Clinical Trial Accrual Research Articles

Novel use of clinical pathways to improve clinical trial accrual.

414 Background: Fewer than 10% of adult cancer patients participate in clinical trials. Clinical pathways platforms have traditionally sought to improve trial accrual by displaying available trials for eligible patients. Our team explored how Pathways navigation data can also be used to identify eligible patients of poorly accruing trials and provide study investigators with a near real-time data feed of those patients. Methods: Providers at Dana-Farber Cancer Institute are asked to navigate the pathways decision-support platform and order systemic cancer therapies 7 days in advance of administration to assist with authorization. We invited Principal Investigators (PIs) of poorly accruing trials to collaborate with our Pathways data team through our Pathways to Accrual to Clinical Trials (PACT) service. Through PACT, PIs are informed of patients who were navigated to nodes involving the trial in question but received standard therapy instead. PIs are given access to a Tableau Dashboard that is updated with new data daily and receive weekly reminders about the dashboard. The current analysis includes two trials that have been using PACT for at least one year. We reviewed monthly trial accrual rates from the time of the trials opening until March 2024. The dataset did not meet criteria for Poisson analysis, so Fischer’s exact test was used to compare accrual rates. We ensured the denominator of potentially eligible patients was relatively consistent. Results: DF-21-519 accrued 16 patients over 14 months prior to PACT and 33 patients over 12 months using PACT. DF-22-028 accrued 0 patients over 6 months prior to PACT and 12 patients over 14 months using PACT. Collectively, use of PACT more than doubled accrual rates for the involved trials (one-tailed p = 0.048). Conclusions: A real-time Pathways data feed can be used to identify patients for appropriate clinical resources. Here, we show how our PACT program helped to more than double clinical trial accrual for the involved studies. Scaling this technology across a broader swath of clinical trials could be an important advance for trial participation for users of this pathways platform. Trial Accruals, Pre PACT Accrual Rate, Pre PACT (Accruals/month) Accruals, Post PACT Accrual Rate, Post PACT (Accruals/month) DF-21-519 16 accruals in 14 mo 1.14 33 accruals in 12 mo 2.75 DF-22-028 0 accruals in 6 mo 0 12 accruals in 14 mo 0.86 Total 16 accruals in 20 mo 0.8 45 accruals in 26 mo 1.73 one-tailed p is 0.048

Building partnerships to improve clinical trial accrual in rural and Native American communities through community health educator interventions.

180 Background: Rural populations and racial minorities are often underrepresented in cancer clinical trials. The low representation is determined by multilevel factors, including lack of geographic access to facilities in rural locations and mistrust in the medical and scientific community. Presented here are partial results of an educational intervention to improve clinical trials-related knowledge among rural residents and racial minorities. Methods: The Center to Reduce Cancer Health Disparities (CRCHD) from the National Cancer Institute (NCI) developed the study materials, that were available in English or Spanish, to be utilized according to participants' preferences. The University of Wisconsin Carbone Cancer Center implemented this intervention in northern Wisconsin, which consisted of a baseline questionnaire, a recorded educational intervention, and a post-educational questionnaire. The chosen community is largely rural and Native. The questionnaires consisted of 11-knowledge- and 6-intention-related questions. After being screened by the rural Community Health Educator (CHE), subjects self-administered the intervention online or received the intervention from the CHE during tribal or other educational group events in rural communities. Results: Between January and May 2024, 62 participants started the intervention. Participants’ mean age was 45.1 (±15.36) years, 64.5% (40/62) were female, and 53.2% (33/62) self-identified as American Indian/ Alaska Native. All resided in rural community, defined as Rural-Urban Continuum Codes 7 or 8. Three participants did not respond to the post-educational questionnaire, and one skipped its intentions section. Although the two questions about informed consent presented the highest percent of correct answers post-intervention, the median total knowledge score pre and post-intervention remained the same (p>0.05). Post-intervention, participants more often agreed it is important for minority groups to participate in clinical trials, reported being likely to search for a clinical trial they might be eligible for, join a clinical trial, and talk to family/friends about joining a clinical trial (p<0.05). Conclusions: The CHE successfully engaged rural community members to participate in the intervention. In addition, the intervention facilitated building trust and partnerships for future cancer-related community driven work.

Abatement of the Survival Cliff in Older Adolescents and Young Adults with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma in the United States.

