Clinical Research Team Research Articles

Abstract B169: Diversifying cancer patient advocate voices to eliminate health disparities

Abstract Cancer patient advocates have become key members in clinical research teams and participating in decision committees at FDA, NCI, ASCO, among others. There is a low number of Latino patient advocates actively participating in the above roles lacking opportunities to share lived experiences and challenges of their communities. Being able to sit at the table where advocates can share key issues and possible solutions can help eliminate health disparities. Based on the need to increase Latinos participation as research advocates, a training program was developed. The Latino cancer patient advocate training program was design to increase knowledge and develop a community of diverse individuals who can seek opportunities to participate in research teams and decision-making committees. The training program included 15 individuals and 4 mentors who were cancer patients, survivors and caregivers and were Latinos or from Latino descent. The training included four virtual sessions, one in-person session, and attending the conference advancing the science of cancer in Latinos. Those chosen to participate received a full scholarship. The dissemination process through emails and social media included a flyer with the requirements, inclusion criteria, and a link to the application form. A total of 34 people applied, 20 were interviewed, and 15 were selected. The participants were from eleven different states and represented different types of cancer. A based questionnaire before the training, one after the training was completed by the participants. A questionnaire comparing their knowledge before and after two virtual sessions and the in-person training was completed by 93.3% participants. Self-rated knowledge scores ranged from 1 (not knowledgeable at all) to 5 (extremely knowledgeable). The average knowledge score across all questions was 2.9 (somewhat knowledgeable) before the training and 4.0 (moderately knowledgeable) after participating in the training. Participants indicated having the most knowledge about “Resources for your cancer type” (average score: 3.6 before and 4.2 after) and “Patient Advocates” (average score: 3.4 before and 4.1 after) and the least knowledge about “Opportunities and Scholarships available for Advocates” (average score: 2.1 before and 3.8 after), which had the largest increase in knowledge. In terms of satisfaction with the overall training program, all participants were very satisfied (85.7%) or satisfied (14.3%). Further, 71.4% of participants strongly agreed and 28.6% of participants agreed that they were interested in becoming a scientific/research advocate because of their participation in the training. Other outcomes after the training include participants being invited to be DoD reviewers, panelists in conferences, participation in important committees. Furthermore, participants communicate weekly with each other sharing opportunities and information. This training provided knowledge and the opportunity to feel represented as Latino patient advocate diversifying the voices of advocates. Citation Format: Barbara Segarra-Vazquez, Sandi Stanford, Susanne Schmidt. Diversifying cancer patient advocate voices to eliminate health disparities [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 B169.

Collecting and reporting adverse events in low-income settings—perspectives from vaccine trials in the Gambia

BackgroundDespite Africa’s significant infectious disease burden, it is underrepresented in global vaccine clinical trials. While this trend is slowly reversing, it is important to recognize and mitigate the challenges that arise when conducting vaccine clinical trials in this environment. These challenges stem from a variety of factors peculiar to the population and may negatively impact adverse event collection and reporting if not properly addressed.MethodsAs a team of clinical researchers working within the MRCG (Medical Research Council Unit The Gambia), we have conducted 12 phase 1 to 3 vaccine trials over the past 10 years. In this article, we discuss the challenges we face and the strategies we have developed to improve the collection and reporting of adverse events in low-income settings.Outcome.Healthcare-seeking behaviors in the Gambia are influenced by spiritual and cultural beliefs as well as barriers to accessing orthodox healthcare; participants in trials may resort to non-orthodox care, reducing the accuracy of reported adverse events. To address this, trial eligibility criteria prohibit self-treatment and herbal product use during trials. Instead, round-the-clock care is provided to trial participants, facilitating safety follow-up.Constraints in the healthcare system in the Gambia such as limitations in diagnostic tools limit the specificity of diagnosis when reporting adverse events. To overcome these challenges, the Medical Research Council Unit maintains a Clinical Services Department, offering medical care and diagnostic services to study participants.Sociocultural factors, including low literacy rates and social influences, impact adverse event collection. Solicited adverse events are collected during home visits on paper-based or electronic report forms.Community engagement meetings are held before each study starts to inform community stakeholders about the study and answer any questions they may have. These meetings ensure that influential members of the community understand the purpose of the study and the risks and benefits of participating in the trial. This understanding makes them more likely to support participation within their communities.ConclusionConducting ethical vaccine clinical trials in resource-limited settings requires strategies to accurately collect and report adverse events. Our experiences from the Gambia offer insights into adverse event collection in these settings.

