 experiences, clinical trial awareness, and trust in the vaccine safety process were associated with willingness to participate in COVID-19 clinical trials. The objective was to investigate the relationship between trust in federal oversight of vaccine safety and willingness to participate in clinical trials for COVID-19 treatment across four distinct time points over an 18-month period during the COVID-19 pandemic. METHODS: We used four waves of data collected from September 2021 to March 2023 among 582 Philadelphia residents (with a missing data rate of 0.9%). Generalized estimating equations estimated the association between willingness to participate in COVID-19 clinical trials and participants' trust in the federal government's oversight of COVID-19 vaccine safety, COVID-19-related variables (COVID-19 related health challenges, history of COVID-19 infection), awareness of clinical trials and how to enroll in them, and sociodemographic characteristics (age, race/ethnicity, sexual orientation, gender, parental status, education, and insurance). RESULTS: On average, willingness to participate in a COVID-19 clinical trial was positively associated with greater trust in the federal government's oversight of vaccine safety [ß = 0.34, 95% confidence interval (CI): 0.15-0.53], having COVID-19 (ß = 0.40, 95% CI: 0.08-0.73), awareness of clinical trials (ß = 0.38, 95% CI: 0.04-0.73), and knowledge of how to enroll (ß = 0.83, 95% CI: 0.44-1.23). Among sociodemographic characteristics, race/ethnicity (p = 0.001) and gender (p = 0.018) were identified as predictors for COVID-19 trial willingness. CONCLUSION: Willingness to participate in clinical trials may be bolstered by strengthening the public's trust in the federal government's role within vaccine safety oversight, increasing the perceived relevance of clinical trials to individuals' health and well-being, and offering tailored information to educate diverse communities about ongoing trials and how to enroll in them.

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Prostate cancer is the second leading cause of death for men in the U.S. and Black men are twice as likely to die from the disease. However, prostate cancer, if diagnosed at an earlier stage, is curable. The purpose of this review is to identify prostate cancer screening clinical trials that evaluate screening decision-making processes of Black men. METHODS: The databases PubMed, Ovid MEDLINE, CINAHL Plus, and PsychInfo were utilized to examine peer-reviewed publications between 2017 and 2023. Data extracted included implementation plans, outcome measures, intervention details, and results of the study. The Critical Appraisal Skills Programme was used to assess the quality of the evidence presented. RESULTS: Of the 206 full-text articles assessed, three were included in this review. Educational interventions about prostate cancer knowledge with shared and informed decision-making (IDM) features, as well as counseling, treatment options, and healthcare navigation information, may increase prostate cancer screening participation among Black men. Additionally, health partner educational interventions may not improve IDM related to screening participation. The quality of the evidence presented in each article was valid and potentially impactful to the community. DISCUSSION: Black men face various social determinants of health barriers related to racism, discrimination, cost of health services, time away from work, and lack of trust in the healthcare system when making health-related decisions, including prostate cancer screening participation. A multifactorial intervention approach is required to address these inequities faced by Black men especially as prostate cancer is curable when diagnosed at an earlier stage.

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BACKGROUND: Due to the exclusion of pregnant and lactating people from most clinical trials, there is an incomplete understanding of the risks and benefits of medication use in these populations and therapeutic decision-making is often conducted without adequate evidence. To change this paradigm, it is imperative to understand the perspectives of pregnant and lactating individuals concerning their participation in clinical trials. OBJECTIVES: To describe attitudes, perceptions, barriers, and preferences of pregnant and postpartum people in the United States (US) regarding participation in clinical trials and to identify factors influencing participation. METHODS: In November 2022, individuals aged ≥ 18 residing in the US who self-identified as pregnant or pregnant within the last 12 months were invited to complete an online survey about their perspectives regarding clinical trial participation. The survey included questions about demographic characteristics, health history, behaviors, and willingness to participate in clinical trials while pregnant and/or lactating. Multivariable logistic regression models were fit to identify predictors of clinical trial participation. RESULTS: Among the 654 respondents, 34.8% and 40.9% reported being likely or extremely likely to participate in a clinical trial for a new medication while pregnant or lactating, respectively; and 24.5% and 41.7% for a new vaccine while pregnant or lactating, respectively. Higher educational attainment (≥ Bachelor's degree) was associated with greater likelihood of clinical trial participation in pregnancy (odds ratio (OR) = 1.50, 95% Confidence Interval (CI): 1.01, 2.25 for medications; OR = 2.00, 95% CI: 1.28, 3.12 for vaccines). Chronic medical conditions were associated with a greater likelihood of participation in clinical trials for vaccines during lactation (OR = 1.59, 95% CI: 1.07, 2.36). The most cited motivator for participation in a clinical trial while pregnant or lactating was anticipated personal medical benefit (85.8% and 75.6%, respectively), while the primary deterrent was possible risk to the fetus or baby (97.9% and 97.2%, respectively). CONCLUSIONS: Willingness of a US sample to participate in clinical trials while pregnant or lactating varied by demographics and health status, with safety to the fetus being a nearly universal concern. These findings have implications for enhancing inclusion of pregnant and lactating people in clinical research and developing effective and equitable recruitment strategies.

