Analyzing the research trends of COVID-19 using topic modeling approach

PurposeThe COVID-19 pandemic has impacted 222 countries across the globe, with millions of people losing their lives. The threat from the virus may be assessed from the fact that most countries across the world have been forced to order partial or complete shutdown of their economies for a period of time to contain the spread of the virus. The fallout of this action manifested in loss of livelihood, migration of the labor force and severe impact on mental health due to the long duration of confinement to homes or residences.Design/methodology/approachThe current study identifies the focus areas of the research conducted on the COVID-19 pandemic. s of papers on the subject were collated from the SCOPUS database for the period December 2019 to June 2020. The collected sample data (after preprocessing) was analyzed using Topic Modeling with Latent Dirichlet Allocation.FindingsBased on the research papers published within the mentioned timeframe, the study identifies the 10 most prominent topics that formed the area of interest for the COVID-19 pandemic research.Originality/valueWhile similar studies exist, no other work has used topic modeling to comprehensively analyze the COVID-19 literature by considering diverse fields and domains.

Connecting the Dots for Pharma

A major driver for innovation within the bio/pharma sector has been the COVID-19 pandemic, which propelled advances such as the approval of messenger RNA (mRNA) vaccines at record-breaking speeds and led to many companies pivoting to deal with the urgent requirements for capacity and supply chain flexibility needed to overcome pandemic challenges. "Before deciding on a location, we conducted extensive market research, and it quickly became clear, just by the sheer proximity of so many biopharmaceutical companies, associations, and research centres, that the event had to be in Geneva. Organized as four half-days, they will each address a theme related to the four main areas of the supply chain present in the exhibition area: pharmaceutical packaging (primary and secondary), medical devices, pharmaceutical sub-contracting, and pharmaceutical equipment. The dream scenario, the real measure of success, is when a product comes to market that happened as a result of a meeting or discussion that took place at our event.

Learning Regulatory Lessons in Times of a Crisis

The bio/pharma sector is an industry that has probably been most affected by the pandemic, not only is there an expectation for bio/pharma companies to step up and develop appropriate treatments quickly, resulting in regulatory flexibility and unprecedented collaborations, but there have also been concerns around supply chain security. Agencies have prioritized protocol consultations, shortened the timelines for clinical trial application review and approvals, and there is some focus on implementing fast-track and priority review processes for the evaluation of marketing authorization applications. Marton (Arriello): Authorities that have more experience in evaluation of data adapted quickly, while other authorities, such as those in the Commonwealth of Independent States area, stopped all activities for a period of time or adapted along the way. Gross (ProductLife): There is already some cooperation between the US and Europe, especially in the regulatory development process and in the evaluation process, so it's possible the current situation could reinforce those efforts and lead to some further joint assessments for clinical trial protocols and marketing authorization reviews.

