Research Coordinators Research Articles

Molecular tumor board: Real-world experience in a tertiary cancer centre in Singapore.

107 Background: Genomic profiling is increasingly employed to support diagnosis and treatment of cancer. Our Molecular tumor boards (MTBs) serves as a collaborative platform for a multi-disciplinary team of oncologists, pathologists, scientists, bioinformaticians, genetic counsellors and research coordinators to discuss and match patients to the most relevant therapies and/or clinical trials. We report here the evaluation of our MTBs for year 2023 with the aim of identifying challenges and opportunities for successful implementation of precision oncology. Methods: Regular monthly MTBs were conducted to discuss molecular profiles from predominantly advanced-stage patients enrolled to the IMPACT study (Individualized Molecular Profiling for Allocation to Clinical Trials NCT02806388). Next-generation sequencing was performed either in-house using Oncomine or commercial FoundationOne panels. Additional tests such as whole transcriptome sequencing (WTS), immunohistochemistry (IHC) and fluorescent in-situ hybridization (FISH) were also performed where indicated. MTB recommendations were documented for follow-up and analysis. Results: A total of 102 out of 611 profiled patients were discussed in MTBs in 2023, with an average of 8.6 patients per month. Top 3 cancer types were gastrointestinal (32%), breast (18%) and lung (18%). 65/102 (63.7%) cases had MTB recommendations, of which 21 (20.6%) had multiple recommendations. Overall uptake rate for recommendations was 23.8% (29/122). Conclusions: MTB plays an important role in identifying therapeutic opportunities by factoring in patient variables, available data and physician experience while at the same time provides an avenue for further investigation to gather cumulative evidence. Frequent reasons encountered for not adopting the recommendations include: (1) insufficient sample to proceed with further investigations, (2) limited access to off-label treatments, and (3) additional considerations to participate in clinical trials. To fully realize the value of MTB, we will focus on (1) defining the molecular tests for efficient profiling, (2) crafting a route for special access to treatments and (3) increasing awareness and understanding of clinical trials. [Table: see text]

Modeling Organismal Responses to Changing Environments.

Throughout their lives, organisms must integrate and maintain stability across complex developmental, morphological, and physiological systems, all while responding to changing internal and external environments. Determining the mechanisms underlying organismal responses to environmental change and development is a major challenge for biology. This is particularly important in the face of the rapidly changing global climate, increasing human populations, and habitat destruction. In January 2024, we organized a symposium to highlight some current efforts to use modeling to understand organismal responses to short- and long-term changes in their internal and external environments. Our goal was to facilitate collaboration and communication between modelers and organismal biologists, which is one of the major aims of the Organismal Systems-type Modeling Research Coordination Network, OSyM. Accompanying this introduction are a series of papers that are aimed to enhance research and education in linking organismal biology and modeling and contribute to building a new community of scientists to tackle important questions using this approach.

Palliative Care Acceptability for Older Adults with Advanced CKD: A Qualitative Study of Patients and Nephrologists

Older adults in the United States often receive kidney therapies that do not align with their goals. Palliative care (PC) specialists are experts in assisting patients with the goals of care discussions and decision support, yet views and experiences of older patients who have received PC while contemplating kidney therapy decisions and their nephrologists remain unexplored. We evaluated the acceptability of CKD-EDU, a PC-based kidney therapy decision support intervention for adults≥75 years of age. Qualitative study. Two trained research coordinators interviewed patients and nephrologists participating in the CKD-EDU study. Three coders analyzed the qualitative data using a thematic analysis approach to identify salient themes pertaining to intervention acceptability. Patients (n=19; mean age: 80 years) viewed the PC intervention favorably, noting PCphysicians' excellent communication skills, whole-person care, and decision-making support, including comprehension of prognostic information. Nephrologists (n=24; mean age) welcomed PC assistance in decision making, support for conservative kidney management, and symptom management; a minority voiced concerns about third-party involvement in their practice. Single-center study. Overall, patients and nephrologists generally found the PC intervention to beacceptable. Future testing of the current PC-based decision support intervention in a larger randomized controlled trial for older people navigating kidney therapy decisions is needed.

