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There is a growing awareness that diversity, health equity, and inclusion play a significant role in improving patient outcomes and advancing knowledge. The Pediatric Heart Network launched an initiative to incorporate diversity, health equity, and inclusion into its 2021 Scholar Award Funding Opportunity Announcement. This manuscript describes the process of incorporating diversity, health equity, and inclusion into the Pediatric Heart Network Scholar Award and the lessons learned. Recommendations for future Pediatric Heart Network grant application cycles are made which could be replicated by other funding agencies.
Emerging societal expectations from biomedical research and intensifying international scientific competition are becoming existential matters. Based on a review of pertinent evidence, this article analyzes challenges and formulates public policy recommendations for improving productivity and impact of life sciences. Critical risks include widespread quality defects of research, particularly non-reproducible results, and narrow access to scientifically sound information giving advantage to health misinformation. In funding life sciences, the simultaneous shift to nondemocratic societies is an added challenge. Simply spending more on research will not be enough in the global competition. Considering the pacesetter role of the federal government, five national policy recommendations are put forward: (i) funding projects with comprehensive expectations of reproducibility; (ii) public–private partnerships for contemporaneous quality support in laboratories; (iii) making research institutions accountable for quality control; (iv) supporting new quality filtering standards for scientific journals and repositories, and (v) establishing a new network of centers for scientific health communications.
Telemedicine enables critical human communication and interaction between researchers and participants in decentralized research studies. There is a need to better understand the overall scope of telemedicine applications in clinical research as the basis for further research. This narrative, nonsystematic review of the literature sought to review and discuss applications of telemedicine, in the form of synchronous videoconferencing, in clinical research. We searched PubMed to identify relevant literature published between January 1, 2013, and June 30, 2023. Two independent screeners assessed titles and abstracts for inclusion, followed by single-reviewer full-text screening, and we organized the literature into core themes through consensus discussion. We screened 1044 publications for inclusion. Forty-eight publications met our inclusion and exclusion criteria. We identified six core themes to serve as the structure for the narrative review: infrastructure and training, recruitment, informed consent, assessment, monitoring, and engagement. Telemedicine applications span all stages of clinical research from initial planning and recruitment to informed consent and data collection. While the evidence base for using telemedicine in clinical research is not well-developed, existing evidence suggests that telemedicine is a potentially powerful tool in clinical research.
During the COVID-19 pandemic, research organizations accelerated adoption of technologies that enable remote participation. Now, there’s a pressing need to evaluate current decentralization practices and develop appropriate research, education, and operations infrastructure. The purpose of this study was to examine current adoption of decentralization technologies in a sample of clinical research studies conducted by academic research organizations (AROs).
Methods:
The setting was three data coordinating centers in the U.S. These centers initiated coordination of 44 clinical research studies during or after 2020, with national recruitment and enrollment, and entailing coordination between one and one hundred sites. We determined the decentralization technologies used in these studies.
Results:
We obtained data for 44/44 (100%) trials coordinated by the three centers. Three technologies have been adopted across nearly all studies (98–100%): eIRB, eSource, and Clinical Trial Management Systems. Commonly used technologies included e-Signature (32/44, 73%), Online Payments Portals (26/44, 59%), ePROs (23/44, 53%), Interactive Response Technology (22/44, 50%), Telemedicine (19/44, 43%), and eConsent (18/44, 41%). Wearables (7/44,16%) and Online Recruitment Portals (5/44,11%) were less common. Rarely utilized technologies included Direct-to-Patient Portals (1/44, 2%) and Home Health Nurse Portals (1/44, 2%).
Conclusions:
All studies incorporated some type of decentralization technology, with more extensive adoption than found in previous research. However, adoption may be strongly influenced by institution-specific IT and informatics infrastructure and support. There are inherent needs, responsibilities, and challenges when incorporating decentralization technology into a research study, and AROs must ensure that infrastructure and informatics staff are adequate.
Edited by
Xiuzhen Huang, Cedars-Sinai Medical Center, Los Angeles,Jason H. Moore, Cedars-Sinai Medical Center, Los Angeles,Yu Zhang, Trinity University, Texas
Ideal healthcare should provide prevention and treatment strategies in the context of individual variability. The promise of genomics and big data for understanding the complex disease etiology and development of treatment strategies for translating research findings in a laboratory setting to the bedside requires a paradigm shift in how we conduct biomedical research. The take-home message from the Human Genome Sequencing Project is the need for a bold vision, even in the absence of a clear path. The No-Boundary Thinking (NBT) approach that advocates a scientific dialogue among individuals with varying expertise in a “discipline-free” manner at the problem definition stage is a pragmatic approach to leverage big data for precision medicine. Genomics big data as it pertains to understanding the molecular function of genes and proteins is discussed in this chapter. We also discuss the challenges in the adoption of NBT to genomics research.
