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Purpose: Thirty years after the NIH Revitalization Act, racial/ethnic minority (REM) patients continue to be underrepresented in oncology clinical trials with disproportionately low rates of participation compared to non-Hispanic whites. Health system, patient, and medical provider factors contribute to this disparity. However, little is known about clinical trial investigator perspectives of REM participation in oncology clinical trials and their contribution to this disparity. To our knowledge there are no published quantitative studies that have investigated this important and actionable topic. Methods: We conducted a cross-sectional, anonymous, pilot survey of medical, radiation, and surgical oncology clinical trial investigators at a large academic center. Over a 5-week period, 107 individuals received a survey. The survey assessed 6 domains regarding disparities in REM participation in clinical trials: investigator knowledge, attitudes, and prior training on the topic, self-efficacy and motivation for improvement in addressing known disparities, and perceived barriers to REM participation in clinical trials. Modified, previously validated items were used when possible. Results: Of 60 respondents (56% response rate), 33 were male (55%). Thirty-six identified as non-Hispanic white (60%), 16 as Asian (27%), 1 as Hispanic/Latinx (2%), and 7 as other/prefer not to state (11%). Respondents included 49 medical (82%), 7 surgical (11%), and 4 radiation oncologists (7%). Average time as a clinical trial investigator was 14 years (2-40). Respondents opened an average of 2 clinical trials as primary investigator in the past year (0-10). A majority (83%) strongly agreed disparities exist in REM clinical trial participation and that the resulting lack of diversity is problematic (75%). However, only 34% strongly agreed they consider ways to achieve racial/ethnic diversity among trial participants when designing clinical trials, or ways to specifically enroll REM patients (28%). Respondents most commonly cited patient rather than health system factors as barriers to REM participation in clinical trials. Notably, nearly half (45%) agreed that lack of REM participation is a problem they cannot directly address. A majority (83%) endorsed wanting to improve their consideration of barriers to REM participation as they design clinical trials and wanted help to improve (86%). Conclusion: Our results suggest there is awareness among clinical trial investigators at our academic center of disparities in REM participation in oncology clinical trials and the problem this poses to cancer care. There is also a pervasive view that primary barriers to REM participation are patient factors, and investigators do not feel they can directly address these. Nonetheless, there is motivation among investigators to improve in their ability to consider barriers to REM participation as they design clinical trials. Interventions that improve investigators’ self-efficacy for addressing barriers to REM participation in clinical trials, especially patient level barriers, are needed. Citation Format: Natalie P. Bransky, Anne M. Walling, John A. Glaspy, Maria Garcia-Jimenez. Exploring the unexplored: Clinical trial investigator perspectives of disparities in racial/ethnic minority participation in oncology clinical trials [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 A078.

B66: Delaware/Christiana Care Oncology patient advocates for clinical trials

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If we are to statistically represent the US population (CIA World Factbook), approximately 20% of all clinical trial participants should be composed of racial and ethnic minorities. However, it is a well documented public health concern that minority participation in clinical trials is minimal at best, namely among cancer trials. The American Cancer Society expects 1.6 million persons to be diagnosed with cancer in 2011 (Cancer Facts and Figures 2011, 1) and in order to develop and evaluate sustainable treatments, clinical trials are a necessity. It is estimated that 3–5 percent of eligible cancer patients will participate in clinical trials (Gotay, C.C., 569). Less than one percent will represent a racial or ethnic minority (npr.org). The purpose of this study is to determine whether or not a Community Research Council can increase minority participation in clinical trials. The Center for Equal Health, a partnership between the University of South Florida, H. Lee Moffitt Cancer Center, and the Tampa Bay Community is committed to increasing minority participation in clinical trials for the purpose of enhancing the current treatment options and research surrounding ailments that directly affect minority communities. The Community Research Council (CRC) was established to advocate for and oversee clinical and translational research activities in the Tampa Bay region. Synthesized by examining examples from several Tribal Nations, this governing body serves to: 1) Strengthen the relationship of the research institutions with the community; 2) Provide oversight, protection, and advocacy of community participants involved in clinical and translational research activities performed by academic and clinical institutions; 3) Create and enhance clinical trial opportunities for underrepresented communities; 4) Empower underrepresented communities with decision-making opportunities concerning research activities that involve their members; and 5) Enhance and expand trust between academic and clinical institutions and the communities that they serve. Within 12 months of formation, the council will expand into at least one other geographical area to build upon existing relationships with other research institutions (i.e., Florida A&M University). This will lead to the development of Minority Clinical Research Networks (MCRN) that will serve as the link between the CRC, clinical practitioners, members of the community, research institutions, and pharmaceutical companies. Long term goals of the CRC include lobbying pharmaceutical companies and private investors to provide more clinical research opportunities in the defined region (i.e., the Florida Counties of Hillsborough, Pasco, and Pinellas). Once clinical trials are created or identified in the region, we will develop a plan to monitor minority participation in these trials over time. We expect to see self-reported increases in clinical research knowledge within one year of CRC implementation in the region. We believe that when clinical practitioners, research institutions, members of the community, and pharmaceutical companies are provided with a central organization that provides education, ethical guidelines, and an opportunity for networking, the long term result will be an increase in minority participation in clinical trials. Citation Information: Cancer Epidemiol Biomarkers Prev 2011;20(10 Suppl):A26.