Impact of an Oncology Clinical Pharmacist Intervention on Clinical Trial Enrollment in The US Oncology Network’s MYLUNG Consortium

Introduction: The Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium™ (MYLUNG) clinical trial platform aims to advance the use of precision medicine in patients with non–small cell lung cancer through a series of prospective and iterative clinical trials. Timely patient accrual onto oncology clinical trials is a known practice challenge and impaired accrual rates can lead to premature trial closure or properly powered trial outcomes. The US Oncology Network recently implemented a clinical pharmacist (ClinReview) initiative to provide remote clinical services to screen patients for enrollment onto MYLUNG Protocol 2. This study aims to evaluate the effect of the remote clinical pharmacist intervention on study enrollment rates. Methods: An oncology-trained clinical pharmacist remotely reviewed systemic chemotherapy treatment orders during normal workflow and, in addition, a weekly custom recruitment report within six community Network practices (149 physicians). The pharmacist identified, screened, and assisted with the communication regarding eligible patients for enrollment. The onsite research team received timely and relevant patient data to facilitate expedited enrollment. Enrollment and intervention data were tracked to monitor the impact of the pharmacist intervention. Monthly enrollment was evaluated using a paired t-test. Results: Over 8 months, the pharmacist screened 506 potentially eligible patients; 34% were enrolled. Average monthly enrollment was significantly greater following the ClinReview intervention (3.4 vs. 6.6 patients/month; p = .02). Among the 289 patients not enrolled, 73% exceeded their eligibility window, 9% died or enrolled into hospice, 4% declined participation, and 13% transferred care or were treated at outside facilities. Conclusions: Incorporating an oncology clinical pharmacist into the clinical research team was associated with improved clinical trial enrollment. Validation of the effect of multidisciplinary interventions across a broader spectrum of differentially resourced oncology practices will be conducted within future MYLUNG iterations.

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.

An Ethnographic Study of Patient Life Experience in Early-Stage Parkinson's Disease in the United States and Germany.

Existing qualitative research on early-stage Parkinson's disease draws on patients' reported disease experience, aiming to capture the symptoms and impacts most relevant to patients living with the disease. As a complement to this research, the present study investigated the patient experience of early-stage Parkinson's disease from a holistic, ethnographic perspective. We explored the attitudes, beliefs, and social structures that shape how people understand and adapt to life with early-stage Parkinson's disease. Researchers interviewed 30 people with early-stage Parkinson's disease, 10 relatives, and 10 neurologists and movement disorder specialists in the USA and Germany. Many of these interviews took place in-person, allowing researchers to spend time in participants' homes and witness their daily lives. A multidisciplinary team of social scientists, clinical researchers, and patient organization representatives led the mixed-methods study design and analysis. In-depth ethnographic interviews yielded qualitative insights, with a quantitative survey following to assess their prevalence in a larger sample of 150 patients. In addition to developing a patient life experience pathway of early-stage Parkinson's disease, we identified five key thematic findings that provide insight into how the clinical features of the disease become meaningful to patients on the context of their daily lives, family relations, and subjective well-being: (1) People with early-stage Parkinson's disease start coming to terms with their disease before receiving a medical diagnosis; (2) Acceptance is not a finalized achievement, but a cyclical process; (3) People with early-stage Parkinson's disease "live in the moment" to make the future more manageable; (4) Slowing disease progression is an important goal driving the actions of people with early-stage Parkinson's; and (5) People with early-stage Parkinson's disease value information that is grounded in lived experience and relevant to their stage of disease progression. This holistic, ethnographic approach to patient life experience provided five key thematic findings that complement insights from qualitative and quantitative datasets on early-stage Parkinson's disease. An enhanced understanding of how early-stage Parkinson's symptoms impact patients' health-related quality of life and their broader social lives can help us better understand how patients make decisions about their usage of healthcare services and therapies.

