Patient Participation In Clinical Trials Research Articles

Abstract 1000: Clinician and clinical trial staff perspectives on factors that impact enrollment of Black women in breast cancer trials

Abstract Background: Black women (BW) are more likely to present with advanced-stage disease and to die following a breast cancer (BC) diagnosis compared with women from other racial and ethnic groups, yet BW are underrepresented in BC clinical trials (CT). Clinicians and CT staff play a key role in patient participation in CT, however, there is limited data on their perspectives on facilitators and barriers for BW in BC trials. Objective: The goal of the FOR ME (Fostering Opportunities in Research through Messaging and Education) study is to develop, optimize, and test a decision-aid intervention (web-based video) for clinical care teams to use with BW who have been recently diagnosed with BC to promote shared decision-making and CT participation. We provide insight into the facilitators and barriers from clinicians and CT staff to effectively discuss and enroll BW in BC trials. The identified themes will be used to inform video content and dissemination strategies. Methods: Key informant interviews (KIIs) (n=20) were conducted by phone and video conferencing. Each KII was recorded and professionally transcribed. Thematic analysis and inductive coding approaches were used to analyze the data. First, a subset of transcripts was annotated, and then annotations were compiled into a preliminary codebook. Inter-coder reliability was established to improve quality and to establish the final codebook. Dedoose was used to analyze quotations and code co-occurrences, application frequencies, and relationships. Results: In total, 16 clinicians and 4 clinical trial staff across academic and community practices were interviewed. Participants expressed multiple opportunities and barriers to CT participation. Facilitators included formal training on communication around clinical trials among clinical trial staff, previous exposure to discussing and enrolling patients in CT during fellowships and other training, institutional support for CT databases, reviewing CTs during tumor boards, and the presence of dedicated research support staff. Barriers included a lack of formal training in communicating CT to patients among clinicians, lack of institutional investment in CT infrastructure, time constraints of clinical visits, and the clinician’s perception of the patient's willingness and ability to complete a CT. Conclusions: Clinicians and clinical trial staff have a unique and important role to play in CT participation for BW who have BC, however, there are barriers, including training, time, awareness of available trials, and institutional support. Clinical trial staff report formal training in communicating clinical trial information to patients, while there is a lack of this type of training for clinicians. Future research in the FOR ME study will integrate patient, clinician, care team, and advocate perspectives into a web-based decision aid. Citation Format: Christen Sandoval, Eliza Brumer Cohn, Leslie R. Carnahan, Vida Henderson, Tigist Mersha, Neha Hippalgaonkar, Joe Horowitz, Sarah Khan, Kauthar Salum, Ana Williams, Lolita Coleman, Beluah Brent, Anne Marie Murphy, Paris Thomas, Paramjeet Khosla, Kent Hoskins, Ryan Nguyen. Clinician and clinical trial staff perspectives on factors that impact enrollment of Black women in breast cancer trials [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 1000.

50 (PB-050) Poster - Ensuring inclusivity of patient participation in clinical trials

50 (PB-050) Poster - Ensuring inclusivity of patient participation in clinical trials

A phase II telemedicine study of pemigatinib in adult patients with unresectable or metastatic pancreas cancer with FGFR2 gene fusions or other FGFR genetic alterations.