Purpose: In 2018, a "survival cliff" in the United States was identified among older adolescent and young adult (AYA) patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). This study reassessed the cliff and associated putative causes. Methods: Survival data were obtained using the U.S. Surveillance Research Program, National Cancer Institute (NCI) SEER 22 Registries. Accrual data on cancer treatment trials conducted by the NCI cooperative groups and NCI-designated cancer centers were obtained from the NCI Cancer Therapy Evaluation Program. Trend and average percent changes and statistical significances were identified with the NCI Joinpoint Regression Program. Results: A previous cliff-like decrement in the survival of 17- to 20-year-olds is no longer apparent, overall and in all racial and ethnic groups. The "survival cliff" age range was coincident with a clinical trial accrual cliff, and both diminished when more clinical trials were available to, and participated in by, young adult patients. Older AYA patients of ages 30-39 had minimal improvement in clinical trial accrual and least survival gain among the AYA age group. Conclusion: The survival cliff has abated, resulting in thousands of fewer premature deaths and tens of thousands of years of life saved-a remarkable achievement. The survival improvement may be attributed to improved clinical trial availability for and recruitment and participation of AYAs on treatment trials, application of pediatric-inspired ALL treatment regimens to AYAs, expanded national health insurance for -18 to 25 year olds, improved AYA cancer services, and a national focus on AYA oncology.

674P Patient enrollment per month (accrual) in clinical trials leading to the FDA approval of new cancer drugs

674P Patient enrollment per month (accrual) in clinical trials leading to the FDA approval of new cancer drugs

Breast cancer clinical trial participation among diverse patients at a comprehensive cancer center

This study was designed to determine the enrollment patterns in breast cancer clinical trials (CCTs) of patients with diverse backgrounds in an equal access setting and to evaluate the factors contributing to low rates of clinical trial accrual in patients of low socioeconomic status (SES). We performed a retrospective review of a prospectively maintained database of new patients seen at the Dan L. Duncan Comprehensive Cancer Center dating from 5/2015 to 9/2021, which included 3043 patients screened for breast CCTs. We compared the rate of CCT availability, eligibility, and enrollment between two patient populations: Smith Clinic, where most patients are of low SES and uninsured, and Baylor St. Luke’s Medical Center (BSLMC) with mostly predominantly insured, higher income patients. We performed logistic regression to evaluate whether differences in age, clinic, race, trial type, and primary language may be underlying the differences in CCT enrollment. More patients were eligible for CCTs at Smith Clinic (53.7% vs 44.7%, p < 0.001). However, Smith Clinic patients were more likely to decline CCT enrollment compared to BSLMC (61.3% declined vs 39.4%, p < 0.001). On multivariate analysis, Black patients had a significantly higher rate of CCT refusal overall (OR = 0.26, 95% CI 0.12–0.56, p < 0.001) and BSLMC only (OR = 0.20, 95% CI 0.060–0.60, p = 0.006). Our data shows that it is likely an oversimplification to assume that equal access will lead to the elimination of CCT disparities. Efforts to diversify CCTs must include consideration of structural and institutional inequities as well as social needs.

Patient Enrollment per Month (Accrual) in Clinical Trials Leading to the FDA Approval of New Cancer Drugs.

Insufficient patient enrollment per month (=accrual) is the leading cause of cancer trial termination. To identify and quantify factors associated with patient accrual in trials leading to the US Food and Drug Administration (FDA) approval of new cancer drugs. All anti-cancer drugs with FDA approval were identified in the Drugs@FDA database (2000-2022). Data on drug indication's background-, treatment-, disease-, and trial-related factors were collected from FDA labels, clinicaltrials.gov, and the Global Burden of Disease study. The association between patient accrual and collected variables was assessed in Poisson regression models reporting adjusted rate ratios (aRR). We identified 170 drugs with approval in 455 cancer indications on the basis of 292 randomized and 163 single-arm trials. Among randomized trials, median enrollment per month was 38 patients (interquartile range [IQR]: 26-54) for non-orphan, 21 (IQR: 15-38, aRR 0.88, p = 0.361) for common orphan, 20 (IQR: 10-35, aRR 0.73, p <0.001) for rare orphan, and 8 (IQR 6-12, aRR 0.30, p < 0.001) for ultra-rare orphan indications. Patient enrollment was positively associated with disease burden [aRR: 1.0003 per disability-adjusted life year (DALY), p < 0.001), trial sites (aRR: 1.001 per site, p < 0.001), participating countries (aRR: 1.02 per country, p < 0.001), and phase 3 vs. 1/2 trials (aRR: 1.64, p = 0.037). Enrollment was negatively associated with advanced-line vs. first-line treatments (aRR: 0.81, p = 0.010) and monotherapy vs. combination treatments (aRR: 0.80, p = 0.007). Patient enrollment per month was similar between indications with and without a biomarker (median: 27 vs. 32, aRR 0.80, p = 0.117). Patient enrollment per month was substantially lower in government-sponsored than industry-sponsored trials (median: 14 vs. 32, aRR 0.80, p = 0.209). Enrollment was not associated with randomization ratios, crossover, and study blinding. Disease incidence and disease burden alongside the number of study sites and participating countries are the main drivers of patient enrollment in clinical trials. For rare disease trials, greater financial incentives could help expedite patient enrollment. Novel trial design features, including skewed randomization, crossover, or open-label masking, did not entice patient enrollment.

Telehealth Utilization in Neuro-Oncology: Commentary on a Single Institution Experience After the COVID-19 Pandemic.