Effect of a novel artificial intelligence (AI) –enabled multi-trial matching system on patient matching using real-world data.

e13501 Background: Currently clinical research teams at sites are manually matching patients to clinical trials, where each trial in our experience takes at least 25 minutes using highly trained dedicated resources. This limits cancer patients’ clinical trial options and enrollment rates. Moreover, the lack of NGS testing results may also negatively impact matching to clinical trials in targeted therapies. PCC, a consortium of 7 of the Top 20 Pharmaceutical companies, collaborated with Massive Bio to demonstrate how cancer patients’ matching rates can be increased if patients are prescreened to multiple trials simultaneously (i.e. multi-trial matching) instead of a single trial and NGS testing results are integrated into the matching process. Methods: Massive Bio has developed a first-in-class AI-enabled matching system to extract 180 structured clinical data from medical records using computer vision and natural language processing and a recommendation system for matching patients to parameterized inclusion/exclusion (I/E) criteria from over 14,000 actively recruiting interventional clinical trials.Our analysis included a sample of 5,707 cancer patients from the Massive Bio Synergy AI real-world database, corresponding to tumor types in 23 selected trials. We developed a decision-tree algorithm for retrospective matching analysis using modeled I/E criteria and compared these results to the theoretical matching rate (TMR) for each trial based on tumor type and biomarker prevalence, extent of disease at diagnosis and prior treatment history. Results: 690 patients matched to at least one trial were matched to 1.82 times more trials in multi-trial matching; 2.10 times more potential matches were obtained with hypothetical 100% NGS testing; and 99.9% matching time was reduced with AI enabled system; key findings are summarized (Table). Conclusions: This study confirms the underutilization of NGS technology and substantial benefits of AI and NGS in cancer trial matching. Their use resulted in a nearly two-fold increase in potential patient eligibility for trials, and an unprecedented reduction in manual effort, underscoring a significant advancement in the efficiency of the clinical trial matching process. A prospective country-wide analysis is under consideration. [Table: see text]

Retinoid Therapy for Neuroblastoma: Historical Overview, Regulatory Challenges, and Prospects

Retinoids are vitamin A derivatives and include trans-retinoic acid, isotretinoin, tamibarotene, and bexarotene, all of which are currently available for clinical use. The clinical development of retinoid therapy for neuroblastoma has a history spanning more than four decades. The most promising agent is isotretinoin, which can contribute to improving event-free survival in patients with high-risk neuroblastoma by approximately 10% when administered over six months as maintenance therapy. Although isotretinoin is regarded as an essential component in the standard clinical management of high-risk neuroblastoma, its use for this purpose in the US and EU is off-label. To promote isotretinoin use in Japan as a treatment for neuroblastoma, our clinical research team is planning to launch an investigator-initiated, registration-directed clinical trial. The present review article discusses the basic science behind retinoid therapy, pre-clinical/clinical evidence on neuroblastoma, the concept of the proposed clinical trial, and prospects for this therapy.

Evaluating the Applicability and Appropriateness of ChatGPT as a Source for Tailored Nutrition Advice: A Multi-Scenario Study

Background: In the rapidly evolving domain of healthcare technology, the integration of advanced computational models has opened up new possibilities for personalized nutrition guidance. The emergence of sophisticated language models, such as Chat Generative Pre-training Transformer (ChatGPT), offers potential in providing interactive and tailored dietary advice. However, concerns remain about the applicability and appropriateness of ChatGPT's recommendations, especially for those with distinct health conditions. Objectives: This study aimed to evaluate the reliability of ChatGPT as a source of nutritional advice. Methods: Three hypothetical scenarios representing various health conditions were presented alongside precise dietary requirements. ChatGPT was tasked to generate personalized dietary programs, encompassing meal timing, specific caloric portions (measured in grams and spoons), as well as alternative meal options for each scenario. Following this, ChatGPT’s generated dietary programs underwent a thorough review by a multidisciplinary team of nutritionist, specialist physicians and clinical researchers. The evaluation focused on the programs' suitability, alignment with dietary standards, consideration of individual health factors, and additional guidance Safety. Results: ChatGPT demonstrated its ability to generate various options of meal plans in accordance with basic nutrition principles. However, there are apparent issues with the recommended individual macronutrient distribution, handling health conditions, drug interactions, and setting realistic weight loss goals. Conclusions: While ChatGPT exhibits promise as a dietary program generator, its application for intervention should be restricted to certified nutrition professionals. Until July 2023, it is not advisable for patients to engage in self-prescription using ChatGPT version 3.5, owing to its inability to provide professional knowledge and acceptable guidance, particularly for individuals with co-existing conditions. The prevailing absence of clinical reasoning highlights the importance of employing ChatGPT solely as a tool, rather than relying on it as an autonomous decision-maker. Its lack of clinical reasoning highlighted the need for human intervention and expert collaboration for precise personalized evaluations.

