Participation In Clinical Research Research Articles

Evaluation of completeness of commonly used data elements for clinical trial eligibility criteria using a registry-enhanced data collection process: Results from patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) at three community oncology practices.

346 Background: Data elements required for clinical trial eligibility assessments are often unstandardized and incomplete in EHR making clinical research participant identification a challenging and biased process. Moreover, the absence of new patient records and disease codes results in monitoring large patient populations until records are completed. These issues can lead to missed opportunities for timely patient identification. N-Power Medicine (NPM) developed a registry-enhanced oncology network platform for unbiased, and real-time quality data collection. We report from this platform on completeness rates of key variables for eligibility assessment in NSCLC and CRC clinical trials. Methods: NPM’s platform consists of 3 parts: patient registry (Kaleido), onsite and remote staff to consent patients and ensure data completeness, quality and standardization, and technology to structure and process the data. Patients with NSCLC and CRC from 3 community oncology practices across different US regions were enrolled in Kaleido and visited the clinic between February and May 2024. Data for 11 key variables were abstracted. To minimize the need for extensive monitoring until a diagnosis was confirmed, we developed a machine learning (ML) model for lung cancer using non-C34 ICD10 codes to construct multiple classes of tunable predictive models. Results: A total of 728 (NSCLC=281, CRC=447) patients were evaluated. The male-to-female ratio was 1 for NSCLC and 1.3 for CRC and 90% of NSCLC and 68% of CRC patients were over 60 years of age. The platform achieved 99% completeness for critical data points such as diagnosis date, histology, metastatic status, recent systemic anti-cancer treatments, ECOG performance status and other cancer diagnoses with diagnosis date. 47% of NSCLC and 43% of CRC patients had metastatic disease at the time of evaluation. Over 90% of patients with metastasis had their current therapy line and relevant genomic test results successfully documented. Imaging-based cancer status completeness was 95% for NSCLC and 89% for CRC. The ML model would identify over 50% of all patients that would eventually receive a lung cancer diagnosis, with over 80% specificity up to 3 weeks before a diagnosis. Conclusions: NPM’s platform demonstrated high completeness rates for the majority of essential data elements, improving the inclusion of all eligible patients in clinical trials. The predictive ML model shows promise in identifying suitable patients before an ICD10 code is assigned, reducing the need for extensive monitoring and ensuring timely completeness of necessary assessments for eligibility. Importantly, these advancements were achieved without adding financial or resource burdens to clinical workflows.

Abstract B120: Understanding Barriers and Facilitators Affecting Participation in Cancer Clinical Research Studies for Racially and Ethnically Diverse Populations in Rural North Carolina

Abstract Increasing representation of minoritized racial and ethnic populations in cancer clinical research studies has been declared a priority in the US for many years. Additionally, it is widely recognized that people living in rural areas of the US have limited access to cancer clinical research studies, and solutions are needed to extend participation opportunities to rural cancer patients. Underrepresentation of minoritized racial and ethnic populations and rural communities perpetuates health inequities, and solutions are needed to remove barriers and implement facilitators for participation. However, a review of existing literature found a lack of attention on the intersection of race and rurality and the needs and values of these populations as it pertains to cancer research. To address this concern, we used a sequential mixed method, community-engaged approach to explore the barriers and facilitators affecting participation in cancer clinical research from the perspectives of cancer survivors and their caregivers, as well as cancer healthcare professionals in rural North Carolina (NC). We used existing publicly available data to identify and characterize four of the most rural, racially and ethnically diverse, and medically underserved counties in NC. The principal investigator collaborated with cancer centers, churches, and American Indian tribal leaders in NC to administer surveys to cancer survivors and caregivers to assess their beliefs and experiences regarding cancer clinical research. Eligible participants included persons who had been diagnosed with cancer or a caregiver of someone diagnosed with cancer. In addition, we conducted key informant interviews with cancer health care professionals providing cancer care in the selected rural NC counties. We analyzed surveys and interview responses with descriptive statistics. Forty-three cancer survivors/caregivers completed surveys and twenty-two cancer healthcare professionals completed semi-structured interviews. Cancer survivors and caregivers indicated that the lack of invitation to participate in cancer clinical research was their greatest barrier to participation, whereas cancer healthcare professionals cited the lack of transportation as the perceived greatest barrier for patients. Cancer survivors, caregivers and healthcare professionals agreed that having support from clinical research personnel would be amongst the most helpful facilitators, along with opportunities to participate in clinical research studies close to home. Cancer healthcare professionals suggested the lack of trust in clinical research was a barrier for their patients; however, cancer survivors and caregivers in this study indicated lack of trust was not a significant barrier to their participation. Recommendations to address barriers and promote facilitators to participation in cancer clinical research include the importance of engaging the community, addressing unconscious bias, decentralizing clinical trials, and providing recruitment materials in culturally responsive formats. Citation Format: Amy Garrett, Karine Dubé, Lisa Spees, Ronny Bell, Marjory Charlot, Sandra Greene. Understanding Barriers and Facilitators Affecting Participation in Cancer Clinical Research Studies for Racially and Ethnically Diverse Populations in Rural North Carolina [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B120.