The book ends in 1940, on the cusp of change that came with the militarization of the North during the Second World War and the Cold War. This was also when the Canadian government asserted greater control over the North, including over healthcare. Epidemics that arrived with resource workers, military, and state personnel, were interpreted by southern observers as ‘virgin soil epidemics’ in ‘isolated’ populations. These epidemics and their northern setting influenced biomedical research into the nature of immunity that was significant to the history of medicine.
Research participation during undergraduate years has a powerful influence on career selection and attitudes toward scientific research. Most undergraduate research programs in academic health centers are oriented toward basic research or address a particular disease focus or research discipline. Undergraduate research programs that expose students to clinical and translational research may alter student perceptions about research and influence career selection.
Methods:
We developed an undergraduate summer research curriculum, anchored upon a clinical and translational research study developed to address a common unmet needs in neonatal nurseries (e.g., assessment of neonatal opioid withdrawal syndrome). Program topics reflected the cross-disciplinary expertise that contributed to the development of this “bedside to bench” study, including opioid addiction, vulnerable populations, research ethics, statistics, data collection and management, assay development, analytical laboratory analysis, and pharmacokinetics. The curriculum was delivered through three offerings over 12 months, using Zoom video-conferencing due to restrictions imposed by the COVID-19 pandemic.
Results:
Nine students participated in the program. Two-thirds reported the course enhanced their understanding of clinical and translational research. Over three-quarters reported the curriculum topics were very good or excellent. In open-ended questions, students reported that the cross-disciplinary nature of the curriculum was the strongest aspect of the program.
Conclusion:
The curriculum could be readily adapted by other Clinical and Translational Science Award programs seeking to provide clinical and translational research-oriented programs to undergraduate students. Application of cross-disciplinary research approaches to a specific clinical and translational research question provides students with relevant examples of translational research and translational science.
Primates are bred in captivity for a number of purposes, from zoo-based captive breeding programmes for conservation to breeding for biomedical research. In each case, breeding animals that are fit for purpose, either as viable candidates for reintroduction or as valid research models, has presented challenges and resulted in steep learning curves. The breeding of animals for biomedical research has become increasingly focused on the production of animals that are less stressed by captive (specifically laboratory) environments. This is because elevated, particularly chronic, stress responses can result in altered physiological, neurological and behavioural states that have the potential to compromise the validity of scientific results. Selective breeding in captivity to, for example, maximise production, select for docile temperament or specific genotypes for biomedical research, is likely to be counter to natural selective pressures for evolutionary fitness. Given that many natural selective pressures active in the wild are absent in captivity, this paper reviews the selective breeding of primates (especially Old World monkeys) in captivity, its potential negative effects, and options that exist for ameliorating these negative effects.
Moore v. Regents of University of California was a California Supreme Court case from 1990 adjudicating the claims of a patient whose tissues were used to produce an immortal cell line. Though Moore consented to several procedures, his physician did not inform him that his cells were valuable to the physician’s research and economic interests. The original opinion recognized Moore’s claims for breach of fiduciary duty and informed consent but rejected his claim for conversion (a tort claim for theft). Professor Lisa Ikeomoto’s feminist judgment illuminates the role of informed consent in transforming the doctor-patient relationship from one that is paternalistic to one premised on patient rights and recognizes the role of the women’s health movement in achieving that transformation. In recognizing the plaintiff’s property-based tort claim, she also discusses how the grievance Moore is expressing is about exploitation by an industry based on commercializing cells and tissues. In her commentary, Professor Jessica Roberts highlights that courts have recently become more receptive to recognizing robust legal rights for individuals who provide tissue and data for research purposes.
In this article we examine how a leading Israeli hospital gradually became a large biomedical research facility, resembling a huge laboratory. For Chaim Sheba (1908-1971), the founder and first director of Tel-Hashomer Hospital, the massive immigration to Israel in the 1950s was a unique opportunity for research of diverse human populations, especially Jews who had arrived to Israel from Asia and Africa. The paper focuses on the way research and medical practices were integrated and their boundaries blurred, and studies the conditions under which an entire hospital became a research field. Using the case of one of Israel’s prominent medical institutes, we explore and expand upon the idea of “the hospital as a laboratory,” arguing that, for Sheba, it was not only the hospital but the entire country that functioned as a great research site—a vast laboratory that “had no walls.”