The Pandemic as a Catalyst for Digital Pathology Adoption as an LDT

Whole-slide images (WSI) are the basis for the application of artificial intelligence/machine learning and other informatics methods to histological diagnosis and will further blur the line separating anatomic and clinical pathology. FDA classified WSI systems for primary diagnosis as class III (highest risk) medical devices until 2017. This discouraged anatomic pathology laboratories at risk-averse domestic institutions like mine from investing in these digital pathology (DP) platforms. In 2017, FDA downgraded WSI to class II (moderate risk) when they de-novo approved a system marketed by Philips. We were not interested in that system at my institution, but the downgrade caused us to reset our perception of the risk of validating a RUO system for primary diagnosis. Cost remained a barrier. In April 2020, FDA issued temporary guidance stating they would not enforce premarket approval of WSI systems to facilitate pathologists working remotely during the SARS-CoV-2 pandemic. The guidance included a statement that "laboratories and hospitals consider performing a validation study.” In January 2021, FDA proposed making the temporary non-enforcement guidance permanent. So, in a little more than three years, WSI for primary diagnosis had gone from class III to exempted from pre-market approval! This nicely aligned the approval framework for WSI with the approval framework for our conventional optical microscopes, which are statutorily exempted from approval, and further reset our perception of risk. In April 2021, FDA withdrew the proposal to make non-enforcement permanent, but the temporary non-enforcement guidance is still in effect at the time of writing. Amid all this FDA activity, the College of American Pathologists updated and reissued their consensus guidelines for validating WSI systems for diagnostic purposes in March 2021. The narrative mentions the FDA's recent approval of a few WSI systems and anticipates more, but the expert panel recommendations do not include any related to the approval status of systems. The reissue of this document reminded us that, as clinical laboratorians, we are capable of safely validating WSI as a laboratory-developed test and are supported in doing so by consensus guidelines from one of our leading professional organizations. In early 2021 we committed to funding a DP initiative to make WSI part of our routine histological process for 10% of our anatomic pathology cases. The initial capital investment is $1.5M. When realized, the microscope slides for designated pathology services will be transported directly from the cover slipper to a slide scanner and electronically distributed to pathologists using a clinical-grade image management system that we share with our radiology department. We made the decision to fund this in the context of the regulatory (decreased perception of risk), sociological (demand for remote telepathology), and technological (availability of scalable WSI systems) changes that occurred during the pandemic.

Enhanced Role of EMA in EU Crisis Response

The regulation also sets out obligations on marketing authorization holders (MAHs) and medical devices manufacturers, authorized representatives, importers, distributors, and notified bodies duties to: * Provide information that will assist with the monitoring by the MSSG/MDSSG of shortages of medicinal products and devices contained in the critical medicines list and updating this when necessary * Provide a justification for any failure to provide the requested information by the established deadlines * Immediately provide any evidence of an actual or potential shortage of medicinal products or devices * Provide information to EMA by 2 Sep. 2022 that will enable the establishment of a Single Point of Contact (SPOC) network, and the industry Single Point of Contact (iSPOC) network, with mandates to updating this when necessary (7). Enhanced advisory role In addition to the measures designed to address medicinal and medical device shortages, an Emergency Task Force (ETF) will also be established within EMA to provide scientific advice and review evidence on medicines that have the potential to address public health emergencies, offer scientific support to facilitate clinical trials, and support existing EMA committees with their authorization and safety monitoring of medicines (8). According to the document published by EMA on Crisis Preparedness and Management, the key benefits for EMA of having these responsibilities include: * Accelerated evaluation and access to safe and effective medicines which could treat or prevent a disease causing, or likely to cause, a public health emergency * Improved quality of data and the effective use of resources through increased support at EU level towards the conducting of clinical trials in preparation for, and during a public health emergency * Improved coordination and harmonization at EU level in preparation for and during a public health emergency (7).

NEW STRUCTURES TO TACKLE NEW CHALLENGES IN EUROPEAN HEALTHCARE

At the official level, the EU has already acknowledged the need for some closer alignment between its distinct but overlapping institutions, with the emergence of declarations of intent to create a European Health Union and promises of a radical review of EU rules on pharmaceuticals-all predating the arrival of COVID's additional impact of concentrating minds. [...]there is support within the European Parliament and the European Commission for more ambitious official EU engagement in health policy and a corresponding extension of EU competences into traditionally national government territory-although as a telling demonstration of the sort of divisions that dominate Europe, this is viewed by many of the member states in the EU's Council with extreme caution and has even provoked some downright resistance. According to its just-released manifesto, collaboration is needed between European policymakers, member states, and all other actors across the health community-and even more so in the wake of COVID.

