Coordination Of Clinical Trials Research Articles

Retrieval-augmented large language models for clinical trial screening.

157 Background: Clinical trial screening is currently manual and laborious. We tested several large language models enhanced with retrieval-augmented generation (RAG-LLM) to assess their performance on this task. Methods: We extracted eligibility criteria of 184 oncology trials with FDA approval notifications between 8 January 2020 and 18 January 2024, as well as information on cancer staging and performance status scoring for the RAG-LLM vector database. A medical oncologist and 2 senior clinical trial coordinators developed a test set of 975 synthetic patient profiles which included primary site, stage, prior therapy, tumor mutations and one additional clinical feature. Each profile was paired with one of the 184 trials and annotated for ground-truth eligibility and the reason for it. This process was repeated for another validation set of 240 longer and more challenging profiles paired with 8 ongoing trials. We developed RAG-LLMs with 4 leading LLMs (Zephyr-7B, Med42, GPT 3.5, GPT4) and evaluated their accuracy in determining trial eligibility as well as retrieval-augmented generation assessment (RAGAs) metrics. A response was deemed accurate only if it correctly assigned both trial eligibility and the reason for assignment. Results: GPT4 performed best and achieved an accuracy of 95.18% and 80.00% on the test and validation set respectively with a mean inference time of 10.95 seconds. It also demonstrated the highest answer relevancy, context relevancy and faithfulness (Table). Conclusions: Our results demonstrate potential for RAG-LLMs to assist with trial screening at scale. Further evaluation in real-world cohorts utilizing electronic records and full protocol data with tracking of impact on trial enrolment can be explored within secure firewalls. [Table: see text]

BIOM-09. TOWARDS CLINICAL IMPLEMENTATION OF LIQUID BIOPSY ANALYSIS FOR PAEDIATRIC BRAIN TUMOUR PATIENTS – A PAN-EUROPEAN EFFORT FOR STANDARDIZATION

Abstract BACKGROUND Liquid biopsies (LBs) allow for analysis of tumour-derived molecules, such as cell-free DNA (cfDNA) and microRNAs (miRNAs), complementing cancer diagnostics, therapy monitoring, and minimal residual disease detection. While circulation-based LB has benefit for extracranial tumour entities, peripheral blood has not historically been a reliable source for diagnosis and disease-monitoring in brain tumours. For these tumours, cerebrospinal fluid (CSF) analysis is better suited for detection despite being a more invasive procedure. However, standardized protocols for sample collection and pre-analytical parameters for these LBs currently are limited. AIM We aim to establish an evidence-based gold standard protocol for cfDNA and miRNA analyses from CSF in paediatric brain tumour patients. In addition to higher compliance in trial-related CSF sampling, this initiative seeks to facilitate identification of clinically relevant indications and time-points for collection, thereby paving the way for well-informed, routine CSF molecular diagnostics. METHODS AND RESULTS We have initiated the Liquid Biopsy Working Group within the framework of the International Society of Paediatric Oncology Europe Brain Tumour Group (SIOPE-BTG). Available literature on LB in brain tumours was critically assessed regarding pre-analytical parameters, downstream analyses and LB assay performance. To directly evaluate confounding by pre-analytical factors, we experimentally compared the impact of CSF sampling sites, storage conditions, and different pre-processing protocols. cfDNA and miRNA yields, purity, and the fraction of tumour-derived material were selected as read-outs and correlated with tumour tissue information. To prepare for clinical translation, we consulted clinical paediatric brain tumour trial coordinators to identify major bottlenecks for CSF sampling in routine clinical practice. In addition, clinical practitioners and patient/ parent representatives have been consulted to comprehensively represent the perspectives and needs of all stakeholders. Together, results of this collaborative effort will be fundamental to the successful clinical integration of LBs to improve the future management of paediatric brain tumour patients.

