Approval Ratings Research Articles

507 A Comparison of Regulatory Mechanisms for the Approval of Herbal Medicines

OBJECTIVES/GOALS: To compare the herbal medicine (HM) programs of the U.S. to those of different countries–including the European Union, South Korea, China, and India–and to examine each regulatory body’s process for obtaining market approval for HM drugs. METHODS/STUDY POPULATION: The European Union, South Korea, China, and India’s respective HM regulatory programs were examined and compared to the U.S. FDA’s HM process. These specific regulatory bodies were chosen based on the country’s long history with HM and/or the robustness of their existing HM review processes. International HM programs were researched using official government websites and journals published by independent, external research institutions that were accessed via USC’s library services. Data regarding the efficacy of HM policies such as HM IND approval rates, number of marketed HM drugs, and establishment of unique HM sectors will be collected. RESULTS/ANTICIPATED RESULTS: Investigational New Drug (INDs) applications regarding HM from each country will be categorized and displayed according to their approval status in order to provide insight on a HM program’s efficiency. Results also included a table displaying common challenges for approval for HM drugs across federal regulatory bodies. If applicable, effective solutions implemented to address some of these obstacles that proved to be effective will also be displayed in the form of a table. DISCUSSION/SIGNIFICANCE: Tables displaying the collective flaws of international HM programs and the resulting regulatory solutions can provide clearer guidance for companies seeking to submit HM INDs and for the U.S. FDA seeking to develop improved HM regulations.

Transparent reporting and equity in mortgage lending: A comprehensive review

This comprehensive review delves into the critical intersection of transparent reporting and equity within the realm of mortgage lending. With the housing market serving as a cornerstone of economic stability and social mobility, the equitable distribution of mortgage loans is paramount for fostering inclusive growth and mitigating systemic disparities. The paper scrutinizes existing literature, regulatory frameworks, and industry practices to assess the extent to which transparency and equity are upheld in mortgage lending processes. By examining key metrics such as loan approval rates, interest rates, and access to credit, this review sheds light on persistent inequities and identifies potential avenues for improvement. Additionally, it explores the role of technology, data analytics, and policy interventions in promoting transparency and equity across various stages of the lending lifecycle. Ultimately, this review underscores the urgent need for concerted efforts from policymakers, financial institutions, and stakeholders to enhance transparency and promote equity in mortgage lending practices. The pursuit of transparent reporting and equity in mortgage lending stands as a cornerstone of fair and accessible housing finance systems globally. This comprehensive review synthesizes current research, regulatory frameworks, and industry practices to illuminate the intricate dynamics shaping mortgage lending equity and transparency. Through a nuanced analysis of factors such as credit scoring mechanisms, discriminatory practices, and regulatory oversight, the review identifies persistent challenges and emerging trends within the mortgage lending landscape. Furthermore, it investigates the potential impact of socioeconomic factors, demographic shifts, and technological advancements on the equitable distribution of mortgage credit. By elucidating the linkages between transparency, equity, and financial stability, this review offers valuable insights for policymakers, practitioners, and researchers seeking to foster more inclusive and resilient mortgage markets. In conclusion, the review calls for concerted action and collaborative initiatives aimed at promoting transparency and equity as foundational principles in mortgage lending practices.

Crumbling in the face of cost? How cost considerations affect public support for European security and defence cooperation

In surveys, Europeans routinely express high levels of support for a common security and defence policy of the European Union. Do these responses reflect real demands or superficial support that would crumble if the issue was politicised? This article provides new answers to this question. We conducted pre-registered survey experiments with more than 40,000 respondents from 25 European countries in which we randomly varied whether respondents received information about potential costs of two hypothetical cooperative activities: military operations and defence procurement. Support for these activities was systematically lower when costs were mentioned. We conclude that, in the event of politicisation, there is considerable potential for shifts in opinion and that caution is required in deriving a mandate for specific activities from high approval rates for cooperation in general.

The impact of presidential economic approval rating on stock volatility: An industrial perspective

This paper examines the influence of presidential economic approval rating (PEAR) on stock volatility in different sectors. We find that PEAR significantly explain future stock volatility in Health Care, Consumer Staples, Information Technology and Telecom Services sectors both in- and out-of-sample. Interestingly, we find this explanatory power for all sectors exists only during the economic expansions. Finally, we show that the PEAR has long-term predictability on stock markets.

2023 in review: FDA approvals of new medicines

An analysis of all new entities approved by both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) identified the approval of 69 new entities in the year 2023, 50 % more than in the previous year. Oncology drugs tied with congenital and infectious diseases drugs for the most approvals. Although orphan and priority approvals continued at a high pace, the rate of fast-track approvals continued to decline. The rate of industry consolidation also picked up again after decreasing slightly in 2022.

Presidential economic approval rating and trade credit

Trade credit has become crucial for businesses, financial institutions, and policymakers due to the significant role it plays in the economy and financial management. In this paper, we discuss how an important public opinion index, the Presidential Economic Approval Rating (PEAR), impacts a firm's decision to supply trade credit. We find convincing evidence that PEAR is positively correlated with trade credit extension. Furthermore, our results indicate that while business cycle and financial flexibility positively moderate the association between PEAR and trade credit, other factors like market concentration, CEO confidence, and oil supply shocks attenuate their link. Additionally, we observe that consumer sentiment mediates the relationship between PEAR and trade credit. Finally, our findings remain statistically unchanged when we conduct a series of robustness tests using alternative measures and the system generalized method of moments (GMM) technique. In summary, our study provides valuable insights into the considerable influence the general public's perception of the way the President is handling the economy has on corporate decision-making and contributes to the emerging literature on the importance of trade credit.

Tragedy of the Commons in Crowd Work-Based Research

Academic scholars have leveraged crowd work platforms such as MTurk to conduct research and collect data, but the data quality crisis in crowd work has been an alarming phenomenon recently. Though prior studies have discussed data quality and validity issues in crowd work via surveys and experiments, they kind of neglected to explore the scholars’ and particularly the IRB's ethical concerns and the related policies in various ethical guidelines for crowd work-based research in these respects. In this study, we interviewed 17 scholars from six disciplines and 15 IRB directors and analysts in the U.S. and analyzed 28 research guidance documents to fill these gaps. We identified common themes among our interviewees and documents but also discovered distinctive and even opposing views regarding the approval rate, rejection, and internal/external research validity. Based on the findings, we discussed a potential Tragedy of the Commons regarding data quality deterioration and the disciplinary differences regarding validity in crowd work-based research. We further explored the origin of the data quality and validity issues in crowd work-based research. We advocated the IRB's ethical concerns in crowd work-based research be heard and respected further and be reflected in the ethical guidance for crowd work-based research. Finally, we proposed our research implications, limits, and future work.

Designing an Intelligent Scoring System for Crediting Manufacturers and Importers of Goods in Industry 4.0

Background: The modern credit card system is critical, but it has not been fully examined to meet the unique financial needs of a constantly changing number of manufacturers and importers. Methods: An intelligent credit card system integrates the features of artificial intelligence and blockchain technology. The decentralized and unchangeable ledger of the Blockchain technology significantly reduces the risk of fraud while maintaining real-time transaction recording. On the other hand, the capabilities of AI-driven credit assessment algorithms enable more precise, effective, and customized credit choices that are specifically tailored to meet the unique financial profiles of manufacturers and importers. Results: Several metrics, including predictive credit risk, fraud detection, credit assessment accuracy, default rate comparison, loan approval rate comparison, and other important metrics affecting the credit card system, have been investigated to determine the effectiveness of modern credit card systems when using Blockchain technology and AI. Conclusion: The study of developing an intelligent scoring system for crediting manufacturers and importers of goods in Industry 4.0 can be enhanced by incorporating user adoption. The changing legislation and increasing security threats necessitate ongoing monitoring. Scalability difficulties can be handled by detailed planning that focuses on integration, data migration, and change management. The research may potentially increase operational efficiency in the manufacturing and importing industries.

Implementation of an early alert system in quizzes of a high complexity subject in higher education: Improvement of student performance and teacher perception

AbstractEarly Alert Systems (EAS) play a fundamental role in education by supporting the learning process and evaluating student performance. In this study, an innovative EAS designed to specifically identify weaknesses in Cognitive Skills (CS) in first-year higher education students is presented, focusing on a challenging course at a South American university. Through big data technology, approval rates linked to various cognitive skills were evaluated using quizzes. Subsequently, teachers, after analysis and dialogue, applied adapted strategies to strengthen these skills in their classes, which were evaluated in subsequent exams. The sample under study included 1,691 students from various health majors enrolled in a complex subject. The experimental group (994 students) that participated in the EAS was compared with a control group (697 students). Evaluations validated by the academic team were used, applying three quizzes throughout the 2022-20 academic period, and the results were analysed with the Power BI computer tool, generating online reports that highlighted CS by section. The EAS, based on teacher surveys, is innovative and it also positively impacts student achievement, evidenced in overall approval rates, by teacher and section. In addition to promoting collaboration among professors, it also improves the teaching quality and suggests a positive impact on the learning of complex subjects in Higher Education Institutions (HEIs). This comprehensive approach to early monitoring of student performance shows promise for the ongoing improvement of educational quality.

A Contemporary Approach to Designing and Implementing Electronic Voting Systems (EVS)

This study delves into the potential of Electronic Voting Systems (EVS) in Ghana, to enhance transparent and trustworthy electoral processes. We presented a comprehensive framework highlighting trust, diaspora engagement, and human factors in voting. The study proposes a robust EVS framework for Ghana, emphasizing trust and accountability, preventing electoral fraud, and encouraging African governments to invest in IT and collaborate with experts in e-government and e-voting systems. We commence with a detailed systems analysis, identifying specific electoral challenges in Ghana. An artifact is designed and developed, and the artifact's effectiveness is demonstrated through Design Science Research Methodology (DSRM). We evaluated its alignment with the desired solution for Ghana's electoral issues. We emphasize the potential of EVS to address electoral challenges in Ghana and underscore the importance of proactive government policies, IT investments, and collaboration with IT experts. User acceptance testing achieved a remarkable 98% approval rate, showcasing the feasibility of implementing EVS at the national level. This research underlines the pivotal role of EVS in Ghana and advocates for visionary government policies and investments in IT. These measures can modernize electoral systems, align them with international standards, and promote democratic progress while preventing electoral fraud in Ghana and other African nations to avoid condemnation and punishment of unconstitutional transfers of power that are being challenged by meticulously planned takeovers.

Empirical study on voting results and proxy advisor recommendations in Japan

This study examines the relationship between proxy advisory firms’ recommendations and investors’ voting behavior in Japan, where corporate governance has been under transition. Based on 1,025 shareholder meeting proposals and recommendations by proxy advisory firms in Japan between March 2010 and March 2022, multivariate regression analyses reveal that the dissenting recommendations of the two main proxy advisory firms are negatively correlated with the approval rate of proposals, as well as the percentage of affirmative votes cast by institutional investors. Furthermore, the institutional investors’ behavior is more consistent with the recommendations of proxy advisory firms than that of other investors.

Animal Research Regulation: Improving Decision-Making and Adopting a Transparent System to Address Concerns around Approval Rate of Experiments.

The use of nonhuman animals in biomedical research is regulated under stringent conditions, not only in response to societal attitudes towards animal experimentation but also because ethical responsibility in scientific research requires researchers and veterinarians to be more invested and aim to improve the welfare of animals used for experiments. Analyses of animal research oversight reveal the frequent approval of experiments, and the approval of some experiments has raised and continues to raise public concerns. Societal compliance is required for a consensus-based approach to animal research policy, prompting the need to have transparent discussions about oversight and the frequency of approvals. We discuss how frequent approval may be perceived and why it seems problematic from a societal perspective: the regulatory process exists to approve only legitimate experiments. Although some experiments remain unacceptable irrespective of their harm-benefit ratios, almost all experiments are approved. We explain some possible legitimate reasons for frequent approval and how the review process could be leading to the approval of illegitimate studies. To ensure transparency and improve public trust and understanding of oversight, we propose the adoption of a platform to inform society about how unethical experiments are screened out.

Credit default swaps and shareholder monitoring

The paper examines how the initiation of credit default swaps (CDSs) influences shareholders' monitoring intensity. Prior studies show that CDSs decrease lenders' monitoring over the referenced firm (Morrison, 2005; Parlour and Winton, 2013). However, there is scant literature on how shareholders react after the initiation of CDSs. Given that the reduced lenders' monitoring could be detrimental to shareholders, we predict that shareholders will directly increase their monitoring intensity. Using a difference-in-differences design, we document that the sensitivity of the voting approval rate on director elections to firm performance increases significantly after the initiation of CDSs. The effect is more evident for firms with higher risk, lower existing shareholders' monitoring intensity, and higher existing lenders' monitoring intensity. Collectively, the results provide direct evidence that shareholders step in after the initiation of CDSs by enhancing their monitoring intensity.

Give the Media What They Need: Negativity as a Media Access Tool for Politicians

Recent studies indicate that politicians’ negativity usage fails to enhance their approval ratings among the general public, yet politicians regularly use it. This begs the following question: why are politicians so negative if this strategy does not bolster their prospects for re-election? In this paper, I argue that the media, driven by audience engagement, plays a pivotal role in shaping politicians’ propensity for negativity. Specifically, politicians resort to negativity because it aligns with the media’s negativity bias, thereby increasing their chances of securing media access and public attention. I test this expectation on the less-likely case of Belgium, using data on politicians’ negativity usage in parliament and their presence in prime-time TV news (2010–2020). The results show that using negativity significantly increases politicians’ chances of gaining media access, particularly when using uncivil negativity. The more media access politicians start to attract due to negativity, the more they resort to negativity.

Improving Best Practices in Assessing the Usage Conditions of Hospital and Long-Term Care Mattresses

Background: Inadequate mattresses can pose risks to users, and the routine inspection of mattresses often falls short in various healthcare settings. Objectives: To evaluate the physical condition of mattresses in hospitals and long-term care facilities and to explore the association with management practices regarding procurement, handling, and maintenance. Methods: This analytical descriptive cross-sectional study was conducted in 13 hospitals and 5 long-term care facilities, examining a total of 278 mattresses through proportional stratified sampling. The Mann-Whitney U test, Kruskal-Wallis test, and Multiple Regression Analysis were utilized for data analysis. Results: A mere 9.9% of the mattresses met the physical evaluation criteria, revealing a significant gap in mattress management standardization. The highest compliance was noted in the utilization of waterproof coverings, whereas the lowest was in mattress labeling. Factors significantly influencing the scores included the involvement of nurses in the evaluation process, periodic replacement of coverings, type of administration, assessment of mattress and covering integrity during bed making, and the nature of the institution. Conclusions: Due to inadequate physical conditions in both hospital and long-term care settings, the low approval rate of mattresses underscores the urgent need for standardized mattress management practices. Descriptors: Beds, Hospital Infection, Disinfection, Long-Term Care Facilities for the Elderly, Patient Safety.

AN INNOVATIVE LEARNING ENVIRONMENT: G-MOOC 4D TO ENHANCE VISUAL IMPAIRMENTS LEARNING MOTIVATION

The proliferation of visual impairment among school-age children in Indonesia has prompted the need for specialized online learning solutions. The G-MOOC 4D platform, a novel Learning Management System (LMS), is designed to address this need by leveraging gamification and artificial intelligence to enhance accessibility for visually impaired users. This study reports on the development and testing of two AI models within the G-MOOC 4D framework: a facial recognition model for secure user authentication and a voice command model for interactive learning. User Acceptance Testing (UAT), conducted with expert users, namely teachers at a special needs school, showed high approval rates for the platform's features. The results show that all metrics, accuracy, precision, and recall reach their optimal values at a distance of 40 cm for face detection. The respective metric scores at that distance, precision: 100%, accuracy: 98%, and recall: 97%. Additionally, the voice command functionality tested achieved a 100% recognition rate, reflecting the platform’s potential to significantly ease the learning process for visually impaired students. The findings underscore the importance of integrating assistive technologies into educational platforms to ensure all students have equal access to learning opportunities.

How do loan officer-borrower gender-driven behavioural differences impact on the microfinance lending market?

This paper analyses the impact of the gender of the loan officer-borrower pair on the loan-size, credit availability and time spent in managing the credit application. By using 3,020 lending transactions from Ecuador during 2016–2019, we document that the loan officer-borrower pair gender drives differences in the microcredit portfolio management. We find that female loan officers grant smaller microcredits to both male and female borrowers. However, the loan-size increases when matching the loan officer-borrower gender. We also demonstrate that female loan officers have greater loan approval rates, mainly in the segment of higher loan-sizes granted to male clients. Finally, our results show that the microcredits that have the fastest evaluation process are those that have a lower loan-size and are granted by female loan officers to female borrowers. Our findings have practical implications for the analysis of the credit availability for entrepreneurs as well as the loan portfolio management.

Augmented Reality-Based 3D Technology Learning Media for Human Respiratory Organs

Augmented Reality (AR) technology is selected for seamlessly integrating virtual objects into the real world. Users can represent objects in three dimensions, offering an interactive, real-time experience. The educational sector widely embraces Augmented Reality due to its interactive and timely advantages. This study focuses on the human respiratory system, demonstrating Augmented Reality's efficacy as an interactive learning tool for understanding respiratory organs. The learning material utilizes three-dimensional visualizations with animations, sound, and vibrant colors, enhancing comprehension and preventing boredom. Employing the Multimedia Development Method and software tools like Unity 3D, Blender, CorelDraw, Vuforia, and Visual Studio Code, the research produces a learning media application facilitating the understanding of human respiratory organs. Evaluation through questionnaires, with a 93.16% approval rate from teachers and students, confirms the application's suitability as an effective learning tool.

Prior authorization for FDA-approved PARP inhibitors in ovarian cancer

ObjectivesPARP inhibitors (PARP-I) improve survival in ovarian cancer, especially in patients with germline or somatic BRCA mutations or other homologous recombination deficiency (HRD). With high efficacy and costs, insurers may enact barriers or facilitators to PARP-I. Our objective was to examine the prevalence of prior authorization for PARP-I in ovarian cancer. MethodsWe performed a retrospective cross-sectional study of patients with ovarian cancer prescribed a PARP-I within the University of Pennsylvania practices from December 2018 through May 2021. We assessed prevalence of prior authorization for PARP-I overall, by frontline or recurrent maintenance, and by genetic status. We then assessed approval and appeal rates and time to PARP-I start. ResultsOf 180 patients with a PARP-I prescription and information regarding prior authorization, 116 (64 %, 95 % CI 57–71) experienced prior authorization. Of patients in the frontline setting, 60 of 90 (67 %, 95 % CI 56–76) experienced prior authorization. Of patients prescribed PARP-I in recurrence, 55 of 85 (65 %, 95 % CI 54–74) experienced prior authorization. Having a germline or somatic genetic mutation was associated with higher risk of prior authorization (adjusted risk ratio 1.35, 95 %CI 1.09–1.67). 102 patients (89 %, 95 % CI 83–94) required one appeal, 8 required two appeals and 5 cases required 3 appeals. Five patients were denied. Mean time from PARP-I prescription to PARP-I start was 10 days longer for patients who experienced prior authorization. Conclusions64% of patients experienced prior authorization for PARP-I. Risk of prior authorization was increased for patients with BRCA, despite greater clinical benefit. Prior authorization contributes to delays in care, and reform is needed.

Federal Tax Deductions and the Demand for Local Public Goods

Abstract The United States tax system allows taxpayers to deduct local taxes from their taxable incomes. Using school district referendum results, we employ a continuous treatment two-way fixed-effects framework to provide causal evidence of a positive relation between the demand for local public goods and the share of residents deducting local taxes. We find that a one-percentage-point decrease in the share of residents deducting property taxes reduces tax and bond referendum approval rates by approximately 0.97 percentage points. Because these federal tax deductions disproportionately benefit higher-income individuals, they potentially widen disparities in public service provision across jurisdictions.