Leading impactful research: applying platform thinking to drive collaborative inquiry in the innovation field

PurposeThis study investigates the application of collaborative inquiry within innovation management, employing platform thinking to address challenges of generalizability and relevance. The aim is to integrate Collaborative Inquiry methods, characterized by participatory, diffuse, and reflective practices, to transform research into a tool for impactful change in organizations in the field of innovation management.Design/methodology/approachA longitudinal participatory case study approach focuses on the IDeaLs case—a research platform that collaborated with multiple companies over several years. The data gathered and analyzed comes from the research project within the research platforms over the first two editions and from the research platform management and coordination activities.FindingsThe study introduces the Collaborative Research Platform Approach (CRPA), demonstrating its effectiveness in addressing typical constraints of traditional research methodologies through a real-world application within the IDeaLs case. The findings highlight the CRPA's potential in fostering a dynamic, co-creative research environment that bridges theoretical knowledge with practical applications, thus enhancing both scholarly and organizational outcomes while pursuing a future change within the organizations.Research limitations/implicationsThere are two main research implications. First, it proposes platform thinking as a theoretical lens to read a multi-stakeholder phenomenon in the research domain, confirming its nature of value-creation mechanisms, using it outside the business model and strategic space. Second, it offers a methodological contribution by presenting the CRPA framework.Practical implicationsThe CRPA framework offers organizations a structured approach to managing collaborative research projects that align with both academic rigor and practical relevance. Companies engaged in the study reported enhanced ability to implement actionable insights from research, influencing real-time decision-making processes.Social implicationsBy fostering collaborative engagements across multiple stakeholders, the CRPA promotes a research culture that values inclusivity and practical impact, potentially leading to broader societal benefits through improved innovation management practices.Originality/valueThis paper contributes to the innovation management field by proposing the CRPA, which integrates principles of Platform Thinking with Collaborative Inquiry. This novel approach is designed to improve the applicability and scope of innovation research, offering a robust framework that enhances engagement and utility across academic and business domains. It uses platforms as a theoretical lens to read a multi-stakeholder environment in the research domain.

Turnover intention and its related factors of clinical research coordinator in Hunan, China: a cross-sectional study

To explore the related factors of turnover intention in clinical research coordinators (CRCs) and assess the mediating effects of professional identity on the association between job burnout and turnover intention. In China, CRC has become increasingly common among clinical trial teams in recent years. However, limited published research focused on the status of turnover intention in CRCs. We invited all the 220 CRCs currently working at Hunan Cancer Hospital located in Changsha city in the central south of China from March to June 2018. Participants were asked to complete structured questionnaires regarding basic demographic information, job burnout, professional identity and turnover intention. A total of 202 participants were included in this study, with a response rate of 91.82%. The main reason for turnover intention among CRCs was human resources, followed by communications, management and material resources (per item score in each dimension: 2.14 vs. 2.43 vs. 2.65 vs. 2.83). All the correlations among job burnout, professional identity and turnover intention were statistically significant, with coefficients ranging from −0.197 to 0.615. Multiple liner regression analysis showed that older age, longer workhours per week, and lower level of professional identity were associated with the prevalence of turnover intention among CRCs. Besides, the association between job burnout and turnover intention was fully mediated by professional identity. This study revealed the status and causes of turnover intention among Chinese CRCs. Effective measures on decreasing working time and improving professional identity should be taken in order to reduce CRCs’ turnover intention.

The Nuts and Bolts of Developing a Sustainable, Collaborative Network for STEM Transformation

The (STEM)2 Network (Sustainable, Transformative Engagement across a Multi-Institution/Multidisciplinary STEM Network) is a National Science Foundation Research Coordination Network-Undergraduate Biology Education funded project intended to bridge disciplinary and institutional silos that function as barriers to systemic change in science, technology, engineering, and mathematics (STEM) in higher education. We utilized three foundational frameworks to develop an adaptable model that we posit is applicable across contexts. The model includes a core infrastructure that, combined with intentional self-reflection, results in an adaptable design that can be tailored to individual institutions, contexts, and goals. Herein, we describe the inception of the network, the foundational theoretical frameworks that guide network development and growth, and detail network structure and operations with the intention of supporting others in creating their own networks. We share the nuts and bolts of how we developed the (STEM)2 Network, and include a supplemental network development planning guide to support others in utilizing the (STEM)2 Network model to reach their own objectives.