TPS717 Background: Advanced pancreas cancer has a poor prognosis with few effective targeted therapies. Given this current state, novel therapies for pancreas cancer are an unmet need. Genomic alterations in FGFR, including fusions and point mutations are known driver mutations in cancer. FGFR kinase inhibitors have been FDA approved in cholangiocarcinoma and urothelial carcinoma, however, have not been well studied in other cancers. Our team previously identified and treated four patients with advanced pancreas cancer and FGFR2 fusions with FGFR kinase inhibitors resulting in durable responses and prolonged survival. Additionally, through a review of Foundation Medicine’s clinical genomic database, consisting of 30,229 pancreas cancer tumors, we determined that FGFR1-3 fusions have a prevalence of approximately 1% in pancreas cancer, most commonly in FGFR2 (0.8%). Our observations provide preliminary evidence that FGFR targeted therapy results in excellent clinical outcomes. We hypothesize that FGFR altered pancreas cancer treated with a FGFR kinase inhibitor will result in durable responses. We developed a phase 2, telemedicine trial of pemigatinib, an FDA approved FGFR kinase inhibitor, in FGFR altered pancreas cancer. Since the COVID-19 pandemic, telemedicine is used in routine oncology care and clinical trials and is associated with cost savings for patients. The growing adoption of this technology provides an opportunity to enhance the study of ultra-rare cancers. Methods: The trial consists of unresectable or metastatic pancreas cancer of any histology in two cohorts: 1) Primary cohort of FGFR2 fusions (n=30) and 2) exploratory cohort of other known activating mutations in FGFR (n=10). Patients are identified from across the United States through Foundation Medicine, Caris Life Sciences, and the Pancreatic Cancer Action Network. Eligible patients will be treated with oral pemigatinib through telemedicine by investigators at The Ohio State University in collaboration with local oncologists for supportive care. This trial uses single-stage phase 2 design with sample size calculations based on an expected overall response rate of ≥ 33% and <10% as unfavorable response, at one‐sided Type I error of 0.05, 90% power and up to 13% attrition rate. Results: The primary objective is overall response rate. Secondary objectives are overall survival, progression free survival, and duration of response. Exploratory objectives are analysis of correlation of circulating tumor DNA with response to treatment and development of resistance. Conclusions: FGFR kinase inhibitorshave the potential to be an effective targeted therapy in pancreas cancer. Additionally, telemedicine is a novel tool that can aid in the study of ultra-rare cancers and reduce barriers to patient participation in clinical trials.

SA55 Considerations for Common Exclusion Criteria in Real-World (RW) Retrospective Observational Studies in Oncology

A key strength of well-designed RW research studies is that they have high potential to include larger and more representative patient populations compared to randomized-controlled trials. While each study generally has unique inclusion and exclusion criteria, two commonly applied exclusion criteria across RW oncology studies involve (1) patient participation in clinical trials or (2) diagnosis with concomitant primary cancers. These two criteria are often specified in an effort to maximize a study’s internal validity (minimize bias), which is prioritized against external validity (generalizability and transportability). However, these criteria are heterogeneously defined across studies, and there may be opportunities to examine their necessity and operational definitions when designing fit-for-purpose research. Examining a series of RW studies based on oncology-specific electronic medical records, we identified key dimensions across which these two common exclusion criteria have been differently defined and examined their impact on patient disqualification. Recognizing a trade-off between sample size, bias reduction, and operational efficiency related to the implementation of these criteria, we propose a conceptual framework for the application of these criteria in future studies. The application of these criteria may have a substantial impact on the internal and external validity of RW studies. Therefore, these criteria should be thoroughly and systematically assessed for each study to ensure selection of the appropriate patient population for the research question being addressed. Customization of eligibility criteria to reduce bias while maximizing sample size and representativeness is a crucially important element of RW study design. Complexity of this task can be reduced for investigators by having a clear and cogent framework for the considerations at play when developing criteria related to trial participation and concomitant primary cancer diagnoses. We encourage investigators to standardize their decision process rather than defaulting to these prevalent, but sometimes restrictive, criteria.

Enhancing Diversity and Inclusion in Clinical Trials.

