Analysis and Optimization of Equitable US Cancer Clinical Trial Center Access by Travel Time.

Importance: Racially minoritized and socioeconomically disadvantaged populations are currently underrepresented in clinical trials. Data-driven, quantitative analyses and strategies are required to help address this inequity. Objective: To systematically analyze the geographical distribution of self-identified racial and socioeconomic demographics within commuting distance to cancer clinical trial centers and other hospitals in the US. Design, Setting, and Participants: This longitudinal quantitative study used data from the US Census 2020 Decennial and American community survey (which collects data from all US residents), OpenStreetMap, National Cancer Institute-designated Cancer Centers list, Nature Index of Cancer Research Health Institutions, National Trial registry, and National Homeland Infrastructure Foundation-Level Data. Statistical analyses were performed on data collected between 2006 and 2020. Main Outcomes and Measures: Population distributions of socioeconomic deprivation indices and self-identified race within 30-, 60-, and 120-minute 1-way driving commute times from US cancer trial sites. Map overlay of high deprivation index and high diversity areas with existing hospitals, existing major cancer trial centers, and commuting distance to the closest cancer trial center. Results: The 78 major US cancer trial centers that are involved in 94% of all US cancer trials and included in this study were found to be located in areas with socioeconomically more affluent populations with higher proportions of self-identified White individuals (+10.1% unpaired mean difference; 95% CI, +6.8% to +13.7%) compared with the national average. The top 10th percentile of all US hospitals has catchment populations with a range of absolute sum difference from 2.4% to 35% from one-third each of Asian/multiracial/other (Asian alone, American Indian or Alaska Native alone, Native Hawaiian or Other Pacific Islander alone, some other race alone, population of 2 or more races), Black or African American, and White populations. Currently available data are sufficient to identify diverse census tracks within preset commuting times (30, 60, or 120 minutes) from all hospitals in the US (N = 7623). Maps are presented for each US city above 500 000 inhabitants, which display all prospective hospitals and major cancer trial sites within commutable distance to racially diverse and socioeconomically disadvantaged populations. Conclusion and Relevance: This study identified biases in the sociodemographics of populations living within commuting distance to US-based cancer trial sites and enables the determination of more equitably commutable prospective satellite hospital sites that could be mobilized for enhanced racial and socioeconomic representation in clinical trials. The maps generated in this work may inform the design of future clinical trials or investigations in enrollment and retention strategies for clinical trials; however, other recruitment barriers still need to be addressed to ensure racial and socioeconomic demographics within the geographical vicinity of a clinical site can translate to equitable trial participant representation.

The promise of data science for health research in Africa.

Data science health research promises tremendous benefits for African populations, but its implementation is fraught with substantial ethical governance risks that could thwart the delivery of these anticipated benefits. We discuss emerging efforts to build ethical governance frameworks for data science health research in Africa and the opportunities to advance these through investments by African governments and institutions, international funding organizations and collaborations for research and capacity development.

Wrestling with Public Input on an Ethical Analysis of Scientific Research.

Bioethicists frequently call for empirical researchers to engage participants and community members in their research, but don't themselves typically engage community members in their normative research. In this article, we describe an effort to include members of the public in normative discussions about the risks, potential benefits, and ethical responsibilities of social and behavioral genomics (SBG) research. We reflect on what might-and might not- be gained from engaging the public in normative scholarship and on lessons learned about public perspectives on the risks and potential benefits of SBG research and the responsible conduct and communication of such research. We also provide procedural lessons for others in bioethics who are interested in engaging members of the public in their research.

Wrestling with Social and Behavioral Genomics: Risks, Potential Benefits, and Ethical Responsibility.

In this consensus report by a diverse group of academics who conduct and/or are concerned about social and behavioral genomics (SBG) research, the authors recount the often-ugly history of scientific attempts to understand the genetic contributions to human behaviors and social outcomes. They then describe what the current science-including genomewide association studies and polygenic indexes-can and cannot tell us, as well as its risks and potential benefits. They conclude with a discussion of responsible behavior in the context of SBG research. SBG research that compares individuals within a group according to a "sensitive" phenotype requires extra attention to responsible conduct and to responsible communication about the research and its findings. SBG research (1) on sensitive phenotypes that (2) compares two or more groups defined by (a) race, (b) ethnicity, or (c) genetic ancestry (where genetic ancestry could easily be misunderstood as race or ethnicity) requires a compelling justification to be conducted, funded, or published. All authors agree that this justification at least requires a convincing argument that a study's design could yield scientifically valid results; some authors would additionally require the study to have a socially favorable risk-benefit profile.

Exclusion cycles: Reinforcing disparities in medicine.

Clinical practice, data collection, and medical AI constitute self-reinforcing and interacting cycles of exclusion.

Cardiologists' Perspectives on BiDil and the Use of Race in Drug Prescribing.