Retrieval-augmented large language models for clinical trial screening.

e13611 Background: Clinical trial screening is currently manual and laborious. We tested several large language models enhanced with retrieval-augmented generation (RAG-LLM) to assess their performance on this task. Methods: We extracted eligibility criteria of 184 oncology trials with FDA approval notifications between 8 January 2020 and 18 January 2024, as well as information on cancer staging and performance status scoring for the RAG-LLM vector database. A medical oncologist and 2 senior clinical trial coordinators developed a test set of 975 synthetic patient profiles which included primary site, stage, prior therapy, tumor mutations and one additional clinical feature. Each profile was paired with one of the 184 trials and annotated for ground-truth eligibility and the reason for it. This process was repeated for another validation set of 240 longer and more challenging profiles paired with 8 ongoing trials. We developed RAG-LLMs with 4 leading LLMs (Zephyr-7B, Med42, GPT 3.5, GPT4) and evaluated their accuracy in determining trial eligibility as well as retrieval-augmented generation assessment (RAGAs) metrics. A response was deemed accurate only if it correctly assigned both trial eligibility and the reason for assignment. Results: GPT4 performed best and achieved an accuracy of 95.18% and 80.00% on the test and validation set respectively with a mean inference time of 10.95 seconds. It also demonstrated the highest answer relevancy, context relevancy and faithfulness (Table). Conclusions: Our results demonstrate potential for RAG-LLMs to assist with trial screening at scale. Further evaluation in real-world cohorts utilizing electronic records and full protocol data with tracking of impact on trial enrolment can be explored within secure firewalls. [Table: see text]

Abstract PR01: Implementation of a real-time AI-guided navigation service for pancreas cancer

Abstract Patient navigation aims to overcome access barriers and optimize care delivery, but navigators cannot identify pre-diagnosed patients using traditional methods, hindering navigation efficacy. We observed care gaps among patients identified at our institution with suspected pancreatic cancer during January 2023: among 67 patients with new pancreas cancer, only 36% underwent biopsy with 22 days between radiology and biopsy; and 30% were seen by an outpatient oncologist with 32 days between radiology and visit. We sought to improve patient care outcomes through daily prospective AI-guided identification and navigation of patients with radiographic findings suspicious for pancreas cancer. In June 2023, we implemented an AI-guided daily workflow using the following steps: 1) at 24-hour intervals, an NLP model reviewed abdominal imaging reports and flagged reports containing language suspicious for pancreatic cancer; 2) a trained coordinator and GI oncologist validated reports with new masses and sent such reports to a GI navigator, and 3) the navigator facilitated appointments for proper follow-up, including GI services, the multi-disciplinary tumor board, and clinical trial coordinator. During June 2023, the model identified 69 patients with suspicion for new pancreas cancer. 19% were immediately eligible for navigation and scheduled for follow-up within our institution with an average of 8 days between report and navigation - 77% saw an outpatient oncologist with an average of 17.5 days between report and visit, 69% underwent biopsy with an average of 4.5 days between report and biopsy, and 54% were seen at multidisciplinary pancreatic cancer tumor board (pcTB) with an average of 16 days between report and pcTB. Furthermore, of these, we were able to enroll 4 patients to clinical trials and 5 accruals to biospecimen studies during this one-month period. 2 of these accruals were to the P-1000 study, which has been open at our institution for the last 2 years with a 0.5 per month accrual rate. Of the 81% who were not immediately eligible for navigation, 23% were already established with an oncologist in our system, 23% sought care elsewhere, 23% were not eligible for or did not desire further workup, and 30% were still undergoing in-patient workup. We show that an AI-guided workflow can transform referral patterns of pre-diagnosed pancreatic cancer patients, creating a new access stream for navigators to intervene much earlier in a patient’s continuum of cancer care with resultant improvement in healthcare delivery, evidenced by an average of 4.5 days between imaging and biopsy and 17.5 days between imaging and outpatient oncology visit, compared to our traditional cancer care approach with averages of 22 and 32 days, respectively. Furthermore, we have rapidly accelerated pancreas cancer clinical trial enrollment and biospecimen accrual at our institution since implementation of this workflow with 4 patients enrolled and 5 biospecimen accruals in a month alone. We are now working to expand this innovative framework across additional cancer types. Citation Format: Kristen M. John, Joseph Tenner, Yuddy Franco, Rolando Croocks, Melissa Perez, Tara McEvoy, Tiffany Zavadsky, Kristen Beyer, Rita Mercieca, Sandeep Nadella, Anthony Carvino, Matthew Barish, Daniel A. King. Implementation of a real-time AI-guided navigation service for pancreas cancer [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Pancreatic Cancer; 2023 Sep 27-30; Boston, Massachusetts. Philadelphia (PA): AACR; Cancer Res 2024;84(2 Suppl):Abstract nr PR01.

Translation of preclinical ethnomedicine data in LMICs: the example of rooibos.