EU PLANNING TO RESPOND EU PLANNING TO RESPOND SMARTER REGULATION BY 2025

The results should be greater leverage of non-clinical models and optimized capabilities in modeling, simulation, and extrapolation, as well as investment in initiatives for special populations, and the conduct of environmental risk assessments in line with the latest scientific knowledge. "Developments in basic science, in medicine, in information technology, and data analytics in particular, continue to pour forth at an astonishing rate," the agenda says, and the network "must have the capacity and knowledge to regulate new types of medicine, making them available to pa- tients with unmet needs while continuing to ensure that any risks are outweighed overall by the benefits." Inevitably, the experience of the pandemic will play into the planning-as will the EU's specific health plans announced in recent months, including its new "EU4Health" health program and the so-called "rescEU" program to build a strategic European reserve of critical medicines and to encourage production of active pharmaceutical ingredients in Europe.

Manufacturing Innovation

(ProQuest: ... denotes non-USASCII text omitted.) The annual Global Innovation Index released in September 2021 ranked China twelfth, surpassing developed economies such as Japan, Israel, and Canada and raising fears in the United States amidst sluggish growth in North America and strong growth in the Asia Pacific region.1 Interestingly, the United States government responded by boycotting the Beijing Olympic Games, citing human rights abuses as the main reason.2 A tech war between China and the United States brewed beneath the diplomatic rancor over the attendance at the Olympic Games. Part I documents how the United States has assisted China's tech and intellectual property domination through President Nixon's historic visit to China, giving China Most Favorite Nation (MFN) status and ascending China to the World Trade Organization (WTO). [...]under Deng Xiaoping's leadership during the reform period, China rapidly developed its special economic zones (SEZs), laying the foundation for subsequent tech innovation and production. [...]broadcasting, telecommunications, office machines, computers, integrated circuits, and cell phones are among China's notable exports to the world.9 China dominates in commodities and raw materials, exporting refined petroleum, cotton, plywood, and tea.10 For agricultural products, China occupies the perch as the world's largest producer. Shenzhen rose as the largest among the four.18 Shenzhen, a small fishing locale in the southern part of China's southern province, Guangdong, served as the pioneer of Deng Xiaoping's embrace of economic reforms.19 A market-oriented economy took root in Shenzhen, allowing foreign companies and entities from Hong Kong and Macau to operate and allowing Chinese talents the freedom to leave their hometowns and move into the SEZs.20 Cheap labor proved to be another significant factor facilitating China's rise as a global manufacturer.21 In the 1980s, multinational corporations from Taiwan, Japan, and South Korea, as well as domestic Chinese companies, opened their factories in the SEZs and other cities in China to take advantage of the cheap and plentiful labor force.22 Indeed, when Deng Xiaoping began his pilot SEZs, China's young workers who wished to lift themselves out of poverty descended into the economic zones in search of better opportunities.23 Shenzhen grew from a population of 59,000 in 1980 to a population of 12,357,000 in 2020.24 The new migrants became the workers, participants, and stakeholders in the global manufacturing frontier.25 Because of the abundance of cheap labor, manufacturers in China have no difficulty keeping production prices low and pleasing consumers and businesses worldwide.26 China's currency manipulation is another factor propelling China to its domination in global manufacturing.27 The United States Congress attempted numerous times to introduce legislation to combat China's currency manipulation.28 China artificially devalued its currency through government control of the exchange rate and refused to let the Chinese Renminbi (RMB) float.29 Despite strong criticisms from the United States, China refuses to allow its currency to freely float.30 China's currency manipulations, according to critics, caused the widening of trade deficits between the United States and China.31 China's currency manipulation allows products to be manufactured at lower prices, hampering competitors and thereafter replacing them.32 In order to cope with China's currency practices, United States manufacturers facing their own existential crises must decide to either outsource jobs overseas or face large risks, including financial ruin.33 The United States lost millions of manufacturing jobs due to massive job outsourcing as the trade deficits between the United States and China continued to persist.34 Geopolitically, in shaping post-Cold-War powers, the United States decided to assist China in its transformation from a poverty-stricken country to a global manufacturer.