Abstract A115: Utilizing digital storytelling to improve the recruitment of Black and Hispanic patients for a genetic predisposition to prostate cancer screening trial

Abstract Introduction: Clinical genomics leads to more effective cancer prevention, diagnosis, and treatment. Prostate cancer (PC) significantly impacts Black and Hispanic men, but participation in clinical trials and PC risk management methods like genetic testing and screening remains low. Barriers to diversity and inclusion in clinical trials include cultural and socioeconomic factors. Digital storytelling is an effective tool for building trust and increasing community engagement. We aim to develop and assess the use of digital storytelling to improve recruitment of Black and Hispanic patients in a trial for men at high genetic risk for developing PC (clinicaltrials.gov NCT03805919) and raise awareness of genetic testing and enrollment in clinical trials within these communities. Methods: Guided by the Assessing Community Engagement Conceptual Model, we will establish a community advisory panel (CAP) comprised of patient advocates, community, and clinical partners with a strong interest in increasing clinical trial representation of Black and Hispanic patients at high genetic risk for developing PC. CAP participants will be identified from existing partners and through snowballing techniques, which involve asking partners to recommend other CAP participants. The CAP will co-design storytelling interview questions, baseline, and outcome assessments and collectively determine effective methods for digital story dissemination. To evaluate the impact of storytelling on awareness, interest, and participation in genetic testing, medical management, and clinical trial recruitment among Black and Hispanic men, outcome assessments co-designed with the CAP will be administered pre and post-video viewing and include viewer qualitative interviews. Results: Filmed interviews with Black and Hispanic participants will be conducted. Interviews will focus on participant experiences with clinical trials, genetic testing, and cancer risk management. Interview transcripts will be in English and Spanish with forward and back translation to ensure accuracy using National Institutes of Health resources. Local and national partners, community organizations, faith-based institutions, healthcare facilities, and advocacy groups identified by the CAP will facilitate dissemination. Digital stories will be distributed across various multimedia platforms to maximize outreach and accessibility, including community web platforms, social media channels, podcasts, local radio stations, educational workshops, health fairs, cultural events, churches, and support groups. Conclusion: Building strategies for improving patient-centered care delivery and community engagement within culturally diverse populations will enhance clinical trial diversity and inclusion. Using digital storytelling as a recruitment strategy for clinical trials can foster trust, engagement, and participation within Black and Hispanic communities. Study findings will contribute to future clinical trial design and recruitment to enhance underrepresented minority participation in clinical research. Citation Format: Yi Liu, Brenda Adjei, Anna Couvillon, Kathleen Calzone, Fatima Karzai. Utilizing digital storytelling to improve the recruitment of Black and Hispanic patients for a genetic predisposition to prostate cancer screening trial [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr A115.

Abstract B119: Evaluation of a navigator training program to increase clinical trials and genomic research participation among adult African Americans and Hispanics residing in the Southern United States