All disease, but especially non-communicable diseases, are related to dysfunction of one or more regulatory systems. In developing countries, long-term management of patients with chronic diseases has many challenges and is generally not financially viable, but Africa in particular, which is rich in diverse ethnomedicines presents a more feasible long-term therapeutic approach in this niche. However, despite comprehensive preclinical investigations on numerous plant-derived candidate medicines, only a small portion of these reach the patient as recognised medicines. In this review, we use the example of rooibos (Aspalathus linearis (Burm.f.) R. Dahlgren)-which is globally consumed as aromatic, caffeine-free tea-to illustrate the hurdles that need to be overcome in the low-to middle-income countries, before progression of ethnomedicines to official treatment regimens can be achieved. In terms of methodology, regulatory system focused rooibos papers indexed on PubMed for the past three decades (n = 112) were accessed. Papers reporting duplication of previous results were excluded, as well as review papers. Topics covered includes the high standard of ethnomedicine drug discovery and efficacy testing research performed in Africa (and South Africa in particular in the case of rooibos), the potential bias in terms of preclinical research focus, ethnomedicine ownership and the requirement for independent clinical trial coordination and/or management.

Team‐Based Learning Approach to Practice Improvements in a Memory Clinic

AbstractBackgroundWorkface projections indicate an increasing shortfall in neurologists and other medical specialists to treat persons with Alzheimer’s disease and other causes of dementia (Dall et al. Neurology 2013). This problem will be further magnified by available disease modifying therapies aimed at earlier stages of illness, markedly expanding the patient pool (Anderson et al. J Prev Alzheimers 2022; Hlavka et al. Rand 2019). With the Alzheimer’s disease treatment landscape approaching these turning points the University of Alabama at Birmingham Brain Aging and Memory (BAM) Clinic undertook a multidisciplinary expansion to improve access and increase the role of nonphysician professionals to optimize care. Onboarding this interdisciplinary team was complicated by separation of staff members mandated by the COVID‐19 pandemic. These factors, along with emerging use of “team‐based learning” educational models led to the creation of the BAM Learning Club (BAM LC).MethodsBAM LC is a weekly synchronous online series of didactics, lectures, case discussions, journal reviews, and team‐building wellness activities. Participants include Neurologists, Psychiatrists, Psychologists, RN Case managers, RN Clinical Care Coordinators, Social Workers, Nurse Practitioners, Pharmacists, Caregiver Counselors, Research Scientists, Clinical Trial Coordinators, Postdoctoral Fellows, Residents, and Medical Students. Sessions are recorded for future onboarding and educational needs. Content is generated by the BAM LC members with support from its director.ResultsBAM LC began in June 2021 and has continued weekly with increasing interest and attendance. Shared learning has led to practice improvements, a collaborative environment, and a cohesive multidisciplinary team. Recorded sessions have been used to provide education outside of our cohort and will be maintained for future use.ConclusionTeam‐based learning has resulted in better academic, clinical, and communication outcomes among health care professionals (Joshi et al. Cureus 2022). Multidisciplinary team‐led learning opportunities focused on dementia care could serve as a tool to promote further practice improvement, collaboration, and cohesion within healthcare organizations. Normalization of synchronous remote learning during the pandemic facilitated acceptance, uptake, and participation across disciplines. This process also has the potential to provide further system‐wide education in health systems to diversify the workforce and improve readiness to treat a rapidly expanding patient population.

간호대학생을 위한 팀프로젝트기반 임상시험연구 교육의 효과

Objectives Project-based learning engages students in practical activities related to course contents and has been demonstrated to improve academic performance. Nurses play a particularly important role in promoting clinical trial research as a new professional workforce. An entry-leveled educational course was developed to learn the future professional workforce roles in clinical trial research for nursing students. This study evaluated the effectiveness of a clinical trial research course on the importance and performance of the clinical research coordinators' role, students' recognized achievement, and cooperative self-efficacy.
 Methods Five professional clinical coordinators and two nursing professors developed the four projects on the clinical research processes and roles based on Good Clinical Practice guidelines. Thirteen junior students divided into 4 small groups completed a new project-based clinical research course composed of 8 sessions of clinical field work, discussion, reflection, portfolio, and presentation from September to October 2022. Students responded questionnaires on the importance-performance clinical trial nurses' roles, recognized achievement, and cooperative self-efficacy, and reported the reflective journal on the class. The students' class evaluation data was retrieved and analyzed using importance-performance analysis (IPA) and Wilcoxon signed rank test.
 Results Compared to baseline scores, protocol assessment (z=-2.59, p=.010), protocol planning (z=-1.96, p=.050), and subject recruitment (z=-2.16, p=.031) increased among the 8-section of clinical trial coordinator's roles. Additionally professional role recognition increased after the class (z=-2.25, p=.025). IPA analysis exhibited that nursing students recognized the 8-section clinical trial nurses' roles as more important and more performing. The mean score of nursing students' recognized achievement was high (4.96 points out of 5 points), and cooperative self-efficacy was high (4.37 points out of 5 points) after completing a clinical trial research course.
 Conclusions An entry-leveled educational course on the clinical trial research using project-based learning may expand the possibility of a new professional career for nursing students.

