Trial Accrual Research Articles

Reversing the restrictive trend in diffuse large B‐cell lymphoma trial eligibility: it’s time to open the gates!

Reversing the restrictive trend in diffuse large B‐cell lymphoma trial eligibility: it’s time to open the gates!

Positive attitudes toward clinical trials among military veterans leaves unanswered questions about poor trial accrual

Participation in clinical trials is essential to bringing novel and innovative cancer treatments to the bedside but trials that specifically enroll Veterans are relatively few. Given the inherent differences between Veterans and the general United States population, we sought to investigate awareness of and attitudes toward clinical trials among Veterans diagnosed with cancer at a large, urban Veterans Administration Medical Center in Bronx, New York. The survey was administered in 2018-2019. Questions assessed sociodemographic characteristics, health literacy, and general attitudes about clinical trials. Based on key informant interviews, we also inquired about military-specific attitudes. Univariable analyses were conducted to evaluate differences in attitudes by age (<65 v ≥65 years) and race/ethnicity (non-Hispanic black v other). Of 115 Veterans approached, 67 (58.3%) completed the survey. Approximately 95% of participants were male, 59.7% were ≥65 years old, and 41.8% were non-Hispanic black. Only 58.2% reported knowing what a clinical trial is but 78.5% of Veterans stated that they trust doctors who do medical research and 87.5% reported they would strongly consider joining a trial if their VA primary care physician recommended it. Many stated that they would be part of a clinical trial if it would help fellow Veterans in the future (93.8%) and would help scientists learn how to treat other Veterans with the same disease (93.8%). Among non-Hispanic black participants, 62.5% agreed that the government has a history of using Veterans in experiments without their knowledge compared to 34.2% of Veterans of other race/ethnicity (P = 0.03). Clearly Veterans in our study were amenable to joining clinical trials. While many are aware of past misconduct in the treatment of military personnel in research, overall attitudes toward clinical trials were favorable and were especially positive when the possibility of improving cancer care for fellow Veterans was considered. In approaching Veterans regarding participation in a clinical trial we recommend education aligned with the literacy level of the Veteran, involvement of the VA primary care provider in clinical trial decisions, and awareness of a Veteran's altruism to help others.

Development of a Digital Research Assistant for the Management of Patients' Enrollment in Oncology Clinical Trials within a Research Hospital.

Clinical trials in cancer treatment are imperative in enhancing patients’ survival and quality of life outcomes. The lack of communication among professionals may produce a non-optimization of patients’ accrual in clinical trials. We developed a specific platform, called “Digital Research Assistant” (DRA), to report real-time every available clinical trial and support clinician. Healthcare professionals involved in breast cancer working group agreed nine minimal fields of interest to preliminarily classify the characteristics of patients’ records (including omic data, such as genomic mutations). A progressive web app (PWA) was developed to implement a cross-platform software that was scalable on several electronic devices to share the patients’ records and clinical trials. A specialist is able to use and populate the platform. An AI algorithm helps in the matchmaking between patient’s data and clinical trial’s inclusion criteria to personalize patient enrollment. At the same time, an easy configuration allows the application of the DRA in different oncology working groups (from breast cancer to lung cancer). The DRA might represent a valid research tool supporting clinicians and scientists, in order to optimize the enrollment of patients in clinical trials. User Experience and Technology The acceptance of participants using the DRA is topic of a future analysis.

Effectively Conducting Oncology Clinical Trials During the COVID-19 Pandemic

PurposeClinical trial enrollment has declined globally as a result of the coronavirus disease 2019 (COVID-19) pandemic. This underscores the importance of structured methods to continue critical medical research safely and efficiently. Methods and MaterialsWe report the effect of a phased trial reopening strategy, remote research staffing, and telemedicine on cancer trial enrollment at one of the largest radiation oncology academic cancer centers. In phase 1, trials investigating definitive therapeutic benefit were opened, followed by trials not increasing patient exposure or pulmonary toxicity risk in phase 2. During phase 2.5, multicenter trials reopened and limited research staff were allowed on site. ResultsDespite initial enrollment declines during the early pandemic, the percentage of new patients enrolling in clinical trials from March to August 2020 was 8.8%, and represented a 10.5% relative increase from 2019. Monthly accrual enrollment from March to August 2019 ranged from 42 to 71, compared with enrollment during COVID-19 from 23 to 73 patients (P < .001). ConclusionsThrough a phased approach to trial reopening and adaptive techniques, the division of radiation oncology maintained cancer trial accrual during the COVID-19 pandemic. The experience may help centers maintain accrual, preserve clinical trial integrity, and minimize risk to patients and staff.