Team science competencies for clinical research professionals: A multileveled Delphi approach

Abstract Background: The knowledge, skills, and abilities needed for clinical research professionals (CRPs) are described in the Joint Task Force (JTF) for Clinical Trial Competencies Framework as a basis for leveled educational programs, training curricula, and certification. There is a paucity of literature addressing team science competencies tailored to CRPs. Gaps in training, research, and education can restrict their capability to effectively contribute to team science. Materials/Methods: The CRP Team Science team consisted of 18 members from 7 clinical and translational science awarded institutions. We employed a multi-stage, modified Delphi approach to define “Smart Skills” and leveled team science skills examples using individual and team science competencies identified by Lotrecchiano et al. Results: Overall, 59 team science Smart Skills were identified resulting in 177 skills examples across three levels: fundamental, skilled, and advanced. Two examples of the leveled skillsets for individual and team competencies are illustrated. Two vignettes were created to illustrate application for training. Discussion: This work provides a first-ever application of team science for CRPs by defining specific individual and team science competencies for each level of the CRP career life course. This work will enhance the JTF Domains 7 (Leadership and Professionalism) and 8 (Communication and Teamwork) which are often lacking in CRP training programs. The supplement provides a full set of skills and examples from this work. Conclusion: Developing team science skills for CRPs may contribute to more effective collaborations across interdisciplinary clinical research teams. These skills may also improve research outcomes and stabilize the CRP workforce.

Reimagining the joint task force core competency framework for rural and frontier clinical research professionals conducting hybrid and decentralized trials.

Introduction: Clinical research professionals (i.e., clinical research assistants, clinical research nurses, clinical research coordinators, etc.), as outlined by the Joint Task Force (JTF) Core Competency Framework, are highly trained to support the breadth of clinical trial operations and manage participant care. Clinical research professionals are uniquely equipped with a scope of practice that permits product administration, participant assessments, and data management. As clinical trials grow in complexity and their management expands beyond traditional, site-based operations models to decentralized and/or hybrid models, the need becomes great to ensure adequate staffing. However, rural hospitals frequently lack the research staff or patient recruiters that would allow them to support decentralized clinical trials across a sizeable rural geographic demographic. Methods: This paper examines the contributory factors of the clinical research professional workforce contraction and response efforts at professional and organizational levels within a large, Magnet-designated healthcare system in the rural northwestern United States. Perspectives are shared on adapting the Core Competency Framework to reflect the unique strengths and opportunities towards decentralized trials in rural regions of the United States and areas of priority for workforce cultivation and retention. A descriptive survey was used to gather initial data identifying the current research perspectives of healthcare workers working across a rural community. Participants were asked to complete questions about the JTF Competency domains and behavior-based questions. Analysis: Both competency and behavior-based questions were asked and related to roles. These were then cross-referenced using a Rasmussen Ladder system. Descriptive statistics were conducted for sample characteristics, self-reported competency domain questions, and behavior questions. Results and discussion: Survey findings suggest that although healthcare workers and clinical research teams interact, they are unlikely to ask their patients to participate in research. Based on the limited response rate, results suggest that better education throughout the rural community could benefit from decentralized research efforts. Increased use of technology was also highlighted as an area of interest.