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BACKGROUND: Chronic obstructive pulmonary disease (COPD) and muscle weakness can cause impaired physical function, significantly impacting patients' health-related quality of life (HRQoL). Loss of muscle strength is usually assessed through clinical and performance outcome (PerfO) assessments, which consists of tasks performed in a standardized manner, providing evidence of a patient's functional ability. However, evidence documenting the patient experience of COPD and muscle weakness is limited. METHODS: This two-stage qualitative study used semi-structured interviews in patients aged 45-80 years with COPD (post-bronchodilator forced expiratory volume in 1s [FEV1]/forced vital capacity ratio < 0.70, and FEV1% predicted of 30-80%) and muscle weakness. In Stage 1, 30-minute concept elicitation interviews were conducted with participants recruited across three US sites to explore impacts on physical functioning and activities of daily living. In Stage 2, interviews were performed with participants exiting a Phase IIa trial investigating the efficacy of a selective androgen receptor modulator (GSK2881078) on leg strength, whereby PerfOs were used to evaluate strength and physical functioning endpoints. These participants completed either 60-minute in-depth (n = 32) or 15-minute confirmatory (n = 35) interviews exploring trial experience, completion of outcome measures, disease experience and treatment satisfaction. RESULTS: In Stage 1 (n = 20), most participants described their muscles as weak (83.3%). Difficulties with walking (100%) and lifting heavy objects (90%) were reported. In Stage 2, 60-minute interviews, all participants (n = 32) reported a positive trial experience. Most participants reported that the home exercise program was easy to fit into daily life (77.8%), the PROactive daily diary was easy to complete (100%) and wearable sensors were easy to use (65.6%). However, technical issues were reported (71%), and few participants (19.4%) found physical assessments easy to complete. Improvements in muscle strength and functional limitations were reported by most participants. The shorter 15-minute confirmatory interviews (n = 35) supported the in-depth interview results. CONCLUSION: The qualitative interviews generated in-depth evidence of key concepts relevant to patients with COPD and muscle weakness and support the assessments of patient strength and physical function as outcome measures in this population in future studies. TRIAL NUMBER: GSK Stage 1: 206869; Stage 2: 200182, NCT03359473; Registered December 2, 2017, https://clinicaltrials.gov/ct2/show/NCT03359473 .

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BACKGROUND: Black Americans remain significantly underrepresented and understudied in research. Community-based interventions have been increasingly recognized as an effective model for reckoning with clinical trial participation challenges amongst underrepresented groups, yet a paucity of studies implement this approach. The present study sought to gain insight into Black male participants' perception of clinical trials before and after participating in a community-based team lifestyle intervention in the United States. METHODS: Black Impact, a 24-week community-based lifestyle intervention, applied the American Heart Association's Life's Simple 7 (LS7) framework to assess changes in the cardiovascular health of seventy-four Black male participants partaking in weekly team-based physical activities and LS7-themed education and having their social needs addressed. A subset of twenty participants completed an exit survey via one of three semi-structured focus groups aimed at understanding the feasibility of interventions, including their perceptions of participating in clinical trials. Data were transcribed verbatim and analyzed using a content analysis, which involved systematically identifying, coding, categorizing, and interpreting the primary patterns of the data. RESULTS: The participants reported a positive change in their perceptions of clinical trials based on their experience with a community-based lifestyle intervention. Three prominent themes regarding their perceptions of clinical trials prior to the intervention were as follows: (1) History of medical abuse; (2) Lack of diversity amongst research teams and participants; and (3) A positive experience with racially concordant research teams. Three themes noted to influence changes in their perception of clinical trials based on their participation in Black Impact were as follows: (1) Building trust with the research team; (2) Increasing awareness about clinical trials; and (3) Motivating participation through community engagement efforts. CONCLUSIONS: Improved perceptions of participating in clinical trials were achieved after participation in a community-based intervention. This intervention may provide a framework by which to facilitate clinical trial participation among Black men, which must be made a priority so that Black men are "more than just a number" and no longer "receiving the short end of the stick".