Abstract OT-08-02: Comparing an operation to monitoring, with or without endocrine therapy (COMET): A prospective randomized trial for low-risk DCIS (AFT-25)

Abstract Background: Approximately 50,000 women in the U.S. are diagnosed with ductal carcinoma in situ (DCIS) annually. Without treatment, it is estimated that 20-30% of DCIS will lead to invasive breast cancer. Currently, more than 97% of women undergo surgery, with many also undergoing radiation. An alternative to surgery for low-risk DCIS is active monitoring (AM), an approach in which regularly scheduled mammography and physical exams are used to monitor breast changes and determine if, or when, surgery is needed. Trial design: COMET, a multicenter phase III prospective randomized trial, opened in the U.S. in June 2017 (clinicaltrials.gov reference: NCT02926911). The hypothesis is that management of low-risk DCIS using an AM approach does not yield inferior invasive breast cancer and/or quality of life outcomes compared to surgery. Eligibility criteria: Patients with a new diagnosis of unilateral, bilateral, unifocal, multifocal, or multicentric DCIS, or atypia verging on DCIS are eligible. Patients must be ≥40 years of age, have no contraindication for surgery, and pathologic confirmation of grade I/II DCIS. DCIS must be ER and/or PR≥ 10% and HER2-negative without invasion, diagnosed within 120 days of registration. Breast tissue, blood and imaging are collected at trial entry and if invasive cancer subsequently occurs, and are stored in central repositories. Specific aims: The primary aim is to assess whether the 2-yr ipsilateral invasive breast cancer rate for AM is non-inferior to surgery. Secondary aims include comparison of 2-, 5-, and 10-yr mastectomy rate, contralateral invasive breast cancer rate, overall survival and invasive breast cancer-specific survival, as well as 5- and 10-yr ipsilateral invasive breast cancer rate between groups. Patient reported outcomes (PRO) using validated tools are critical secondary endpoints, and will enable comparison of health-related quality of life and psychosocial outcomes between surgery and AM groups at prespecified time points over a period of 5 years. Statistical methods: An accrual goal of 1200 was estimated using a 2-group test of noninferiority of proportions, with the 2-yr invasive breast cancer rate in the surgery group assumed to be 0.10, including accounting for upstaging. The projected drop-out rate is 25%, for a total of 900 patients treated per allocation arm. The non-inferiority boundary was set at 0.05. Based on a 1-sided un-pooled z-test, with alpha=0.05, a sample size of n=446 per group will have 80% power to detect the specified noninferiority margin. Intention-to-treat analysis of the 2-yr invasive breast cancer rate will be conducted using all patients as randomized, and will be completed using Kaplan-Meier estimates, stratified by group, combined with Greenwood’s confidence interval. Several sensitivity analyses (per protocol, as-treated, and instrumental variable) are also planned to account for loss of follow-up, rejection of randomization allocation and withdrawals. Present and target accrual: Trial accrual as of 7/1/20 is 540 randomized patients from 84 activated Alliance for Clinical Trials in Oncology sites. Despite logistical challenges posed by the COVID-19 crisis, patients continue to be recruited to the COMET trial. Over 80% of patients have sample sets/images stored in the tissue and image repositories. This trial will provide definitive clinical, quality of life and biomarker evidence regarding the trade-offs of surgery vs AM in patients with low-risk DCIS. Support: CER-1503-29572; https://acknowledgments.alliancefound.org Contact: Thomas Lynch (Project Manager) - thomas.lynch2@duke.edu Citation Format: Thomas Lynch, Ann Partridge, Alastair Thompson, Elizabeth Frank, Donna Pinto, Deborah Collyar, Desiree Basila, Louise Davies, Jenny Donovan, Terry Hyslop, Linda McCall, Marc Ryser, Taylor O' Donnell, Anna Weiss, Shelley Hwang. Comparing an operation to monitoring, with or without endocrine therapy (COMET): A prospective randomized trial for low-risk DCIS (AFT-25) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-08-02.