Abstract Introduction: Patient Navigators (PNs) have have proven to be effective along the cancer care continuum. However, emerging data suggest that the scope of patient navigation should be expanded to include other contexts such as the recruitment of racial/ethnic minorities for cancer clinical trials. Because the processes of recruitment and retention are often linked, the same barriers hindering minority recruitment often hinder minority retention. The potential benefits of studying generalizability and statistical power for subgroup analyses may be lost with disproportionately high attrition among the enrolled minorities. The dual focus of the training curriculum on both recruitment and retention distinguishes it from the few previous efforts focused on the traditional PN model for minority recruitment in clinical trials and genomic research studies. Methods: A two-phased navigator training program was implemented. Components of the training program was adapted in collaboration, with the Joint Cancer Advisory Council and Bioethics Co-Leaders, from the existing UAB IMPACT Patient Navigation Training Curriculum. A systematic literature review will be conducted to identify the most salient genomic educational and resource needs and concerns of AAs and Hispanic populations regarding participation in genomic-focused research and clinical trials. These findings informed the adaptation of the training curriculum based on principles of adult education. Results: We conducted a joint training for the Clinical Trials and Genomic Navigators at each Partnership institution (MSM, TU, UAB) for the proposed project. The Co-Leaders from the Partnership Outreach Cores, the Bioethics Shared Resource, and the Joint Cancer Advisory Council planned and assigned responsibilities and dates for completion of the training activities. The initial training was the GW Navigator On-line Training Program. A supplemental training was held at one of the partnering sites, a safety-net hospital (Grady Cancer Center for Excellence). The in-person training featured an overview presentation on Genetic Risk Assessment in Oncology by a licensed genetic counselor, followed by a case study approach to enrollment and the implementation of a research study with training materials such as tablets provided by the training conductors. An evaluation was completed by the team for training conductors. The third training was held at Tuskegee University and ttopics included the importance of consent training. For this presentation, we will present the qualitative and quantitative findings. Conclusions: The training outcomes were standardized and included input from the Bioethics Co-Leaders and JCAR members. We measured changes over time (pre vs. posttest) in: 1) knowledge and skills of clinical trials and genomic research; 2) ability to identify barriers and solutions to participation in research, 3) ability to implement the two toolkits, and 4) level of ease in identifying open protocol research studies and clinical trials. Citation Format: Osato Eke, Makeeta Rayton, Teresa Hall, Lleana Barrios-Zermeno, Jennier Culbertson, Angela Morris, Vivian Carter, Yu-Mei Schoenberger, Victoria Churchill, Desiree Rivers, Stephen Sodeke, Mohamed Mubasher, Roland Matthews, Brian Rivers. Evaluation of a navigator training program to increase clinical trials and genomic research participation among adult African Americans and Hispanics residing in the Southern United States [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B119.

Abstract B058: Preliminary findings of a multilevel community-based clinical trials and genomic navigation program implemented in the southern United States

Abstract Introduction: Advances in genomics have increased our understanding of the interplay between genetics, environment, behavior, and disease. However, these scientific advances are hampered by the inadequate representation of African American (AA) and Hispanic populations in genomic studies and clinical trials; thus, it is important to identify effective engagement and navigation strategies. The goal of the MSM/TU/UAB OCCC Partnerships to Advance Cancer Health Equity (PACHE) Outreach Core is to implement and evaluate an evidence-based, theory-informed, multi-level, clinical trial and cancer genomics education program (CTC-GEP) to address the determinants for AA and Hispanic participation in clinical trials and genomic research. The program consists of a clinical and genomic navigator and a high and low-tech toolkit. We will present preliminary data characterizing the feasibility phase of this two-arm behavioral trial. Methods: The Attitudes and Intentions to Enroll in a Therapeutic Trial (AIET) questionnaire and a culturally tailored social and demographic questionnaire were used by navigators to obtain participants information. Cumulative logistic regression was used to assess the correlation of age, race, education, and type of health insurance with attaining a higher score on the Likert scale used in AIET survey questions at pre- and post-test. Results: Younger participants (18-49 years) were significantly more likely than older participants (ages 50 and above) to hold several positive views about participating in clinical trials. Specifically, they were 3.6 times as likely to believe that participating in a clinical trial could help advance science to improve community health (P-value = 0.0393); 4.6 times as likely to think there are benefits for others like them (P-value = 0.25); 5.6 times as likely to trust that clinical trial centers have rules to protect their records (P-value = 0.024); and 3.9 times as likely to trust health workers (P-value = 0.002). Additionally, participants with a high school education or less were 3.2 times as likely to consider themselves at risk of cancer compared to those with a college education or higher (P- value = 0.0015). Medicare & Medicaid recipients, compared to those with private insurance, viewed privacy as a major concern when participating in research (P-value = 0.008). Furthermore, Black/AA participants were more likely than White participants to believe that Blacks are used in research without their knowledge (P-value = 0.005). Conclusions: CTC- GEP was demonstrated to be feasible and acceptable among study participants. Findings from the AIET survey highlight privacy concerns are more pronounced among Medicare & Medicaid recipients, indicating a need for better communication about privacy protections. As well, age and racial disparities exist in trust regarding the ethical conduct of research, with older and AA participants expressing significant concern about being used in research inappropriately and without their knowledge. Citation Format: Mohamed Mubasher, Osato Eke, Victoria Churchill, Vivian Carter, Yu-Mei Schoenberger, Desiree Rivers, Jamirah Chevrin, Stephen Sodeke, Christina Wilkerson, Makeeta Rayton, Teresa Hall, Illeana Barrios Zermeno, Angela Morris, Jennifer Culbertson, Roland Matthews, Brian Rivers. Preliminary findings of a multilevel community-based clinical trials and genomic navigation program implemented in the southern United States [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B058.