1762. Clinical application of handheld ultrasound devices during the 2022 Sudan Virus disease Ebola outbreak in Uganda

Abstract Background The fluid status and causes of respiratory failure in patients with Ebola disease can be challenging to determine due to concomitant severe diarrhea, vascular leakage, and multiorgan failure. Point-of-care ultrasound (POCUS) could guide fluid resuscitation for patients in resource-limited settings. We present the clinical application of POCUS in the 2022 Sudan Virus disease Ebola outbreak in Uganda. Figure. Ultrasound findings from patient 2. 2A: Discrete B lines observed with an irregular pleural line; 2B: Inferior vena cava collapsibility <50% suggestive of adequate fluid resuscitation; 2C: parasternal short cardiac view with small pericardial effusion identified; 2D: apical cardiac view with small pericardial effusion redemonstrated. Methods A clinical research team in Fort Portal, Uganda was trained in advanced Infection Prevention and Control (IPC) to care for patients with Ebola disease and in POCUS for septic shock. The clinical team learned a standardized lung and cardiac critical care ultrasound approach to evaluate patients in septic shock. The scanning procedure was used during the care of 6 patients with confirmed Sudan virus disease within 2 weeks of outbreak declaration to make critical patient care decisions like fluid management. Chest X-ray services and mechanical ventilation were not accessible. A handheld Philips Lumify device was kept in the biocontainment area and was used in full personal protective equipment. Scanning procedures included 12-zone lung ultrasound and 4-view cardiac ultrasound scans to determine causes of respiratory disease and evaluate fluid status. Results Among 6 patients (age range 27 to 58 years; 1/6 female), 5/6 were in their third week of illness, and 1/6 was in his second week of illness. Lung ultrasound abnormalities included discrete B-lines (5/6 patients), confluent B-lines (1/6), irregular pleural lines (3/6 patients), and subpleural consolidations (1/6 patients). Two participants in respiratory distress had cardiac POCUS. Both had hyperdynamic left ventricular function and one had a small pericardial effusion (Figure). One patient had inferior vena cava (IVC) collapsibility < 50% (1.5 cm diameter), and another with a >50% IVC collapsibility (1.3 cm diameter). These findings contributed to a decision to continue fluid resuscitation. Conclusion Portable handheld ultrasound devices identified previously undescribed ultrasound features of Sudan virus disease. POCUS helped determine causes of respiratory failure and guided fluid resuscitation in a biocontainment ward without access to mechanical ventilation. Disclosures All Authors: No reported disclosures

PRALIMAP-CINECO Cohort: 10-year post-intervention weight trajectories of PRALIMAP-INES adolescents

Abstract Background Between 2012 and 2015, the PRALIMAP-INES trial was carried-out in the France including 1143 adolescents aged 13-18 years old and aimed at reducing weight social inequalities in adolescence. The main result showed that a proportionate universalism principle is an effective way to reduce weight social inequalities in adolescence. About 10 years later, the PRALIMAP-Cineco study aims to investigate the social, economic, educational and health trajectories among PRALIMAP-INES participants. Methods Young adults are contacted by clinical research team and invited to participate to the follow-up. If they agree, they are asked to complete a self-reported questionnaire (sociodemographic, diet, tobacco, alcohol, physical activity, sedentary behaviour, quality of life) and then invited to realise a medical visit for global check-up including weight measures. Results Inclusion is currently in progress and 248 participants are contacted (Male: 130, 52.4%). The mean BMI is 28.5±5.4 kg/m2, 40% of overweight and 30.7% obesity. Among overweight/obese adolescents, 80.1% remain overweight/obese (50.5% of overweight adolescents remain overweight while 67.6% of obese remain obese in adulthood) and 19.9% switch to normal weight in adulthood. No significant difference is observed between advantaged with standard intervention (81.3%) and less advantaged with strengthened intervention (80.7%) groups. Conclusions Post-intervention follow-up suggest that overweight/obesity in adolescence is strongly predictive of overweight/obesity in adulthood without differential trajectories according to socioeconomic status. It would be very interesting to investigate the profile of overweight adolescents who switch to normal to understand the determinants of this favourable trajectory. Key messages • Adolescents with overweight or obesity are more likely to be overweight or obese in adulthood confirming the need of early age public health prevention programmes. • Lifelong prevention is also necessary to ensure more effective public policy.