Impact of Organ Function-Based Clinical Trial Eligibility Criteria in Patients With Diffuse Large B-Cell Lymphoma: Who Gets Left Behind?

Exclusion of patients needing urgent treatment or requiring novel biomarkers before enrollment has impacted the ability to enroll real-world patients in frontline trials of diffuse large B-cell lymphoma (DLBCL). The impact of baseline organ function-based eligibility criteria on this effect and clinical trial exclusion is less well-understood. Consecutive patients with newly diagnosed lymphoma were enrolled from 2002 to 2015 into the Molecular Epidemiology Resource (MER) of the University of Iowa and Mayo Clinic Lymphoma Specialized Program of Research Excellence. The current analysis includes 1,265 patients with DLBCL receiving standard immunochemotherapy. Organ function parameters were identified from criteria for hemoglobin, absolute neutrophil count, platelet count, creatinine clearance, and bilirubin, as reported in frontline DLBCL trials. Abstracted laboratory values from MER were used to determine the percent (%) of patients excluded. Outcomes and cause-of-death analyses comparing ineligible and eligible groups in MER were conducted. An interactive online tool was developed to estimate exclusions based on organ function for future trial design. Between 9% and 24% of MER patients with DLBCL receiving standard immunochemotherapy were excluded on the basis of baseline organ function alone. Ineligible patients based on organ function had significantly inferior event-free survival (hazard ratios, 1.67-2.16), overall survival (hazard ratios, 1.87-2.56), and event-free survival at 24 months (odds ratio, 1.71-2.16). Ineligible patients were more likely to die from lymphoma progression than increased therapy-related complications. Current national and international trials exclude up to 24% of patients from participation on the basis of organ function alone. A significant difference in the outcomes, notably lymphoma-related death, suggests issues with generalization and potential exclusion of high-risk patients. These data will help future clinical trial development and meet US Food and Drug Administration and ASCO recommendations to increase trial accrual.

Handling Poor Accrual in Pediatric Trials: A Simulation Study Using a Bayesian Approach.

In the conduction of trials, a common situation is related to potential difficulties in recruiting the planned sample size as provided by the study design. A Bayesian analysis of such trials might provide a framework to combine prior evidence with current evidence, and it is an accepted approach by regulatory agencies. However, especially for small trials, the Bayesian inference may be severely conditioned by the prior choices. The Renal Scarring Urinary Infection (RESCUE) trial, a pediatric trial that was a candidate for early termination due to underrecruitment, served as a motivating example to investigate the effects of the prior choices on small trial inference. The trial outcomes were simulated by assuming 50 scenarios combining different sample sizes and true absolute risk reduction (ARR). The simulated data were analyzed via the Bayesian approach using 0%, 50%, and 100% discounting factors on the beta power prior. An informative inference (0% discounting) on small samples could generate data-insensitive results. Instead, the 50% discounting factor ensured that the probability of confirming the trial outcome was higher than 80%, but only for an ARR higher than 0.17. A suitable option to maintain data relevant to the trial inference is to define a discounting factor based on the prior parameters. Nevertheless, a sensitivity analysis of the prior choices is highly recommended.

Reimbursement Matters: Overcoming Barriers to Clinical Trial Accrual.

Accrual to cancer clinical trials is suboptimal. Few data exist regarding whether financial reimbursement might increase accruals. The objective of this study was to assess perceptions about reimbursement to overcome barriers to trial accrual. This was a cross-sectional survey. Oncologists identified from the American Medical Association Physician Masterfile. We report descriptive statistics, associations of physician characteristics with perceptions of reimbursement, domains, and subthemes of free-text comments. Respondents (n=1030) were mostly medical oncologists (59.4%), ages 35-54 (67%), and male (75%). Overall, 30% reported discussing trials with >25% of patients. Barriers perceived were administrative/regulatory, physician/staff time, and eligibility criteria. National Cancer Institute cooperative group participants and practice owners were more likely to endorse higher reimbursement. Respondents indicated targeted reimbursement would help improve infrastructure, but also noted potential ethical problems with reimbursement for discussion (40.7%) and accrual (85.9%). Free-text comments addressed reimbursement sources, recipients, and concerns about the real and apparent conflict of interest. Though concerns about a potential conflict of interest remain paramount and must be addressed in any new system of reimbursement, oncologists believe reimbursement to enhance infrastructure could help overcome barriers to trial accrual.