Analysis: FDA's COVID-19 Accelerated Pathways

Current FDA programs to accelerate access In order to accelerate the product approval process, four regulatory programs currently exist to reduce development and review times for products that address unmet medical needs for the treatment of serious or life-threatening conditions. In May 2014, FDA issued a Final Guidance for Industry entitled, "Expedited Programs for Serious Conditions-Drugs and Biologics" which addresses fast track designation, breakthrough therapy designation, priority review designation and accelerated approval.3 In addition to this guidance document, under section 564 of the FD&C Act, 21 U.S.C. 360bbb3, in a situation where the Secretary of Health and Human Services (HHS) issues a declaration of emergency or threat justifying authorization of emergency use for a product caused by chemical, biological, radiological or nuclear (CBRN) agents, as well as an infectious disease, the Commissioner of the FDA may authorize an EUA of an unapproved product or an unapproved use of an approved product. In January 2017, the "Emergency Use Authorization of Medical Products and Related Authorities" guidance was finalized.4 Fast Track designation Section 112 of the Food and Drug Administration Modernization Act of 1997 (FDAMA), entitled "Expediting Study and Approval of Fast Track Drugs," mandates the facilitation of the development and processes to expedite review of therapeutics intended to treat serious or life-threatening conditions presenting with unmet medical needs. [...]a two-tiered system of review times, Standard Review and Priority Review was created.

An optimisation approach for determining the efficiency of vital medical devices in intensive care units with COVID-19 patients using Apriori algorithm

Improving the process of strategic management in hospitals preparation and equipping the intensive care units (ICUs) and the availability of medical devices plays an important role for knowing consumer behaviour and need. This cross-sectional study was performed in the ICU of Farhikhtegan Hospital, Tehran, Iran for a period of six months. During these months, ten medical devices have been used 5,497 times. These devices include: ventilator, oxygen cylinder, infusion pump, electrocardiography machine, vital signs monitor, oxygen flowmeter, wavy mattress, ultrasound sonography machine, ultrasound echocardiography machine, and dialysis machine. The Apriori algorithm showed that four devices: ventilator, oxygen cylinder, vital signs monitoring device, oxygen flowmeter are the most used ones by patients. These devices are positively correlated with each other and their confidence is over 80% and their support is 73%. For validating the results, we have used equivalence class clustering and bottom-up lattice traversal (ECLAT) algorithm in our dataset.

Strategizing for Strength in EU PharmaN

"Though Europe's response has demonstrated strengths," the strategy document reports, "existing vulnerabilities have been thrown into sharp focus, including those related to data availability, the supply of medicines, or the availability of manufacturing capacities to adapt and support the production of medicines" (2). [...]a lot of the strategy's proposals stem from the European Green Deal, published in late 2019 (4), from which has emanated last year's EU industrial strategy (5). [...]setting up critical medicines production capacity in the EU would have to be compliant with the Union's competition rules and those of the World Trade Organization, the commission warned (2).

Analysis of the Professional Aspects of Medical Drugs Industry in the Republic of Serbia in Times of COVID-19 Pandemic

The research subject of this paper is the analysis of the attitudes of employees in pharmaceutical companies towards the business aspects of the pharmaceutical industry during and after the end of the pandemic in the Republic of Serbia. The aim is to examine the differences in the attitudes of employees, as well as to determine which variables predict the situations of endangering the professional reputation of pharmaceutical companies during the COVID-19 pandemic. The research was conducted by means of a survey during 2021 on a sample of 27 innovative and generic pharmaceutical companies. We used the SPSS program for descriptive statistics analysis, chi square test and binary logistic regression models. The findings show that there is a statistically significant difference in the expressed attitudes of employees in innovative and generic pharmaceutical companies in terms of coming to the office during the pandemic;the lack of medicines and medical devices used in the treatment of COVID-19 infections;the patient access to a chosen doctor;the expectations of the employees to continue working from home after the outbreak of the COVID-19 pandemic. The findings of the binary regression models show the slowdown in the supply chain, the access to doctors and working from the home office have not been perceived as creating situations of endangering professional reputations, that is, they contribute to the sustainable economic success. On the other hand, the introduction of digital technologies decreases the occurrence of conditions in which their professional reputation has been threatened.