Women and people from most racial and ethnic groups in the United States have historically been under-represented in clinical trials of investigational medical products. Inadequate representation of these groups may lead to an incomplete understanding of the safety and efficacy of new drugs, devices, biologics, and vaccines, and limit the generalizability of trial findings. As a result, new medical products may not be beneficial to all people who need them, and existing inequities in outcomes among various population groups may remain unchanged or worsen, or new disparities may arise. Although much work has focused on study-level strategies, research organizations must make systemic changes to how clinical trials are envisioned and implemented to achieve sustainable support for diversity and inclusion in clinical trials. The Clinical Trials Transformation Initiative (CTTI) conducted interviews with leaders at institutions that conduct clinical trials to explore perspectives on organizational-level practices that promote diversity and inclusion in clinical trials. Leaders described motivations, such as an ethical and moral imperative; organizational practices, such as staff investment and resource allocation; perceived return on investments, such as better science; and deterrents, such as cost and time. The CTTI also convened an expert meeting to discuss the interview findings and provide guidance. We present the interview findings and expert guidance in a framework that describes four key areas-commitment, partnerships, accountability, and resources-on sustaining organizational-level approaches for improving diversity and inclusion in clinical trials, with the ultimate goal of advancing health equity. Institutions who conduct and support clinical trials should implement organizational-level approaches to improve equitable access and diverse patient participation in clinical trials.

Minority groups underrepresented in hematologic cancer trials

Minority groups underrepresented in hematologic cancer trials

32097 Factors associated with eczema clinical trial participation in adults

There is a paucity of dermatology literature describing motivators and barriers to patient participation in clinical trials (CTs). This study aimed to identify the degree of patient awareness and understanding of CTs, and motivators/barrier to CT participation (CTP) in adults with eczema. The online survey was administered to a National Eczema Association audience of adults ≥ 18 years of age with one or more self-reported forms of eczema. Analysis included univariable and multivariable logistic regression.

Factors that influence clinical trial participation by patients with cancer in Australia: a scoping review protocol

IntroductionClinical trials are the backbone of research. It is well recognised that patient participation in clinical trials can be influenced by a myriad of factors such as access to a...

P-169: Outcome of non-transplant eligible patients with newly diagnosed multiple myeloma depending on the eligibility for clinical trials: a single institution experience

<h3>Background</h3> Patient participation in clinical trials forms the backbone of cancer clinical research as they represent a key step in the development of new treatment strategies to improve the outcome of incurable diseases such as multiple myeloma (MM). Although the results obtained from them will determine the future therapeutic approaches due to several reasons, the vast majority of patients with MM do not participate in clinical trials. <h3>Methods</h3> To determine the reasons they were or weren't recruited into prospective clinical trials and evaluate their outcome in one group or the other, we retrospectively reviewed from our database all consecutive patients with newly diagnosed MM, non-candidate to autologous stem cell transplantation, who received first line treatment at our institution from 2003 to 2017. We thoroughly reviewed their characteristics and their outcome after first line treatment only. We analyzed the reasons why they were or not included in a trial and compared the outcome of those included in a clinical trial versus those who did not meet the eligibility criteria and who received standard therapy. Patients who didn't have a clinical trial available at the time of diagnosis were excluded from the analysis. <h3>Results</h3> Between January 2003 and December 2017 we analyzed 211 patients diagnosed and treated at our institution; 105 entered a clinical trial and 106 did not meet the eligibility criteria. The causes for not entering in a clinical trial were as: 1) Didn't fulfill inclusion criteria due to comorbidities (26.7%), other previous malignancies (16.2%) or renal insufficiency (13.3%); 2) Didn't have measurable disease (1.9%); 3) The urgency to start treatment didn't allow the delay of a screening period (8.6%); 4) Very advanced age (10.5%), cognitive impairment (1.9%) or performance status (4.85%); 5) Patient refusal (10.5%). Finally 1.9% were screen failures and 3.8% did not participate for unknown reasons. Patients included in clinical trials were significantly younger (median 71 vs. 78 p<0.001) and had better ECOG (0/1 78.4% vs. 35.6 p<0.001). No differences regarding immunological subtype or bone marrow plasma cells infiltration were found. ISS stage was slightly lower in the clinical trial group although not statistically significant. The ORR was 79 vs.46 p<0.001 and the CR rate was 17% vs. 3% p<0.001 both significantly higher in the clinical trial group. Patients included in clinical trial had a significantly longer OS than those who were not (median 62.5 vs.31.8 p<0.001). <h3>Conclusion</h3> Patients included in clinical trials have a significantly higher response rate and OS than those who do not meet the eligibility criteria. Only half of the elderly patients at our institution fulfill the inclusion criteria to enter a clinical trial. This questions the extrapolation of the results of clinical studies to broader populations.