Integrating Patient-Centred Research in the Canadian Cancer Trials Group.

The inclusion of patients as partners in research is a key link in the delivery of patient-centred care in healthcare systems. Despite genuine intentions to engage patients in authentic partnerships, efforts can result in tokenism and benefits of engagement are missed. Understanding how patient engagement provides value along the research to patient-care continuum and how to best engage patients as partners are key. This document describes the method taken by the Canadian Cancer Trials Group (CCTG) to implement meaningful patient centricity and engagement and the benefits realized. Originally, Patient Representatives were recruited and assigned to CCTG Committees. Lacking guidance, the role was one of a passive meeting attendee. A gap analysis identified a need for clarity in expectations, understanding of the linkage to CCTG strategic objectives, and supporting tools and training. A plan was developed and successfully implemented in three phases, each phase building on the previous, the level of patient engagement simultaneously changing from “Inform” to “Involve” to “Collaborate” on the International Association for Public Participation (IAP2) scale. Results include significant contributions to increased patient accrual in CCTG trials, to increased CCTG grant funding, as well as recognition and adoption of these practices within Canada and internationally.

Deploying an AI-based online search tool to increase patients’ access to and understanding of solid tumor GI clinical trials.

456 Background: The number and complexity of clinical trials has been growing, making finding and accessing trials increasingly challenging. Additionally, the goal of representative trial populations remains elusive with sometimes devastating medical consequences. A key barrier to increasing recruitment efficiency is patients’ low awareness of clinical trials as an option. They rarely hear about trials from their oncologists, unless they are based at a research center, which introduces trial population biases by including only patients with good healthcare access. And even if patients decide to search for information on trials themselves, the information is difficult to understand. There are existing trial search tools, but they have multiple shortcomings: complex navigation, limited search functionality, clinical trial data is too complex for non-specialists to understand, and lack of clarity on next steps. Methods: Access to trials via a novel trial search tool (www.ancora.ai) which uses AI to restructure trial information was the main focus of this study. For increased GI cancer specificity, 6 key GI cancers were included into the AI model and information was restructured based on key eligibility differentiators identified (see data structure table). Research participants (xx GI oncology patients) were recruited with the support of patient associations (e.g. The Colon Club) leveraging social media. They were asked to complete a 20 minute survey evaluating both an established tool (clinicaltrials.gov) and the novel tool to find trials relevant for them. They had to assess different aspects of the tools’ usability on a 5-level Likert scale. Survey results were analyzed in MS Excel, using built-in statistical functions (mean, standard deviation, student’s t-test). Results: Please note the survey is ongoing and results will be updated. Current survey respondents had a base level of awareness of clinical trials (3.1±1.2), with patient associations and the internet as leading information sources. The novel tool seemed to make it easier to find trials (3.7±0.9 vs. 2.7±1.3), showed an improvement in ease of understanding information presented (3.8±1.1 vs. 2.6±1.3) and directionally provided more clarity on what next steps towards trial enrollment would be (4.2±0.8 vs. 3.7±1.4). Overall, this led to higher patient satisfaction (3.4±1.1 vs. 2.3±0.5). Conclusions: Novel patient-focused, AI-driven clinical trial support tools can unlock trial access for all patients. Democratizing trial information will not only increase trial accrual, but also patient satisfaction while reducing disparities. [Table: see text]

Abstract PO-231: Development and evaluation of a theory-based, multilevel intervention to improve the delivery of timely, guideline-adherent adjuvant therapy for patients with head and neck cancer