A Validation Study to Confirm the Accuracy of Wearable Devices Based on Health Data Analysis

This research article presents an analysis of health data collected from wearable devices, aiming to uncover the practical applications and implications of such analyses in personalized healthcare. The study explores insights derived from heart rate, sleep patterns, and specific workouts. The findings demonstrate potential applications in personalized health monitoring, fitness optimization, and sleep quality assessment. The analysis focused on the heart rate, sleep patterns, and specific workouts of the respondents. Results indicated that heart rate values during functional strength training fell within the target zone, with variations observed between different types of workouts. Sleep patterns were found to be individualized, with variations in sleep interruptions among respondents. The study also highlighted the impact of individual factors, such as demographics and manually defined information, on workout outcomes. The study acknowledges the challenges posed by the emerging nature of wearable devices and technological constraints. However, it emphasizes the significance of the research, highlighting variations in workout intensities based on heart rate data and the individualized nature of sleep patterns and disruptions. Perhaps the future cognitive healthcare platform may harness these insights to empower individuals in monitoring their health and receiving personalized recommendations for improved well-being. This research opens up new horizons in personalized healthcare, transforming how we approach health monitoring and management.

COVID-19 Pandemic Learning: The Uprising of Remote Detailing in Pharmaceutical Sector Using Sales Force Automation and Its Sustainable Impact on Continuing Medical Education

The availability of resources is vital when rapid changes and updated medical information in the provision of care are needed, such as in the fight against COVID-19, which is not a conventional disease. Continuing medical education plays an essential role in preparing for and responding to such emergencies. Workflow has improved based on the virtual meetings, online trainings, and remote detailing conducted by medical representatives in order to deliver educational content instantly through digital tools, such as salesforce automation (SFA), webinars, etc. In terms of its regulatory barriers, the pharmaceutical industry mainly targets healthcare professionals, unlike most businesses that reach end users directly. Medical representatives are equipped with an SFA to enhance customer relationship management (CRM) and closed loop marketing (CLM) capabilities in pharmaceutical companies. This study aimed to fill a gap in the literature by investigating the use of SFA in work patterns, such as health professionals' loyalty and involvement in their medical knowledge in Turkey, and how it allows for differentiating training from marketing. This study intended to compare the data on internists and medical products gathered from a well-known pharmaceutical company's SFA. The data covered the first three months of the year 2020, when medical representatives had a normal daily routine, and that of 2021, when Turkey experienced the most powerful surge of the COVID-19 pandemic. The analysis was based on simple correspondence analysis (SCA) and multiple correspondence analysis (MCA) for 11 variables. Monitoring product, physician's segment, and medical representatives' behaviors with SFA had a significant influence on the pharma-physician relationship strategy, as expected. The findings supported the view that SFA technologies can be deployed to advance the medical knowledge of physicians, in addition to managing and designing superior CRM and CLM capabilities.

Moving into the Future of Clinical Trials

Every delay, from equipment not arriving at a clinical site on time to patients unable to arrive for an onsite visit, creates an avalanche of effects, from decreased patient retention to increased time to market. [...]extending beyond logistical complexities, data compliance regulations, such as HI PA A or GDPR, expand further back in the supply chain as partners need to handle patient data that enables home delivery of equipment as well as labeling for sample collections. Delivering training in a decentralized clinical trial Logistics is more than the movement of people and products;it's also about the movement of information. [...]hybrid and virtual trials require partners to ship directly to or pick up directly from patients, requiring partners to have access to a range of personal information, from the patient's name and address to the study type to the serial number of the equipment used. Data that is not properly secured can create cybersecurity risks that potentially expose confidential patient information as well as violate regulatory standards.