Nature and nurture have always been a prerogative of evolutionary biologists. The environment’s role in shaping an organism’s phenotype has always intrigued us. Since the inception of humankind, twinning has existed with an unsettled parley on the contribution of nature (i.e. genetics) versus nurture (i.e. environment), which can influence the phenotypes. The study of twins measures the genetic contribution and that of the environmental influence for a particular trait, acting as a catalyst, fine-tuning the phenotypic trajectories. This is further evident because a number of human diseases show a spectrum of clinical manifestations with the same underlying molecular aberration. As of now, there is no definite way to conclude just from the genomic data the severity of a disease or even to predict who will get affected. This greatly justifies initiating a twin registry for a country as diverse and populated as India. There is an unmet need to set up a nationwide database to carefully curate the information on twins, serving as a valuable biorepository to study their overall susceptibility to disease. Establishing a twin registry is of paramount importance to harness the wealth of human information related to the biomedical, anthropological, cultural, social and economic significance.
Research on opioid use in pregnancy is critically important to understand how the opioid epidemic has affected a generation of children, but also raises significant ethical and legal challenges. Embedded ethicists can help to fill the gaps in ethics oversight for such research, but further guidance is needed to help strike the balance between integration and independence.
Graeme Laurie’s notion of reflexive governance, rooted in learning from experiences as issues arise, reminds us that the future is built upon past lessons. This chapter looks to the past better to understand our present and future. It begins with the past, examining the complex interaction of law, ethics and science through the prism of three types of human rights: the rights of children and decisionally vulnerable adults, the right to benefit from scientific advancement, and the rights of future generations. It traces the maturation of each from humble beginnings to playing an increasingly central role in biomedical research policy-making. It then turns to the future, largely uncertain but nevertheless responding to the past and the present. It contends that the future of policy-making is partly in the debates spurred by advances in epigenomics and microbiomics, human heritable genome editing, and the Covid-19 pandemic. Each has put our policy-making legacy to the test, illustrating how new ethical paradigms build upon older ones. It concludes by reflecting on the role that biomedical research policy plays in ensuring that science serves the interests of humanity above all else.
The top biomedical research institutions have traditionally been assumed to provide better medical treatment for their patients. However, this may not necessarily be the case. Low-to-moderate negative associations between research activity and the quality-of-care provided by clinical departments have been described. We aimed to examine this relationship in the psychiatric units of the largest hospitals in Spain.
Methods
Scientific publications for 50 hospitals were retrieved from the Web of Science (2006–2015), and quality of mental healthcare data were gathered from Spanish National Health System records (2008–2014). Spearman-rank correlation analyses (adjusting for number of beds and population) were used to examine the associations between research data and quality-of-care outcomes in psychiatry. Stepwise regression models were built in order to determine the predictive value of research productivity for healthcare outcomes.
Results
We found a positive association between research activity indicators (i.e., number of publications, number of citations, cumulative impact factor, and institutional H-index) and better quality-of-care outcomes in psychiatry (i.e., number of readmissions, transfers, and discharges from hospital). In particular, a higher research activity predicted a lower level of readmissions for individuals with psychoses (p = 0.025; R = 0.317), explaining 8.2% of the variance when other factors were accounted for.
Conclusions
Higher research activity is associated with better quality of mental healthcare in psychiatry. Our results can inform decision-making in clinical and research management settings in order to determine the most appropriate quality measures of the impact of research on the prognosis of individuals with psychiatric conditions.
In March 2020, academic medical center (AMC) pharmacies were compelled to implement practice changes in response to the COVID-19 pandemic. These changes were described by survey data collected by the Clinical and Translational Science Awards (CTSA) program which were interpreted by a multi-institutional team of AMC pharmacists and physician investigators.
Methods:
The CTSA program surveyed 60 AMC pharmacy departments. The survey included event timing, impact on pharmacy services, and corrective actions taken.