Abstract Background: Delays initiating guideline-adherent postoperative radiation therapy (PORT) in head and neck squamous cell carcinoma (HNSCC) occur in more than 50% of patients and are key drivers of excess mortality and racial disparities in survival. Theory-based multilevel interventions to address delays and racial disparities in timely PORT have not been described and effective interventions to improve timely, equitable PORT are lacking. Purpose: This study aims to describe the development of NDURE (Navigation for Disparities and Untimely Radiation Therapy), a novel theory- based, multilevel intervention to decrease delays starting PORT and evaluate its feasibility, acceptability, and preliminary clinical efficacy. Methods: An intervention mapping approach was used to develop NDURE. Consecutive patients with locally- advanced HNSCC undergoing surgery and PORT were enrolled into a single-arm clinical trial. Results: NDURE targets the determinants of timely, guideline-adherent PORT through the following core functions: 1) patient education, 2) standardization of the process for initiating the discussion of PORT, 3) PORT care plans, 4) provider role definition, 5) referral tracking and follow-up, and 6) transportation assistance. NDURE was feasible, as judged by trial accrual (88% overall; 100% for African Americans) and dropout (n=0). 100% of patients reported moderate/strong agreement that NDURE helped solve challenges starting PORT; 86% were highly likely to recommend NDURE. The rate of timely, guideline-adherent PORT was 86% overall and 100% for African Americans. Conclusions: NDURE is a novel, theory-based, multilevel intervention targeting determinants of timely PORT among HNSCC patients. NDURE is feasible, acceptable, and has potential to improve the timely, equitable, guideline-adherent PORT. These results support conducting a randomized controlled trial to test NDURE’s clinical efficacy. clinicaltrials.gov number NCT04030130 Citation Format: Evan M. Graboyes, Katherine R. Sterba, Hong Li, Graham Warren, Anthony J. Alberg, Elizabeth A. Calhoun, Brian Nussenbaum, Jessica McCay, Courtney H. Marsh, David M. Neskey, John Kaczmar, Anand K. Sharma, Jennifer Harper, Terry A. Day, Chanita Hughes Halbert. Development and evaluation of a theory-based, multilevel intervention to improve the delivery of timely, guideline-adherent adjuvant therapy for patients with head and neck cancer [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-231.

The Impact of COVID-19 on Cancer Clinical Trials Conducted by NCI-Designated Comprehensive Cancer Centers.

The Impact of COVID-19 on Cancer Clinical Trials Conducted by NCI-Designated Comprehensive Cancer Centers.

Age-Based Disparities in Clinical Trials Supporting FDA Approval of Therapies for Hematologic Malignancies

Introduction: Older adults comprise the largest proportion of patients diagnosed with hematologic malignancies, with most new cases occurring in adults age 65 years and older. The under-representation of older adults in oncology clinical trials has been previously described, however data specific to hematologic malignancy trials is sparse. We conducted an analysis of the trials supporting Food and Drug Administration approval of new hematologic malignancy therapies over a 5-year period to evaluate the median age of participants and compared it to the real-world age distribution for the respective malignancy. Methods: Prescribing information for novel new hematologic malignancy therapies that were first approved for an indication in adult patients between 2015 and 2019 was reviewed for the median age in the evaluable population of the supporting clinical trials. Pediatric indications were excluded. Median age estimates among adults for each indication were obtained from the Surveillance, Epidemiology and End Results database. The difference in median age (DMA) was calculated for each trial by subtracting the median age in the disease population from the median age in the trial (Ludmir et al, JAMA Onc 2019). Additional details on trial protocols were obtained from approval packages accessed in the Drugs@FDA database and FDA's Office of Tissues and Advanced Therapies approvals website. Data are presented using descriptive statistics. Results: A total of 22 hematological malignancy therapies were approved based on 26 trials, with 6033 patients in the evaluable populations. Less than half of the trials were phase 3 (10; 38%) or were randomized with a control group (11; 42%). The median age of the trial participants was a mean of 3.8 years younger than the median age of the disease populations (95% CI: −6.0 to −1.6 years; p&amp;lt;0.01). By indication (Table), acute myeloid leukemia trials most often enrolled younger participants (mean DMA -7.8 years), followed by large B-cell lymphoma trials (mean DMA -7.0 years). The protocols for the majority of the trials (24; 92%) did not specify upper age limits, however most required an ECOG performance status ≤2, with only 2 trials (8%) permitting ECOG status 0-3. All trials had eligibility restrictions related to comorbidities, organ function, or hematopoietic function. Conclusions: The median age of hematologic malignancy clinical trial participants was nearly 4 years younger than their respective disease populations, despite few trial protocols having upper age limits. Poor performance status, the presence of comorbidities, or organ/hematopoietic impairment may have contributed to older patients' ineligibility to participate in the trials. Adequate representation in clinical trials is critical to evaluate the safety and efficacy of new therapies in the patient population who will eventually receive them. Given the inherent limitations of clinical trial design and accrual on older patient inclusion, post-approval real-world research is needed to understand the effect of these therapies on older adults. Disclosures Gajra: Cardinal Health: Current Employment. Zettler:Cardinal Health: Current Employment. Phillips Jr.:Cardinal Health: Current Employment. Feinberg:Cardinal Health: Current Employment.