Incorporating the perspectives of participants and research coordinators on home spirometry into clinical trial design: The example of the OUTREACH study

BackgroundWe undertook a human-centered design approach to design the OUTREACH study of home spirometry as a CF clinical trial endpoint. We conducted a qualitative needs assessment to elicit the perspectives of people with CF (PwCF) and research coordinators (RCs) about home spirometry in the research setting and co-produced written and video home spirometry instructions in partnership with representatives from these stakeholder groups. MethodsWe conducted 7 focus groups of PwCF (N = 27), caregivers of children with CF (N = 6), or RCs (N = 24) to elicit current experiences, barriers and facilitators of home spirometry across 6 target areas, followed by discussion and prioritization. The co-production team, composed of 3 PwCF, 3 RCs and study team members created written and video training materials. ResultsWhile most PwCF and caregivers found home spirometry convenient, many experienced technical barriers, reported a “learning curve”, and expressed uncertainty about the quality and reliability of measurements. Major barriers identified by RCs included tailoring participant training to individual needs, scheduling remote coaching, and performing effective coaching remotely. Participants offered age-specific recommendations in key domains: training materials and procedures, remote coaching, monitoring progress and maintaining engagement. Co-produced training materials included handouts and videos on how to perform spirometry, and troubleshooting, cleaning, and maintaining home spirometers. ConclusionsThe OUTREACH design was improved by incorporating results of the needs assessment. The home spirometry training materials are freely available for public use. We hope our results and materials can help to inform the design and success of remote clinical trials of the future.

Message Factors Affecting the Recruitment of Black Caribbean and African American Participants for Clinical Trials

The need for effective and ethical recruitment of Black Caribbean and African American individuals for participation in research studies and clinical trials is urgent; without adequate representation, findings cannot be generalized to these populations. The factors affecting recruitment are complex, including many systems-based issues. However, communication issues have received relatively little attention. To advance knowledge of communication behaviors that impact recruitment of research participants from Black communities, we describe the findings from a study of 48 participants in 9 focus groups. Participants included 31 African American and Black Caribbean individuals who described their experiences being recruited for research studies and clinical trials as well as 17 (primarily Hispanic and African American) clinical research coordinators who described how message factors impacted recruitment and retention of Black Caribbean and African American participants. Using the lens of the Elaboration Likelihood Model (ELM), which describes the communication factors that help motivate the cognitive processing of information, we describe how the amount of information provided, the accessibility of information, and the complexity of information all impact study recruitment. Participants offered insights about the adequacy (and excess) of information provided, tensions related to deviation from consent form language when simplifying complex terminology, preemptively addressing common conspiracy theories during recruitment, the importance of using metaphors and analogies, and communicating complex information using multiple communication modalities.

Core socioDemographic data variables in ICU Trials (CoDe-IT): a protocol for generating core data variables using a Delphi consensus process

IntroductionSociodemographic variables influence health outcomes, either directly (ie, gender identity) or indirectly (eg, structural/systemic racism based on ethnoracial group). Identification of how sociodemographic variables can impact the health of critically...

Beyond the Prescription Pad—Finding a Window of Opportunity to Prevent Antibiotic Diversion and Non-Prescription Use