108 Background: Thirty years after the NIH Revitalization Act, racial/ethnic minority (REM) patients remain underrepresented in oncology clinical trials. Little is known about clinical trial investigator perspectives of REM participation in clinical trials. To our knowledge no published studies exist assessing differences in investigator perspectives based on their primary role in the clinical trial process. We hypothesized that differences exist in investigator perspectives regarding REM participation in oncology clinical trials based on having a more design-oriented (principal (PI)/co-investigator (co-I)) or recruitment-oriented role (sub-investigator (sub-I)). Methods: We conducted a cross-sectional, anonymous, pilot survey of oncology clinical trial investigators at an academic center. Over 5 weeks, 107 individuals received a survey assessing 6 domains about disparities in REM participation in clinical trials, including knowledge, attitudes, and prior training. Modified, previously validated items were used if possible. We performed a subset analysis of mid- and late-career investigators (>/= 10 years of experience) comparing those who opened at least 1 clinical trial in the past year as PI or co-I to those who did not (sub-I). Results: There were 60 respondents (56% response rate). Average time as a clinical trialist was 14 years (2-40). Average number of trials opened in the last year as PI/co-I was 4 (1-30). Among all respondents, 83% strongly agreed disparities exist in REM clinical trial participation and that lack of diversity is problematic (75%). Notably, 45% agreed this is a problem they cannot directly address. Among mid- and late-career investigators, those who opened at least 1 trial as PI/co-I were more likely to have received training about barriers/facilitators (OR=3.56; 95% CI=1.05, 12.04; p=.04) to REM clinical trial participation and about strategies for improving participation (OR=3.75; 95% CI=1.06, 13.29; p=.04). Despite this, they were more likely to endorse wanting help to improve in this area (OR=4.95; 95% CI=1.17, 21.02; p=.03). Conclusions: Our results suggest there is awareness among clinical trial investigators of disparities in REM clinical trial participation, but investigators do not feel they can directly address these. Investigators who are more involved in clinical trial design are more likely to want help to improve their ability to address disparities in REM trial participation despite being more likely to have received prior training on the topic. Our findings suggest training alone is inadequate support for investigators involved in designing clinical trials. More studies eliciting the needs of investigators with varying roles in the clinical trial process are needed to inform targeted interventions to enhance investigators’ self-efficacy for improving REM participation in clinical trials.