Diverse Research Teams and Underrepresented Groups in Clinical Studies

Several ophthalmic diseases disproportionately affect racial and ethnic minority patients, yet most clinical trials struggle to enroll cohorts that are demographically representative of disease burden; some barriers to recruitment include time and transportation, language and cultural differences, and fear and mistrust of research due to historical abuses. Incorporating diversity within the research team has been proposed as a method to increase trust and improve engagement among potential study participants. To examine how demographic factors of potential research participants and personnel may be associated with patient consent rates to participate in prospective ophthalmic clinical studies. This retrospective cohort study included patients from an urban, academic hospital who were approached for consent to participate in prospective ophthalmic clinical studies conducted between January 2015 and December 2021. Multivariable logistic regression assessing associations between patient and research personnel demographics and rates of affirmative consent to participate was used. In total, 1380 patients (mean [SD] age, 58.6 [14.9] years; 50.3% male) who were approached for consent to participate in 10 prospective ophthalmic clinical studies were included. Of prospective patients, 566 (43.5%) were Black; 327 (25.1%), Hispanic or Latino; 373 (28.6%), White; 36 (2.8%), other race and ethnicity; and 78 (5.8%) declined to answer. Black patients (odds ratio [OR], 0.32; 95% CI, 0.24-0.44; P < .001) and Hispanic or Latino patients (OR, 0.31; 95% CI, 0.20-0.47; P < .001) were less likely to consent compared with White patients. Patients with lower socioeconomic status were less likely to consent than patients with higher socioeconomic status (OR, 0.43; 95% CI, 0.33-0.53; P < .001). Concordance between patient and research staff race and ethnicity was associated with increased odds of affirmative consent (OR, 2.72; 95% CI, 1.99-3.73; P < .001). In this cohort study, patients from underrepresented racial and ethnic groups and those with lower socioeconomic status were less likely to participate in ophthalmic clinical studies. Concordance of race and ethnicity between patients and research staff was associated with improved participant enrollment. These findings underscore the importance of increasing diversity in clinical research teams to improve racial and ethnic representation in clinical studies.

Tixagevimab-cilgavimab as an Early Treatment for COVID-19 in Kidney Transplant Recipients.

Tixagevimab-cilgavimab as an Early Treatment for COVID-19 in Kidney Transplant Recipients.

Effectiveness of laparoscopic removal of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (ESPriT2): protocol for a multi-centre randomised controlled trial

BackgroundEndometriosis affects 190 million women and those assigned female at birth worldwide. For some, it is associated with debilitating chronic pelvic pain. Diagnosis of endometriosis is often achieved through diagnostic laparoscopy. However, when isolated superficial peritoneal endometriosis (SPE), the most common endometriosis subtype, is identified during laparoscopy, limited evidence exists to support the common decision to surgically remove it via excision or ablation. Improved understanding of the impact of surgical removal of isolated SPE for the management of chronic pelvic pain in women is required. Here, we describe our protocol for a multi-centre trial to determine the effectiveness of surgical removal of isolated SPE for the management of endometriosis-associated pain.MethodsWe plan to undertake a multi-centre participant-blind parallel-group randomised controlled clinical and cost-effectiveness trial with internal pilot. We plan to randomise 400 participants from up to 70 National Health Service Hospitals in the UK. Participants with chronic pelvic pain awaiting diagnostic laparoscopy for suspected endometriosis will be consented by the clinical research team. If isolated SPE is identified at laparoscopy, and deep or ovarian endometriosis is not seen, participants will be randomised intraoperatively (1:1) to surgical removal (by excision or ablation or both, according to surgeons’ preference) versus diagnostic laparoscopy alone. Randomisation with block-stratification will be used. Participants will be given a diagnosis but will not be informed of the procedure they received until 12 months post-randomisation, unless required. Post-operative medical treatment will be according to participants’ preference. Participants will be asked to complete validated pain and quality of life questionnaires at 3, 6 and 12 months after randomisation. Our primary outcome is the pain domain of the Endometriosis Health Profile-30 (EHP-30), via a between randomised group comparison of adjusted means at 12 months. Assuming a standard deviation of 22 points around the pain score, 90% power, 5% significance and 20% missing data, 400 participants are required to be randomised to detect an 8-point pain score difference.DiscussionThis trial aims to provide high quality evidence of the clinical and cost-effectiveness of surgical removal of isolated SPE.Trial registrationISRCTN registry ISRCTN27244948. Registered 6 April 2021.