Abstract 2624: Clinical trial participation in real-world patients with metastatic breast cancer: disparities and barriers

Abstract Background: Reducing barriers to patient participation in clinical trials is vitally important to the cancer care community. Using data from a real-world cohort of metastatic breast cancer (mBC) patients (pts), we evaluated how race/ethnicity and other socioeconomic, institutional, and clinical barriers play a role in trial participation. Methods: Adult females with mBC were selected from Flatiron Health EHR-derived de-identified database (2011- 2020). Clinical trial participation was determined by having “clinical study drug” in any line of therapy. Multivariate logistic regressions were used to assess how various barriers impact trial participation. Results: In this cohort of 22,220 mBC pts, 1,131 (5.1%) were enrolled in clinical trials and participation rates vary by line of therapy, race/ethnicity, age, insurance, location, and care setting (Table 1). Comparing pts characteristics between enrolled vs. not enrolled, pts ever enrolled were significantly younger (mean age: 59 vs 63), had better performance status (ECOG PS ≥ 2: 3% vs 8%), and less Brain/CNS metastasis (3% vs 6%), more likely to be white (75% vs 61%), lived in the south (55% vs 38%), and had commercial insurance (34% vs 29%), with all p&amp;lt;0.001. Controlling for all SES and clinical characteristics that significantly differ between pts enrolled vs. not enrolled, racial/ethnic minority status remained as a strong predictor for lack of trial participation ([OR(95%CI)]: African-American(AA) [0.5(0.4-0.7)]; Hispanic: [0.6(0.4-0.8)], vs White). Conclusions: Preliminary results of this study reveal significant demographic and socioeconomic disparities in trial participation among mBC patients. In particular, AA and Hispanic patients were less likely to participate in clinical trials after controlling for other individual- or system-level factors that may impact enrollment. Future efforts to understand the relationship between racial disparity and other well-known barriers are needed. TABLE 1.Proportion of Patients Enrolled in Clinical Trials (N=22,220)Total, NProportion enrolled in clinical trials, n(%)Line of Therapy1L19,559435 (2.2%)2L12,627336 (2.7%)3L+7,959360 (4.5%)*Age at Diagnosis&amp;lt;6511,356732 (6.4%)*65 - 755,801273 (4.7%)75+5,063126 (2.5%)Race/EthnicityAfrican-American2,39597 (4.1%)Hispanic or Latino1,70251 (3.0%)Asian49420 (4.1%)White13,707851 (6.2%)*Other/Unknown3,922112 (2.9%)Geographic RegionMidwest3,062106 (3.5%)Northeast3,89476 (2.0%)South8,645618 (7.2%)*West3,998174 (4.4%)Insurance at DiagnosisCommercial6,398388 (6.1%)*Medicaid49013 (2.7%)Medicare4,232158 (3.7%)Other or Missing11,100572 (5.2%)Care SettingAcademic1,558137 (8.8%)*Community20,662994 (4.8%)Note: * denotes subgroup of patients with the highest rate of clinical trial participation Citation Format: Ruoding Tan, Rongrong Wang, Ibrahim Abbass, Lourenia Cassoli, Edith P. Mitchell. Clinical trial participation in real-world patients with metastatic breast cancer: disparities and barriers [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 2624.