The clinical trials that are conducted by the National Cancer Institute (NCI) represent the core of the clinical program of the NCI’s Center for Cancer Research. At the Center for Cancer Research, clinical and basic science are integrated with the goal of reducing the burden of cancer through discovery, exploration, and bench-tobedside translational treatment and prevention modalities. The goal of the NCI clinical trials program is to answer questions about particular cancers and to identify new therapeutic and prevention interventions, which are performed across the United States at centers participating in NCI-supported research. Sadly, only 2% to 7% of adult patients with cancer across the United States participate in these clinical trials. To make matters worse, the following populations are under-represented among participants in NCI-funded clinical trials: Latinos/Hispanics, Asian and Pacific Islanders, African American men, American Indians/Alaskan Natives, adolescents, older adults (age 65 years), individuals who reside in rural areas, and individuals of low socioeconomic status. The lack of diversity in clinical trials populations reduces the opportunity for discovering effects that may be relevant to a particular under-represented population. The literature has focused on barriers to participation in clinical trials—including both physician and patient issues—such as cost, lack of support personnel, limited access to clinical trials, and the distance that patients may live from centers that participate in NCI clinical trials. In a study by Meropol et al, cognitive, affective, and practical barriers to participation in clinical treatment trials were characterized among Pennsylvania oncologists. Eligible physician participants were practicing medical oncologists in Pennsylvania, and eligible patients were adults at least 18 years of age with cancer undergoing follow-up by medical oncologists in Pennsylvania. Of 137 oncologists and 170 patients who completed the surveys, of patients, 84% were aware of clinical trials, and both oncologists and patients generally agreed that clinical trials were important to improve cancer treatment. It was interesting that oncologists and patients in this report were more likely to consider clinical trials in advanced or refractory disease. When considering seven potential barriers to clinical trials, random assignment and fear of receiving a placebo were highly ranked by both patients and oncologists. Patients identified fear of adverse effects as the greatest barrier to clinical trial participation, whereas oncologists ranked this psychosocial barrier as of least importance to their patients. Although the study found that oncologists and patients in Pennsylvania were aware of clinical trials and had favorable attitudes toward them in principle, psychosocial barriers existed for patients that more than likely reduced participation. One of the key issues in this study was the fact that the oncologists who were surveyed had favorable attitudes toward clinical trials. Surely, there must be oncologists who don’t have favorable attitudes toward clinical trials and are not advocates of clinical trials. This is reflected in the fact that 30% of oncologists are responsible for 70% of the accrual to NCI clinical trials. Although some important pragmatic issues, such as fiscal and administrative support, may affect participation, these are issues that affect all oncologists to varying degrees, yet some oncologists are more successful than others in accruing patients to clinical trials. As reported by the Coalition of Cooperative Groups, community-based practices are responsible for 64% of adult patients accrued in cooperative group–sponsored clinical trials. Academic centers are responsible for 34%, whereas military/Veteran’s Administration hospitals contribute the remaining 2%. Hence, the NCI Community Clinical Oncology Programs (CCOPs) play a major role in adult recruitment to NCI-sponsored clinical trials. Created in 1983 by the National Cancer Institute, the CCOP network allows patients and physicians to participate in state-of-the-art clinical trials for cancer prevention and treatment in their local communities. There are 50 CCOPs and 13 minority-based CCOPs currently funded in 35 states across the United States, the District of Columbia, and Puerto Rico. The Delaware Christiana CCOP was initially funded in 1987. After a restructuring of the cancer program at the Helen F. Graham Cancer Center at Christiana Care in 2001, accrual to NCI clinical trials increased from 9.9% in 2001% to 20% in 2006. There are many reasons for this dramatic increase in clinical trial accrual over a 5-year period, which represents six times the national average. All the reasons for this increase in patient accrual to NCI clinical trials are beyond the content of this article. Briefly, however, this increase has been partly due to the establishment of multidisciplinary disease site centers, placing clinical research nurses in the private practice offices, with a continuous marketing campaign. Nevertheless, despite the improvement of this clinical trials accrual, there is a core of physicians participating in the cancer program whose track record to clinical trial accrual can best be described as dismal. This is despite the fact that there are more than 110 clinical trials available for their patients covering every disease site, with personnel support to help in the recruitment to clinical trials. These individuals are designated members of the NCI Cooperative Groups and many have membership in cooperative groups on their curriculum vitaes. Some investigators have suggested that access to clinical trials should be an objective and a component of state-of-the-art cancer JOURNAL OF CLINICAL ONCOLOGY COMMENTS AND CONTROVERSIES VOLUME 26 NUMBER 15 MAY 2