During the COVID-19 pandemic, regulatory and reimbursement policy changes provided patients improved access to neuro-oncology by telehealth. Here we discuss benefits and limitations of telehealth use in neuro-oncology. We review utilization of telemedicine services following the COVID-19 pandemic. Utilization of telemedicine by neuro-oncology during the COVID-19 pandemic was 52%, compared to 27-29% for other solid tumors groups. Following the pandemic, between January 2021 and April 2024, telehealth utilization has remained high in neuro-oncology with approximately 30% of all visits completed by telemedicine, compared to 10-15% for other solid tumor groups. The striking difference between telehealth visit utilization in neuro-oncology and general medical oncology even after expiration of the COVID-19 Public Health Emergency expiration and end of pandemic-related restrictions, underscores the potential value of convenient access to care for patients with central nervous system tumors. Given widespread use of telehealth in neuro-oncology, prospective evaluation to determine the safety, usability, and acceptance of video-enabled, telehealth visits is critical. Such data may lead to broader adoption of telehealth, lead to regulatory and reimbursement reform for telehealth sustainability, and improve clinical trial access and accruals.

Improving diversity in phase I oncology clinical trials: A single institution experience at the University of Colorado Cancer Center.

e13687 Background: Despite continued improvements in cancer outcomes, disparities persist between racial, ethnic, and socioeconomic groups. One potential driver is the lack of appropriate representation in clinical trials, including dose-finding studies. We implemented a set of initiatives including patient education, outreach, a Spanish-speaking bicultural clinic, and regular review of enrollment by race and ethnicity. To investigate the impact of these initiatives, we examined phase I clinical trial patient demographics and treatment outcomes before and after the intervention. Methods: We performed a retrospective review of patients enrolled in 2018-2019 (cohort 1[C1], pre- intervention) and 2022-2023 (cohort 2[C2], post-intervention). We collected patient demographics, area deprivation index (ADI), body mass index (BMI), ECOG performance status, and tumor type. Differences between cohorts were evaluated with T-tests, Chi-Square test, or the Fisher Exact test. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method. Hazard ratios (HR), confidence intervals (CI) and p values were derived using the cox proportional hazards method. A multivariable model for patients with colorectal cancers (CRC) was selected using the Akaike information criterion (AIC). Results: A total of 361 patients (C1 n = 209, C2 n = 152) were included. Overall, 52.4% of patients were female. The most common tumor sites were CRC (18.3%), pancreas (11.9%) and breast (10.8%). Study participants were 85.0% White, 3.3% Asian, 1.4% Black and 9.1% Hispanic, compared to cancer incidence in Colorado of 92.8%, 1.6% and 3.3% and 10.0%, respectively. Following our intervention, there was an increase in language preference other than English from 1.9% (4/209) to 6.6% (10/152) (p = 0.028) and in translated consents from 1.4% (3/209) to 5.9% (9/152) (p = 0.033). There was no statistically significant difference in race, ethnicity, insurance, or tumor type, although there was a non-statistically significant increase in Hispanic patients from 8.1% to 10.5%. Median PFS improved from 1.9 to 2.8 months (HR = 0.72, 95% CI 0.57-0.90, p = 0.003). ECOG 1 v. 0 was associated with inferior OS (HR = 1.35, 95% CI 1.06-1.73, p = 0.017), and BMI ≥18.5 v. &lt;18.5 was associated with superior OS (HR = 0.59, 95% CI 0.37-0.95, p = 0.03). AIC model of CRC (n = 66) revealed that ADI scores of 6-10 were associated with worse PFS and OS (p = 0.022 and p = 0.001, respectively). Conclusions: Our interventions resulted in an increase in accrual of non-English speaking patients, however, there was not yet a statistically significant change in overall race and ethnicity. Our study confirms poorer clinical outcomes for patients with higher ADI scores. Further research and intervention are warranted to mitigate disparities in clinical trial accrual and improve clinical outcomes for disadvantaged patients.

Impact of eligibility criteria discordance on clinical trial accrual in diffuse large B-cell lymphoma (DLBCL).