Informed consent of palliative patients to participate in quality of life research

Informed consent as a procedure is mandatory in cases of patient participation in clinical trials of pharmaceuticals, preparation for surgical interventions, diagnostic and therapeutic invasive procedures, and even in surveys (questionnaires) on health issues according to the legislation of most countries of the world. The practice of obtaining informed consent in Ukraine is widespread and well-studied in cases of preparing palliative patients for operations, hospitalizations, invasive procedures, but there is a certain lack of information on obtaining informed consent when studying quality of life. In our research, we used the method of systematic analysis and the bibliosemantic method, with references to scientific and legal sources. As a result of the study, it was determined that informed consent is an important part of the legal regulation of medical care and social security in Ukraine and the world. We researched the issue of legal capacity, identified separate issues of confidentiality, compliance with the requirements of Ukrainian legislation regarding the observance of individual rights of patients that could potentially be violated during the study of the quality of life, collecting and processing answers to questionnaire, signing informed consent. The text of the informed consent can be modified for the purposes of the scientific study, but without violating the procedure of informing the patient (or his legal representative) about the goals and possible inconveniences of the study. The text of the informed consent must be signed by the patient (in his own hand) and the attending physician. If the patient cannot write independently, but understands the essence of the text of the informed consent and the questions of the questionnaire and gives clear and unambiguous answers to them, the questionnaire and the informed consent can be signed only by the attending physician. Keywords: medical deontology, medical ethics, medical law, palliative and hospice care.

Impact of clinical trial enrollment on episode costs in the Oncology Care Model (OCM).

6513 Background: Clinical trials are critical for improving outcomes for patients with cancer. However, there is some concern from health insurers that clinical trial participation can increase total cost of care for cancer patients. We investigated the impact of clinical trial participation on total costs paid by Medicare during the OCM program in a large community-based practice. Methods: Tennessee Oncology (TO) is a community oncology practice comprising over 90 oncologists across 30 sites of care. We linked TO trial data and electronic medical record data with OCM data for episodes of care from 2016-2018. To assess the impact of trial participation on total cost relative to routine care, we created matched comparator groups for each OCM episode based on cancer type, metastatic status, number of comorbidities, performance status, and age. Patients with breast cancer receiving hormone therapy only were excluded. Absolute and percent cost differences between groups were calculated for episodes that had a comparator group size of five or greater. Differences in total cost for trial episodes were compared to non-trial episodes, and significance was assessed using the Mann–Whitney U test. We also studied the impact of trial participation on receipt of active treatment in the last 14 days of life (TxEOL), hospice use, and hospitalizations. Results: During the study period, 8,026 completed OCM episodes met study criteria. Patients were enrolled in a clinical trial for 459 of these episodes. On average, episodes during which patients were on trial cost $5,973 less than matched non-trial episodes (Table), independent of early versus late-phase trial. Most savings resulted from decreased drug costs. There were no differences in rates of TxEOL (15% vs. 14% p=1.0), rates of hospitalizations (31% vs. 30% p=0.54), or hospice use (52% vs. 62% p=0.08) between trial and non-trial episodes. Median difference from comparator group average cost was significantly lower for clinical trial episodes (-18% vs. -6%, p&lt;0.01). Conclusions: In the community setting, total costs paid by Medicare for patients participating in clinical trials during OCM episodes were lower than costs for similar patients receiving routine care. Clinical trial participation did not adversely impact end-of-life care or likelihood of hospitalization. These findings suggest that patient participation in clinical trials does not increase total cost of care nor enhance financial risk to payers.[Table: see text]

Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration

Several studies have estimated the financial inputs for successful drug development. Such analyses do not capture the large investment that patient study participants commit to drug development. To estimate the volume of patients required to achieve a first US Food and Drug Administration (FDA) approval for a new anticancer drug or biologic therapy. This cohort study included a random sample of prelicense oncology drugs and biologics with a trial site in the United States that were launched into clinical efficacy testing between January 1, 2006, and December 31, 2010. Drugs and biologics were identified using ClinicalTrials.gov registration records. Total patient enrollment was captured over an 8-year span, and each intervention was classified based on whether it received FDA approval and was deemed as having intermediate or substantial value according to the American Society of Clinical Oncology Value Framework (ASCO-VF) score. Secondarily, the association between patient numbers and intervention characteristics was tested. Data were analyzed in February 2020. The prespecified primary outcome was the number of patients enrolled in prelicense trials per FDA approval. A total of 120 drugs and biologics were included in our study, with 84 (70.0%) targeted agents, 20 (16.7%) immunotherapies, and 71 (59.2%) novel agents. A total of 13 drugs and biologics (10.8%; 95% CI, 5.3%-16.8%) in our sample gained FDA approval within 8 years, of which 1 (7.7%) was deemed of intermediate value and 3 (23.1%) were deemed of substantial value using ASCO-VF scoring. Overall, 158 810 patients were enrolled in 1335 trials testing these drugs and biologics, 47 913 (30.2%) in trials that led to FDA approval and 110 897 (69.8%) in trials that did not. An estimated 12 217 (95% CI, 7970-22 215) patient study participants contributed to prelicense trials per FDA approval. The estimated number of patients needed to produce a single FDA-approved drug or biologic of intermediate or substantial ASCO-VF clinical value was 39 703 (95% CI, 19 391-177 991). The results of this cohort study make visible the substantial patient investment required for prelicense oncology drug development. Such analyses can be used to devise policies that maximize the clinical impact of research on a per-patient basis.