Editorial introductions.

Editorial introductions.

“Nothing to lose and the possibility of gaining”: a qualitative study on the feasibility and acceptability of registry-based randomised controlled trials among cancer patients and clinicians

BackgroundRandomised controlled trials (RCTs) are considered the “gold standard” for evaluating the effectiveness of interventions in clinical research. However, conventional RCTs are typically complex, expensive, and have narrow eligibility criteria, which limits generalisability. Registry-based randomised controlled trials (RRCTs) are an alternative approach that integrates the internal validity of an RCT with the external validity of a clinical registry by recruiting real-world patients and leveraging an existing registry platform for data collection. As RRCT is a novel research design, there has been limited research on the feasibility and acceptability of RRCTs from the patients’ and trial team’s perspectives. This study aims to explore patients’, clinicians’, and study coordinators’ perspectives towards participation in and conduct of oncology RRCTs in Australia.MethodsThirty-seven semi-structured interviews were conducted with 15 cancer patients, 15 clinicians, and 7 study coordinators. Interviews were audio-recorded and transcribed verbatim. The data were analysed using thematic analysis.ResultsThree overarching themes were identified: (1) enablers and barriers to recruitment and enrolment of patients in RRCTs, (2) experiences of patients participating in RRCTs, and (3) recommendations for the implementation of future RRCTs. For patients, altruism and “trust in the clinician” were key reasons to participate in a RRCT. For clinicians and clinical trial coordinators, the RRCT study design was perceived as “simple and straightforward” but “less exciting” than RCTs. Competition from commercially sponsored RCTs poses challenges for investigator-led RRCTs recruitment, particularly if eligible patient numbers are low. There were limited impacts on patients’ treatment experiences and clinicians’ clinical workflow given that the RRCTs explored different standards of care. Recommendations to improve the enrolment of patients in RRCTs included generating greater buy-in from clinicians by increasing awareness of RRCTs via education initiatives and broader promotion of the “selling point” of RRCTs and providing monetary compensation to hospitals for enrolling patients.ConclusionsWhilst patients, clinicians, and study coordinators were generally supportive of RRCTs, several barriers to effective RRCT implementation in oncology were identified. Developing strategies to increase acceptance of the methodology by clinicians will help enhance the uptake of RRCTs in Australia and internationally.

599 - Role of Clinical Trial Coordinator RN within Immunotherapy Clinic

599 - Role of Clinical Trial Coordinator RN within Immunotherapy Clinic

The importance of Communication and Education: Lessons learned from AGREEDementia

AbstractBackgroundWhen and how to communicate effectively the results of genetic and biomarker based prediction, detection, and quantification of the brain substrates of dementia involve important ethical and legal issues critical for precision medicine. AGREEDementia is an open working group that focuses on informed discussions and development of educational material to support communication and use of this information.MethodMembers attend two meetings monthly via videoteleconference. One meeting is a targeted working group that focuses on the following: 1. People with Symptoms, 2. People without Symptoms, 3. Research, 4. Ethics/Healthcare Law, 5. Diversity. Members also attend a monthly “all hands” meeting where they receive updates from other groups, partner organizations, and hear presentations on emerging research and resources.ResultOver the past few years AGREEDementia has produced several collaborative papers, webinars, and decision tools for people considering undergoing biomarker testing that will be discussed. Membership continues to grow to over 120 though level of involvement varies. The group is largely comprised of academic researchers (76%) including neurologists, neuropsychologists, clinical trial coordinators, ethicists, and healthcare lawyers. The second largest subgroup was from advocacy groups and stakeholders (18%) and 6% are students. Collaborations with other organizations including the NIA, Alzheimer’s Association/ISTAART, the Lewy Body Dementia Association, Association for Frontotemporal Dementia, and Cohen Veterans Bioscience greatly enrich the group by publicizing conferences and collaborating on papers and products. The Alzheimer’s & Dementia Outreach, Recruitment & Engagement at NIA also disseminates decision tools and other materials. Over time, the stakeholder group developed from an audience providing consultation to a creative force that pioneered a program to support people with cognitive dysfunction attending AAIC and other scientific conferences. The Diversity workgroup was added in order to mentor and teach research staff in sensitive outreach to diverse cohorts. The ongoing, monthly, lecture series and links to all these materials are hosted at a website, AGREEDementia.com.ConclusionWith controversies around how best to integrate biomarker and genetic information into clinical care, when to share research data with the public, and implement novel biomarker‐based therapies, AGREEDementia has provided an open forum for all to visit and consult.