e13707 Background: Excessively stringent clinical trial eligibility criteria may hinder trial accrual, differentially exclude racial-ethnic minority groups, and limit generalizability. This study reviewed the association between trial accrual and concordance of eligibility criteria with known drug safety data in DLBCL clinical trials. Methods: Eligibility criteria and accrual of completed phase II/III clinical trials for DLBCL that opened in the US between 2010-2020 were abstracted from ClinicalTrials.gov. Trials missing posted results or studying cellular therapy / transplant were excluded. Concordance with known safety data was assessed by comparing study eligibility criteria for QTc, renal, hepatic, and cardiac function to FDA labels and phase I safety signals of study drugs. Excessively strict discordant criteria (ExSDC) were defined as eligibility criteria without supporting safety signals. Logistic regression +/- dispersion was used for analysis. Results: 58 trials met criteria for inclusion, accruing 6,232 participants. 88% of studies involved a non-FDA-approved agent, 74% were multicenter, 55% were industry sponsored, 66% only accrued in the US, and 86% were phase II. Eligibility criteria were highly variable (Table). Discordance of renal, hepatic, cardiac function, and QTc criteria from known safety data occurred in 31%, 26%, 41%, and 29% of studies, respectively. Race and ethnicity data were not reported in 22% and 45% of studies, respectively. Trials after 2015 were more likely to report race (p=0.04) and ethnicity (p=0.01). In a multivariable model adjusted for international study sites, greater number of ExSDC was associated with a lower proportion of black patients in the trial (OR 0.45, CI 0.29-0.71, p=0.001). ExSDC in cardiac function were most associated with reduced accrual of this minority group (OR 0.17, CI 0.05-0.58, p=0.007). 11 studies (19%) had early termination for lack of accrual (ETLA). In multivariable analysis, greater number of ExSDC was independently associated with ETLA (OR 3.53, CI 1.45-8.64, p=0.006), while multicenter status protected against ETLA (OR 0.05, CI 0.01-0.31, p=0.002). Industry sponsor and concordance of cardiac criteria protected against ETLA in univariable analysis only. Other eligibility criteria were not associated. Conclusions: Eligibility criteria in DLBCL trials varied widely and were often discordant with known safety data. Higher number of ExSDC was associated with lower accrual of black patients and higher risk of ETLA. Optimizing concordance of eligibility criteria with safety data may improve trial accrual and diversity. [Table: see text]

Enhancing the patient journey to clinical trial enrollment with navigation to optimize accrual: A pilot study for a pragmatic multicentre, stepped wedge, cluster randomized controlled trial (The CTN Pilot Trial).

11093 Background: Clinical trials are essential to the advancement of clinical therapies, yet accrual rates remain disappointing. Multiple challenges lead to less than 5% of cancer patients enrolled onto clinical trials. The Clinical Trials Navigator (CTN) program was established to assist patients and health care professionals identify appropriate clinical trials for patients. Methods: Between March 2019 to January 2024, a novel navigator-assisted clinical trials search program was offered to Canadian patients. Three non-medical navigators were trained to receive referrals, review medical information, and search five different clinical trial search engines. Eligibility criteria was scrutinized. A second review of the clinical trial list was conducted by two physicians. The final curated list of clinical trials was provided to patients and their oncologist. Results: A total of 373 patients were referred to the CTN program during the study period. A unique clinical trial search was performed for each patient yielding a median of only one potentially eligible trial per patient. Clinical trial enrolment occurred in 3.2% of patients in our database which translates to a 19% rate of successful enrolment of those referred to a trial by the CTN. Most patients (78%) were referred to clinical trial sites that conducted more than 100 clinical trials at any time. Compared to the Canadian cancer statistics, lung, lymphoma, pancreatic and brain cancers were overrepresented in referrals to the CTN program while prostate cancer was underrepresented. Type of cancer played a significant role in the likelihood of a successful referral (p &lt; 0.01). Lung cancer was the most frequently reported cancer that resulted in referrals and breast cancer showed a lower frequency of referrals. The cancer type, stage and number of lines of prior therapy were not significantly associated with the patient enrollment onto a clinical trial. An increase in survival of referred patients from last analysis from 3.0 months to 5.3 months. Conclusions: The CTN program is a successful tool to identify clinical trials for cancer patients and can improve clinical trial accrual, as almost one fifth of patients (19%) who were referred to a clinical trial were enrolled. Ongoing iterative changes to the program to improve these metrics are underway and efforts to improve implementation of the CTN program across Canada are ongoing.

Performance of a trained large language model to provide clinical trial recommendation in a head and neck cancer population.

