COVID ADVANCES CLINICAL TRIAL TRANSPARENCY

Growing public concerns about politics playing a role in vetting potential vaccines and therapies to combat the COVID-19 pandemic has prompted sponsors of leading clinical trials to make public their study protocols and statistical analysis plans. [...]AstraZeneca's timeframe for enrolling and assessing study participants was delayed by the need to address the report of a serious adverse event in its Phase III study. The disclosure of these usually confidential details on research endpoints, assessment timeframes, and study analysis plans aim to promote information sharing among vaccine developers, and also build public confidence.

Exploring the Preference of Corporations for Sponsorship Motives and the Impact of Sponsorship Motives on Sponsoring Intention in Post-Epidemic Era: Using Two Different Approaches-FPR and SEM

The aim of this study is to explore the preference of corporations for sponsorship motives and the impact of sponsorship motives on sponsoring intention in the post-epidemic era of COVID-19. Taking a Taiwanese company as a case study, a total of 60 expert groups comprising 300 respondents (the management of the sampled companies) were surveyed in the post-epidemic period, with data being collected from 60 sampled companies in February-May 2022. Data were analyzed by using two different functional approaches, including fuzzy preference relations (FPR) for the first survey (study 1) and structural equation model (SEM) for the second survey (study 2). Results reveal that corporate image is the most preferential motive of sponsorship and also demonstrates the most significant and positive influence on sponsoring intention. Meanwhile, the measured factor of performing corporate social responsibility (CSR) appears the most correlated with the construct of corporate image. Based on the results, the study can fully fill the gap between sponsorship motives and sponsoring intention in sponsorship knowledge. Additionally, the conjunction of FPR and SEM can also create methodological synergies, namely, enhancing complementary effects and achieving better holistic analysis. Findings also suggest that special attention should be paid to CSR, which plays a pivotal role in affecting the decision of corporations for sponsorship motives and sponsoring intention and, in a post-epidemic era, continuing to develop CSR actions to enhance corporate image can be the best strategy while facing internal and external challenges of implementing sustainable development (SD).

Getting the Most From FSP Model

Examining best practices in using the functional service provider model for clinical operations, pharmacovigilance, regulatory, and other areas The COVID-19 pandemic has shown that there's a lot more flexibility in clinical trial systems than what was realized in the past. Some of these and other aspects leading to the rise of FSP outsourcing in drug development has been shared by other experts as well.3 Key functions and sub-functional areas within clinical development that have been outsourced as part of FSP model include: * Clinical monitoring (CM) * Clinical data management (CDM) * Biostatistics, statistical programming (BS&P), data standards, conversions (e.g., CDISC) * Medical writing (MW) * Pharmacovigilance/drug safety (PV) * Regulatory affairs (RA) Based on our experience in advising clients and providing FSP/CRO services over the past 20 years, we have seen the creative bundling of some of these functions as part of the extended FSP partnership model. * Combination of CDM, BS&P, and data conversions * Extension of the CDM, BS&P, and MW into a "clinical data services' package * Combination of clinical monitoring, CDM, BS&P, and medical monitoring into a "centralized monitoring team" (potential future services) * Combination of PV and regulatory activities due to regional synergies and submission/compliance requirements (potential future services) To ensure that the FSP model is strategic and provide the sustainable mode of partnership, we have shared some of the best practices ahead (and summarized in Figure 1 above) that can be leveraged and further customized as needed by sponsors: 1.Functional sourcing strategy: Sponsors must include specific criteria as part of their evaluation of service providers for the FSP sourcing plan (some of these are also typically done during a full-service CRO outsourcing process): Size and geography focus of provider that needs to be aligned with the strategic plans of the sponsor (e.g., where they plan to conduct trials to meet their regulatory needs or the size of stud ies). Team strength, capacity, and experience with both FTE and unit/deliverables-based pricing models of delivery. * Commitment to deliver year-over-year productivity gains using automation, digital/AI/ML technologies, and other approaches. * Partnership approach to play a critical role in initiating, driving/participating in innovation, and transformation initiatives of the sponsor. * Past client and employee turnover (attrition) that should be on par or below benchmark for the same function and similar type of service. * Executive commitment to participate actively in joint-governance discussions that ensures proactive monitoring and tracking of the program milestones and drive mitigatory actions, should milestones not be delivered on time, quality, and cost. 4.RFI/RFP process, joint solution development, and rigorous scoring of proposals and solutions:

The Role of Transferable Skills and Data Science in the Move to Digitally-Enabled Clinical Research

According to the job's website Recruiter, clinical data management vacancies have increased by almost 94% since 2019.' Artificial intelligence (AI), including machine learning (ML) and natural language processing (NLP), is allowing for the more intelligent analysis of trial data. New approaches, new roles Centralized statistical monitoring, which streamlines drug development by allowing for the near real-time analysis of data as it accumulates, is the perfect example of how the changing research paradigm is creating new roles.