Results:
Almost all departments (98.4%) reported at least one disruption. Shortages of personal protective equipment (PPE) were common (91.5%) as were drug shortages (66.0%). To manage drug shortages, drug prioritization protocols were utilized, new drug supply vendors were identified (79.3%), and onsite compounding was initiated. PPE shortages were managed by incorporating the risk mitigation strategies recommended by FDA and others. Research pharmacists supported new clinical research initiatives at most institutions (84.0%), introduced use of virtual site visits, and shipped investigational drugs directly to patients. Some pharmacies formulated novel investigational products for clinical trial use. Those AMC pharmacies within networked health systems assisted partner rural and inner-city hospitals by sourcing commercial and investigational drugs to alleviate local disease outbreaks and shortages in underserved populations. Pharmacy-based vaccination practice was expanded to include a wider range of pediatric and adult vaccines.
Conclusion:
The COVID-19 pandemic radically altered hospital pharmacy practice. By adopting innovative methods and adapting to regulatory imperatives, pharmacies at CTSA sites played an extremely important role supporting continuity of care and collaborating on critical clinical research initiatives.
Generating innovative antibiotics is an essential part of addressing antimicrobial resistance. New policies and incentives are necessary to overcoming the multiplicity of scientific, regulatory, and economic hurdles that obstruct antibiotic discovery and development. This chapter assesses the changing landscape of the antibiotics market, barriers to drug discovery and development, incentive mechanisms and strategies to overcome these barriers, and the current product pipeline for antibiotics and alternative therapies. Over recent years, many incentive programmes have been implemented to foster the antibiotic value chain. This chapter proceeds to review the key multilateral, European Union, United States, United Kingdom and regulatory initiatives incentivizing antibiotic research and development. While these initiatives have helped lift the antibiotic pipeline out of dormancy, the recent progresses in development are not sufficient to counter the unrelenting advancement of antimicrobial resistance. We argue that the current global incentive package could be strengthened by ensuring that a continuum of incentives is offered to developers, reflecting the economic need, cost distribution, and barriers of the antibiotic value chain. A global governing body that provides overarching guidance to international and national-level incentive programmes will be critical to achieving such a continuum.
This chapter discusses the regulation of germline editing in Europe, the only region in the world to date to have set up a regulatory framework for biomedical research. First, we consider the principal contributions of the Council of Europe to this framework. After a brief introduction of the history, goals and structure of this organization, we analyse key provisions of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Oviedo Convention) as well as its additional protocols. Relevant case law of the European Court of Human Rights related to the protection of human embryos is also taken into account. Then we turn to the European Union (EU) to examine its efforts to articulate a regulatory for biomedical research. Again, after a brief introduction to the EU, we discuss the basic elements of its framework. This includes the relevant rights included in the EU Charter of Fundamental Rights, the EU directive on the legal protection of biotechnological inventions (98/44/EC) and the EU regulation on clinical trials on medicinal products for human use (EU 536/2014), as well as significant case law of the European Court of Justice. Throughout our analysis, we highlight contradictions, gaps and unresolved issues of the current European regulatory framework, which slow down or even block scientific advancement on human germline modification in Europe. We conclude the chapter not only by pointing to the need for a public debate to address the challenges faced, but also by acknowledging the difficulties of making progress in the light of the complexity of the EU framework and the current political climate.
The need to diversify the biomedical research workforce is well documented. The importance of fostering the careers of fledgling underrepresented background (URB) biomedical researchers is evident in light of the national and local scarcity of URB scientists in biomedical research. The Career Education and Enhancement for Health Care Research Diversity (CEED) program at the University of Pittsburgh Institute for Clinical Research Education (ICRE) was designed to promote career success and help seal the “leaky pipeline” for URB researchers. In this study, we aimed to quantify CEED’s effect on several key outcomes by comparing CEED Scholars to a matched set of URB ICRE trainees not enrolled in CEED using data collected over 10 years.
Method:
We collected survey data on CEED Scholars from 2007 to 2017 and created a matched set of URB trainees not enrolled in CEED using propensity score matching in a 1:1 ratio. Poisson regression was used to compare the rate of publications between CEED and non-CEED URB trainees after adjusting for baseline number of publications.
Results:
CEED has 45 graduates. Seventy-six percent are women, 78% are non-White, and 33% are Hispanic/Latino. Twenty-four CEED Scholars were matched to non-CEED URB trainees. Compared to matched URB trainees, CEED graduates had more peer-reviewed publications (p=0.0261) and were more likely to be an assistant professor (p=0.0145).
Conclusions:
Programs that support URB researchers can help expand and diversify the biomedical research workforce. CEED has been successful despite the challenges of a small demographic pool.