Background: Non-prescription antibiotic use is defined as taking antibiotics without medical guidance, which includes using leftover antibiotics, obtaining antibiotics from friends or relatives, or purchasing antibiotics without a prescription. This study aimed to (1) determine the symptoms prompting individuals to use non-prescription antibiotics, identify their sources of acquisition, and document the types of antibiotics utilized, (2) identify any associated side effects, and (3) gain insights into antibiotic storage practices, including whether antibiotics were used beyond their expiration date. Methods: A cross-sectional quantitative survey was conducted from January 2020-June 2021 in waiting rooms of six safety-net primary care clinics and two private emergency departments in Houston, Texas. Participants were read survey questions in English or Spanish by a bilingual research coordinator, and their responses to five questions about antibiotic use were recorded. Descriptive analysis was performed. Results: Among the 564 patients surveyed, the median age was 51 (range 19-92). The majority identified as female (72%), Hispanic/Latinx (47%), Black/African American (33%), held a college education (44%), and received public health insurance, such as Medicaid or County Financial Assistance (56%). Of all patients surveyed, 44% (246) reported taking an antibiotic without a prescription and answered questions about associated symptoms. Of all symptoms/illnesses associated with non-prescription use, the most common were sore throat (18%), dental symptoms (16%), and cold/flu (13%). The most common sources for non-prescribed antibiotics were leftover antibiotics (50%), from friends or relatives (31%), and purchased abroad (13%), although 3% had purchased non-prescription antibiotics from a local store or market (Figure 1). The most common antibiotics used were amoxicillin (38%) and penicillin (7%). The reported side effects were stomach pain/upset (24%), nausea and vomiting (19%), allergic reaction (e.g., rash) (14%), and diarrhea (14%). Among 246 participants reporting antibiotic use, 63% reported that the antibiotic they took had been previously prescribed for the same symptom/illness, and 93% had acquired antibiotics in a container, of which 90% reported that the container had an expiration date. Conclusions: Our survey reveals that 63% of individuals who use non-prescription antibiotics were motivated by having received prescribed antibiotics for similar symptoms previously. Leftover antibiotics were the source for half of all non-prescription use. These observations suggest that outpatient antibiotic stewardship campaigns have a window of opportunity at the time of the initial prescription of antibiotics, to focus on providing the shortest course possible, and to deliver antibiotic safe use information at that time. Acknowledgments: Financial Support AHRQ R01HS026901Disclosure: Barbara Trautner: Stock: Abbvie--sold in December 2023; Abbott Laboratories--sold in December 2023; -Bristol Myers Squibb--sold in December 2023; Pfizer--sold in December 2023; Consultant--Phiogen—consultant. Contracted research through NIAID for STRIVE trial, currently testing Shionogi product; Contracted research--Peptilogics; Contracted research—Genentech

Data Flow Construction and Quality Evaluation of Electronic Source Data in Clinical Trials: Pilot Study Based on Hospital Electronic Medical Records in China.

The traditional clinical trial data collection process requires a clinical research coordinator who is authorized by the investigators to read from the hospital's electronic medical record. Using electronic source data opens a new path to extract patients' data from electronic health records (EHRs) and transfer them directly to an electronic data capture (EDC) system; this method is often referred to as eSource. eSource technology in a clinical trial data flow can improve data quality without compromising timeliness. At the same time, improved data collection efficiency reduces clinical trial costs. This study aims to explore how to extract clinical trial-related data from hospital EHR systems, transform the data into a format required by the EDC system, and transfer it into sponsors' environments, and to evaluate the transferred data sets to validate the availability, completeness, and accuracy of building an eSource dataflow. A prospective clinical trial study registered on the Drug Clinical Trial Registration and Information Disclosure Platform was selected, and the following data modules were extracted from the structured data of 4 case report forms: demographics, vital signs, local laboratory data, and concomitant medications. The extracted data was mapped and transformed, deidentified, and transferred to the sponsor's environment. Data validation was performed based on availability, completeness, and accuracy. In a secure and controlled data environment, clinical trial data was successfully transferred from a hospital EHR to the sponsor's environment with 100% transcriptional accuracy, but the availability and completeness of the data could be improved. Data availability was low due to some required fields in the EDC system not being available directly in the EHR. Some data is also still in an unstructured or paper-based format. The top-level design of the eSource technology and the construction of hospital electronic data standards should help lay a foundation for a full electronic data flow from EHRs to EDC systems in the future.

NURS-19. IMPLEMENTING A NURSING LED WORKING GROUP WITHIN THE PEDIATRIC NEURO-ONCOLOGY CONSORTIUM (PNOC), A TWO-YEAR EXPERIENCE AND EVALUATION