11081 Background: Chatbots based on large language model (LLM) have demonstrated ability to answer oncology exam questions; however, leveraging LLM in medical-decision support have not yet demonstrated suitable performance in oncology practice. We evaluated the performance of a trained a LLM, GPT-4, to recommend appropriate clinical trials for a head &amp; neck (HN) cancer population. Methods: In 2022, we developed an artificial intelligence powered clinical trial management mobile app, LookUpTrials, and demonstrated promising user engagement among oncologists. Using LookUpTrials database, we applied direct preference optimization to train GPT-4 as an in-app assistant to LookUpTrials. From Nov 7 to Dec 19, 2023, we collected consecutive, new patient cases and their respective clinical trial recommendations from oncologists in the HN medical oncology service at Memorial Sloan Kettering Cancer Center. Cases were categorized by diagnosis, cancer stage, treatment setting, and physician recommendation on clinical trials. Trained GPT-4 is prompted using a semi-structured template: “Given patient with a &lt;diagnosis&gt;, &lt;cancer stage&gt;, &lt;treatment setting&gt;, what are possible clinical trials?” Physician recommendations were compared with trained GPT-4 responses. We analyzed the performance of GPT-4 based on its response precision (positive predictive value), recall (sensitivity), and F1 score (harmonic mean of precision and recall). Results: We analyzed 178 patient cases, mean age 65.6 (SD 13.9), primarily male (75%) with local/locally advanced (68%) HN (61%), thyroid (16%), skin (9%), or salivary (8%) cancers. Majority were treated in the definitive setting with combined modality therapy (42%) and modest proportion were treated under clinical trials (10%). Overall, trained GPT-4 achieved a moderate performance matching physician clinical trial recommendations with 63% precision and 100% recall (F1 score 0.77), narrowing a total list of 56 HN clinical trials to a range of 0-4 relevant trials per patient case (mean 1, SD 1.2). Comparatively, performance of our trained GPT-4 exceeded historic performance of untrained LLMs to provide oncology treatment recommendation by 4-20 folds (F1 score 0.04 - 0.19). Conclusions: This proof-of-concept study demonstrated that trained LLM can achieve moderate performance in matching physician clinical trial recommendation in HN oncology. Our results suggest the potential of embedding trained LLM into oncology workflow to aid clinical trial search and accelerate clinical trial accrual. Future research is needed to optimize precision of trained LLM and to assess whether trained LLM may be a scalable solution to enhance the diversity and equity of clinical trial participation.

Strategies for increasing accrual in cancer clinical trials: What is the evidence?

Despite the importance of clinical trial participation among cancer patients, few participate-and even fewer patients from ethnic and racial minoritized groups. It is unclear whether suggested approaches to increase accrual are successful. We conducted a scoping review to identify evidence-based approaches to increase participation in cancer treatment clinical trials that demonstrated clear increases in accrual. Notably, more stringent than other published reviews, only those studies with comparison data to measure a difference in accrual rates were included. We searched PubMed/MEDLINE, Embase, CINAHL, and Web of Science for English-language articles published from January 1, 2012, to August 8, 2022. Studies were included if they were conducted in the United States, described single or multicomponent interventions, and provided data to measure accrual relative to baseline levels or that compared accrual rates with other interventions. Sixteen articles were included: six with interventions addressing patient barriers, two addressing provider barriers, seven describing institutional change, and one describing policy change. Key themes emerged, such as a focus on patient education, cultural competency, and building the capacity of clinics. Few studies provide comparative accrual data, making it difficult to identify with certainty any effective, evidence-based approaches for increasing accrual. Some patient- and system-level interventions studies showed modest increases in accrual primarily through pre-post measurement. Despite an extensive body of literature about the barriers that impede cancer treatment trial accrual, along with numerous recommendations for how to overcome these barriers, results reveal surprisingly little evidence published in the last 10 years on interventions that increase accrual relative to baseline levels or compared with other interventions. As clinical trials are a primary vehicle through which we improve cancer care, it is critical that evidence-based approaches are used to inform all efforts to increase accrual. Strategies for increasing participation in cancer clinical trials must be developed and rigorously evaluated so that these strategies can be disseminated, participation in trials can increase and become more equitable, and trial results can become more generalizable.

Top advances of the year: Cervical cancer.

The year 2023 was an extraordinary year for the further development and expansion of novel treatments for all patients with cervical cancer, ranging from early stage to later stage and metastatic or recurrent disease. Individuals with early-stage disease will benefit from less invasive surgery with subsequent improvement in quality of life. The effectiveness of immunotherapy has been demonstrated in upfront, locally advanced cervical cancer and confirmed in advanced metastatic disease. Induction chemotherapy will play a role in some patients with locally advanced disease, particularly those in low resource areas of the world. Novel therapeutics including antibody-drug conjugates have shown efficacy even in pretreated patients. As we continue to explore innovative therapeutics in this space, however, we must also continue to improve the diversity of clinical trial accrual to allow for generalizable results. At the same time, we must focus on eradicating this disease with appropriate screening and vaccination.

Accrual Quality Improvement Program for clinical trials.