Assessing Genitourinary Cancer Clinical Trial Accrual Sufficiency Using Archived Trial Data.

Clinical trials often fail to reach their anticipated end points, most frequently because of poor accrual. Prior studies have analyzed trial termination, but it has not been easy to assess accrual estimates using international databases such as ClinicalTrials.gov because of limitations in accessing accrual information. Specifically, it is not easy to extract both anticipated and actual accrual of clinical trials. We designed a new algorithmic approach to extracting trial accrual data from ClinicalTrials.gov and used it to estimate the sufficiency of patient accrual onto genitourinary (GU) cancer trials. We queried ClinicalTrials.gov for completed/terminated phase II and III clinical trials for prostate, bladder, kidney, testicular, and ureteral cancers registered after 2007. We extracted trial characteristics from available XML files. We then used a Python algorithm to access prior trial registrations on the ClinicalTrials.gov archive site and extract both anticipated and actual accrual numbers. We then compared the actual accrual of each trial to its anticipated accrual and defined sufficient accrual as 85% of anticipated accrual. The algorithm was 100% accurate compared with hand extraction in a small validation subset. A total of 925 trials were included, of which 840 (91%) had both anticipated and actual accrual. Only 418 (50%) trials had sufficient accrual (≥ 85% of anticipated). Considering only trials marked as successfully completed, 395/597 (66%) reached sufficient accrual. GU cancer trials often do not meet their anticipated accrual goals. New approaches to trial conduct are direly needed. Our reproducible and scalable approach to extracting accrual information can be applied to analysis of ClinicalTrials.gov in future analyses in the hope of improving the efficiency of the clinical trials enterprise.

Utilization of telemedicine to meet the demand throughout the COVID-19 pandemic at a community oncology practice.

263 Background: A large community oncology practice in Tennessee participates in value-based payment arrangements, the success of which depends on close patient monitoring. Telemedicine as an innovative solution was initiated in 2017. The service was limited, due to regulation, licensure requirements, and lack of reimbursement, to survivorship visits, clinical trial consent visits, rural hospital consults and genetic counseling. During the COVID pandemic and loosening of restrictions, telemedicine services were expanded. Methods: We identified a cloud-based platform that allowed patients to use any device with a camera and microphone and required no software downloads. On-line training sessions were provided to clinical staff. All training and workflow implementation were completed in a 2-week time frame. Telemedicine was expanded to include surveillance, urgent care, psychology, palliative care and post-BMT visits as well as new patient consults for medical, radiation and gynecologic oncology patients. Patient satisfaction surveys were administered. Results: Our telemedicine visits increased weekly beginning March 1, peaking in the month of April with an average of 77 scheduled telemedicine visits per day across the practice. During the month of April, our practice saw a record clinical trial accrual in our Phase-1 Drug Development Unit with a 22% increase over the previous average. Patients who responded to a satisfaction survey were highly satisfied with the telemedicine visit with a 73% positive response rate. Nearly half of our eligible patients did not have the technology or broad-band access to be able to participate in telemedicine. Conclusions: Our prior experience with telemedicine, though limited, facilitated the development of an infrastructure that provided adequate number of devices and internet bandwidth capacity to support rapid expansion of telemedicine. We were able to maintain high quality care and access to clinical trials during the pandemic and see the value of this service long-term. We hope to add tele-pharmacy and care coordination services. Political leadership and patient advocacy groups should explore ways to ensure that all patients may benefit from this technology, especially those in under-served areas.

A provider-focused, point-of-care technology to improve clinical trial accrual.