The Role of Patient-reported Outcomes and Medication Adherence Assessment in Patient-focused Drug Development for Solid Organ Transplantation.

The Role of Patient-reported Outcomes and Medication Adherence Assessment in Patient-focused Drug Development for Solid Organ Transplantation.

Proposed Additions to the NCCN Guidelines for Adult Medulloblastoma.

Medulloblastoma is a rare brain tumor that occurs in both children and adults, with patients aged 15 to 39 years accounting for 30% of all cases. In adults, guidelines for diagnosis and treatment are often based on retrospective data and extrapolated from the pediatric experience due to limited availability of prospective trials or registries involving adults. Importantly, adult patients differ from pediatric patients in many aspects, including the molecular features of the tumor and tolerance to treatment. In 2017, the NCI was granted support from the Cancer Moonshot initiative to address the challenges and unmet needs of adults with rare central nervous system (CNS) tumors through the NCI Comprehensive Oncology Network for Evaluating Rare CNS Tumors (NCI-CONNECT). On November 25, 2019, NCI-CONNECT convened a multidisciplinary workshop on adult medulloblastoma. Working groups identified unmet needs in clinical care and research and developed specific action items, including a proposal for inclusion of new items in the NCCN Guidelines for Adult Medulloblastoma, delineated in this review along with the evidence supporting their incorporation. Recommendations included facilitating referral of patients to centers of excellence; promoting patient participation in clinical trials or registries; encouraging use of DNA methylation for confirmation of diagnosis and subgrouping; offering counseling on contraception and fertility preservation; evaluating patients for symptoms and medical management of endocrine, vision, hearing, and neurocognitive deficits; providing psychosocial support and referral to neurorehabilitation; minimizing delays in therapy; and incorporating imaging standards and criteria for progression.

“When offered to participate”: A systematic review and meta-analysis of patient agreement to participate in cancer clinical trials.

92 Background: Patient participation in clinical trials (CTs) is vital for knowledge advancement and outcomes improvement. The rate of CT participation for adult cancer patients is between 5%-8%; many CTs fail due to poor accrual. Although patient decision-making is a common focus of studies examining barriers to CT participation, the rate of trial participation for patients actually offered a CT is unknown. Methods: We conducted a systematic review and meta-analysis using PubMed, Web of Science, and Ovid Medline search engines to identify studies over 20 years (1/1/2000-1/1/2020) that examined CT participation. Studies must have been conducted in the United States and specified the number of patients offered a CT and the number enrolled. We conducted a meta-analysis of single proportions using random effects. Rates were examined for both treatment trials and cancer control (CC) studies. We also compared the rates of enrollment between Black, Hispanic, and Asian patients versus White patients. Clinical care setting (academic vs community) was examined as a potential moderator. Results: We screened 3,241 unique citations and identified 35 (30 treatment and 5 CC) studies among which n = 9,759 patients were offered CT participation. Overall, 55.0% (95% CI: 49.4%-60.5%) of patients offered a CT agreed to enroll. Trial participation rates did not differ between treatment (55.0%, 95% CI: 48.9%-60.9%) and CC trials (55.3%, 95% CI: 38.9%-71.1%, p = .98); however, participation rates were significantly higher at academic centers (58.4%, 95% CI: 52.2%-64.5%) versus community centers (45.0%, 95% CI: 34.5%-55.7%, p = .04). In common studies, Black patients agreed to participate at similar rates (58.4%, 95% CI: 46.8%-69.7%) compared to White patients (55.1%, 95% CI: 44.3%-65.6%, p = .88). Results were also similar comparing White versus Hispanic or Asian patients. The main reasons for non-participation were treatment choice or lack of interest. Conclusions: More than half of all cancer patients who are offered CTs do participate; results were consistent between major race/ethnicity groups. This finding upends several conventional beliefs about cancer clinical trial participation, including that Black patients are less likely to agree to participate and that patient decision-making is the primary barrier to participation. Policies and interventions to improve CT participation should focus more on modifiable systemic structural and clinical barriers, such as improving access to existing trials and broadening trial eligibility.