Abstract BACKGROUND Incorporation of nurses and advanced practice providers (APPs) creates an opportunity to enhance the work of clinical trial consortia in providing care to children and young adults with central nervous system tumors enrolled on clinical trials. Within PNOC, a formalized APP and nursing working group (“APPNIC”) was established in 2021. Since inception, APPNIC has assigned members to each clinical trial committee, developed support documents to partner with protocols, highlighted supportive care measures, and provided nursing education across all PNOC sites. METHODS A de-identified, electronic Qualtrics survey was distributed to PNOC members in Fall 2023 to evaluate the 2-year impact of APPNIC. Physicians, nurses or APPs, and CRCs were eligible to participate. RESULTS Thirty-six surveys were completed in total from physicians or principal investigators (n=15; PIs), nurses/APPS (n=18), and clinical research coordinators (n=3; CRCs) representing multiple institutions. PI satisfaction with APPNIC was high with all reporting APPNIC to be “somewhat helpful” (40%) or “very helpful” (60%) and most PIs (53%) working directly with APPNIC members. Nurses confirmed they use the protocol roadmaps (87%) and education sheets (80%) generated by APPNIC. Barriers to APPNIC participation continue to indicate scarce resources allowing time for APPs and nurses to participate in hybrid meetings and limited travel funds to attend meetings and conferences. Identified education needs of APPs and nurses include identifying supportive care for novel treatments, understanding developmental therapy strategies, and receiving routine study updates. CONCLUSIONS With high overall satisfaction of PIs and utilization of study deliverables by consortium site members, we plan to continue APPNIC as currently structured. Ongoing efforts to integrate APPNIC members early in protocol development will increase PI and APPNIC member collaboration. Education for APPs and nursing will continue to be a priority, along with investigating mechanisms to increase funding to attend meetings and conferences.

OTHR-17. FACILITATING THE POSTMORTEM DONATION OF WHOLE BRAIN AND SPINAL CORD IN PEDIATRIC PATIENTS WITH CENTRAL NERVOUS SYSTEM CANCERS

Abstract BACKGROUND Postmortem tissue donation is often presented to families during end-of-life discussions. The sensitive nature requires every step to be handled with care, leading with empathy and delicately balancing scientific research and humanity. The Children’s National Hospital Postmortem Tissue Donation Workflow (The Workflow) provides a step-by-step guide for coordinating a successful donation. It outlines the order in which clinical research teams communicate with patient care teams, families and collaborators to make the donation possible. This program, established in 2010, aims to acquire more pediatric brain and spinal cord tumor specimens to further understand the disease biology. OBJECTIVE This paper aims to provide a template for coordinating a successful postmortem tissue donation. Ultimately, to broaden the network of tissue donation across all hospitals and institutions, thus furthering scientific research. METHOD In order to create The Workflow, Clinical Research Coordinators from Children’s National Hospital conducted numerous postmortem donations and noted the failures and successes of each case. This information was compiled into a stepwise workflow including email templates and checklists. It begins with contacting the care team, and the following hours to days are spent obtaining a pathologist for tissue procurement, and facilitating the shipment of samples. While these steps must be completed in a timely manner for sample integrity, we also prioritize the wishes of the family and act with compassion at the forefront. RESULTS/DISCUSSION Children’s National Hospital was designated as a Center of Excellence for postmortem coordination by the Swifty Foundation in 2018. Our team has since established and standardized a workflow for the donation process. The Children’s National Hospital Postmortem Workflow allows our research team to study brain tumors including DMGs, High and Low Grade Gliomas, and Medulloblastomas. The generosity of the families and hard work of each collaborator allows us to expand our knowledge of tumor biology.

Policies Affecting the Efficiency of Beef Production in Alberta: A Supply Chain Analysis

Shoppers face high beef prices at the supermarket, but those prices are not a reflection of what Canadian farmers and ranchers earn from their cow-calf herds. In the past 30 years, the average beef producer’s operating margin has never reached $50,000, despite the fact that the average beef farm’s asset base stands at more than $2 million. Better access to export markets, including the U.S., South Asia and North Africa, would help to remedy the producers poor returns. Export prices would need to cover production costs, the largest of which is feed for the producers’ cattle herds, accounting for 77 per cent of the average ranch’s cash costs. As of July 2023, Alberta’s herd consisted of 1.77 million beef and dairy cows. With demand for livestock-derived food expected to jump by 38 per cent in the next 30 years, Canadian cattle ranchers need to take advantage of this global increase through freer trade. Canadian beef can remain competitive globally if the supply chain accesses world markets beyond the U.S., especially in developing countries where consumer incomes are increasing. The industry also needs investments in research, farm extension and supply chain co-ordination from national and provincial self-funded producer groups. Producers must look outward to global trade but be ready to capture new innovations at home. The dominant economies of scale are available to beef processors and finding savings is difficult for farmers and ranchers. However, there is potential for the supply chain to see savings from new technology, which is why investment in continuing support for ranch-level production research is necessary. Producers also need to focus on national co-ordination aimed at protecting trade access and responding to trends in consumer demand for beef. Any new industry policies must also consider key factors that currently affect market demand and expansion including: changing consumer preferences globally, the welfare of animals raised for slaughter and the effects of greenhouse gas emissions on supply chain sustainability. As some of the output and byproducts of the grain production sector provide feed for cattle, policies meant to support the grain sector may be indirectly influencing the beef sector significantly — for good and bad. Infrastructure required for worker safety, animal welfare improvements or improved food safety also adds to the cost of the beef supply. Protectionist trends and increased tariffs pose a threat to the supply chain because they too can create new costs. This is why access to foreign markets is crucial for producers, along with continued investment in research, sector-wide co-ordination to support market access and reviewing crop support to ensure livestock producers are compensated if grain policy changes harm them. Although live animals and much processed Canadian beef are exported to the U.S., fostering good trade relations in Asia and Africa is vital, given the growth in incomes and consumer demand for beef that is predicted for those regions. Free trade is the basis of good agriculture policy and any move towards protectionist policies and higher tariffs is the biggest threat for new costs in the supply chain. Canada’s beef sector requires low-cost access to foreign markets, making free trade policy the single most important policy focus for the sector.