Diversity, Equity, and Inclusion in Local Clinical Trials (P5-9.004)

<h3>Objective:</h3> To promote diversity, equity, and inclusion (DEI) in clinical trials through remote research practices <h3>Background:</h3> Clinical trials tend to disproportionately enroll white, male subjects calling into question the generalizability of these studies. The University of Minnesota Stroke Program has helped pioneer telemedicine and remote research practices in stroke clinical trials in collaboration with NIH Stroke Trials Network. This infrastructure supports 24-7 study recruitment that is directly integrated into clinical practice and informs an internal culture of approaching all eligible patients for participation in clinical trials without internal selection bias. <h3>Design/Methods:</h3> We retrospectively reviewed all enrollments in three Phase-III acute stroke clinical trials (NCT03735979, NCT03785678, NCT02864953) enrolled at our tertiary stroke center (Fairview Southdale Hospital) from June 30, 2019 – April 30, 2022. We compared demographics (age, gender, race, ethnicity, and primary language [English: yes/no]) of cohort enrolled in clinical trials versus demographics of general stroke patient population utilizing chi-squared testing and descriptive statistics. <h3>Results:</h3> Sixty-eight patients were enrolled in acute stroke trials (34 in MOST,30 in TIMELESS, 4 in CHARM) with a median age of 71 (IQR 20.25) at Fairview Southdale Hospital. <h3>Conclusions:</h3> We found no notable differences in gender, race, and ethnicity between our clinical trial and non-clinical trial stroke cohorts. Remote research practices eliminates inherent selection bias in clinical research teams and may reduce disparities in clinical trial representation. <b>Disclosure:</b> Dr. Annam has nothing to disclose. Dr. Ramezani Hashtjin has nothing to disclose. Dr. Khan has nothing to disclose. Abbey Staugaitis has nothing to disclose. Dr. Streib has nothing to disclose.

115 The Clinical Research Internship Portal (CRISP): Creating a mechanism for the onboarding and placement of clinical research interns in the Duke University School of Medicine

OBJECTIVES/GOALS: To address investigator frustration and appropriate oversight for student interns performing clinical research activities, we created infrastructure to support matchmaking with clinical research teams and onboarding of student interns, thereby allowing for more meaningful internship experiences with access to clinical research systems. METHODS/STUDY POPULATION: Internship requests may be initiated by a student, an affiliated institution, or an investigator. Requests are triaged accordingly. Affiliation agreements define the parameters for these placements. Unaffiliated institutions may request an agreement by contacting CRISP; otherwise, unaffiliated interns will be classified as visiting scholars with restricted access. If a student is from an affiliated institution, the Clinical Research Internship Portal (CRISP) is used to collect and track information regarding the internship. CRISP provides: Matchmaking for student interns with placements Compilation of onboarding documentation Tools (e.g., learning agreements) for student intern supervisors Professional development workshop series for all student interns RESULTS/ANTICIPATED RESULTS: Launched in 2021, CRISP is a relative newcomer to the Duke research training landscape, but preliminary impact may be measured by the following metrics: Affiliated institutions: 8 agreements in place, 4 pending 25 student interns from 7 institutions placed across 11 departments/institutes 7-session professional development series garnering positive feedback from interns and supervisors Improved access to clinical and research systems aligned with clinical research activities Enhanced oversight and tracking of student interns across Duke enterprise Expansion of program to include internal and external student interns CRISP has engaged invested parties within and outside of Duke to ensure robust oversight of these valuable training opportunities and to create new pathways into our workforce. DISCUSSION/SIGNIFICANCE: Streamlining intern placements has lessened pain points related to including students in our research environment, both for investigators and institutional partners. Future plans include expanding the number of affiliation agreements, creating an interface to quickly triage intern requests, and scaling up the professional development series.

122 DIAMOND 2.0: Updating a Pioneering Digital Platform for Study Team Workforce Development

OBJECTIVES/GOALS: There is a critical need to provide quality training for study teams. Materials need to be flexible and available at the learner’s preferred time and format. DIAMOND was developed to provide nimble education offerings that respond to the changing landscape of clinical and translational research. METHODS/STUDY POPULATION: In 2018 four CTSA institutions (the University of Michigan, the Ohio State University, Rochester University, and Tufts University) collaborated to launch the DIAMOND portal. Developed as a CTSA-wide web-based platform, DIAMOND allows members of clinical and translational research teams to widely share and access training and education resources. In 2022 a MICHR-led update of DIAMOND used principles of user centered design to improve the platform. New features include updated search functions to quickly find and sort training materials, tagging training materials to the characteristics of a translational scientist, and development of user controlled customized playlists. RESULTS/ANTICIPATED RESULTS: DIAMOND currently includes 217 training resources developed by 30 CTSA hubs and private industry. The platform has over 600 page views per day from users across the U.S. and internationally. DIAMOND includes an easy-to-use form to upload new materials to the platform. Contributors are asked to include key words and select competency domains and characteristics of a translational scientist that apply to their materials. Other new features include tagging materials to streamline and improve search results, the ability to sort materials by competency domain or characteristics of a translational scientist, and the ability for users to create and share customized, personalized playlists. DISCUSSION/SIGNIFICANCE: DIAMOND is an important tool to support workforce development for study teams. Updates to the flexible digital platform meet the needs and preferences of adult learners and busy health professionals. Lessons learned from the design process and future plans for the platform will be explored.