Abstract B086: Increasing clinical research participation and input from underserved communities: Results from community engagement studios inform clinical study design

Abstract Underrepresentation of marginalized racial and ethnic groups has been a consistent challenge in clinical trials. With an intent to increase trial accessibility for underserved communities, we conducted community engagement studios (CES) to understand the various cultures, values, worldviews, and lived experiences from different communities that might affect clinical trial participation. We report on the CES discussions and how they modified the design of an early cancer detection clinical study. CES were developed in partnership with an academic community engagement expert, OHSU and via the patient advocacy group, Touch4Life, which focuses on decreasing cancer disparities in the BIPOC (Black, Indigenous, and people of color) population. Four CES were conducted: 1 with members of Asian (n=11), 2 with members of African American (AA) (n=16), and 1 with members of rural (n=7) communities. One AA CES was conducted with members of the Touch4Life network, with whom we piloted a subsequent oral debrief session to review CES thematic results and relay the impact it had on clinical study implementation, the results of which led to a corollary CES to be initiated in this network (n=7) to evaluate recruitment messages in the BIPOC population. Common themes for clinical trial recruitment strategies included the importance of messaging from trusted sources. While clinicians were a shared trusted source, Asian CES members preferred a personal connection, rural CES members preferred non-profit foundations, and AA CES members highlighted community networks (church and patient advocacy groups with shared experiences). Asian CES participants were hesitant to engage with pharmacists for clinical study recruitment due to a lack of personal relationships, but rural and AA communities would be open to hearing about clinical studies at their pharmacy, combined with consultation with their doctor. All communities expressed shared barriers for trial participation (time commitment, transportation, cost) and unique barriers were also expressed: childcare and distrust in biopharma in the AA CES; language in the Asian CES. All CES expressed interest in receiving updates on clinical trial progress and outcomes. Themes from the CES have been used to inform changes to both our recruitment and education strategies and outreach efforts for this clinical study for the early detection of cancer. One such modification included adding recruitment channels focused on engaging participants through patient advocacy groups and specific clinical study sites. Following guidance from both CES participants and our CES partners, and by sharing the CES results with the Touch4Life community, we developed a bidirectional flow of information and fostered a joint mission to deepen our working relationship with the community. Our research demonstrated that early collaboration between industry-sponsored researchers, community experts, and patient advocacy groups is an ideal model for gaining insights into specific communities and fostering relationships that can improve access to clinical studies. Citation Format: Monique Gary, Laura Crandon, Tiffani L. Howard, Paul Bollinger, Natalie Bonilla, Jackilen Shannon, Shifra Krinshpun, Sarah Sawyer, Sara L. Bristow, Meenakshi Malhotra, Adham Jurdi, Alexey Aleshin, Breeana L. Mitchell. Increasing clinical research participation and input from underserved communities: Results from community engagement studios inform clinical study design [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B086.

Strengthening the Application of the DAIDS GCLP Guidelines: The Implementation of an Integrated Laboratory Oversight Framework.

The Division of AIDS (DAIDS) Good Clinical Laboratory Practice (GCLP) Guidelines establish a framework to guide the oversight of laboratories supporting DAIDS-sponsored clinical research or trials. Compliance with these guidelines promotes data reliability, validity, and safety of the clinical research or trial participants and laboratory staff and ensures adherence to regulatory requirements. Acknowledgment and adoption of the DAIDS GCLP Guidelines are critical in building laboratory capacity and preparedness for conducting clinical trials. In collaboration with DAIDS, laboratory experts support the implementation of the DAIDS Integrated Laboratory Oversight Framework (Framework) activities. This article describes the implementation of the GCLP Guidelines, the Framework activities, and the coordinated efforts to strengthen laboratory performance. The Framework activities include four components: Quality Assurance Oversight, GCLP Audits, GCLP Training, and Laboratory Quality Improvement. Comparison of GCLP Guidelines with other regulations or standards, including U.S. Clinical Laboratory Improvement Amendments regulation 42 CFR 493, College of American Pathologists, World Health Organization GCLP, and International Organization for Standardization, ISO 15189:2012 standards, highlighted the differences and similarities to guide integration and harmonization efforts. Processes related to the Framework activities are outlined in detail, including key data derived from the managed activities of over 175 laboratories worldwide. Via the evolution of the DAIDS GCLP Guidelines and laboratory oversight workflows, the laboratories participating in DAIDS-sponsored clinical research and trials have successfully participated in internal and external regulatory audits. The collaborative and integrated oversight approach promotes knowledge-sharing and accountability to support the implementation of the DAIDS GCLP Guidelines and compliance monitoring. Lessons learned have helped with the implementation of the DAIDS integrated laboratory oversight approach and quality oversight programs at multiple laboratories worldwide.

A Mixed Method Study in Young Children Participating in Clinical Research During A Kidney Transplantation Trajectory.