The Early Phase Cancer Prevention Clinical Trials Program (Consortia), led by the Division of Cancer Prevention, National Cancer Institute, supports and conducts trials assessing safety, tolerability, and cancer preventive potential of a variety of interventions. Accrual to cancer prevention trials includes the recruitment of unaffected populations, posing unique challenges related to minimizing participant burden and risk, given the less evident or measurable benefits to individual participants. The Accrual Quality Improvement Program was developed to address these challenges and better understand the multiple determinants of accrual activity throughout the life of the trial. Through continuous monitoring of accrual data, Accrual Quality Improvement Program identifies positive and negative factors in real-time to optimize enrollment rates for ongoing and future trials. The Accrual Quality Improvement Program provides a web-based centralized infrastructure for collecting, analyzing, visualizing, and storing qualitative and quantitative participant-, site-, and study-level data. The Accrual Quality Improvement Program approaches cancer prevention clinical trial accrual as multi-factorial, recognizing protocol design, potential participants' characteristics, and individual site as well as study-wide implementation issues. The Accrual Quality Improvement Program was used across 39 Consortia trials from 2014 to 2022 to collect comprehensive trial information. The Accrual Quality Improvement Program captures data at the participant level, including number of charts reviewed, potential participants contacted and reasons why participants were not eligible for contact or did not consent to the trial or start intervention. The Accrual Quality Improvement Program also captures site-level (e.g. staffing issues) and study-level (e.g. when protocol amendments are made) data at each step of the recruitment/enrollment process, from potential participant identification to contact, consent, intervention, and study completion using a Recruitment Journal. Accrual Quality Improvement Program's functionality also includes tracking and visualization of a trial's cumulative accrual rate compared to the projected accrual rate, including a zone-based performance rating with corresponding quality improvement intervention recommendations. The challenges associated with recruitment and timely completion of early phase cancer prevention clinical trials necessitate a data collection program capable of continuous collection and quality improvement. The Accrual Quality Improvement Program collects cumulative data across National Cancer Institute, Division of Cancer Prevention early phase clinical trials, providing the opportunity for real-time review of participant-, site-, and study-level data and thereby enables responsive recruitment strategy and protocol modifications for improved recruitment rates to ongoing trials. Of note, Accrual Quality Improvement Program data collected from ongoing trials will inform future trials to optimize protocol design and maximize accrual efficiency.

1232 Outpatient Stereotactic Needle Biopsy Is a Cost-effective Strategy for Brain Tumor Patient Decision-making That Enhances Clinical Trial Accrual

INTRODUCTION: Although neuroradiological techniques have expanded, stereotactic needle biopsy is a simple, ubiquitous,and immediate strategy for established or potential brain tumor patients with atypical clinical and/or radiographic findings. METHODS: Outpatient stereotactic needle biopsies performed by a single surgeon from August 2020 through November 2022 were retrospectively reviewed. Electronic medical records were queried for clinical, perioperative, and tumor demographics. Financial records were queried for insurance and payment reports. Descriptive statistics were used to characterize comparisons among collected variables. RESULTS: 107 consecutive stereotactic needle biopsy procedures were conducted in adult brain tumor patients. All biopsies were performed using a single needle-pass in the outpatient setting, targeting supratentorial lesions in 89.7% of cases. Tissue diagnosis was established in 96% of procedures, with glioma being the most common histology. No intraoperative or perioperative complications occurred. Four patients (3.7%) were admitted overnight due to urinary retention (n = 2) and asymptomatic tract hemorrhage (n = 2), respectively. Insurance approval was sought preoperatively from non-commercial (31.7%) and commercial (68.3%) payors and approved in all cases. Postoperatively, 30.8% of patients received an experimental therapeutic on the basis of tissue analysis. CONCLUSIONS: We report the largest experience to date with outpatient stereotactic needle biopsy in newly-diagnosed and recurrent brain tumor patients. Our findings identify this strategy as a cost-effective alternative to advanced imaging that facilitates clinical trial accrual through tissue acquisition.

Abstract 1008: Pilot evaluation of an online course for primary care providers on preparing patients for cancer discussions with their oncologists

Abstract Introduction: Cancer clinical trial (CCT) accrual is only 5-8%, and barriers to participate can be more acute for underserved groups. Enrollment of racial/ethnic minorities, older adults, adolescents, and young adults is not adequate to understand treatment outcomes unique to these populations. Education before seeing an oncologist can increase patients’ willingness to ask and consider receiving treatment through a CCT. Because primary care providers (PCPs) interact with patients during diagnosis, provide ongoing care, and are a trusted source of information, they can educate and normalize inquiries about therapeutic CCTs. The aim of this study was to pilot test an innovative, tailored online CCT course for PCPs. Methods: To participate, PCPs (MD, DO, NP, or PA) had to provide care in an outpatient setting, refer patients to a cancer treatment specialist in the past year, and be an English speaker residing in the U.S. or its territories. PCPs were recruited from Clinical Directors Network, University of Pennsylvania, and University of Florida. The 1-hour online course includes four modules hosted by a PCP and radiation oncologist with video segments of a CCT expert who summarized CCT recruitment research. Participants interact with patient scenarios and learn about the patient’s cancer diagnosis and medical/personal background. Videos of actors playing the roles of patient and doctor demonstrate communication skills taught in the course. PCPs completed short surveys prior to and immediately after completing the course. Results: 28 PCPs participated. PCPs were mainly MDs (88.9%), residents (17, 60.7%), White (46.4%), non-Hispanic/Latino (92.9%), and 50% women. Mean knowledge of CCTs scores (0-100%) increased significantly from pre (M=56.7, SD=17.5) to post (M=82.1, SD=12; p&amp;lt;.001) indicating that PCPs answered more true/false statements about CCTs correctly after training. Using a 1-5 scale with 5=strongly agree, PCPs’ attitudes and beliefs scores also increased significantly from pre (M=4.2, SD=.6) to post (4.7, SD=.4, p&amp;lt;.001) indicating that PCPs were more likely to agree they have a role in their patients’ cancer treatment, including CCTs, after training. Using the same scale, PCPs’ willingness to communicate about CCTs increased significantly from pre (M=4.4, SD= .5) to post (M=4.7, SD=.5, p=.007), indicating that PCPs were more willing to engage with patients diagnosed with cancer before referring them to a cancer specialist after training. Conclusions: Significant pilot findings in knowledge, attitudes and beliefs, and communication scores demonstrate that the online course was effective at educating PCPs about CCTs, and improving PCPs’ attitudes about the CCT referral process, and their willingness to engage in their patients’ cancer care. Future research will include a larger sample and explore the course’s impact on PCP’s referral behavior. Citation Format: Alyssa Crowe, Elisa S. Weiss, Margo Michaels, Domenic Durante, Maria Sae-Hau, Andrea Cassells, Carla L. Fisher, Jason Arnold, Taylor Vasquez, Ana Natale-Pereira, Raymond Mailhot, Zhongyue Zhang, Carma L. Bylund. Pilot evaluation of an online course for primary care providers on preparing patients for cancer discussions with their oncologists [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1008.