Navigating the challenges of clinical trial professionals in the healthcare sector.

Clinical trials (CTs) are essential for medical advancements but face significant challenges, particularly in professional training and role clarity. Principal investigators, clinical research coordinators (CRCs), nurses, clinical trial pharmacists, and monitors are key players. Each faces unique challenges, such as maintaining protocol compliance, managing investigational products, and ensuring data integrity. Clinical trials' complexity and evolving nature demand specialized and ongoing training for these professionals. Addressing these challenges requires clear role delineation, continuous professional development, and supportive workplace environments to improve retention and trial outcomes. Enhanced training programs and a collaborative approach are essential for the successful conduct of clinical trials and the advancement of medical research.

Planning for the forgotten fourth trimester of pregnancy: A parallel group randomized control trial to test a postpartum planning intervention vs. standard prenatal care

BackgroundBlack and brown birthing people experience persistent disparities in adverse maternal health outcomes, partially due to inadequate perinatal care. The goal of this study is to design and evaluate a patient-centered intervention for obstetric patients with one or more cardiometabolic risk factors for severe maternal morbidity [gestational diabetes, diabetes mellitus, hypertensive disorders of pregnancy (chronic hypertension, preeclampsia, eclampsia, or gestational hypertension), or preconception obesity (BMI > 30)] to promote postpartum visit attendance. MethodsTo address identified unmet needs for postpartum support and barriers to postpartum care, we developed 20 thematic postpartum planning modules, each with corresponding patient educational materials, community resources, care coordination protocols, and clinician support tools (decision aids, electronic medical record prompts and fields). During prenatal care encounters, a research coordinator delivers the educational content (in English or Spanish), facilitates the participant's planning and shared decision-making, provides the participant with resources, and documents decisions in the electronic medical record. We will randomize 320 eligible patients with a 1:1 ratio to the intervention or standard prenatal care and evaluate the impact on postpartum visit attendance at 4–12 weeks and secondary outcomes (postpartum mental health, perceived future maternal and cardiometabolic risk, contraceptive use, primary care use, readmission, and patient satisfaction with care). DiscussionThrough engagement with patients and community stakeholders, we developed a guideline-based, locally tailored intervention to address drivers of engagement with postpartum care for high-risk obstetric patients. If demonstrated to be effective, the educational materials and electronic medical record based-tool can be adapted to other settings. Trial registrationThis trial was registered on ClinicalTrials.gov (NCT05430815) on June 23, 2022.

Human-AI teams to improve accuracy and timeliness of oncology trial prescreening: Preplanned interim analysis of a randomized trial.