Regulations designed to protect children participating in clinical research often restrict the availability of research data necessary for the development of age-specific therapies and drug dosing. Few data exist on how children experience participation in clinical research, and studies investigating young children undergoing an intensive medical treatment are lacking. Mixed methods with semi-structured interviews and DISCO-RC questionnaires were used to explore young children's and their parents' experiences in clinical research participation during a kidney transplantation trajectory. Nine children and their parents were interviewed. Children's median age at kidney transplantation was 4 years (IQR 4,7); age at interview was 7 years (IQR 6,9). Thematic content analysis of interviews revealed that most children were unaware of having participated in a study. Both children and their parents frequently were unaware whether procedures were standard care or research related. The additional burden attributed to study participation varied from not at all to heavy in combination with intensive medical treatment. Positive experiences included kind healthcare professionals, effective distraction techniques, educational aspects, contributing to science and extra check-ups. Most reported negative experiences were conflicting communication, spending much time in the hospital, missing school and suboptimal planning. Venous puncture was stressful for all children, whereas the discomfort of other procedures varied. Pediatric clinical research design should focus on education and fun during research procedures, smart planning, consistent communication, close collaboration between clinical and research team and age appropriate distraction techniques.

Social determinants of health and outcome disparities in spine tumor surgery. Part 2: Neighborhood disadvantage and long-term outcomes.

Neighborhood-level resource disadvantage has been previously shown to predict extent of resection, oncological follow-up, adjuvant treatment, and clinical trial participation for malignancies, including glioblastoma. The authors aimed to characterize the association between neighborhood disadvantage and long-term outcomes after spine tumor surgery. The authors analyzed all patients who underwent surgery for primary or secondary (all metastatic pathologies) spine tumors at a single spinal oncology specialty center in the United States from 2015 to 2022. The Area Deprivation Index (ADI), a validated metric compositing 17 social determinants of health variables that ranges continuously from 0% (higher advantage) to 100% (higher disadvantage), was used to quantify neighborhood disadvantage. Patient addresses were matched to ADI on the basis of the census block of residence. Subsequently, the study population was dichotomized into advantaged (ADI 0%-33%) and disadvantaged (ADI 34%-100%) cohorts. The primary endpoint was functional status, as defined by Eastern Cooperative Oncology Group (ECOG) Performance Status Scale grade, with secondary endpoints including inpatient outcomes, mortality, readmissions, reoperations, and clinical research participation. Multivariable logistic, gamma log-link, and Cox regression adjusted for 14 confounders, including patient and oncological characteristics, general and tumor-related presenting severity, and treatment. In total, 237 patients underwent spine tumor surgery from 2015 to 2022, with an average age of 53.9 years, and 57.0% had primary tumors whereas 43.0% had secondary tumors; 55.3% (n = 131) were classified by ADI into the disadvantaged cohort. This cohort had higher rates of ambulation deficits on presentation (39.1% vs 23.5%, p = 0.015) and nonelective surgery (35.1% vs 23.6%, p = 0.030). Postoperatively, disadvantaged patients exhibited higher odds of residual tumor (OR 2.55, p = 0.026), especially for secondary tumors (OR 4.92, p = 0.045). Patients from disadvantaged neighborhoods additionally exhibited significantly higher odds of poor functional status at follow-up (OR 3.94, p = 0.002). Postoperative survival was 74.7% (mean follow-up 17.6 months), with the disadvantaged cohort experiencing significantly shorter survival (HR 1.92, p = 0.049). Moreover, this population had higher odds of readmission (OR 1.92, p = 0.046) and, for primary tumors, reoperation (OR 9.26, p = 0.005). Elective participation in prospective clinical research was lower among the disadvantaged cohort (OR 0.45, p = 0.016). Neighborhood disadvantage predicts higher rates of residual tumor, readmission, and reoperation, as well as poorer functional status, shorter postoperative survival, and decreased elective research participation. The ADI may be used to risk stratify spine oncology patients and guide targeted interventions to ameliorate neurosurgical disparities and to reduce barriers to research participation.

Association between nurses' personal, professional and work characteristics, and engagement in hospital-based clinical research.