309 Background: Low accrual to clinical trials is a significant burden to advancing research efforts, particularly detrimental to patients who may benefit clinically from enrollment in a promising trial. Low accrual has been linked to a lack of provider awareness of clinical trials at the point of care and current technology solutions have not adequately addressed this important issue. Methods: We aimed to develop a system to improve clinical trial access for patients throughout UCLA Hematology-Oncology through the development of a point of care web-based tool to allow providers to easily identify available clinical trials for their patients. First, we built a comprehensive database of current clinical trials at UCLA, with special emphasis on streamlined exclusion/inclusion criteria. We incorporated this database into a front-end web and mobile-responsive tool with a user-friendly interface allowing users to rapidly identify patients eligible for clinical trial enrollment. We launched this tool 1/15/2019 to 56 oncologists at UCLA Health. Results: From 1/15/19 to 6/14/19 we had had a total of 713 unique logins to the clinical trials website. This included “academic oncologists,” those oncologists specializing in a particular disease sub-type and often a ‘hub’ for clinical trials, with an average of 6.4 logins per oncologist, and “community oncologists” with an average of 18.8 logins per oncologist over that time frame. A brief survey of users who logged in over 4 times during that time revealed that on average, 4-5 additional patients per user were screened for clinical trials not previously identified. Conclusions: Clinical trial accrual can be enhanced through improved provider awareness of available trials at the point-of-care. A well-designed user interface with features to help facilitate provider navigation to available trials and quick inclusion and exclusion criteria were critical to the success of the tool. Although the web-based tool achieved its primary purpose in improving clinical trial awareness, its utility diminished over time due to the lack of real-time updates of trial data. Based on provider feedback, if the available trial data can be updated and maintained on a regular basis, this can be a valuable tool to improve clinical trial awareness and subsequently, accrual.

Revisiting Barriers to Clinical Trials Accrual.

Revisiting Barriers to Clinical Trials Accrual.

Experts discuss cancer care and research in the age of COVID-19: Findings presented at the American Association for Cancer Research's virtual meeting could shift clinicians' thinking about immunotherapy and point to encouraging changes in the way that clinical trials are being conducted during the pandemic.

Experts discuss cancer care and research in the age of COVID-19: Findings presented at the American Association for Cancer Research's virtual meeting could shift clinicians' thinking about immunotherapy and point to encouraging changes in the way that clinical trials are being conducted during the pandemic.

Increasing accrual of minority patients in breast cancer clinical trials.

Black and Hispanic patients participate in clinical trials at lower rates than white patients nationally; lack of diversity in clinical trials prevents appropriate safety and efficacy testing of new treatments in these populations. The Oncology Welcomes New Haven into Trials (OWN IT) initiative at the Yale Cancer Center used a multi-tiered approach to improve breast cancer minority clinical trial accrual through community focus groups, ongoing community outreach, institutional executive council representation, grand rounds presentation, and didactic lectures with healthcare providers. Eligibility criteria of breast cancer trials at Smilow Cancer Center were reviewed using clinicaltrials.gov. Also, an anonymous, 5-min survey was conducted at regular visits with Smilow Breast Center patients to gauge awareness of and access to clinical trials. Survey data were compared to the Yale Cancer Center Clinical Trials Office, Connecticut Tumor Registry, and U.S. Census records. Two-tailed Fisher's tests were used for all analyses. There was a significant increase in the number of minority patients who participated in clinical trials at Smilow Cancer Center from 2016 (95/750) to 2018 (155/944) (p = 0.0325). Two hundred patients participated in the survey; response rate 92%. There was no significant difference in the rate at which patients were invited to participate in clinical trials or the rate at which they declined to participate based on race or ethnicity. Black and Hispanic patients were significantly less likely to be aware of clinical trials than white patients (p < .001). The review of eligibility criteria showed that over half of the studies reviewed had restrictions regarding increased liver function tests, and many restricted the participation of patients with other chronic conditions. Low participation in clinical trials among black and Hispanic patients is likely multifaceted. This study indicated that there are likely structural factors at work which can be modified with institutional effort. The role of patient education regarding clinical trials and accrual should be studied further as should eligibility criteria as a potential barrier to participation.

Association of Industry Sponsorship With Cancer Clinical Trial Accrual

Association of Industry Sponsorship With Cancer Clinical Trial Accrual