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Background: Representativeness in clinical trials (CT) serves as a metric of access to healthcare and reflects differences that may determine differential efficacy of medical interventions; thus, quantifying representativeness in CT participation is critical. Methods: This retrospective, descriptive study utilized patient demographic data extracted from the largest Midwestern non-profit healthcare system. Using data between January 1, 2019 and December 31, 2021, a CT Participant Sample of 4,537 system patients who were active CT participants was compared to a CT Patient Population of 195,726 system patients receiving care by the PI of active CTs, which represented the target population. Chi-square goodness-of-fit tests were used to test differences in distributions of demographic variables between groups, indicating disparity in CT participation. Two metrics adapted from literature - participation incidence disparity (PID) and participation incidence ratio (PIR) - were calculated to quantify absolute and relative disparity in representativeness proportions, respectively. Descriptive approaches to assessing representativeness are also provided. Results: Results showed significant differences by race/ethnicity (χ2 = 50.64; p < 0.0001), age categories (χ2 = 56.64; p < 0.0001), and insurance (χ2 = 41.29; p < 0.0001). PID and PIR metrics revealed reduced CT participation among non-White racial/ethnic groups and increased CT participation among White Non-Hispanic patients. Further, CT participants ≥80 or Worker's Compensation were underrepresented while those with Self-Pay insurance were overrepresented as CT participants. Conclusions: Despite progress, continued efforts to not only enroll participants into CTs that are representative of the healthcare system and region, but also to better assess representativeness quantitatively are still needed.

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Introduction: Clinical trials lead the progress in healthcare. To ensure reliable research conclusions, it is essential to enroll diverse patient groups. Identifying and understanding patient-reported barriers to clinical trials may help enhance recruitment among diverse patient groups.The clinical potential of proton therapy (PT) to reduce late effects is being investigated in clinical trials worldwide. Thus, for some patients, PT is only accessible by participating in clinical trials.Individuals with smoking-related head and neck cancer (HNC) are sometimes socioeconomically deprived, leading to barriers to trial participation. This study aims to identify barriers to their participation in a randomised controlled trial (RCT) involving PT. Method: Interviews were conducted with 14 HNC patients declining participation in an RCT involving PT. The interviews were transcribed and systematically analysed using an inductive approach identifying categories and themes. Results: The identified barriers to RCT-participation are: (1) existential distress, which influenced participants' mental and cognitive capacities, (2) insufficient RCT-related knowledge arising from information overload during clinical consultations, (3) the wish for safety and familiarity during the treatment trajectory, particularly for participants needing accommodation during  radiotherapy, and (4) the motivation for study participation was impacted by uncertainty due to randomisation and clinical equipoise. Existential distress is identified as an overarching theme because it influences and amplifies the other three themes. Conclusion: Existential distress is a central theme that influences and amplifies other participation barriers in PT RCTs. It affects participants' comprehension of trial information, their preference for familiar environments, and their motivation to participate in clinical trials.

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The design of a clinical trial for a rare disease can be challenging. An optimal study design is required to effectively study the clinical outcomes for possible therapies for these types of disorders. Understanding the study participants' experiences as well as barriers and facilitators of participation are important to optimize future research and to inform clinical trial management. Centronuclear myopathies (CNMs) including X-linked myotubular myopathy (XLMTM) are a group of rare congenital myopathies for which there is no cure currently. Since 2014, a number of natural history studies and clinical trials have been conducted in CNMs. Two trials have been prematurely terminated because of severe adverse events. Since no research has been conducted regarding trial experience in CNM, we performed a scoping literature research on clinical trial experience of patients with neuromuscular disorders in general. The most common barriers to trial participation of patients comprise concerns about potential harmful effects, opportunity loss and the expected burden on daily life. The most common facilitators were an expected benefit on the disease course, altruism and collateral benefit. While several results are in line with trial experiences of other types of patients, for example oncological patients, distinctions can be made for patients with CNM and other neuromuscular disorders. However, the limited availability of relevant literature suggests that future (qualitative) research should focus on trial experiences in CNM patients.