OBJECTIVES: We explored cardiologists' attitudes and prescribing patterns specific to the use of generic isosorbide dinitrate and hydralazine hydrochloride, and the fixed-dose patented drug, BiDil. BACKGROUND: Since the Food and Drug Administration approved BiDil in 2005 with an indication for self-identified black patients, disagreement about the appropriateness of race-based drugs has intensified and led to calls for providers and researchers to abandon race-based delimitations. This paper reports empirical evidence of cardiologists' views on BiDil's race-based indication and their ongoing inertia with respect to the debate about BiDil. METHODS: We conducted a 2010 cross-sectional online survey of members of the Association of Black Cardiologists. RESULTS: Fifty-nine cardiologists responded to the survey. Most participants (62.7%) prescribed BiDil to their patients. More than 40% of respondents did not prescribe BiDil to any non-African Americans. When considering whether to prescribe BiDil, a patient's race determined by physician assessment was the third most important factor considered by participants. The majority of participants (72.7%) selected symptoms as the most important factor. Most participants (59.2%) perceived race as defining biologically distinct individuals. Respondents prescribed BiDil more often to African American patients than non-African American patients. However, they prescribed the generic components that makeup BiDil to African Americans and non-African American patients similarly. CONCLUSIONS: The survey provides useful findings that, when viewed within the context of ongoing debates about race-based medicine, show little progress toward appropriately utilizing BiDil to maximize health outcomes, yet, might inform the development of practical and effective guidelines concerning the use of race in medicine.

Diversity and Inclusion in Unregulated mHealth Research: Addressing the Risks.

mHealth devices and applications, with their wide accessibility and ease of use, have the potential to address persistent inequities in biomedical research participation. Yet, while mHealth technologies may facilitate more inclusive research participation, negative features of some unregulated use in research - misleading enrollment practices, the promotion of secondary mHealth applications, discriminatory profiling, and poorer quality feedback due to dependencies on biased data and algorithms - may threaten the trust and engagement of underrepresented individuals and communities. To maximize the participation of currently disenfranchised groups, those involved in unregulated mHealth research must become aware of potential risks, adopt targeted education policies, audit algorithms for hidden biases, and engage citizen scientists and other community members to identify and forestall possible harms.

Evaluating the promise of inclusion of African ancestry populations in genomics.

The lack of representation of diverse ancestral backgrounds in genomic research is well-known, and the resultant scientific and ethical limitations are becoming increasingly appreciated. The paucity of data on individuals with African ancestry is especially noteworthy as Africa is the birthplace of modern humans and harbors the greatest genetic diversity. It is expected that greater representation of those with African ancestry in genomic research will bring novel insights into human biology, and lead to improvements in clinical care and improved understanding of health disparities. Now that major efforts have been undertaken to address this failing, is there evidence of these anticipated advances? Here, we evaluate the promise of including diverse individuals in genomic research in the context of recent literature on individuals of African ancestry. In addition, we discuss progress and achievements on related technological challenges and diversity among scientists conducting genomic research.

Attitudes and experiences regarding genetic research among persons of African descent.

Minorities are underrepresented in genetic research. This study examined the attitudes, experiences, and willingness of persons of African descent related to participation in genetic research. A total of 272 persons of African descent completed a questionnaire about attitudes and experiences associated with genetic research. Descriptive, Chi-square, and logistic regression were used to examine the impact of attitudes and experiences in predicting the odds of willingness to participate in genetic research. A majority of participants (97%) indicated that they have never participated in genetic research; however, a majority also reported that they would be willing to participate in a genetic study specifically for the detection of risk factors for cancer (87%), diabetes (89%), alcohol use disorder (73%), and Alzheimer's disease (88%). Participants who disagreed that "results from genetic research can explain why some diseases are found more often in some ethnic groups than others" were less likely to be willing to participate in studies related to cancer (OR = 0.16), diabetes (OR = .16), alcohol use disorder (OR = 0.27), and Alzheimer's disease (OR = 0.27). Participants reported limited experiences engaging in genetic research; yet, they overwhelmingly acknowledged the importance of genetic research and expressed willingness to participate in multifactorial genetic studies despite concerns about genetic discrimination, stigma, and/or a potentially poor prognosis. Further research on the underlying reasons why persons of African descent choose to participate in genetic research should be explored and addressed to make research more inclusive and ethically sound.

Cardiologists' Perspectives on Race-Based Drug Labels and Prescribing Within the Context of Treating Heart Failure.

Purpose: Cardiologists are known to consider patients' race when treating heart failure, but their views on the benefits and harms of this practice are largely undocumented. We set out to explore cardiologists' perspectives on the benefits and harms of race-based drug labels and guidelines. Specifically, we focused on isosorbide dinitrate and hydralazine hydrochloride (sold in a patented form as BiDil), a combination of drugs recommended for the treatment of black patients receiving optimal medical therapy for symptomatic heart failure and reduced ejection fraction. Methods: We conducted 81 semistructured interviews at an American College of Cardiology Annual meeting to assess cardiologists' and cardiology fellows' attitudes toward the use of race in drug prescribing. Investigators reviewed and coded the interviews using inductive qualitative analysis techniques. Results: Many participants believed that race-based drug labels might help doctors prescribe effective medications to patients sooner. More than half of the participants expressed concerns, however, that considering race within the context of treating heart failure could potentially harm patients as well. Harms identified included the likelihood that patients who could benefit from a drug may not receive it because of their race; insufficient understanding about gene-drug-environment interactions; and simplistic applications of race in the clinic. Conclusions: Few participants expressed approval of using race in drug prescribing without recognizing the potential harms, yet most participants stated that they continue to consider race when prescribing isosorbide dinitrate and hydralazine hydrochloride. Within the context of treating heart failure, more open discussions about the benefits and harms of race-based drug labels and prescribing are needed to address cardiologists' concerns.