Interpreting blood‐based biomarker results in heterogeneous populations with multiple co‐morbidities

AbstractBackgroundA major benefit of the use of blood‐based biomarkers in screening for Alzheimer’s disease (AD) pathology, or diagnosing AD dementia, is that the collection of blood is less invasive and costly than cerebrospinal fluid or neuroimaging markers. Blood biomarkers are also more feasible and available at the primary care levels, where most individuals will present with cognitive symptoms. However, most studies examining blood‐based biomarkers of amyloid, phosphorylated tau, or neurodegeneration for screening or diagnosis have been conducted in neurology or memory clinics. Patients that reach these clinics often have less comorbidities and are younger than those seen and followed in primary care. Thus, there is a need to assess the utility of these blood‐biomarkers in diverse, community‐based cohorts of older ages, with multiple comorbidities, and with brain co‐pathologies (i.e., cerebrovascular disease).MethodUsing examples from the Mayo Clinic Study on Aging and other community‐based studies, we will synthesize the impact of demographics, comorbidities, and co‐pathologies on blood measures of amyloid‐beta, phosphorylated tau, neurofilament light chain (NfL), total tau, and glial fibrillary acid protein (GFAP). Additional discussion will focus on how these factors may impact cut‐points and the interpretation of the blood biomarkers across the AD clinical spectrum, as well as potential methods to better elucidate the biomarker results for clinical care.ResultBlood measures of amyloid‐beta, phosphorylated tau, NfL, total tau, and GFAP are differentially affected by age and sex and some comorbidities (e.g., chronic kidney disease, stroke, myocardial infarction, diabetes, body mass index). Although adjusting for covariates has been a method used in some research studies, adjustment will not work on an individualized level for patients seen in primary care. Different cutpoints may be needed based on age and the presence or absence of specific comorbidities. In addition, when interpreting the results for diagnosis and prognosis, co‐occurring co‐pathologies (e.g., cerebrovascular disease) must be considered.ConclusionSeveral studies have shown the promise of blood‐based biomarkers for screening and diagnosing AD in memory clinics. However, several considerations and steps are needed before these blood biomarkers can be implemented for use at the population level and in primary care.BackgroundWhen and how to communicate effectively the results of genetic and biomarker based prediction, detection, and quantification of the brain substrates of dementia involve important ethical and legal issues critical for precision medicine. AGREEDementia is an open working group that focuses on informed discussions and development of educational material to support communication and use of this information.MethodMembers attend two meetings monthly via videoteleconference. One meeting is a targeted working group that focuses on the following: 1. People with Symptoms, 2. People without Symptoms, 3. Research, 4. Ethics/Healthcare Law, 5. Diversity. Members also attend a monthly “all hands” meeting where they receive updates from other groups, partner organizations, and hear presentations on emerging research and resources.ResultOver the past few years AGREEDementia has produced several collaborative papers, webinars, and decision tools for people considering undergoing biomarker testing that will be discussed. Membership continues to grow to over 120 though level of involvement varies. The group is largely comprised of academic researchers (76%) including neurologists, neuropsychologists, clinical trial coordinators, ethicists, and healthcare lawyers. The second largest subgroup was from advocacy groups and stakeholders (18%) and 6% are students. Collaborations with other organizations including the NIA, Alzheimer’s Association/ISTAART, the Lewy Body Dementia Association, Association for Frontotemporal Dementia, and Cohen Veterans Bioscience greatly enrich the group by publicizing conferences and collaborating on papers and products. The Alzheimer’s & Dementia Outreach, Recruitment & Engagement at NIA also disseminates decision tools and other materials. Over time, the stakeholder group developed from an audience providing consultation to a creative force that pioneered a program to support people with cognitive dysfunction attending AAIC and other scientific conferences. The Diversity workgroup was added in order to mentor and teach research staff in sensitive outreach to diverse cohorts. The ongoing, monthly, lecture series and links to all these materials are hosted at a website, AGREEDementia.com.ConclusionWith controversies around how best to integrate biomarker and genetic information into clinical care, when to share research data with the public, and implement novel biomarker‐based therapies, AGREEDementia has provided an open forum for all to visit and consult.