The purpose of this study was to assess the associations between demographic, professional and other personal nurse characteristics, social support factors and comfort in conducting research with nurses' level of active participation in clinical research. A prospective, cross-sectional, correlational design was used. Clinical nurses working in a multihospital healthcare system were recruited by email to complete an anonymous survey that used multiple valid and reliable scales to assess demographic and professional work characteristics, curiosity, grit, locus of control, perceived social support (for research activities), comfort in conducting research, and level of being research-active. Univariate and multivariable analyses were completed. Of 310 participants, 274 (88.4%) were female and mean (SD) age was 42.9 (13.1) years. After condensing 11 levels of research activity to four categories, 179 (57.7%) were not research-active, and 91 (29.4%), 26 (8.3%) and 14 (4.5%) were engaged at low, moderate, and high levels, respectively. Of 78 factors, 69 (88.5%) were associated with being research-active in univariate analyses. In multivariable analysis that adjusted for age, personal experience as a patient, years as a nurse and hours in direct patient care, professionalism characteristics, higher curiosity, internal locus of control, grit perseverance, support of a nurse scientist and nurse friends, and comfort in conducting research remained associated with higher levels of being research-active (all p < 0.01). Research-active nurses were more likely to be engaged professionally in hospital-based activities beyond their work roles and displayed higher levels of positive psychological characteristics and mentorship that supported research capacity. Research-active nurses were more likely to have internal factors and external resources that promoted higher levels of being research-active. A strong professional governance model may enhance clinical nurses research activities.

An Integrated DAIDS Laboratory Oversight Framework: Application of the DAIDS GCLP Guidelines.

The Division of AIDS (DAIDS) Good Clinical Laboratory Practice (GCLP) Guidelines establish a framework to guide the oversight of laboratories supporting DAIDS-sponsored clinical research or trials. Compliance with these guidelines promotes data reliability, consistency, and validity, and the safety of the clinical research or trial participants and laboratory staff, as well as ensures adherence to regulatory requirements. This article describes the application of the DAIDS GCLP Guidelines, the DAIDS Integrated Laboratory Oversight Framework, and the coordinated efforts of the collaborative oversight team of laboratory experts to support and monitor the performance of over 175 participating laboratories worldwide. Data from two self-administered online surveys conducted in 2017 and 2023 assessed the laboratory staff's experience implementing the GCLP Guidelines. The results of the 2017 survey were instrumental in informing changes to GCLP audit activities and promoting harmonization in the approach to laboratory oversight. A key finding from the 2023 survey results is the preference for hybrid GCLP training, encompassing face-to-face and online modules. Overall, both surveys acknowledged satisfaction with applying and implementing GCLP Guidelines. The need to effectively disseminate information about DAIDS laboratory oversight requirements to support the improved implementation of GCLP Guidelines was notable from both survey results. The collaborative team of laboratory experts and the integrated oversight approach promote knowledge-sharing and accountability to support the application of the GCLP Guidelines and compliance monitoring. The systematic implementation of the integrated laboratory oversight activities helped identify valuable lessons for improving laboratory performance and opportunities to strengthen quality oversight for laboratories participating in clinical research or trials.

User Preferences and Needs for Health Data Collection Using Research Electronic Data Capture: Survey Study.

Self-administered web-based questionnaires are widely used to collect health data from patients and clinical research participants. REDCap (Research Electronic Data Capture; Vanderbilt University) is a global, secure web application for building and managing electronic data capture. Unfortunately, stakeholder needs and preferences of electronic data collection via REDCap have rarely been studied. This study aims to survey REDCap researchers and administrators to assess their experience with REDCap, especially their perspectives on the advantages, challenges, and suggestions for the enhancement of REDCap as a data collection tool. We conducted a web-based survey with representatives of REDCap member organizations in the United States. The survey captured information on respondent demographics, quality of patient-reported data collected via REDCap, patient experience of data collection with REDCap, and open-ended questions focusing on the advantages, challenges, and suggestions to enhance REDCap's data collection experience. Descriptive and inferential analysis measures were used to analyze quantitative data. Thematic analysis was used to analyze open-ended responses focusing on the advantages, disadvantages, and enhancements in data collection experience. A total of 207 respondents completed the survey. Respondents strongly agreed or agreed that the data collected via REDCap are accurate (188/207, 90.8%), reliable (182/207, 87.9%), and complete (166/207, 80.2%). More than half of respondents strongly agreed or agreed that patients find REDCap easy to use (165/207, 79.7%), could successfully complete tasks without help (151/207, 72.9%), and could do so in a timely manner (163/207, 78.7%). Thematic analysis of open-ended responses yielded 8 major themes: survey development, user experience, survey distribution, survey results, training and support, technology, security, and platform features. The user experience category included more than half of the advantage codes (307/594, 51.7% of codes); meanwhile, respondents reported higher challenges in survey development (169/516, 32.8% of codes), also suggesting the highest enhancement suggestions for the category (162/439, 36.9% of codes). Respondents indicated that REDCap is a valued, low-cost, secure resource for clinical research data collection. REDCap's data collection experience was generally positive among clinical research and care staff members and patients. However, with the advancements in data collection technologies and the availability of modern, intuitive, and mobile-friendly data collection interfaces, there is a critical opportunity to enhance the REDCap experience to meet the needs of researchers and patients.

