Clinical research disruption in the post-COVID-19 era: will the pandemic lead to change?

Diversity and Inclusion in Pancreatic Cancer Clinical Trials

Mitigating Administrative Risks in Industry-sponsored Clinical Trials

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

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

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

The participation of underserved ethnic minorities in clinical research is critical to achieving progress in cancer control. Ethnic minority patient accrual in clinical trials is a formidable challenge that requires patient trust, commitment, and overcoming of barriers. Racial and ethnic minorities make up about 40% of the United States population, yet are not well represented in research studies. Less than 10% of all patients with cancer enrolled in clinical trials are minorities. Diverse participation may lead to more generalizable results for under-represented groups, more best practices for prevention and treatment to specific minority groups, increase in knowledge and awareness of disparities about cancer, and a more accurate reflection of the United States' increasingly diverse population. Although there is a proliferation of patient navigation programs to increase health care among the underserved, there is little known on its potential effects as a strategy to enhance minority clinical trial and biospecimen accrual. City of Hope has built a functional and sustainable program for addressing health inequity, which includes training a network of community research navigators (CRN) to address gaps in knowledge, medical mistrust, and access, and navigate participation and engagement of under-represented groups in research. The research navigator program draws from the patient navigation and promotora model and is a novel and innovative application to this approach. This approach has utility and applicability to address research participation barriers, including trust and referrals. It promises sustainability and cost effectiveness as trained CRNs can deliver the program. The Community Research Navigator (CRN) project enhances community advocates' capacity by training community health leaders/promotoras as community research navigators (CRN) to widen the dissemination of the clinical trial and research participation enrollment for increased ethnic minority participation in clinical trials and health-related research. CRNs attended a 1-day training on clinical trials and research. The training included educating and encouraging individuals to proactively think about and discuss clinical trial participation with their family, friends, and health care providers; disseminating information about specific research studies, targeting the African and Latino communities; and referring individuals to specific biospecimen, clinical trials, and population studies. In total, we trained and mentored a team of 14 CRNs. Participants were 24-66 years old; most were female (86%), Latino (69%), and single (43%). After participating in the training, participants were more likely to correctly define HIPAA (p=.040) and the types of clinical trials (p=.038). In addition, CRNs were more likely to encourage clinical research participation among their family after the training (p=0.034). Further, we measured confidence in various domains, including: increase in confidence in describing the purpose and process of clinical research (p=0.006); educating minority communities about clinical trials (p=0.045); and providing informational workshops/forums on clinical research (p=0.046). Participants had an increase in overall confidence (p=.033). Our findings demonstrate that the CRN strategy holds promise in increasing minority participation in cancer clinical trials. It is an innovative application of the extensively studied patient navigation approach that warrants research. Future research should focus on the CRN project as a cost-effective tool for enrollment and retention of ethnic minorities in cancer clinical trials and the potential of enhancing clinical trial understanding outcomes among participants. Citation Format: Marisela Garcia, Mayra Serrano, Alejandro Fernandez, Katty Nerio, Kimlin Ashing. Community research navigators: The bridge to increasing ethnic minority participation in clinical research [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr A25.

e13743 Background: Black/African Americans (B/AA) have a disproportionate cancer burden and the highest mortality rates of any racial/ethnic group for most cancers. Racial/ethnic variation in cancer burden reflects health inequities, differences in risk factors, heredity and genomic diversity, and lack of access to and participation in cancer prevention, screening, treatment, and clinical trials. Twelve percent of the United States population are B/AA; however, only about 5% B/AA participate in clinical trials. As a result, data regarding tumors from B/AA are not equally represented in new drug discovery efforts. Methods: Participatory Action for Access to Clinical Trials (PAACT) used a Community Based Participatory Research (CBPR) approach to support a partnership between Henry Ford Health (HFH) and eight African American, Caribbean, and continental African community-based organizations (CBOs). Focus group data were collected in-person and virtually with representatives from the CBOs and HFH cancer survivors. CBOs participated in Steering Committee meetings throughout the project and two community forums to obtain feedback on recommendations identified through the qualitative data. Results: Factors contributing to participation in cancer clinical trials included systemic issues related to racism, health disparities and trust in government, health systems, and clinical research. Other factors included personal experiences with healthcare systems, healthcare provider-patient communication, socio-economic barriers (e.g., time away from work, family), and perceptions of future benefits from trials for B/AA communities. Recommendations included: 1) on-going health system outreach to B/AA communities regarding cancer prevention and treatment, as well as clinical trials. 2) B/AA community liaisons and cancer survivors as providers of information related to clinical trials; 3) two-way provider-patient communication to address questions and concerns about treatment options and trial information; 4) monetary compensation for indirect trial costs; 5) information on the importance of diversity within trials; and 6) ensuring information is provided to patients’ support networks. Conclusions: CBPR is effective in the identification of factors that influence participation in clinical trials. Building trust between patients and the healthcare system begins before patients walk into a clinic and every interaction contributes to institutional worthiness of community and patient trust. It is possible and imperative for health systems to work with B/AA communities and jointly identify and implement recommendations to ensure informed decision-making regarding trial participation. We are currently designing intervention strategies based on the recommendations for implementation at HFH.