Evaluating the Utility of Existing Plasma Biomarkers in a Clinical Patient Cohort

AbstractBackgroundBiomarker assessments will become an instrumental component of effective clinical management and trial coordination for Alzheimer’s Disease (AD) and related dementias and will enable precision medicine approaches to diagnosis and treatment. Plasma offers an inexpensive non‐invasive peripheral biofluid for biomarker assessments that can easily be collected longitudinally. The development of ultrasensitive single molecule array (SIMOA) assays has enabled plasma measurements for AD‐related blood biomarkers. Indeed, several plasma biomarkers were recently identified as potentially useful for AD and related dementias. However, their utility in additional clinical cohorts requires further investigation.MethodsPlasma samples were collected from participants clinically diagnosed as cognitively unimpaired (CU; n=30), mild cognitive impairment (MCI; n=60) or probable AD (AD; n=34) from the Michigan ADRC. Levels of total Tau, phospho‐tau 181 (pT181), amyloid β40 (Aβ40), and amyloid β42 (Aβ42) were measured using SIMOA. Ongoing studies will include additional samples and measure plasma neurofilament light chain, glial fibrillary acidic protein, placental growth factor, vascular endothelial growth factor, and phospho‐tau 231. Biomarker levels were compared across diagnostic groups and correlated with cognitive and demographic variables.ResultsAmong the biomarkers assessed, interim results indicated significantly elevated pTau181 in AD compared to CU and receiver operating characteristic (ROC) analysis showed an AUC of 0.81 for CU versus AD. This analyte correlated significantly with CDR sum of boxes (p=0.01). There was a nonsignificant reduction (8%) in the Aβ42:Aβ40 ratio and an AUC of 0.65 for CU versus AD. Aβ40 and the Aβ42:Aβ40 ratio were significantly correlated with age. No sex differences were detected. Except for pTau181, no significant correlations with CDR sum of boxes or CDR global were found. Biomarker levels showed no correlation with body mass index (BMI) within diagnostic groups.ConclusionsGenerally, our results align fairly well with other studies using clinical patient cohorts with extensive additional biomarkers (e.g. PET tracer measurements and CSF biomarkers). The AD‐associated increase in plasma pT181 levels support the potential utility of this form of phospho‐tau as a useful plasma biomarker. The lack of significant effects with the other biomarkers used here suggests additional novel biomarkers are necessary.

Using Technology to Enhance Cancer Clinical Trial Participation.

The COVID-19 pandemic presented many challenges to health care systems, including oncology clinical research programs. There were substantial negative effects on oncology clinical trial screening, enrollment, and study activities that forced institutions and regulatory bodies to develop innovative solutions to maintain robust and equitable participation in these trials. Digital pathology innovations at Memorial Sloan Kettering Cancer Center have streamlined the diagnostic life cycle for patients with cancer, and the seamless integration of digital pathology services with next-generation sequencing and other molecular pathology services have accelerated the time to diagnosis and receipt of molecular results. Timely access to these results, coupled with Memorial Sloan Kettering Cancer Center's knowledge engine OncoKB, enhances patient clinical trial coordination precisely and efficiently. At the Sarah Cannon Research Institute, centralized remote clinical trial matching and screening, virtual molecular tumor boards, and centralized molecular interpretation support services have empowered clinic staff to identify more efficiently potential participants in clinical research, despite the COVID-19 pandemic. In addition, the U.S. Food and Drug Administration Oncology Center of Excellence has been involved in several efforts to address challenges for patients with cancer during the COVID-19 pandemic, including writing guidance documents and participating in efforts to modernize clinical trials. The enclosed personal experience of a patient with cancer currently participating in an oncology clinical trial emphasizes the need for continued decreasing of barriers to study participation. Clinical trial advances that were accelerated by the pandemic will ultimately help patients with cancer and the greater oncology health care community.