Representativeness of race, ethnicity and social determinants of health in patients with advanced non-small cell lung cancer via linkage of real-world electronic health records, administrative claims, and consumer financial data.

e13559 Background: Social determinants of health (SDOH) are both drivers of health disparities and barriers to clinical research participation, particularly among historically underserved or marginalized populations. Using real-world data (RWD), diversity plans in cancer clinical trials frequently aim to reduce disparities and improve representation. Our aim was to describe the representativeness of patients with advanced non-small cell lung cancer (aNSCLC) with respect to race, ethnicity and person-level SDOH in a curated electronic health record (EHR) database. Methods: This was a retrospective cohort study of individuals diagnosed with aNSCLC between 2016–2022 in a US-based oncology EHR database (ConcertAI). Information on person-level SDOH was derived from linkage of curated EHR data to administrative claims and consumer financial data. These data were also compared to a sample of patients diagnosed with first primary NSCLC from the Surveillance, Epidemiology, and End Results (SEER) Program and American Community Survey (ACS), where possible. The Kaplan-Meier product limit estimator was used to compare time from advanced diagnosis to treatment initiation. Results: From an overall sample of 17,772 patients with aNSCLC, a total of 10,390 patients had 1 or more SDOH characteristics of interest documented. Compared with patients without linked SDOH data, a higher proportion of patients with linked person-level SDOH data were non-Hispanic (NH) White patients (79% vs 71%) and lower proportions were NH Black (10% vs 13%), NH Asian/Pacific Islander (2% vs 4%) and Hispanic patients (2% vs 4%). Patients with linked SDOH were also more likely to have aNSCLC progressed from an earlier stage and received biomarker testing for targetable alterations. Overall, 54% of patients were married, 38% completed a bachelor’s degree or higher, 14% worked in a blue-collar occupation, and 61% had an individual income of ≤$35,000. All 4 of these SDOH characteristics differed significantly by race/ethnicity. Differences in time-to-treatment initiation were statistically significant by marital status (median of 50 [married] vs 55 [not married] days; P=0.02) and individual income (median of 50 [&gt;$60,000] vs 55 [≤$30,000] days; P=0.04). Patients with aNSCLC in these data differed from patients in SEER and ACS estimates with respect to greater representation of patients who are NH White, have lower levels of education, and lower individual income. Conclusions: This analysis demonstrated the feasibility of measuring person-level SDOH using EHR from patients with aNSCLC treated at oncology clinics across the US. RWD with linked SDOH characteristics should be used cautiously to address the representativeness gap in evidence from oncology trials given their potential inherent selection biases.

Enhancing diverse representation in clinical studies: Recommendations from external subject matter experts (SMEs) and patients to optimize protocols, informed consent and study designs.

e23004 Background: Well-characterized disparities in clinical research have disproportionately affected patients of color, particularly in underserved communities. To tackle these barriers, the Roche-Genentech U.S. Advancing Inclusive Research Site Alliance solicited feedback from external SMEs about recommendations for strategies and tactics to increase Black, Hispanic/Latinx and older adult patient clinical research participation. Methods: Feedback was received virtually and via 1:1 interviews from 13 external SMEs defined as investigators, study coordinators or other clinical research roles that engage directly with patients regarding a Phase III small-cell lung cancer protocol as a use case. Two patients provided recommendations for future clinical study protocols and designs. Additionally, multiple healthcare providers from International Society of Geriatric Oncology provided recommendations for the inclusion of older adults in study protocols. A cross-functional, pan-Roche-Genentech team reviewed the feedback and finalized all materials. Results: Six key themes emerged: (a) use lay terms and humanizing language in patient materials; (b) integrate patient lifestyle realities by allowing flexibility in protocol inclusion/exclusion criteria; (c) improve the ease of patient participation and seek only what is clinically necessary for study assessment; (d) incorporate options for sites to enable them to make the right, and fastest, decision(s) for patients without sacrificing safety or data quality; (e) show commitment to diversity in words and actions such as including target enrollment goals in protocols and incorporating patient input on protocols before protocol finalization; (f) include older patients &gt; 70 years. Patient feedback reinforced the SME themes, except for inclusion of older patients. Patients suggested efficiency, clarity and local community realities be factored into future study designs. Some examples are fewer clinic visits, remote visit options, providing patient transportation and food support in connection with protocol-required visits. Patients also highlighted the importance of explaining the probability of side-effects, clinics being present in the community and the need for greater education and awareness regarding barriers to clinical trial enrollment. One patient relayed the importance of early trial education through general physician offices before a trial is actually needed for a given patient. Conclusions: These SME recommendations provide actionable insights to inform protocol design and patient recruitment strategy and tactics to enhance future protocols from an inclusivity-specific lens. Study teams can use these recommendations to address barriers that make enrollment/retention by underrepresented patient populations difficult.

