Research Burden in the Portuguese Residency Program: Cardiology's Unique Challenge.

Diversity and Inclusion in Pancreatic Cancer Clinical Trials

AIDS Clinical Trials Is There Access for All?

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.

AIDS clinical trials. Is there access for all?

Encouraging participation in cancer clinical trials, one step at a time.

Mitigating Administrative Risks in Industry-sponsored Clinical Trials

Same-Day Consent for Regional Anesthesia Clinical Research Trials: It's About Time.

Audience segmentation as a strategy for enhancing the use of research registries for recruiting patients into clinical trials

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.

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.

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).

Rethinking trial eligibility in the NCD era

620 Creating a culture of clinical research in the clinic: Integrating clinical trials into the care of patients with lupus

The Native Hawaiian population of Hawaii has disproportionately high cancer incidence and mortality rates. Native Hawaiian women with breast cancer present at an advanced stage and have death rates that are 52 % above the state average. Prostate cancer among Native Hawaiian men is diagnosed at more advanced stage. Native Hawaiian participation in cancer clinical trials was historically low. Reasons for this were varied including access, health literacy, lack of primary and referring physician awareness/time constraints and cultural barriers. Since the establishment of the University of Hawaii Minority Based Clinical Oncology Program (UHMBCCOP) participation in cancer clinical trials has definitely increased. MBCCOP provided clinical trial promotion, increased access and clinical trial support for a group of hospital and office based oncologists across the islands of Oahu and Kauai have all contributed to the increase. Education programs in Hawaii by multiple organizations, in particular, Imi Hale, the Native Hawaiian Cancer Network Program have enhanced knowledge of cancer and clinical trials in the Native Hawaiian community. Imi Hale's emphasis has focused on community based patient training, patient navigation and referring physician cancer clinical trial training. In fact, a recent program was recently initiated in conjunction with Education Network to Advance Clinical Trials (ENNACT) and Queens Medical Center. Review of Native Hawaiian participation in both cancer prevention and treatment trials through the UHMBCCOP over the last 20 years shows a significant gender difference with more women participating in both prevention and treatment trials. The reasons for this are not well understood but are under investigation. In summary, increased focused access and community based education have improved Native Hawaiian participation in cancer clinical trials but challenges persist including gender disparities in enrollment onto clinical trials and lack of access outside of Oahu and Kauai islands. Citation Format: Jeffrey L. Berenberg. Overcoming cultural and geographic barriers to participation in clinical trials among Native Hawaiians. [abstract]. In: Proceedings of the Sixth AACR Conference: The Science of Cancer Health Disparities; Dec 6–9, 2013; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2014;23(11 Suppl):Abstract nr PL02-03. doi:10.1158/1538-7755.DISP13-PL02-03

Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors