OA-903 Breaking barriers, bridging knowledge: inclusion of women in clinical research by addressing gender and diversity regional gaps in clinical research capacity in Africa

THE NINTH FORUM OF THE EUROPEAN & DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIP

Societal Impact Statement Plant viruses spread by insects decimate crop yields globally, causing food security challenges in vulnerable areas including regions of Africa. Interdisciplinary research is needed to protect future crop supplies. CONNECTED, the Community Network for African Vector‐Borne Plant Viruses, increased research capacity in Central, East, West and Southern Africa through networking, funding research and training. Here, we describe how CONNECTED developed a community of 1675 members across 97 countries, delivered new research and trained early career researchers in interdisciplinary techniques. The approach used by CONNECTED can be replicated by other initiatives to increase international plant research capacity and collaboration, particularly between the Global South and North. Summary Plant viruses, often spread by insects, decimate staple and nutritious crop yields globally. This contributes to economic and food security challenges in vulnerable areas, including regions of Africa. Interdisciplinary research is required to better understand plant virus epidemiology to protect future crop supplies, but this is often hindered by limited collaboration and knowledge exchange between plant pathology and entomology research communities. Collaborative networks are a useful model for promoting collaborative and interdisciplinary research. CONNECTED, the Community Network for African Vector‐Borne Plant Viruses, was a collaborative research network supported by the UK Global Challenges Research Fund. CONNECTED sought to convene international plant pathology and entomology communities through networking, pump‐priming new collaborative research, and training, to increase vector‐borne plant virus (VBPV) research capacity in Africa. Combining analysis of CONNECTED's activities programme with qualitative methods, we identify the outcomes achieved by CONNECTED for the global VBPV community, and the value it provided to its members. CONNECTED developed a multidisciplinary community of 1675 members across 97 countries. CONNECTED delivered 20 new strategically‐relevant research projects involving 55 researchers from 33 institutions across 14 countries working on 11 different crops. CONNECTED trained over 140 early career researchers from 23 countries in interdisciplinary VBPV techniques, providing new training materials co‐created in partnership with Africa‐based research organisations. These outcomes demonstrate the impact of CONNECTED's phased programme of activities in building the capacity of international VBPV research communities, towards plant science and food security outcomes, which can be expanded and replicated in different contexts.

The total value to society of eliminating all life expectancy disparities attributable to the underrepresentation of minorities for the three common conditions of diabetes, heart disease, and hypertension was approximately $11 trillion based on a commissioned analysis that applied the Future Elderly Model for the National Academies of Sciences, Engineering, and Medicine (NASEM) Committee on Improving the Representation of Women and Underrepresented Minorities in Clinical Trials and Research.1 While older adults experience higher rates of these comorbidities2 and polypharmacy3 than the general population and are the major utilizers of medications,4 they are considerably underrepresented in clinical trials and clinical research overall.5 The prioritization of COVID-19 vaccines for older adults as part of phase 1 by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices was a prominent example of the importance of studying older adults and, particularly, older adults with chronic disease in clinical trials.6 To address the societally pressing challenge of the lack of older adults, women, and minorities in clinical trials and medical research in general, NASEM hosted a virtual workshop titled "Drug Research and Development for Adults Across the Older Age Span" in 2020. The following year through 2022, NASEM performed a Congressionally mandated consensus study with culminating report titled "Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups." The goal of these NASEM activities was to examine and shed light on the challenges and opportunities in drug research and development for older adults, women, and underrepresented groups and explore hurdles that impair clinical studies in these populations. The NASEM events described the array of consequences due to the underrepresentation of women and minoritized populations as well as the salient conclusions based on the evidence (Table 1). 1. Lack of representation compromises generalizability and relevance of clinical research findings to the whole U.S. population. 2. Lack of representation translates to hundreds of billions of dollars in medical costs in the United States. 3. Lack of representation may hinder innovation and new discoveries. 4. Lack of representation may compound low accrual that causes many trials to fail. 5. Lack of representation may lead to a lack of access to effective medical interventions. 6. Lack of representation may undermine the trust of the clinical research enterprise and the medical establishment. 7. Lack of representation may lead to the absence of determination and measurement of outcomes meaningful to these populations. 8. Lack of representation precludes ascertaining important variations in medication absorption and metabolism, which may be altered by age, sex/gender, and race/ethnicity. 1. Improving representation in clinical research is urgent. 2. Improving representation in clinical research requires substantial investment that must include education and dialogue with patients and communities who may be unfamiliar with clinical trials and may have concerns about potential risks as well as benefits. 3. Improving representation requires transparency and accountability. 4. Improving representation in clinical research is the responsibility of everyone involved in the clinical research enterprise. 5. Creating a more equitable future entails a paradigm shift. Barriers to the necessary representation of underrepresented and excluded populations in clinical research in the current research system have reduced participation by a diverse population in clinical trials and clinical research at multiple levels. Individual research studies, the institutions that conduct research, funders of studies, institutional review boards (IRBs), medical journals, and the broader landscape of national policies and practices that govern research all contribute to barriers of populations historically excluded from clinical research. At the level of an individual research study, the factors and problems that lead to the underrepresentation and exclusion of certain populations in clinical trials and research begin with and follow the life cycle of a project. Understanding and resolving the underrepresentation and exclusion of these populations in research require careful examination of almost every stage in the research process itself. This includes at the time research questions are developed. The composition, training, and attitudes of the research team must also be considered to foster the thoughtful dialogue and insight necessary to maximize representation of needed populations. Research site selection is also a key facet in bolstering access to priority populations for increasing representativeness. Intentionality in "meeting people where they are" has been identified as a key pillar in improving the representativeness and validity of studies. Consideration on participant selection and study protocols in general that includes determination of sampling approaches, recruitment methods, inclusion, and exclusion criteria must also be carefully evaluated. Appropriately performed this includes review of informed consent processes, remuneration for study participants, as well as development and inclusion of multilingual recruitment and consent documents. For older adults, it has been noted that while most older adults with the most common chronic conditions that result in hospitalization in the United States occur in older people with multiple conditions, having multiple conditions was often an exclusion criterion in the National Institutes of Health (NIH) trials. This approach effectively ensured that the representative older population was systematically excluded from the studies. Deliberate considerations of the consequences of inclusion and exclusion criteria decisions on representativeness must be prioritized as fundamental to the research. Institutional structures are also a barrier to appropriate inclusivity. Medical institutions of different types face a range of structural barriers to inclusion in clinical trials. For example, although academic medical centers conduct 55% of the extramural medical research supported by the NIH and operate 98% of the nation's 41 comprehensive cancer centers as of 2019, sustainably and meaningfully engaging underrepresented and excluded populations often does not align with the traditional incentive structures for researchers at these institutions. Recruiting diverse population groups and properly engaging with community members, which is time-consuming and requires investments to build and sustain trust, are only minimally considered in promotion and tenure decisions at academic medical centers. While community health centers serve a much more diverse community than academic medical centers, these institutions also face barriers to clinical trials and research recruitment, which include limited provider knowledge about available research opportunities and challenges with electronic health record (EHR) infrastructure, that can limit providers' ability to query the EHR using study inclusion and exclusion criteria. IRBs can also present barriers to diverse participation in clinical trials by limiting the types and amount of compensation given to research participants to avoid the impression of coercion or undue influence. However, limiting incentives may ultimately compromise beneficence and justice, two of the ethical principles for research with human subjects detailed in the Belmont Report.7 Research funders also have several roles and responsibilities, which can influence the diversity of clinical trials. These include setting funding priorities, deciding which projects ultimately get funded, providing adequate funding to recruit and retain participants, requiring transparent reporting, and evaluating research outputs. Most clinical trials are funded by pharmaceutical firms. These trials present barriers, including out-of-pocket costs for participants, which are often not discussed in the informed consent process, industry pressures to gather data quickly, and the selection of easy-to-recruit samples often being incentivized. It should be noted that some of these barriers are not solely unique to industry-sponsored trials. Peer-reviewed medical journals serve as the gatekeepers to scientific advancements in clinical practice and health. Their editors wield great power for what is, and is not, published in their pages. Lack of representation on editorial boards and other journal leadership positions may contribute to biases in publication. Recent focused efforts have been formalized to improve representation on journal editorial boards. This included the release of The Journal of the American Medical Association priorities to strive for and promote diversity, equity, and inclusion (DEI) that included the following key approaches: update journal mission statements to include inclusivity aims, appoint an editorial director of equity, improve editorial diversity, promote awareness of and responsibility for DEI, formalize process for assessment and reporting, expand editorial fellowship program, hold seminars on excellence in scientific writing, continue to publish articles on DEI, identify and invite peer reviewers and authors of opinion articles with DEI expertise, encourage authors to address systemic and structural problems to advance DEI, review and update inclusive language guidance for authors and editors update statistical analysis guidance, and participate in International Collaboration on Standards and Policies.8 While the JAMA effort is a necessary step, many more journals must plan, execute, and monitor their efforts to ensure representativeness regarding inclusivity. These activities from NASEM developed an array of policy considerations and recommendations to narrow the inclusiveness gap for minorities, women, and older adults in clinical research. In terms of bolstering reporting, transparency, and accountability, the NASEM report recommended that The Department of Health and Human Services (HHS) create a research equity task force within HHS charged with coordinating data collection and designing study subject recruitment and accrual monitoring that would track across federal agencies, including the Food and Drug Administration (FDA), NIH, CDC, Agency for Healthcare Research and Quality (AHRQ), Health Resources Services Administration (HRSA), Indian Health Services (IHS), and the Centers for Medicare & Medicaid Services (CMS). This task force would submit an annual report to Congress on the status of clinical trial and clinical research enrollment in the United States, which would include patient counts recruited into clinical studies by phase and condition. Mandated data would include the study patients' age, sex, gender, race, ethnicity, study location, and recruitment site. The annual report would also describe to what degree the study population was representative of the conditions studied as well as the sponsors of the research. Creating a real-time, data dashboard was offered as an example of a tool to make data more accessible and transparent continuously. The report also recommended clarifying how "representativeness" was determined and evaluated for protocols and product development plans.1 This would serve to not only help discern the older adult representation but allow for stratification of the older adult categories by minority, gender, and location to ensure that studies line up with actual disease prevalence for older adult subpopulations. This was coordinated with a frequent comment that the heterogeneity of older adults must be better tracked with improved tools and technology to enhance knowledge and treatment outcomes to increase the proportion of heterogeneous older adults in clinical trials. The improved use of modern tools was also broached in terms of better use of technology such as social media to improve recruitment of older adults from diverse backgrounds into trials.9 For a path toward equitable compensation to research participants and their caregivers, the NASEM report recommended developing specific guidance that would include systematically modified compensation for those who will experience a financial burden when participating in research activities. Receipt of a detailed recruitment plan should be required by the FDA no later than at the time of Investigational New Drug and Investigational Device Exemption application submission. To facilitate that trial characteristics are consistently labeled throughout the database and can be easily disaggregated, exported, and analyzed by the public, NIH should standardize the submission of demographic characteristics to ClinicalTrials.gov beyond current guidelines. A theme across the NASEM activities was that NIH can better leverage its role as a funder to motivate improved inclusiveness of older adults and minorities. The score-driving criteria that measure the scientific integrity and overall impact of a NIH grant proposal should formally include participant representativeness data. Patient representativeness data should be components of the assessment of the scientific approach, including whether it is appropriate for concluding insights for the populations to whom the results are intended to generalize. In the 2020 NASEM workshop, Alzheimer's disease research was referenced as an area in which representation of older adults would be expected. The concept of requiring a justification for not including older adults was described on several occasions.9 The NIH should also assess in its annual review of progress reports of funded studies whether a given study has met the proposed enrollment goals of representativeness by race/ethnicity, sex, and gender and should establish a plan for remediation that includes criteria for pausing funding that has not met predefined recruitment goals. Journal publisher, editors, and the International Committee on Medical Journal Editors should (1) require information on the representativeness of studies for submissions to their journals in context to the affected population; (2) consider this information in acceptance decisions; and (3) publish this information for manuscripts that are accepted. The overall representativeness of the trial, including how well the study population aligns with the target population, should be evident in the publication. The Office of Human Research Protections (OHRP) and the FDA should advise local IRBs determine and report the representativeness of clinical trials as one measure of sound research design. Study protocols in which the pre-specified enrollment departs markedly from the disease prevalence would trigger a request for a justification statement or possible remediation. The commitment to and value of educating review bodies across the clinical development continuum to incorporate considerations of age, gender, and minority status dimensions was a prevailing theme. In terms of coverage and payment, CMS should revise its guidance for coverage with evidence development to require that study protocols include a plan for recruiting and retaining participants who are representative of the affected beneficiary population in age, race, ethnicity, sex, and gender. Congress should direct the FDA to enforce accountability measures already present, as well as establish a taskforce to study new incentives for new drug applications for trials that achieve representative enrollment. This recommendation has in fact been enacted in the Food and Drug Omnibus Reform Act of 2022 (FDORA)10 that requires sponsors of phase 3 or other pivotal medication studies to submit diversity action plans by the time the study protocol is submitted. A synthesis of the current environment was recently detailed in the special article "Current status of inclusion of older groups in evaluations of new medications: Gaps and implementation needs to fill them" in this journal.11 Incentive programs should be designed to improve representativeness in clinical research and ensure they do not impede access to new therapies. Expedited coverage decisions should be considered for therapies based on clinical programs that achieve representativeness of the populations most affected. To incentivize community providers to enroll participants in trials, CMS should develop reimbursement approaches for the time and infrastructure that is required. Development of new payment codes would allow CMS to reimburse activities associated with clinical trial participation including data collection and personnel to support research education and recruitment endeavors. The Government Accountability Office (GAO) should assess the impact of previously enacted policies reimbursing routine care costs associated with CMS trials. To foster equitable compensation to research participants and their caregivers, federal agencies, including the OHRP, NIH, and FDA, should develop guidance to direct IRBs on appropriate remuneration for study participation. This new guidance should encourage and allow for variable compensation to research participants and their caregivers commensurate with the time commitment and financial burden of participating. There are trial designs tested that offer the prospect of increasing enrollment of older adults, including adaptive platform trial designs, home-based trials, mechanistic modeling, simulations, real-world data, and pragmatic clinical trials. Clinical trials can now be successfully completed in many non-traditional clinical trial environments that have included barber shops and pharmacies.9 Similarly, all sponsors of clinical trials and clinical research (e.g., federal, foundation, private, and/or industry) should ensure that trials provide adequate compensation for research participants. A diverse, inclusive, and representative workforce, particularly in leadership circles, should be maintained for all organizations involved in clinical research. Recognition of research, training, and professional activities to promote community-engaged scholarly efforts and other research to enhance clinical trial representativeness should be included as areas of excellence for promotion or tenure considerations. The HHS should substantially invest in research infrastructure in the community. To bolster the capacity of community health centers and safety net hospitals to participate in clinical research, funding should be directed to agencies such as the HRSA, NIH, AHRQ, CDC, and IHS. These recommendations and recent advances to date in each area are summarized in Table 2. Progress has been made at the government level with the passage of FDORA as well as coordinated efforts to improve representativeness in clinical research by other agencies, academic institutions, foundations, and non-governmental organizations. Yet, recommendations on changing the composition of the workforce and individual academic entities will require a longer timeframe and concerted effort as will building trust across all communities. Bridging the inclusion gaps for older adults, minorities, and women in clinical research is achievable and necessary. However, it will demand intentional and committed policy efforts with coordination from an array of stakeholders. Fortunately, informed guidance now exists that we must immediately harness and apply to reverse our flagging population health outcomes and move us closer to peer nations. Dr. Jonathan H. Watanabe contributed to the concept, design, and preparation of the manuscript. Dr. Jonathan H. Watanabe credits his involvement as a Member of the Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine (NASEM), a planning committee member for the Drug Research and Development for Older Adults Across the Older Age Span NASEM Workshop, and a prior National Academy of Medicine Emerging Leader in Health and Medicine Scholar. He would like to thank Dr. Janice Schwartz for her insightful feedback that strengthened this manuscript. The information or contents are those of the author and should not be construed as the official position or policy of, nor should any endorsements be inferred by NASEM or NAM. Jonathan H. Watanabe has received research funding from the National Institutes of Health and the National Academies of Sciences, Engineering, and Medicine. These organizations played no role in the design, development, writing, or review of this manuscript. None. None.

Training Africans to Lead and Execute Neurological Trials and Studies (TALENTS): program overview and rationale

Scaling up clinical research capacity in Africa requires more non-communicable disease studies.

To explore the role played by human research ethics committees (HRECs) with regard to the fair inclusion of men and women in Australian clinical research. Semi-structured face-to-face and telephone interviews with 25 chairs (or their nominees) of Australian HRECs between 9 June 2006 and 24 January 2007. Chairs' views about the role of HRECs in identifying sex discrimination, monitoring the inclusion of men and women in clinical research, and interpreting and applying National Health and Medical Research Council (NHMRC) guidelines relating to fair inclusion in research. In general, HRECs do not take an active role in monitoring the sex of research participants. They do not ask for or often receive information about the sex of participants. Most HREC chairs did not believe that sex discrimination in research is currently a significant or widespread problem, and were confident that their committees would be able to identify arbitrary exclusion of either men or women from research. However, many chairs expressed a lack of familiarity with debates about sex equity in research. Most chairs were unaware that anti-sex-discrimination legislation could apply to research. "Fair inclusion" was interpreted in a number of ways by chairs, but most frequently that the sex balance among research participants should reflect the sex distribution in the community of the condition under investigation. Chairs said their committees would be reluctant to reject a research protocol on the grounds that the sex balance among participants was perceived to be unfair. Views about, and expertise on, sex equity in research vary among chairs of HRECs. Many HRECs require further guidance about the appropriate standards for fair inclusion of men and women in Australian clinical research.

BackgroundThere is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as a case-study.MethodsWe conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members (RECs) and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands.ResultsThree themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals’ individual perception of risk may influence recruitment.ConclusionsHealthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women.

Gender diversity in corporate governance is a highly debated issue worldwide. National campaigns such as “2020 Women on Boards” in the United States and “Women on the Board Pledge for Europe” are examples of just two initiatives aimed at increasing female representation in the corporate boardroom. Several European countries have adopted board quotas as a means toward achieving gender diversity. Japan has passed an Act on Promotion of Women’s Participation and Advancement in the Workplace to lay a foundation for establishing targets for promoting women. This Article examines the status of women in positions of leadership in the United States, several major countries in the European Union, and Japan. We focus on the legal backdrop in each jurisdiction regarding gender discrimination and studies tending to demonstrate the economic benefits of gender diversity. We conclude that although important steps have been taken in the direction of narrowing the gender gap in all jurisdictions examined, progress has been slow and difficult across the board. The issue of too few women at the top will not be resolved until there is a wider acceptance that female leaders can benefit their organizations and contribute to social and economic progress. Moreover, the presence of women on corporate boards is valuable in and of itself and the status quo ought to be further challenged in international business.

The Purpose: The purpose of this study was to systematically gather information on the barriers interviewers encounter when recruiting African American women (AAW) study participants, identify approaches that increase the likelihood that an individual will agree to participate, and describe the resources and support that interviewers believe is important for them to be successful. Background: The challenge of recruiting African Americans for clinical and epidemiologic research have been presented in numerous papers, with some focusing on patient/community perceptions (Herring, 2004; Corbie-Smith, 1999; Scharff, 2010) and others focusing on the perspective of the investigator. One viewpoint that has received relatively little attention is the role of the recruiter or interviewer. These individuals are often the first point of contact between the research study and the potential participant, and they may be a prime determinant of overall participation rates. Although some papers have examined the association between participation rates and interviewer characteristics such as race, age and years of experience, (Hansen, 2006; Davis 2010; Moorman, 1999) these papers have not solicited the input and opinions of the interviewers. There is little in the scientific literature about barriers to participation and strategies for improving response rates from the perspective of the interviewer. Methods: To address this gap in knowledge, we conducted a series of focus groups with interviewers experienced in recruiting African American women for observational epidemiologic studies, including case-control and prospective cohort studies. Focus groups were conducted reaching 18 recruiters from three research intensive academic/medical institutions along the east coast and the Midwest. Sessions were conducted via 90 minute recorded conference calls and a $10 incentive was provided to each participant. Study approval was obtained through the University's IRB. The following questions guided the focus groups: (1) What barriers do you hear and face when recruiting AAW into research? (2) What strategies have you used to overcome challenges associated with recruiting AAW in research studies? (3) What resources, tools, and skills would you find helpful so as to more effectively recruit AAW in research? Recordings were transcribed and a thematic analysis of the data was implemented using a systematic, multistep, rigorous process outlined by Braun and Clarke (2006). Summary of Data: Commonly cited barriers to research participation among AAW include “the gatekeeper,” maintaining confidentiality, lack of community engagement among researchers, requesting bio specimens, and lack of buy-in among clinic staff. As with other studies, research participation among AAW included fear of being a guinea pig, historical medical atrocities, fear and distrust of the medical system, and competing priorities. Key strategies often used to address barriers and increase enrollment include being open about the historical relationship between research and minorities, emphasize the voluntary role, treat potential and current enrollees as a “whole” person, address competing needs with resources, be flexible with protocol, specimen requests, and schedules. Unique recommendations include highlighting the importance of system and research team engagement by understanding clinic culture and increasing researcher's engagement within local minority communities. Consistent with the literature, other cited recommendations to improve enrollment include training around building rapport, understanding bias, cultural competence, and role play with significant feedback on the nuances to consider when engaging minorities in clinical research. Conclusion: The strategies and recommendations gleaned from front line recruiting personnel have significant policy and practice implications. These findings will inform training and interventions designed to more effectively support research teams as they aim to reach, enroll, and retain African American women and other minorities in clinical research. Citation Format: Nadine J. Barrett, Patricia Moorman, Tracey Vann Hawkins, Chamali Wickramasekara. Barriers, strategies, and recommendations to engaging African American women in clinical research: The recruiter's perspective. [abstract]. In: Proceedings of the Seventh AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 9-12, 2014; San Antonio, TX. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2015;24(10 Suppl):Abstract nr A43.

<p indent="0mm">A clinical trial is a key step in the process of pharmaceutical research and development (R &amp; D). It is a key indicator of the innovative potential of the pharmaceutical industry. ClinicalTrials.gov shows that the average annual growth rate of the total number of clinical trials globally in the past decade (2012–2021) was 20.7%, mainly distributed in Europe and the United States, and the total number of clinical trials registered in China accounted for 6% of the world. According to the statistics of IQVIA Institute for Human Data Science, the global proportion of early-stage R &amp; D pipelines from China-headquartered companies increased from 1% in 2005 to 12% in 2020, which was still far behind that of European and American companies. Among 871 new active substances approved for marketing globally in the past two decades, 522 were for marketing in China, with the high number driven by regulatory acceleration mechanisms from National Medical Products Administration, such as breakthrough and orphan designations and priority reviews. Considering the gap in clinical research strength between China and developed countries such as Europe and the United States, the clinical trial research capacity and level should be improved to assist China in the R &amp; D of innovative drugs. According to the Registration and Information Disclosure Platform for Drug Clinical Studies and the clinical trial institution filing management information platform in China, in the last five years (2017–2021), the average annual growth rates of the total number of new drug clinical trial registration and clinical trial units in China reached 26.9% and 12.6%, respectively. However, clinical trial resources are mainly concentrated in major institutions, municipalities, or provincial capital cities in the eastern and central regions of China, with distributions becoming increasingly polarised. Under the background of China’s new medical reforms, the strategic direction of national political support is to motivate equitable access to high-quality clinical trial resources and cross-regional collaborative development of medical institutions by means of medical unions, national clinical medical research centres, Chinese national major projects for new drug innovation and so on. In the context of this background, clinical trial research unions (CTRUs) have been built in China. A CTRU is defined as a consortium formed by medical institutions, sponsors and third-party service institutions of various levels and functions, led by a national clinical medical research centre or clinical trial medical institutions undertaking major national science and technology projects or supporting projects of national key R &amp; D plans, radiating and driving the improvement of clinical trial research capacity in multiple regions. CTRUs develop a multi-level clinical research centre system and collaborative network by vertically and horizontally combining multi-level medical institutions, sponsors and third-party service institutions. All participants of CTRUs are crucial. The leading clinical trial research medical institution, as the core, is responsible for establishing institutional system standards in CTRUs, designing and leading high-quality multi-centre clinical trials, central ethics and personality training. The major clinical trial research medical institutions are responsible for implementing high-quality, multi-centre, complex and high-risk clinical trials. The other member institutions are responsible for implementing basic clinical trials. The sponsors, contract research organizations (CROs), site management organizations (SMOs) and other enterprises are responsible for funding, supporting and promoting the construction of a clinical trial centre system and collaborative network. The specific construction contents of CTRUs include building a clinical trial research resource sharing platform, homogenising clinical trial quality management, constructing a rapid clinical trial process platform, diversified multi-level and multi-form talent training, information interconnection, deepening strategic cooperation and designing and leading high-level trials. CTRUs have established the selection criteria and assessment exit mechanism and conducted work performance assessments from the dimensions of organisation and implementation, division of labour and cooperation, the connection of clinical trial resources from top to bottom, efficiency and benefit and sustainable development to ensure their good and sustainable development. Through CTRUs, we can achieve high-quality clinical trial resource sharing, improve the clinical trial research capability of member institutions, cultivate high-level skills, such as principal investigators (PIs), sub-investigators, institutional managers and clinical research coordinators (CRCs), and promote the development of clinical trials, economically and with high-quality. Through the trial operation with one member of CTRUs, it was found that the key points should be strengthened in deepening resource sharing, implementing central ethics review, interconnecting information platforms and leading high-quality clinical trials. The construction of CTRUs is an effective means for China’s clinical trial research to solve the current problems and change from a ‘follow-on pattern’ to leading high-level and high-quality international multi-centre trials. However, the construction of CTRUs is a complex systematic project. In addition to performing an excellent job in the top-level design and overall planning, CTRUs’ specific implementation process and measures need to be continuously explored in the practice process.