The Emergence of Genomic Research in Africa and New Frameworks for Equity in Biomedical Research.

Individuals with African ancestry have the greatest genomic diversity in the world, yet they have been underrepresented in genomic research. To advance our understanding of human biology and our ability to trace human history, we must include more samples from Africans in genomic research. Additionally, inclusion of more samples from participants of recent African descent is imperative to provide equitable health care as genomics is increasingly used for diagnosis, treatment, and to understand disease risk. The Human Heredity and Health in Africa initiative (H3Africa) seeks to expand the number of Africans included in genomic research and to do so by expanding the research capacity on the continent. In this article, we discuss how H3Africa is endeavoring to achieve these goals while promoting equitable research collaborations.

The Use of Racial Categories in Precision Medicine Research.

Scholars have shown that promoting diversity and inclusion in precision medicine research is important for ethical and scientific reasons. The processes for classifying the populations that enroll in biomedical research, however, are often unclear, inconsistent, and poorly justified. Precision medicine research promises increasingly meticulous approaches to defining research cohorts and assessing the multivariate factors at the root of racial health disparities. Insofar as precision medicine is promoted to members of historically underrepresented populations as a tool for illuminating these factors, the use of race-based classifications is fraught with risks for society and medicine. This article examines the drivers and limitations of the ongoing use of race by investigators juxtaposed with recent efforts to enroll underrepresented populations in precision medicine research.

Diversity and inclusion in genomic research: why the uneven progress?

Conducting genomic research in diverse populations has led to numerous advances in our understanding of human history, biology, and health disparities, in addition to discoveries of vital clinical significance. Conducting genomic research in diverse populations is also important in ensuring that the genomic revolution does not exacerbate health disparities by facilitating discoveries that will disproportionately benefit well-represented populations. Despite the general agreement on the need for genomic research in diverse populations in terms of equity and scientific progress, genomic research remains largely focused on populations of European descent. In this article, we describe the rationale for conducting genomic research in diverse populations by reviewing examples of advances facilitated by their inclusion. We also explore some of the factors that perpetuate the disproportionate attention on well-represented populations. Finally, we discuss ongoing efforts to ameliorate this continuing bias. Collaborative and intensive efforts at all levels of research, from the funding of studies to the publication of their findings, will be necessary to ensure that genomic research does not conserve historical inequalities or curtail the contribution that genomics could make to the health of all humanity.

Ethical, Legal, and Social Implications of Personalized Genomic Medicine Research: Current Literature and Suggestions for the Future.

PURPOSE: This review identifies the prominent topics in the literature pertaining to the ethical, legal, and social issues (ELSI) raised by research investigating personalized genomic medicine (PGM). METHODS: The abstracts of 953 articles extracted from scholarly databases and published during a 5-year period (2008-2012) were reviewed. A total of 299 articles met our research criteria and were organized thematically to assess the representation of ELSI issues for stakeholders, health specialties, journals, and empirical studies. RESULTS: ELSI analyses were published in both scientific and ethics journals. Investigational research comprised 45% of the literature reviewed (135 articles) and the remaining 55% (164 articles) comprised normative analyses. Traditional ELSI concerns dominated the discourse including discussions about disclosure of research results. In fact, there was a dramatic increase in the number of articles focused on the disclosure of research results and incidental findings to research participants. Few papers focused on particular disorders, the use of racial categories in research, international communities, or special populations (e.g., adolescents, elderly patients, or ethnic groups). CONCLUSION: Considering that strategies in personalized medicine increasingly target individuals' unique health conditions, environments, and ancestries, further analysis is needed on how ELSI scholarship can better serve the increasingly global, interdisciplinary, and diverse PGM research community.

Genomic Test Results and the Courtroom: The Roles of Experts and Expert Testimony.

The rapid advancement from single-gene testing to whole genome sequencing has significantly broadened the type and amount of information available to researchers, physicians, patients, and the public in general. Much debate has ensued about whether genomic test results should be reported to research participants, patients and consumers, and at what stage we can be sure that existing evidence justifies their use in clinical settings. Courts and judges evaluating the utility of these results will not be immune to this uncertainty. As scholars increasingly explore the duty of care standards related to reporting genomic test results, it is timely to provide a framework for understanding how uncertainty about genetic and genomic tests influences evidentiary considerations in the court room. Here, we explore the subtleties and nuances of interpreting genetic data in an environment of substantial discord related to the value that individuals should place on genetic and genomic tests. In conjunction, we discuss the roles courts should play in qualifying experts, expert testimony, and genetic and genomic tests given the intricate and complex nature of genetic and genomic information.