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BACKGROUND: Black patients with cancer are less likely to receive precision cancer treatments than White patients and are underrepresented in clinical trials. To address these disparities, the study aimed to develop and pilot-test a digital intervention to improve Black patients' knowledge about precision oncology and clinical trials, empower patients to increase relevant discussion, and promote informed decision-making. METHODS: A community-engaged approach, including a Community Advisory Board and two rounds of key informant interviews with Black patients with cancer, their relatives, and providers (n = 48) was used to develop and refine the multimedia digital intervention. Thematic analysis was conducted for qualitative data. The intervention was then pilot-tested with 30 Black patients with cancer to assess feasibility, acceptability, appropriateness, knowledge, decision self-efficacy, and patient empowerment; Wilcoxon matched pairs signed-rank test was used to analyze quantitative data. RESULTS: The digital tool was found to be feasible, acceptable, and culturally appropriate. Key informants shared their preferences and recommendations for the digital intervention and helped improve cultural appropriateness through user and usability testing. In the pilot test, appreciable improvement was found in participants' knowledge about precision oncology (z = -2.04, p = .052), knowledge about clinical trials (z = -3.14, p = .001), and decisional self-efficacy for targeted/immune therapy (z = -1.96, p = .0495). CONCLUSIONS: The digital intervention could be a promising interactive decision-support tool for increasing Black patients' participation in clinical trials and receipt of precision treatments, including immunotherapy. Its use in clinical practice may reduce disparities in oncology care and research. PLAIN LANGUAGE SUMMARY: We developed a digital interactive decision support tool for Black patients with cancer by convening a Community Advisory Board and conducting interviews with Black patients with cancer, their relatives, and providers. We then pilot-tested the intervention with newly diagnosed Black patients with cancer and found appreciable improvement in participants' knowledge about precision oncology, knowledge about clinical trials, and confidence in making decisions for targeted/immune therapy. Our digital tool has great potential to be an affordable and scalable solution for empowering and educating Black patients with cancer to help them make informed decisions about precision oncology and clinical trials and ultimately reducing racial disparities.

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OBJECTIVE: To characterize the representation of Black and Hispanic cancer patients in tobacco treatment trials, and to offer recommendations for future research. METHODS: We conducted two systematic searches of the literature (2018, 2021) using 5 databases (MEDLINE via EBSCO, Pubmed, PsycInfo, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Excerpta Medica Database (EMBASE)) to examine the prevalence of tobacco trials that included Black or Hispanic cancer patients. Two coders independently screened all articles at title, abstract, and full-text to identify eligible trials. Information about the proportion of Black and Hispanic patients included, trial design features, and whether the authors analyzed outcomes for Black and Hispanic patients were documented. RESULTS: Of 4682 identified studies, only 10 published trials included and reported on the rates of Black or Hispanic cancer patients enrolled in their tobacco trial. The proportion of enrolled Black cancer patients ranged from 2 to 55.6%. Only our studies documented enrollment rates for Hispanics, and rates were less than 6%. None of the studies offered strategies to promote or the accrual of Black or Hispanic patients. DISCUSSION: There remains a large gap in the literature regarding the reach and efficacy of tobacco treatment for Black and Hispanic cancer patients. Black and Hispanic cancer patients remain largely under-represented in tobacco cessation trials, limiting the applicability of existing, evidence-based treatments. To optimize intervention generalizability, future studies should emphasize the targeted recruitment and engagement of these patients in tobacco trials.

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BACKGROUND: Clinical trial participation for patients with non-curative cancer is unlikely to present personal clinical benefit, which raises the bar for informed consent. Previous work demonstrates that decisions by patients in this setting are made within a 'trusting relationship' with healthcare professionals. The current study aimed to further illuminate the nuances of this relationship from both the patients' and healthcare professionals' perspectives. METHODS: Face-to-face interviews using a grounded theory approach were conducted at a regional Cancer Centre in the United Kingdom. Interviews were performed with 34 participants (patients with non-curative cancer, number (n) = 16; healthcare professionals involved in the consent process, n = 18). Data analysis was performed after each interview using open, selective, and theoretical coding. RESULTS: The 'Trusting relationship' with healthcare professionals underpinned patient motivation to participate, with many patients 'feeling lucky' and articulating an unrealistic hope that a clinical trial could provide a cure. Patients adopted the attitude of 'What the doctor thinks is best' and placed significant trust in healthcare professionals, focusing on mainly positive aspects of the information provided. Healthcare professionals recognised that trial information was not received neutrally by patients, with some expressing concerns that patients would consent to 'please' them. This raises the question: Within the trusting relationship between patients and healthcare professionals, 'Is it possible to provide balanced information?'. The theoretical model identified in this study is central to understanding how the trusting professional-patient relationship influences the decision-making process. CONCLUSION: The significant trust placed on healthcare professionals by patients presented an obstacle to delivering balanced trial information, with patients sometimes participating to please the 'experts'. In this high-stakes scenario, it may be pertinent to consider strategies, such as separation of the clinician-researcher roles and enabling patients to articulate their care priorities and preferences within the informed consent process. Further research is needed to expand on these ethical conundrums and ensure patient choice and autonomy in trial participation are prioritised, particularly when the patient's life is limited.