Cardiovascular disease (CVD) is the most common cause of death in American women and accounts for a full one-third of all deaths.1 Although the common perception may be that CVD affects mainly men, there is equal prevalence of this disease between the genders by the age of 40, and by the age of 60 more women than men are affected. More women than men have died from CVD causes on a yearly basis since the mid 1980s, and whereas the CVD mortality has steadily declined in men over the past 30 years, it has remained steady in women until very recently when CVD mortality was noted to decrease for both genders.2 See accompanying article on page 277 The impact of cardiovascular disease (CVD) on the health status of American women is gaining more recognition and has become the focus of public education efforts such as the “Go Red for Women” campaign sponsored by the American Heart Association and the “Red Dress” project sponsored by the Department of Health and Human Services, the National Institutes of Health (NIH), and the National Heart Lung and Blood Institute (NHLBI). These programs are, in part, a response to the increasing awareness of cardiovascular disease as a major source of morbidity and mortality in U.S. women. The importance of CVD as a major source of mortality in women was recognized early on by federally funded institutes including the Public Health Service Task Force, which brought attention to concerns about the health information available to women and the historical lack of research focus on women’s health in its 1985 Report of the Public Health Service Task Force on Women’s Health Issues .3 In response to this report, the National Institutes of Health adopted a policy for the inclusion of women in clinical research …

Many organizations seek to highlight diversity, equity, and inclusion efforts, but African American women are still significantly underrepresented in leadership roles within the workplace (McKinsey, 2023). Within the technology (i.e., tech) space, there is concern regarding the inclusivity of African American women in leadership positions. A hostile and unsupportive environment raises concern for the future of African American women being able to attain key leadership roles. (McGee, 2018). This study explored multifaceted experiences of eight African American women leaders in for-profit tech organizations. Black feminist thought and organizational culture and belonging were conceptual frameworks that shed light on the persistent barriers and cultural adversities. Narrative inquiry was employed to amplify participant voices through a three-phased data collection approach, including open-ended questionnaires, sista circle conversations, and follow-up interviews. The study contributes to a broader discourse on how organizations can support the inclusion and advancement of African American women in leadership positions, ultimately enriching the diversity and effectiveness of leadership within the tech industry and beyond. The study identified four themes: (a) breaking barriers: Navigating isolation and echoes of exclusion; (b) African American women leadership: Normalcy of resiliency and supportiveness while experiencing cultural adversity; (c) perceptions of leadership and organizational culture; and (d) complexity and contradictions of sense of belonging. Using sista circle conversation in this study offered compelling evidence on the necessity of supportive networks and inclusive practices to enhance the presence and success of African American women in leadership within the tech industry and beyond. Findings revealed a complex landscape where African American women navigate isolation and illuminates the remarkable resilience, persistence, and adaptability of African American women in leadership roles within the tech industry. The study underscored the critical importance of understanding the nuances of organizational culture and its impact on African American women’s sense of belonging and leadership experiences. This study contributes to leadership and belonging research while highlighting the importance of acknowledging historical and current factors that may hinder or enable a sense of belonging for African American women leaders in tech.

Successful educational leadership entails possessing the knowledge, skills and understanding of effective leadership skills along with the personal ability to effectively implement those skills. In Zimbabwe the occupational and leadership status of women in general is still suffering a wide gap, as there is unequal representation in leadership positions between men and women. This study, conducted in a rural district in Zimbabwe, aimed at understanding the challenges facing women in school leadership positions. In this article we argue that there are cultural, social and structural domains among others that impede the effective operations of women in school leadership positions. Using a qualitative research paradigm, six schools in one rural district were chosen for the study. A semi-structured interview guide was used to collect data from six female heads - three from primary schools and three from secondary schools. Focus group discussions were held with teachers from the same schools. The study established that there are cultural, structural, economic and social barriers facing women in school leadership positions. We recommend that different strategies should be set up for developmental programs for women in leadership positions. Keywords : Women in leadership, female school heads, school leadership, challenges facing women, women in school leadership positions DOI : 10.7176/JEP/10-14-05 Publication date :May 31 st 2019

IntroductionThe issue of underrepresentation of women in medical leadership roles, particularly in their retention and long-term engagement, is a pressing challenge in healthcare. Despite advancements in women’s initial entry into...

How to Promote Career Advancement and Gender Equity for Women in Gastroenterology: A Multifaceted Approach