Regulating Digital Therapeutics

Conversely, in Italy DTx are classed as medical devices and must pass International Organization for Standardization (ISO) standards to ensure they are compliant with safety requirements. The new EU MDR should help to simplify the exchange of data on medical devices and improve data collection and post-market surveillance to reinforce end-user confidence in DTx solutions. In Germany, Ireland, and the Netherlands, DTx manufacturers have directly targeted self-insured employer health plans, whereas in France, Belgium, and the United Kingdom, a B2P reimbursement model has proven successful.

Performing Remote Audits During a Pandemic

For medical devices, FDA has published a "Remote Auditing Pilot Program" document outlining a voluntary pilot programme for remote auditing of processes, the Medical Device Single Audit Program (MDSAP) as part of the audit of a medical device organization (2). An important aspect of this pilot is the use of technology that facilitates remote audits, including: * Videoconferencing * Web-based meeting systems with screen sharing capability * Teleconferencing in conjunction with e-mail * Smart glasses or optical mounted head displays * Secure fileshare repositories * Remote 'read only' access to automated systems, such as electronic quality management systems (e.g., to view standard operating procedures [SOPs], deviations, electronic batch records, video recordings from the operational area, etc.). The meeting, which was moderated by Janet Woodcock, the US Food and Drug Administration's (FDA')s director of the Center for Drug Evaluation and Research, was conducted to align global regulations and approaches to clinical trial management, drug supply issues, and pharmacovigilance during the pandemic (1).

Business on Hold? EMA's Full Recovery in Question

The EMA pandemic Task Force (COVID-ETF) helps EU member states and the European Commission (EC) to take quick and coordinated regulatory action on COVID-19 treatments and vaccines. Delayed submissions As a result of pressure on the work time of regulators from COVID-19 matters, pharmaceutical companies are thought to be holding back the application for marketing authorizations of their products or approval of variations of marketing authorizations. Regulators are not only worried about having to grapple with a rush of delayed submissions but also the extra burden of implementing new EU legislation in areas like veterinary medicine, medical devices, and personal data protection. A joint HMA/EMA Big Data Task Force recommended in December 2019 that the regulatory network set up a platform for access and analysis of healthcare data from across the EU (5).

Seven days in medicine: 6-12 May 2020

In a report summarising the feedback it had received,2 the charity noted a litany of "horrendous” safety concerns, as workers were concerned about a lack of personal protective equipment and about their mental health. NICE: assess covid patients for kidney injury Patients with suspected or confirmed covid-19 should be assessed for acute kidney injury (AKI) on hospital admission or transfer, said the National Institute for Health and Care Excellence (NICE). In a new guideline aimed at healthcare professionals who are not kidney specialists, the institute said that patients with suspected or confirmed covid-19 should be monitored for AKI throughout their stay in hospital and managed appropriately if it develops.

Management of medical equipment in the Brazilian public health system (SUS), historical situation and the context of the pandemic COVID-19: a cut for lung ventilators.

Purpose: The main objective of this paper is to analyze the Brazilian Ministry of Health (MoH) efforts in the management of medical equipment, with a specific approach for lung ventilators in the pandemic scenario of COVID-19. Methods: The methodology included a review of the normative framework and literature on technological management and research on the database of the Ministry of Health. Results: As a promoter for acquiring medical equipment, the MoH role is highlighted and added to this competence; its function as the coordinator of the National Policy on Health Technology Management (PNGTS). According to the PNGTS the MoH has to support health managers in the implementing, monitoring, and maintaining health technologies. The scenario of lung ventilators in the pandemic was discussed, with research to verify demands, offers, installed capacity, and investments. In less than one year, the Ministry of Health acquired several pulmonary ventilators, 8.55 times greater than the annual averages of equipment acquired from 2016 to 2019. So far, there is still no maintenance plans or strategy of management for that equipment, especially in a post-pandemic scenario. Conclusion: It is possible to conclude that the Ministry of Health needs to improve health technology management systems. On the scale of the Policy, it is necessary to commit to permanent and long-term actions to ensure sustainability and reduce the technological vulnerabilities of the SUS.