1524 Background: Identifying eligible patients for oncology clinical trials (“prescreening”) relies on manual chart review by clinical research coordinators (CRCs), which is time-consuming and often inaccurate. Consequently, 70% of patients with cancer who meet trial eligibility criteria are not offered participation. Natural language processing (NLP) may improve the accuracy and timeliness of prescreening. Methods: This was a preplanned interim analysis of a paired-design noninferiority trial, powered to assess timeliness. We adapted NLP algorithms to identify 13 common eligibility criteria related to cancer type/stage, prior systemic therapy, actionable biomarkers, and response criteria. NLP systems performed optical character recognition, entity and relationship extraction, and natural language inference through deep learning and symbolic AI techniques. Deidentified unstructured electronic health records (EHRs) from real-world patients with non-small cell lung (NSCLC) or colorectal (CrCa) cancer were presented to CRCs via a secure platform. Two CRCs were randomized 1:1 to view blocks of 20 charts each with (Human+AI) or without (Human-alone) NLP annotations. In pre-trial assessment, the CRCs had 86% inter-rater agreement. The primary outcome was overall chart-level accuracy, defined as percent of the 13 CRC-coded eligibility items matching a gold standard set, determined by 2-3 clinicians blinded to experimental arms. Paired t-tests compared overall accuracy (noninferiority margin 5%) and criteria-specific accuracy. Significant differences were assessed for superiority using two-sided paired t-tests. Mann-Whitney tests compared the secondary outcome of timeliness (time per chart review). Results: Among 74 (40 NSCLC; 34 CrCa) of a planned 400 patients, overall accuracy for Human+AI was noninferior to Human-alone (78.7% vs. 76.7%, mean difference 2.0%, p<0.001 rejecting inferiority); both were greater than AI-alone (63.5%). Superiority for Human+AI was demonstrated for RECIST response, but not for overall nor other criteria-specific accuracy (Table). Median time per review was lower for Human+AI than Human-alone (34.1 vs 43.9 min, adjusted p=0.05). Conclusions: Human+AI teams can improve timeliness of trial prescreening with noninferior accuracy. This platform is being used for eligibility assessment in an ongoing clinical trial. [Table: see text]

Challenges and solutions to recruiting diverse populations to oncology clinical trials: A mixed-methods study of clinical research coordinators.

1619 Background: Multiple barriers limit the enrollment of diverse populations in oncology clinical trials (CTs). A review of our institutional CTs recruitment dashboard identified underrepresentation of Black and Latinx adults among thoracic and gastrointestinal (GI) oncology CTs participants compared to demographics of our catchment area and patient population. We conducted a mixed-methods study to identify barriers and potential solutions to the enrollment of diverse populations in oncology CTs in our institution. Methods: We conducted a mixed methods study enrolling clinical investigators and clinical research coordinators’ (CRCs) at an NCI-designated CCC in Northern California. Data from CRCs is presented. All CRCs supporting CTs in the thoracic and GI medical oncology were invited to participate in qualitative, one-on-one, semi-structured interviews. Participants completed 60-90 minutes interview and a short survey. Data were analyzed using a thematic inductive approach. Results: Of 14 CRCs, the majority were female (78.6%), with primary focus on thoracic (50.0%) and GI (35.7%) oncology CTs. 64.3% of CRCs reported >80% of their work was dedicated to coordinating and managing therapeutic cancer CTs. In survey responses CRCs identified inability to take time away from work/family (64.3%), inadequate insurance coverage (42.9%), lack of transportation (35.7%), and language barriers (35.7%) as major barriers to enrollment of diverse patients in CTs. In qualitative interviews CRCs expressed the need of culturally and language appropriate materials for CT recruitment, establishing a sense of connection between clinical research staff/PI and patients, accommodating socioeconomic concerns, and resources to respond to potential participants’ mistrust of medical research. Main obstacles faced by CRCs during patient enrollment in CTs included lack of time, low patient awareness, resistance from colleagues, lack of multilingual staff, and inadequate logistical support. CRCs identified in-person interpretation as beneficial and identified a strong rapport between the clinical provider and the potential participant as the most important component to boost recruitment of minorities. Lastly, CRCs highlighted that institutional efforts are needed to increase CT participation among all populations. Conclusions: Lack of representation of diverse populations in CTs remains a complex challenge. Our study of CRCs’ perceptions highlights access to in-person translators, culturally and language concordant materials, education resources, and increased rapport as key areas for intervention to facilitate patient enrollment of diverse populations. Analysis into practice-specific patterns within our cancer centers can help identify areas for interventions to support the recruitment and enrollment of diverse populations in oncology CTs.