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BACKGROUND: Diverse, equitable and inclusive participation in clinical research is needed to ensure evidence-based clinical practice and lessen disparities in health outcomes. Yet, clinical trial participation remains critically low in minoritized communities, particularly among Blacks. The Louisiana Community Engagement Alliance against COVID-19 Disparities (LA-CEAL) was launched in response to the disproportionate impact of COVID-19 on Black Louisianans to understand community barriers and preferences and increase inclusive participation in research. This study aims to understand perceptions regarding COVID-19 trial participation among underrepresented Louisianans. METHODS: A rapid assessment integrating cross-sectional, surveys among federally qualified health center (FQHC) patients and community residents, and focus group discussions (FGDs) from community representatives was conducted in 2020-2021. Factors and perceptions underlying trial participation were identified using logistic regression models and thematic analyses, respectively. RESULTS: Quantitative findings (FQHC: N=908, mean age=46.6 years, 66.4% Black; community: N=504, mean age=54.2 years, 93.7% Black) indicated that 0.9% and 3.6%, respectively, ever participated in a COVID-19 trial. Doctors/Healthcare providers were most trusted (FQHC=55.1%; community=59.3%) sources of information about trials. Advancing age was associated with increased odds of being very willing to participate (ORFQHC=1.03, 95% CI 1.02-1.05; ORCommunity=1.02, 95% CI 1.00-1.04). Qualitative data (6 FGDs, 29 attendees) revealed limited awareness, experimentation/exploitation-based fears, and minimal racial/ethnic representation among trialists as barriers to participation. CONCLUSION: COVID-19 trial participation rates were low in our sample. Altruism was a key facilitator to participation; fear, mistrust, and low awareness were predominant barriers. Community-centered approaches, engaging informed providers and trusted community members, may facilitate inclusive trial participation.

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To analyze the temporal trend in enrollment rates in a COVID-19 platform trial during the first three waves of the pandemic in the United States. DESIGN: Secondary analysis of data from the I-SPY COVID randomized controlled trial (RCT). SETTING: Thirty-one hospitals throughout the United States. PATIENTS: Patients who were approached, either directly or via a legally authorized representative, for consent and enrollment into the I-SPY COVID RCT. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Among 1,338 patients approached for the I-SPY COVID trial from July 30, 2020, to February 17, 2022, the number of patients who enrolled (n = 1,063) versus declined participation (n = 275) was used to calculate monthly enrollment rates. Overall, demographic and baseline clinical characteristics were similar between those who enrolled versus declined. Enrollment rates fluctuated over the course of the COVID-19 pandemic, but there were no significant trends over time (Mann-Kendall test, p = 0.21). Enrollment rates were also comparable between vaccinated and unvaccinated patients. In multivariable logistic regression analysis, age, sex, region of residence, COVID-19 severity of illness, and vaccination status were not significantly associated with the decision to decline consent. CONCLUSIONS: In this secondary analysis of the I-SPY COVID clinical trial, there was no significant association between the enrollment rate and time period or vaccination status among all eligible patients approached for clinical trial participation. Additional studies are needed to better understand whether the COVID-19 pandemic has altered clinical trial participation and to develop strategies for encouraging participation in future COVID-19 and critical care clinical trials.

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Background: The decentralised clinical trial (DCT) model has been popularised given its remote or virtual design, permitting expanded participant enrolment into community settings. Clinical research nurses (CRNs) are specially trained in the management of clinical trials; however, the utilisation of the research nurse role relating to decentralised trial conduct is not well-established. Aims: A literature review was conducted to describe the role of the research nurse in the conduct of DCTs and the current utilisation of this nurse specialty for decentralised trial management. Methods: Use of keywords 'DCT' or 'virtual trial' and 'nursing' were used to identify full-text, peer-reviewed literature in the English language and published within the last 10 years that described the clinical research nursing role. Results: Of the 102 pre-screened articles identified across five databases, 11 articles were eligible for full-text analysis. Thematic groupings of common discussion elements included Variance in Decentralised Clinical Trial Model Implementation, CRN Involvement in Decentralised Trial Conduct and Reporting and Shared Challenges of Decentralised Trial Implementation Affecting the CRN Role. Conclusions: Implications of this literature review include expanded trial sponsor awareness of the support requirements to facilitate research nurse utilisation and optimal decentralised trial conduct.