Abstract TP30: Retention And Trial Coordinator Outreach In A Multicenter Clinical Trial During Covid 19

Introduction: Human subjects research requires the retention of enrolled patients in order to provide accurate data. The COVID-19 pandemic introduced unique challenges for clinical trial coordination. AtRial Cardiopathy and Antithrombotic Drugs in Prevention After Cryptogenic Stroke (ARCADIA) is an NIH StrokeNet national clinical trial designed to test superiority of apixaban over aspirin for secondary stroke prevention in patients with cryptogenic stroke and atrial cardiopathy. We sought to explore the methods that allowed our site to maintain a high retention rate in our local ARCADIA population. Methods: Prior to COVID-19, our trial coordinator (JP), conducted home visits to enroll and complete study visits every 3 months for the first year. This was approved by our local institution, IRB and study sponsor. During COVID-19 precautions, phone contact was maintained and encouraged. Face-to-face visits were not possible, but our coordinator continued to deliver study drug while maintaining distancing precautions. This was followed by a phone call to remind patients of drug instructions and dosages, and inquiring about any adverse events that may have occurred since the last visit. We evaluated the number of follow up visits before and during the COVID lockdown (March through June 2020). Results: Enrollments decreased during the pandemic, in large part due to a study-wide pause in recruitment efforts. The median monthly follow-up prior to COVID-19 was 3, and increased to 5 during lockdown. Before, during and after COVID, our local retention rate has remained 100%. Conclusions: In conclusion, despite complicating factors of COVID-19, our local coordinator’s retention rate remained 100% during the COVID-19 pandemic and our median number of monthly follow up visits increased, which may be attributable to our coordinator’s efforts of socially distanced home visits and frequent communication.

Clinical Research Coordinator and Clinical Research Nurse: education and role at the Clinical Trial Center of Alessandria

The increasing complexity of clinical research makes it indispensable for an Institution that wants to conduct clinical trials to have an Organisational Structure and a dedicated multidisciplinary team. Since 2013, the public Hospital "SS Antonio and Biagio and C. Arrigo" of Alessandria (AO AL) has established a Clinical Trial Center (CTC), that has now become a centralized inter-company sector of the Research and Innovation Department. The CTC is part of the Research Infrastructure with its head office at AO AL and a further office at the Local Health Authority Territorial Hospital "S. Spirito" of Casale Monferrato (ASL AL). The CTC aims to design high standard clinical trials, ensuring better efficiency in their activation, management and data management according to the Good Clinical Practice (GCP) guidelines. Over the years, the CTC has grown and gained professional skills such as the Clinical Research Coordinator (CRC) and the Clinical Research Nurse (CRN), not yet officially recognized by the National Health System. These are skilled professional figures, that have been adequately trained even with post-graduate education through a 1st level Master in "Data Management and Coordination of Clinical Trials" which was activated by the University of Eastern Piedmont in collaboration with AO AL. The number and diversity of the activities carried out by CRCs and CRNs within the CTC has led them to develop a tool that strategically permits to recollect and record the time needed to perform these tasks with the aim of evaluating the different types of activities undertaken and assessing the needs of new staff. The organizational model adopted by the AO AL and the ASL AL through a centralized inter-company CTC represents a unique organizational model in the regional scenario and a peculiarity within the Public Health Authority not as yet recognized as Scientific Institutes for Research, Hospitalization and Healthcare.

Tennessee Academy of Science Executive Committee Meeting Minutes, November 2021

Tennessee Academy of Science Executive Committee Meeting Minutes, November 2021

Dedicated clinical trial tissue tracking database to improve turn-around time at high-volume center.