Trials and tribulations of coronavirus disease-2019 research: with a few bright lights in the fog.

Trials and tribulations of coronavirus disease-2019 research: with a few bright lights in the fog.

Abstract IA07: Biobanking and genomic research: Understanding and acceptance of individuals unrepresented in clinical trials

Abstract Disparities exists in recruitment in clinical trials and biorepositories among minority groups, rural residents, and low-income individuals. The objective of this study to identify barriers and facilitators to awareness, understanding, and acceptance of clinical trials and biobanking among English- and Spanish-speaking safety-net patients and providers and African American (AA) and Hispanic social and church groups. We conducted 14 focus groups and 7 individual interviews January-May 2017 among English-speaking adults in urban and rural communities in Louisiana. In September 2018 we expanded the study to Hispanic adults. (This study is ongoing.) Sites included safety-net oncology and primary care clinics, social service agencies, Alzheimer support groups, and social and church groups. Themes were identified. The first study included 103 individuals: 78 patient and community participants and 25 providers; 24% lived in rural areas. Patients and community members' age ranged from 45-88; 85% were female, 78% AA. Participants were aware of clinical trials and personalized medicine due to ads on TV. Low-income and minority patients were open to participating in genomic trials and biobanking even if it would not benefit them directly. Cancer patients and Alzheimer family caregivers were highly interested in clinical trials that might benefit them or their family. Community participants were less trusting of clinical trials than patients. All said information about clinical trials would be most effective and actionable if it comes from a trusted physician. Terms such as clinical trials and biobanking were scary to some and not understood—medical studies and a bank to store blood and tissue were clearer. AA participants indicated that a recruitment message needs to be “ALL people are needed for studies to improve treatments” rather than “AA have been under-represented and most treatments based on whites,” which raises suspicion. Some participants were concerned with who would see data and if it would be a barrier to jobs or insurance, despite being told of protections in place for confidentiality. Community providers were interested in being more involved in clinical trials. They lacked time to identify trials and explain them to patients. They wanted brief, plain-language handouts with talking points and a card to give patients to call for more information. Transportation to academic centers is a barrier to patient participation in clinical trials. Very few patients, caregivers, or providers had looked for clinical trials on the Internet or social media. AA and lower-income white adults were interested in clinical trials but not clear how to learn about them. Most were willing to participate but had never been asked. Recommendation to participate in a clinical trial is most effective coming from a trusted physician; however, community physicians lack appropriate information to give patients. Strategies to create understandable and actionable information that can be shared with community providers and the public are urgently needed. Citation Format: Terry C. Davis, Connie Arnold, Glenn Mills, Lucio Miele. Biobanking and genomic research: Understanding and acceptance of individuals unrepresented in clinical trials [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr IA07.