Access to data from clinical trials in the COVID-19 crisis: open, flexible, and time-sensitive

PL03-05: International clinical research-Barriers and challenges: A vision from independent and publicly funded trials

Introduction: Clinical trials are important tools for advancing cancer treatment, prevention, and control. To identify and describe clinical effects relevant to underserved groups, representation of medically underserved cancer survivors in clinical trials is necessary. Medically underserved groups historically have been defined to include racial/ethnic minorities, under-insured or uninsured groups, those with low levels of education, and those with low socioeconomic status. The recent Institute of Medicine report on the Health of Lesbian, Gay, Bisexual, and Transgender People also describes lesbian, gay, and bisexual (i.e., LGB) people as medically underserved. Medically underserved groups are known to be underrepresented in cancer clinical trials, except in the case of LGB cancer survivors. Currently, no published research has examined LGB cancer survivor's participation in cancer trials. Given this paucity in the literature, this study aimed to test the hypothesis that prevalence of clinical trial participation would be lower among LGB cancer survivors than heterosexual cancer survivors. Methods: Data were from the Behavioral Risk Factor Surveillance System (BRFSS), which is a health surveillance program sponsored collaboratively by the Centers for Disease Control and Prevention (CDC) and U.S. states. The BRFSS is administered annually to probability-based samples of non-institutionalized adults over 18 years of age. The Cancer Survivorship module is an optional module that states may elect to use and that assesses cancer survivor participation in cancer clinical trials. Data for this study are from five states' 2010 BRFSS surveys that included both the Cancer Survivorship module and an item asking self-identified LGB status to either their entire survey population (Massachusetts, New Mexico, Wisconsin, and Alaska) or to one or more probability-based sample splits (California) (n=4,339). Results: Participation in cancer clinical trials was higher among LGB cancer survivors (12.5%) than among heterosexual cancer survivors (6.0%) (p = .005). In the multivariate model, adjusted by age, sex, education, race/ethnicity, and survey state, LGB cancer survivors were more than twice as likely, as heterosexual cancer survivors, to report participation in a clinical trial (AOR 2.17, 95% CI 1.21-3.90). Conclusion: LGB cancer survivors had greater likelihood of cancer clinical trial participation than heterosexual cancer survivors, and this association was not explained by education. The finding was not expected given the historic marginalization of this group and previous reports that up to 15% of clinical trials explicitly excluded LGB participants. The finding may be explained by insurance coverage. LGB people are more likely to lack health insurance than heterosexuals. Thus, LGB cancer survivors may be more inclined to seek care through clinical trial participation. Small sample size precluded examining whether denial of insurance coverage was an explanatory factor for trial participation; however this is a logical next step for future research. Citation Format: Jennifer M. Jabson, John R. Blosnich. Lesbian, gay, and bisexual cancer survivor's participation in cancer clinical trials: Findings from a national health survey. [abstract]. In: Proceedings of the Fifth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2012 Oct 27-30; San Diego, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2012;21(10 Suppl):Abstract nr B22.

Imagine the following: A 58-year-old surgeon recently diagnosed with Stage 4 lung cancer comes to see you for clinical trial options. He is otherwise in excellent health, and he takes no medications. He is highly motivated to receive cutting-edge treatments, has a thorough understanding of the nature of the disease and potential therapies, and states he will be strictly adherent to any recommended treatment regimen. However, he is not eligible for any clinical trial available at your institution due to a history of localized prostate cancer treated surgically three years previously.