1543 Background: Tissue requirements in oncology clinical trials are increasingly complex due to prescreening protocols for patient selection and serial biopsies to understand molecular-level treatment effects. Novel solutions for tissue processing are necessary for timely tissue procurement. Based on these needs, we developed a Tissue Tracker (TT), a comprehensive database for study-related tissue tasks at our high-volume clinical trial center. Methods: In this Microsoft Access database, patients are assigned an ID within the TT that is associated with their name, medical record number, and study that follows their request to external users: pathology departments, clinical trial coordinators and data team members. To complete tasks in the TT, relevant information is required to update the status. Due to the high number of archival tissue requests from unique pathology labs, the TT has a “Follow-Up Dashboard” that organizes information needed to conduct follow-up on all archival samples with the status “Requested”. This results in an autogenerated email and pdf report sent to necessary teams. The TT also includes a kit inventory system and a real-time read only version formatted for interdepartmental communication, metric reporting, and other data-driven efforts. The primary outcome in this study was to evaluate our average turnaround time (ATAT: average time from request to shipment) for archival and fresh tissue samples before and after TT development. Results: Before implementing the TT, between March 2016 and March 2018, we processed 2676 archival requests from 235 unique source labs resulting in 2040 shipments with an ATAT of 19.29 days. We also processed 1099 fresh biopsies resulting in 944 shipments with an ATAT of 7.72 days. After TT implementation, between April 2018 and April 2020, we processed 2664 archival requests from 204 unique source labs resulting in 2506 shipments (+28.0%) with an ATAT of 14.78 days (-23.4%). During that same period, we processed 1795 fresh biopsies (+63.3%) resulting in 2006 shipments (+112.5%) with an ATAT of 6.85 days (-11.3%). Conclusions: Oncology clinical trials continue to evolve toward more extensive tissue requirements for prescreening and scientific exploration of on-treatment molecular profiling. Timely results are required to optimize patient trial participation. During the intervention period, our tissue sample volume and shipments increased, but the development and implementation of an automated tracking system allowed improvement in ATAT of both archival and fresh tissue. This automation not only improves end-user expectations and experiences for patients and trial sponsors but this allows our team to adapt to the increasing interest in tissue exploration.

COVID-19 vaccines and treatments: When speed is necessary and not enough.

COVID-19 vaccines and treatments: When speed is necessary and not enough.

Un exemple de réorganisation dans le fonctionnement d’un Centre d’investigations cliniques en période de confinement national suite à la pandémie COVID-19

ContexteLe Centre d’investigations cliniques de l’Hôpital Saint-Louis (CIC-1427) est une structure dédiée qui accueille des patients inclus dans des essais cliniques essentiellement de phases précoces (première administration chez l’homme, phases I et II). Ces patients sont accueillis dans des locaux autorisés et validés par l’Agence régionale de santé (ARS). En mars 2020, face à la pandémie de la COVID-19 et aux mesures de confinement national de la population décidées, par le gouvernement français, le CIC-1427 a dû adapter rapidement ses procédures de fonctionnement pour assurer la sécurité des patients et de son personnel.ObjectifAssurer une prise en charge optimale des patients inclus dans les essais cliniques de phases précoces, tout en respectant les bonnes pratiques cliniques (BPC) et les bonnes pratiques professionnelles des CIC (BPP des CIC), les exigences des promoteurs de chaque protocole, la sécurité des patients et du personnel multidisciplinaire (infirmiers, aide-soignants [AS], assistants de recherche clinique [ARC], coordonnateur d’études cliniques [CEC]), chefs de projets, cadre de santé et médecins investigateurs), dans le contexte de la crise sanitaire liée à la COVID-19.Méthodes et résultatsDe par son activité, nécessitant des tâches en présentiel, chaque personnel de l’équipe spécialisée en recherche clinique du CIC-1427 a dû adapter son activité quotidienne aux contraintes de la crise sanitaire. De nouvelles procédures spécifiques ont été rapidement élaborées, pour faire face à la pandémie. La plupart des visites médicales sur site ont été remplacées par des téléconsultations avec bilans biologiques dans les laboratoires de proximité, les « remote monitoring » ont remplacé les visites de monitoring sur site, les traitements ont été envoyés au domicile de chaque patient via des coursiers après accord des CPP (Comité de protection des personnes) de chaque protocole. Les visites indispensables ont pu être maintenues sur site grâce à l’implication sans faille de notre équipe soignante et sous condition de mise en place d’un protocole sanitaire adapté.ConclusionGrâce à l’implication de l’ensemble de notre équipe de recherche multidisciplinaire, et malgré les difficultés rencontrées, chaque patient a pu bénéficier d’un suivi personnalisé et poursuivre son traitement protocolaire. Les procédures mises en place ont également permis la collecte d’un maximum de données de sécurité et d’efficacité pour les promoteurs des essais cliniques et le respect des bonnes pratiques réglementaires. L’ensemble de ces mesures prises dans le contexte de l’urgence sanitaire, lors de la première vague épidémique, ont permis d’aborder plus sereinement la suite de l’épidémie.