Key Barriers to Clinical Trial Enrolment: A Survey of Clinical Trial Staff at an NCI Designated Cancer Center

Background: Clinical trials, key elements of the processes that account for many of the recent advances in cancer care, are becoming more complex and challenging to conduct. The Stephenson Cancer Center (SCC) has been the lead accruer to NCI-LAP trials over the past three years, and in addition, fields investigator initiated and industry sponsored trials. To identify opportunities for continued improvement in clinical trial enrolment, we sought to identify the obstacles encountered by our clinical trial staff in these activities. Method: We conducted a survey of our research staff including all research nurses and disease site coordinators who participate in recruitment, screening, consenting, data collection and compliance. The survey, sent by email to the clinical trial list-serve at SCC (90 staff member), invited respondents to enumerate obstacles to patient participation in clinical trials. We then performed a follow up meeting with our research coordinators to clarify responses. A total of 26 responses from 90 respondents were received and tabulated by disease site. Results: The most commonly reported obstacles to enrolment were, in descending order: communication/language barriers, cultural bias, time/procedure commitment, and complexity of the trial protocol, financial logistics, comorbidities, and stringent trial criteria. Respondents identified 83 obstacles as frequently encountered obstacles to enrolment. The 83 reported obstacles were classified into 9 categories and organized by disease site as presented in tabular format (below). The most commonly identified obstacles to patient enrolment were communication and language barriers. In patients for whom Spanish is the primary language this was a universal obstacle, as there is a lack of consistent Spanish consents across the clinical trial portfolio. Cultural bias, as an obstacle was manifested as a general mistrust by prospective trial participants of experimental therapies and clinical trials. After communication and cultural bias as barriers, travel requirements and the associated expenses playing a role in patients from rural areas were identified as the most commonly encountered barrier. The complexity of trial protocols and the associated large number of clinic visits, frequent laboratory and imaging tests were also identified as common obstacles. Clinical trial complexity with strict inclusion and exclusion criteria and trial-specified biopsies were frequently cited. Implications: In this descriptive study, common barriers to patient enrolment in clinical trials were identified by clinical trial staff. Assessing barriers encountered by clinical trial staff is infrequently used as a metric for improving clinical trial enrolment, but provides important perspective. In our study, some obstacles are inherent in our patient populations, others appear to be actionable. Development of Spanish language consents and specific programs to overcome negative bias regarding clinical trials are potential areas for improvement. The complexity of clinical trial protocols and the increasingly strict inclusion/exclusion criteria, are issues that will require consideration and action at the level of the cooperative groups and industry. Disclosures No relevant conflicts of interest to declare.

USING ECHO TO SUPPORT DEMENTIA DIAGNOSIS IN THE PRIMARY CARE NETWORK

Approximately 60% of those with dementia do not carry a diagnosis, undermining patient participation in clinical trials and family access to support. Under-diagnosis is driven by lack of knowledge about dementia, stigma, clinician inexperience and therapeutic nihilism. To address clinician-based contributors to under-diagnosis, we developed and implemented “Dementia 360,” a telementoring program modeled on the ECHO (Extension for Community Health Outreach) framework. Remote participants (n=67) learned about the diagnostic process, pharmacological management, family support and dementia-related resources. The video-conference-based one-hour sessions occurred weekly over 2 months. Instruction was provided by a multi-disciplinary faculty team with extensive clinical experience. Didactic presentations were followed by case studies offered by participants. Physicians, nurses, psychologists and social workers from 40 organizations participated, of which 62% were from medically underserved rural clinics. Participants were administered pre- and post-program questionnaires about their level of confidence in assessing and treating individuals with memory loss and dementia-related behavioral symptoms. Of the 54 clinicians who completed pre-intervention confidence assessments, 30 completed post-assessment. The clinicians had significantly increased confidence in diagnosing and treating dementia and managing behavioral symptoms of dementia (p ranging from .0002 to .003). Qualitative feedback from focus groups was generally positive, for example, “Knowing the diagnosis criteria and steps to take to rule out other diagnoses will help me more accurately diagnose and rule out dementia for my patients.” Our findings suggest that delivering case-based education via ECHO has potential to increase clinician workforce confidence in diagnosing and managing dementia.