Addressing disparities in cancer clinical trials: a roadmap to more equitable accrual.

The Georgia Center for Oncology Research and Education (Georgia CORE) and the Georgia Society of Clinical Oncology (GASCO) held a one-day summit exploring opportunities and evidence-based interventions to address disparities in cancer clinical trials. The purpose of the summit was to identify clear and concise recommendations aimed at decreasing clinical trial accrual disparities in Georgia for rural and minority populations. The summit included expert presentations, panel discussions with leaders from provider organizations throughout Georgia, and breakout sessions to allow participants to critically discuss the information presented. Over 120 participants attended the summit. Recognizing the need for evidence-based interventions to improve clinical trial accrual among rural Georgians and persons of color, summit participants identified four key areas of focus that included: improving clinical trial design, providing navigation for all, enhancing public education and awareness of cancer clinical trials, and identifying potential policy and other opportunities. A comprehensive list of takeaways and action plans was developed in the four key areas of focus with the expectation that implementation of the strategies that emerged from the summit will enhance cancer clinical trial accrual for all Georgians.

Using Bayesian hierarchical modeling for performance evaluation of clinical trial accrual for a cancer center

IntroductionSlow patient accrual in cancer clinical trials is always a concern. In 2021, the University of Kansas Comprehensive Cancer Center (KUCC), an NCI-designated comprehensive cancer center, implemented the Curated Cancer Clinical Outcomes Database (C3OD) to perform trial feasibility analyses using real-time electronic medical record data. In this study, we proposed a Bayesian hierarchical model to evaluate annual cancer clinical trial accrual performance. MethodsThe Bayesian hierarchical model uses Poisson models to describe the accrual performance of individual cancer clinical trials and a hierarchical component to describe the variation in performance across studies. Additionally, this model evaluates the impacts of the C3OD and the COVID-19 pandemic using posterior probabilities across evaluation years. The performance metric is the ratio of the observed accrual rate to the target accrual rate. ResultsPosterior medians of the annual accrual performance at the KUCC from 2018 to 2023 are 0.233, 0.246, 0.197, 0.150, 0.254, and 0.340. The COVID-19 pandemic partly explains the drop in performance in 2020 and 2021. The posterior probability that annual accrual performance is better with C3OD in 2023 than pre-pandemic (2019) is 0.935. ConclusionsThis study comprehensively evaluates the annual performance of clinical trial accrual at the KUCC, revealing a negative impact of COVID-19 and an ongoing positive impact of C3OD implementation. Two sensitivity analyses further validate the robustness of our model. Evaluating annual accrual performance across clinical trials is essential for a cancer center. The performance evaluation tools described in this paper are highly recommended for monitoring clinical trial accrual.

Abstract B036: Trends in disparities in clinical trial accrual: An analysis of National Cancer Institute (NCI)-sponsored early phase clinical trials over the last 22 years