ogists, radiation oncologists, and surgeons who were involved in the care of patients with colorectal or lung cancer. The investigators identified physician and infrastructure factors associated with clinical trial participation within the Cancer Care Outcomes Research and Surveillance Consortium, a partnership of academic and Veterans Administration hospitals with community outreach that are funded to do clinical research on cancer outcomes (2). Among the more telling findings: Physicians who saw a higher number of patients and who spent more time with each new patient had higher clinical trial accrual rates. Specifically, the majority of medical oncologists (59.4%) saw more than 20 colorectal or lung cancer patients per month, whereas the majority of surgeons (65%) saw fewer than five of these patients per month. The majority of medical oncologists (63.5%) and radiation oncologists (84%) spent 60 minutes or more with a new cancer patient visit, whereas the majority of surgeons (81.4%) spent less than 60 minutes. Factors that may facilitate discussion of treatment options with other physicians, such as teaching medical students or residents and attending tumor board meetings, were found to be associated with a higher likelihood of accruing or referring patients to trials. As expected, frequent participation in tumor board meetings (ie, weekly or monthly) was associated with higher rates of accrual, most likely because patients could be promptly referred to trials with specific eligibility requirements. However, participation in discussion formats is only a small part of the story, given that only 869 (56.7%) of physicians in the study had accrued or referred at least one patient to a clinical trial during the previous 12 months. Clinical trials require additional work beyond the usual practice of cancer care. Physicians who participate in clinical trials do not necessarily do so for their own financial gain, as supported by this study. Specific resources in the form of trained staff such as research nurses, staff to handle institutional review board issues, and investigational pharmacists and resources, such as physical space and information technology support, are essential to incorporate clinical trials into daily practice. Physicians who were affil iated with a National Cancer Institute–designated cancer centers (3) or a Community Clinical Oncology Program (4), two programs designed to provide that infrastructure, were associated with more accrual and referral. And yet, the research support is not sufficient: As Klabunde et al. (1) show in their secondary analysis, 34% of physicians affiliated with an organization designed to support clinical trial participation are not actively participating in the research. It appears that “the desire is present, but the body is unwilling.” What are the barriers to active participation by these physicians who have agreed (implicitly or explicitly) to participate? Are physicians inadequately trained for the additional responsibilities required of them to participate in clinical trials? Is it the additional work at a time when so many demands are made of them inhibiting their participation? What are reasonable expectations of physicians with regard to participation in clinical trials? The American public continues to value investment in medical research. In 2010, more than 70% of the general public were likely to consider participating in a clinical trial, but only 6% of their physicians offered that participation (5). A recent survey of patients seen at the Mayo Clinic showed that 76% of patients expected their treating physician to inform them about current trials (6). A more in-depth evaluation of the physician–patient encounter noted that of those patients who were offered participation in a cancer clinical trial, 75% agreed to participate, but only 20% of all of the patients (who were potentially eligible) were explicitly offered participation in a trial (7).

Previous abusive clinical trials have caused several obstacles in recruiting African Americans for clinical trials today. The memory of the Tuskegee Syphilis Study alone remains a hard pill to swallow and is a constant hindrance to recruiting potential African Americans specifically males, for clinical trials. The basic trust that African Americans have for physician researchers, U.S. government doctors, U.S. government-sponsored research, and biomedical research in general has been seriously, although not irrevocably, breached. The purpose of this study was to gain an understanding of the knowledge, attitudes, and beliefs African Americans have that support decisions to either participate or not participate in a clinical trial. Specific areas that were examined by perceptual and demographic measures included: knowledge of clinical research processes, perceptions of clinical research purposes and procedures, advantages and disadvantages for the individual of participation in clinical research trials, characteristics of current and past participation in clinical research trials, exposure to selected experiences which are preliminary to participation in clinical research trials, perceptions regarding the need for selected changes in preparation for participation in clinical research trials; and selected personal demographic characteristics: gender, age, marital status, education level, employment status, household income, distance from research center, and overall health status. The survey method was utilized in this study. The discriminant analysis model was used to determine if a model existed that significantly increased the researcher's ability to correctly classify volunteers on their participation status in clinical research trials. The overall model was meaningful and successful in correctly classifying 74.6% of the original grouped cases. The strongest findings suggest that African Americans are likely to participate in future clinical trials based on their knowledge and perceptions of clinical research trials. Principal Investigators and research teams which focus on African Americans in clinical research trials should therefore place an increased emphasis on strategic planning that involves participants representative of the study population. To yield results, the plan should be tailored to African Americans, presented as a credible study, designed to reflect trust in the medical care team, and implemented through a continuous educational process.

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