Inequity in clinical research access for service users presenting comorbidity within alcohol treatment settings: findings from a focused ethnographic study

BackgroundWhile healthcare policy has fostered implementation strategies to improve inclusion and access of under-served groups to clinical care, systemic and structural elements still disproportionately prevent service users from accessing research opportunities embedded within clinical settings. This contributes to the widening of health inequalities, as the absence of representativeness prevents the applicability and effectiveness of evidence-based interventions in under-served clinical populations. The present study aims to identify the individual (micro), organisational (meso) and structural (macro) barriers to clinical research access in patients with comorbid alcohol use disorder and alcohol-related liver disease.MethodsA focused ethnography approach was employed to explore the challenges experienced by patients in the access to and implementation of research processes within clinical settings. Data were collected through an iterative-inductive approach, using field notes and patient interview transcripts. The framework method was utilised for data analysis, and themes were identified at the micro, meso and macro levels.ResultsAt the micro-level, alcohol-related barriers included encephalopathy and acute withdrawal symptoms. Alcohol-unrelated barriers also shaped the engagement of service users in research. At the meso-level, staff and resource pressures, as well as familiarity with clinical and research facilities were noted as influencing intervention delivery and study retention. At the wider, macro-level, circumstances including the ‘cost of living crisis’ and national industrial action within healthcare settings had an impact on research processes. The findings emphasise a ‘domino effect’ across all levels, demonstrating an interplay between individual, organisational and structural elements influencing access to clinical research.ConclusionsA combination of individual, organisational and structural barriers, exacerbated by the COVID-19 pandemic, and the socioeconomic landscape in which the study was conducted further contributed to the unequal access of under-served groups to clinical research participation. For patients with comorbid alcohol use disorder and alcohol-related liver disease, limited access to research further contributes towards a gap in effective evidence-based treatment, exacerbating health inequalities in this clinical population.

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 5 min 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.

Evolution of informed consent in research: From the Hippocratic Oath to the tailored consent.

Informed consent (IC) is essential in defending the autonomy of potential participants in clinical research. Despite the advances in research ethics, particularly in IC, the different guidelines and codes have not been fully implemented. Several studies have presented consent deficiencies that have resulted in unethical practices or poor understanding of the IC. This article reviews the evolution of IC, from its philosophical origins and initial use in the Ottoman Empire (16th century) to its use in clinical research today. It also presents the vision of the European project i-CONSENT (Grant Agreement number: 741856), whose main purpose is to improve the understanding of ICs in research and identifies the key components of a new paradigm to develop patient-centred ICs. In many cases, the IC has served to protect the investigator or sponsor from complaints. Different ethical guidelines have sought to make the IC a more useful tool, with little success. Today's IC is mainly a bureaucratic and legal process that fails to consider the patient's point of view. In this context, the Guidelines for Tailoring the Informed Consent Process in Clinical Studies provide alternatives to the current IC process, focusing on the patient's opinions and making them part of the process, thereby improving clinical research quality.

Patient Advocates for Clinical Research (PACER): A Step Toward Ethical, Relevant, and Truly Participatory Clinical Research in India.

Background Clinical research presents a promising path for improving healthcare in contemporary India. Yet, researchers identify gaps in trust, awareness, as well as misconceptions about being a '"guinea pig." We proposed building the capacity of training patient advocacy groups (PAGs) in patient-centered clinical research and through them creating aware patients as research partners. Methodology Patient Advocates for Clinical Research (PACER) is a tiered program to share information and education about clinical research with PAGs. Tier one is a self-paced online learning course, followed by workshops on clinical research, Good Clinical Practice, research consent, case studies, and group discussions. Results A total of 20 PAGs represented by 48 participants, active in areas of pediatric cancer, breast cancer, multiple myeloma, type I diabetes, spinal muscular atrophy, sickle cell disease, and inflammatory bowel diseases, participated. Among 48 participants 30 successfully completed the online course (multiple-choice question evaluation score cut-off >70%), attaining an average score of 23.9 ± 2.1 out of 30. Overall, 48 participants attended workshop 1 and 45 workshop 2, with 140 participants joining the focus group discussion (FGD). An overall improvement of 9.4% (𝜒2 = 46.173; p < 0.001) for workshop 1 and 8.2% (𝜒2 = 25.412; p < 0.001) for workshop 2 was seen in knowledge gain about clinical research. The FGD raised issues such as misleading information from research teams, unethical recruitment, incomprehensible information sheets, and limited trial-related knowledge fostering fear of participation in clinical research. Conclusions Multimodal and tiered learning of clinical research such as that used by PACER has a good participatory and learning response from PAGs and may be further explored.

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.