Abstract Using the NCI Cancer Therapy Evaluation Program (CTEP)-sponsored early phase oncology clinical trials database, we evaluated trends in disparities in patient enrollment over the last 22 years. Counts and percentages of enrolled patients were calculated directly from the full population of patients enrolled to CTEP-sponsored Phase 1, 2, and 1/2 trials during 2000-22. Trends in enrollment were assessed based on single-year data, four-year periods, and using a three-year rolling average. Analyses of patient residential ZIP code were restricted to patients residing and enrolled at institutions within the United States. Geographical data corresponding to patient ZIP codes was obtained using the zipcodeR package, including geographical region and median household income corresponding to each ZIP, and distance between patient residential and enrolling institution ZIPs. A total of 14,877 patients were enrolled in CTEP-sponsored early phase trials evaluated during 2000-22, with 14,342 residing and enrolled within the US. The proportion of patients aged 40-64 at enrollment decreased from 59.8% in 2000-03 to 47.5% in 2020-22, with corresponding increases in ages 65-74 (24.2% to 32.9%) and 75-84 (5.9% to 12.3%). There were fluctuations in gender, most likely based on the specific agents being studied in clinical trials enrolling at a given time. In 2020-22, 72.9% of the population was non-Hispanic white when compared to 2000-03 when enrollment of non-Hispanic whites was 83.7%. Hispanic/Latino population enrollment increased from 4.2% in years 2000-03 to 6.9% in years 2020-22. Asian/Pacific Islander population increased from 2.5% in 2000-03 to 5.4% in 2020-22. Enrollment of non-Hispanic Black patients increased slightly over the last 20 years (6.3% to 7.1%), as did the proportion with unknown or unspecified race/ethnicity (3.3% to 7.6%). Trial enrollment trends by geographic regions revealed that enrollment in South and West overall increased (29.1% to 40.9%; 7.9% to 18.2%), Northeast representation remained static (23.9% to 20.8%) and Midwest representation decreased (24.4% to 19.4%) from 2000-03 to 2020-22. Most early phase participants in our database were from localities with a moderate median household income ($52,200 - $156,600; 51.9% to 59.4%), with an increase in representation from low-income localities (income &amp;lt; $52,000; 31.1% to 37.7%) over the last 22 years. We observed an overall increase in patients enrolling within a 50-mile radius of their residence over the 22-year period (46.5% to 64.5%) and an overall decrease in patients traveling over 200 miles to enroll in clinical trials (16.1% to 8.3%). We also examined trends in disparities during the COVID-19 pandemic and saw no significant differences in trial enrollment by race/ethnicity and gender when compared to pre-pandemic enrollment. Disparities in patients enrolled in early-phase clinical trials have marginally improved over the span of two decades, and outreach and inclusion efforts for enrollment of underrepresented patients should be continued to sustain these observed trends. Citation Format: Maria Farooq, Elad Sharon, Naoko Takebe, Ana F. Best, Shanda Finnigan. Trends in disparities in clinical trial accrual: An analysis of National Cancer Institute (NCI)-sponsored early phase clinical trials over the last 22 years [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr B036.

Abstract C065: Developing and sustaining an NCI U54 CPACHE partnership

Abstract Purpose: The South Carolina Cancer Disparities Research Center (SC CADRE) is a mature and vibrant multi-institutional Comprehensive Partnership to Advance Cancer Health Equity (CPACHE) enterprise between South Carolina State University (SCSU), an institution serving underserved health disparity populations and underrepresented students (ISUPS) and the Medical University of South Carolina-Hollings Cancer Center (MUSC-HCC), an NCI-designated Cancer Center. Methods: The SC CADRE was built on a foundational relationship that began in 2009, including three consecutive inter-institutional Department of Defense Summer Undergraduate Prostate Cancer Research Training grants and an NCI CPACHE P20 grant. Awarded in 2017, the inaugural U54 SC CADRE had four main goals: 1) further elucidating the biological and social contributors to cancer disparities; 2) enhancing the pipeline of diverse cancer researchers; 3) increasing the number of NIH research proposals led by SCSU faculty as independent investigators; and 4) including greater community engagement in cancer research. Results: Since 2017, the U54 partnership has produced 77 peer-reviewed publications (8 included inter-institutional co-authors) and, not counting the SC CADRE research project awards, 33 grants have been funded (9 were awarded to SCSU investigators as PIs or MPIs), and a national virtual cancer health equity symposium was established. Four ESIs were hired (three at SCSU). An inaugural Biorepository was created at SCSU. Cancer research education was provided for 640 undergraduate students at SCSU, including 22 SC CADRE Scholars. The SC CADRE team members serve as Advisory Board members of South Carolina’s statewide cancer control consortium, the South Carolina Department of Health and Environmental Control, ISUPS and other colleges/universities in South Carolina, and statewide faith-based, professional, and civic organizations. These combined efforts have led to an overall 30% representation of diverse participants in the MUSC-HCC’s cancer clinical trial accruals. Conclusions: While much work remains, mammography and colorectal cancer screening rates, and HPV vaccination rates, are now higher in South Carolina than in the US. The longstanding academic partnership between SCSU and MUSC-HCC, leveraging each entity’s research and educational strengths and community relationships, has positioned the SC CADRE to transform cancer health outcomes in South Carolina and beyond. Citation Format: Marvella E. Ford, Tammy Loucks, James Stukes, Cammie Berry, Joni Nelson, Kathleen Cartmell, Audrey McCrary-Quarles, Amy Martin, Joseph Tahsoh, Alexander Alekseyenko, Janae Sweeney, Steven Carroll, Debra McAlister, Ellen Gomez, Yaoling Long, David P. Turner, Judith D. Salley. Developing and sustaining an NCI U54 CPACHE partnership [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr C065.