92 Effectiveness of an Academic Medical Center Clinical Research Coordinator Intern Program on Learning and Workforce Expansion

OBJECTIVES/GOALS: The Clinical Research Coordinator (CRC) Intern Program was developed to increase knowledge and awareness of CRC’s vital role in conducting clinical studies. Program outcomes are to provide students with marketable skills and knowledge leading to employment within the clinical research ecosystem. METHODS/STUDY POPULATION: The CRC Intern Program is available to college students for health-related academic courses requiring an internship component. Didactic and experiential learning are incorporated into the program with students imbedded within well-established clinical research teams. Activities include attending IRB meetings, recruitment and enrollment, data collection and entry, and regulatory items. Students complete knowledge pre- and post-assessments (Competency Index for Clinical Research Professionals-CIRCP) via REDCap surveys to assess learner knowledge acquisition and program effectiveness. Demographic, program evaluation, and 3-month follow up survey data are analyzed using descriptive statistics. RESULTS/ANTICIPATED RESULTS: Beginning in Spring 2022, the Intern Program has accepted 9 students with 5 completing the program, with 2 of this 5 having been offered employment as CRCs. Preliminary CIRCP assessment data indicates increased CRC knowledge upon Intern Program completion. Demographic data shows that students are mostly female and non-white (43% African American, 29% Hispanic). Additional results from the current cohort will be shared upon program completion. Of note is the development of partnerships with local colleges, including community colleges, to build awareness of the CRC career path and to provide opportunities for CRC exploration resulting in expansion and diversification of the clinical research workforce. DISCUSSION/SIGNIFICANCE: There is an industry wide shortage of CRCs. Our internship program has provided an effective method to expand and diversify the CRC workforce through knowledge acquisition and application building CRC skills and competencies. Lessons learned and future plans for intern expansion will be discussed.

412 Utility of a Team Science and Project Management Approach to Providing Effective Participant Recruitment Support to Research Teams: The Indiana CTSI Recruitment Concierge Service (RCS)

OBJECTIVES/GOALS: Evaluate effectiveness of participant recruitment service to improve study enrollment through customer feedback surveys and recruitment data obtained by research teams utilizing services. Use survey information to conduct gap analysis of additional support needed for participant recruitment. METHODS/STUDY POPULATION: Participant enrollment is often cited as one of the most challenging aspects of clinical research. In 2021, the Indiana CTSI used project management techniques to design and pilot a Team Science approach for providing participant recruitment support to clinical research teams. This service called the Indiana CTSI Recruitment Concierge Service (RCS) is comprised of recruitment, community engagement, social media, communications, and project management expertise. Additional experts are chosen to participate based on the study needs (regulatory, population insight, informatics, clinical services, etc.) RCS customers are comprised of study teams from a variety of areas and research experience. These customers are sent surveys to evaluate the support they received and provide suggestions for improvement. RESULTS/ANTICIPATED RESULTS: The RCS assisted 72 study teams in 2021 and 85 (as of November) in 2022. These studies were referred via word of mouth as no advertising of the service had been done to date. All customers were provided a study specific consultation with recommendations of services and resources that would assist their study. Some services recommended were: local study listing and volunteer registry (All IN for Health), digital marketing support, materials design expertise, community engagement and healthcare patient recruitment guidance. The overall feedback from RCS customers has been positive with most teams indicating the support improved their study recruitment and/or engagement plan. RCS will use information obtained to develop a strategy for prioritizing services due to the overwhelming number of requests received. DISCUSSION/SIGNIFICANCE: Using project management techniques and a Team Science approach, the Indiana CTSI was able to develop a comprehensive participant recruitment service that integrates clinical research operations, community engagement, and informatics expertise to design study specific recruitment plans and coordination of services.