A prospective study comparing AI-based clinical trial eligibility screening with traditional EMR-based screening.

e13636 Background: For clinical trials of novel oncology therapies, screening patients for eligibility relies on research staff manually abstracting complex eligibility criteria, which is time-consuming and subject to inconsistent interpretations. AI algorithms based on structured data fields may facilitate automated eligibility criteria extraction, assure more complete screening for the benefit of all patients, improve workflow for research staff, and assure no bias in who is reviewed. AI algorithms can support abstraction and imputation approaches to assure the greatest number of clinical records get reviewed. Prospective validation of such algorithms and approaches for sponsored registrational clinical trials is lacking from literature. Methods: We conducted a prospective controlled observational study of an AI model to prioritize potentially eligible patients, as part of a phase 3, randomized, multi-site therapeutic trial for Relapsed or Refractory Multiple Myeloma. In this observational study, we studied eligibility criteria focused on measurable disease and prior anti-myeloma treatments. The AI eligibility model extracted structured eligibility criteria to predict likelihood of meeting study eligibility. A single CRC (Clinical Research Coordinator) allocated 40 hours to screening in both control and intervention phases of the study. In the control phase, the CRC screened myeloma patients’ electronic health records in alphabetical order by last name. In the intervention phase, the CRC screened a different set of patients ranked by the eligibility likelihood model. Descriptive statistics were used to compare primary outcomes of efficiency (percentage of patients watch-listed) and speed (average time to screen a patient) between control and intervention phase. Patients marked as watch-listed meet eligibility criteria but need additional testing or disease progression before becoming eligible for the study. Results: The AI Eligibility method captured the same share (19%1) of screened patients as the EMR method, with a 3.3x (12.5 versus 41 minutes) improvement per screened patient. Conclusions: The AI eligibility method allows research staff to screen three times more patients with similar outcomes as compared to routine CRC EMR screening. Future work can leverage AI to identify and predict patient progression, further enhancing screening efficiency. [Table: see text]

Participant adherence in a lung cancer screening (LCS) program in a non-smoking population.

10556 Background: LCS guidelines in smoking populations includes an annual low-dose CT Chest (LDCT) scan. Historically, real-world adherence to repeat imaging following the baseline LDCT has been low at 22% (Silvestri et al. Chest 2023). Various reasons for non-adherence have been cited and can be amplified in populations where English is not the primary language, low health literacy, or logistical reasons that interfere with scheduling. We are conducting the Female Asian Nonsmoker Screening Study (FANSS), which is a pilot study for Asian women with no smoking history to provide LDCTs to this population. We describe the strategies utilized to address potential barriers to adherence and report the participant (pt) adherence observed to date for this population. Methods: FANSS is an IRB-approved trial that provides LDCTs annually for 3 years and has an interim follow-up phone call every 6 months. All aspects of the study other than the LDCT could be conducted virtually pending pt preference. All pt interactions were conducted in the pt’s requested language. LDCTs were interpreted according to Lung-RADS. Review of the LDCT results were available in-person or virtually by a nurse practitioner or the principal investigator. The timeline for the 2nd and 3rd LDCT after the baseline scan was determined as follows: pts with negative findings were recommended for a repeat LDCT in 1 year; pts with suspicious findings were reviewed at the NYU Multidisciplinary Nodule Board and recommended for a repeated LDCT in a 3 or 6 month interval. A bilingual (English and Chinese speaking) research coordinator and medical secretaries reached out to pts at their preferred contact (email, phone, or text) for scheduling the follow-up LDCT. Up to three attempts to reach pts to schedule their follow-up LDCT were made. Results: From 3/5/21 to 1/27/24, 634 subjects completed their baseline LDCTs. Language interpretation services were utilized in 30% of pts. As of 1/27/24, 215 pts were due for their 2nd LDCT: 195 (91%) completed (186) or scheduled (9) the LDCT, 5 pts withdrew their consent, and 15 did not complete the scan. The main reasons for not completing the scans were: living outside New York City, other health concerns, and lost to follow-up. As of 1/27/24, 95 pts were due for their 3rd LDCT: 87 (92%) completed (82) and scheduled (5) the LDCT, and 8 did not complete the scan due to being lost to follow-up. Conclusions: The FANSS population is a unique pt cohort comprised of all Asian women who do not qualify for current LCS guidelines. Interventions to address potential adherence issues were implemented. In our research-based setting, virtual conduct of most of the study procedures allowed pt flexibility. Pt outreach to ensure follow-up by contacting through various methods also ensured adherence of >90%. These interventions can be considered for use in other LCS programs to improve adherence to LCS follow-up.