Background: The Komen Tissue Bank (KTB), a clinical trial that collects women’s healthy breast tissue for use as research study controls, currently stores samples demonstrating a noted paucity of minority specimens. Studies have shown minority groups’ participation in clinical trials is dependent upon the groups’ knowledge about the associated research. This study’s purpose is to conduct formative research on animated storytelling’s effectiveness as a communication tool to address minority groups’ expressed need for knowledge and encourage participation in cancer clinical trials. Methods: I re-coded data previously gathered from a KTB study to evaluate the perceptions of Latinas (n=14) and Asian Americans (n=17) toward breast tissue donation. Extensive review of the current literature yielded data concerning African Americans’ outlooks toward clinical trial participation, and also illustrated the efficacy of using narratives and animation as communication and education tools. Results: The literature review clearly illuminated the importance of storytelling in minority cultures and suggested the success of using narratives as communication tools. We anticipate our findings could be influenced by a) minorities’ lack of, and need for, comprehensive knowledge, b) previously obscured participation barriers, and c) animated storytelling as an effective delivery method. Projected Conclusion and Potential Impact: Using an animated storytelling communication tool may successfully increase knowledge about, and comfort with, participation in a cancer clinical trial. The next phase, an animated video production, will tell the comprehensive story of healthy breast tissue donation. The use of this tool could help increase minority participation in cancer prevention and cancer clinical trials.

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

American Society of Clinical Oncology policy statement: oversight of clinical research.

For cancer patients, participation in a clinical trial is more attractive than receiving standard therapies, which may be limited in effectiveness. Lately, however, this choice has been complicated by the fact that insurers explicitly refuse to reimburse for expenses incurred as part of a clinical trial. In the pre-managed care era, procedures were routinely covered by a combination of sources: the administrative and agent costs of clinical trials were borne by the pharmaceutical industry or the government (through the National Institutes of Health or the Veterans Administration), and other costs were unwittingly absorbed by patients' third-party insurers.[1] As managed care review brought this expenditure to light, insurers began to deny reimbursement for or experimental regimens, on the grounds that covering unproven services was outside the intended use of the pooled funds for which managed care insurers were responsible. Clinical researchers at first responded to this refusal by persuading insurers to cover investigational treatments on a case-by-case basis, or by camouflaging a patient's research participation so as to slip the claims through the increasingly vigilant payment systems.[2] In spite of increases in government funding for clinical research, an ongoing conflict evolved among doctors, patients, and insurers over the question of whether insurers should reimburse for investigational procedures. Some patients have gone to court when faced with the prospect of paying for an investigational intervention themselves, or when they were unable to pay for an therapy that they saw as a last chance treatment. But attempts to resolve this controversy in the courts have resulted in such varied and at times illogical outcomes that no consistent legal direction has emerged.[3] In response, researchers and patients have taken the problem to Congress and to state legislatures. Thus Arizona's Cancer Clinical Trials legislation. In April 2000, the governor of Arizona signed into law a bill requiring insurers to provide coverage for some costs associated with their enrollees' participation in cancer clinical trials. The bill was modeled on legislation already enacted in Georgia, Maryland, and Rhode Island, among other states, and was developed in the same year as similar legislation in Illinois and Louisiana.[4] In Arizona, the legislation had been sharply contested since its inception, and it remained controversial at the time it was signed into law. Predictably, oncologists at academic medical centers, cancer patients, and their advocates were the most vocal supporters of the bill, while third party payers, including Medicaid medical administrators, were opposed to it. Problems with the Law The Cancer Clinical Trials bill was supposed to respond to the fact that cancer clinical trials are underenrolled.[5] Most people from both sides of the debate agreed that only 3 percent of cancer patients currently enroll in clinical trials, while up to 20 percent may be eligible. The hypothesis behind the legislation was that patients do not participate in clinical trials because they would have to pay for it themselves, since most managed care insurers explicitly refuse to reimburse their enrollees for any interventions. The trouble with this hypothesis is that it is flatly contradicted by the best evidence available. According to a study by the United States General Accounting Office, insurers tend to make case-by-case exceptions to their general policy not to cover interventions.[6] The finding was corroborated by lobbyists for managed care organizations during public hearings on the Arizona bill, as well as by research oncologists in a study at the University of Arizona's Medical Center.[7] The GAO study concluded that many factors, in addition to insurance coverage practices, can influence patient participation in clinical trials. …