Why Centralized Monitoring and RBQM are Here to Stay

Suddenly, concepts such as remote and centralized monitoring along with the broader RBQM paradigm, which have long been lingering at the side lines of clinical trial management, were brought into sharp focus. The approach allows study leaders to use the risk assessment process to first identify and then focus on the most critical data-the safety and endpoint data that matters most to each individual trial. RBQM has proved its worth during the pandemic, especially in the race to find a vaccine References 1.https://www.outsourcing-pharma.com/Article/2020/12/07/How-has-COVID-19-impacted clinical-trial-data-collection 2.<https://www.ema.europa.eu/en/human-regula tory/overview/public-health-threats/coronavirus disease-covid-19/guidance-medicine-developers> other-stakeholders-covid-19 3.<https://globalforum.diaglobal.org/issue/septem ber-2020/looking-to-the-future-with-rbqm/ 4. https://www.centerwatch.com/articles/24898 remote-monitoring-wont-require-post-pandem ic-re-monitoring-fda-says

Building Relationships Key for Smaller Sponsors

Strong collaboration critical as trial development advances Prior to the COVID-19 pandemic, biotech and emerging biopharma companies were increasingly turning to contract research organizations (CROs) to contain costs and secure therapeutic and clinical trial expertise to help meet their individual objectives. Therapeutic and clinical trial expertiseWith exploratory drug development often focused on multiple indications, a CRO with depth of tic expertise optimize clinical delivery enhancing quality and reducing timelines. Furthermore, years of therapeutic expertise and interaction with investigational sites ensure site engagement with heightened interest and attention to the target patient population.

Accelerating Clinical Trial Design and Operations

Fully-integrated, component-based CDMS offers flexibility, customization, and efficiency Effective and efficient clinical data collection and management is one of the key factors affecting clinical trial success and is of heightened importance during the COVID-19 pandemic.1 Not only have the scope and complexity of clinical trials continued to increase over the past decade, but the volume and diversity of clinical study data grows ever larger. Researchers have accelerated the development of vaccines and therapeutics for COVID-19 as evidenced by the 4,846 trials found on clinicaltrials. gov.2 The COVID-19 pandemic presents a unique opportunity for understanding technologies that can enable trial data management and their effects on streamlining;and expediting clinical trial design and implementation. Specific measurements evaluated in this study were: database build efficiency, velocity of data collection, frequency of protocol amendments on the database, and the time impact of mid-study updates to the database. [...]the ability to execute mid-study updates or post-go live changes with minimal to no downtime (< one hour) allowed the users and sponsors to work in parallel rather than in serial fashion, speeding up trial start dates and implementation of protocol amendments, and accommodating adaptive COVID-19 trial design.

CONTEMPLATING THE FULL MEASURE OF PANDEMIC RESPONSE

The top contributing factors include: * The proactive and accommodating way that regulatory agencies and ethical review committees have supported development planning and activity. * The rapid mobilization of internal and external scientific and operating teams with a singular and common focus. * The fast deployment of remote and virtual technology solutions supported by more open data, information sharing, and advanced analytics. * The execution of parallel clinical trials and the compressed time between clinical trial phases. * The de-risking of development activity through the availability of global funding and resources. * The unusual frequency and extent of global media coverage contributing to unusually high public visibility. Many of the approaches and solutions deployed-such as remote monitoring, e-consent, home nursing visits, and integrated data management platforms-faced significant difficulty replacing legacy approaches before the pandemic. Clinical research data volume has been rising dramatically for decades as protocol design objectives and scope have increased.

APPLYING PRE-PANDEMIC BENCHMARKS TO ASSESS FUTURE SPEED STRATEGIES

To name but a few: they have rapidly mobilized scientific and operating teams;entered into an unprecedented number and variety of co-development arrangements;scaled-up manufacturing capabilities;and leveraged technology solutions and advanced analytics to access and analyze data from animal and early human studies and from commercially available therapies treating other diseases. Clinical trial durations and scope metrics were obtained from summaries of drug approvals available on the FDA website, from medical reviews, and from the ClinicalTrials.Gov website. [...]Phase III clinical trial durations have increased by more than 6% between the two time periods, from an average of 26.8 months in the 2008-2013 period to an average of 28.5 months per individual trial in the 2014-2018 timeframe. Very high variation was observed around the mean number of participants per clinical trial and this variation has increased over time. Mean clinical duration for non-orphan drug approvals increased substantially (16.2 months) in the 2014-2018 period, whereas mean regulatory review duration for non-orphan drugs decreased by one month.

Managing Risks in Clinical Trials During a Pandemic with ICH E6 (R2)

Consisting of a variety of required components-including but not limited to quality risk assessments, a written Quality Risk Management Plan, and strategic, centralized data reviews-the revision underscores the importance of a robust RBQM framework to ensure clinical trial execution in compliance with GCP. In this article, we will examine the overall value of ICH E6 (R2) to sponsors, as well as how COVID-19 has and will continue to influence sponsors' consideration of risk-based monitoring as a key component of clinical trial operations. [...]if they have not proactively identified key data and processes that could bring potential risk, they run the danger of getting "lost in the weeds" and overlooking risk factors that later breached tolerance limits and resulted in issues that had some level of impact on the study and its results. At Rho, we consider a robust RBQM framework to include dedicated quality risk managers, RBQM templates to assist with creating the plans required by ICH E6 (R2), a strategic approach to data review, among other components.

Post-Pandemic: An Argument for Protocol Simplicity

Study protocols were overwrought with unnecessary data points (blood draws, invasive procedures) before the pandemic, and the rush to add flexibility in home health visits or telehealth visits to protocols has not translated to ease of implementation in study start-up or maintenance. Protocol complexity translates to R&D cost;sites globally during this pandemic have either had the network support to sustain themselves, pivoted to COVID-19 research exclusively, or made the difficult decision to close. Protocol simplicity is directly correlated to reduction in overall cost and increased patient adherence, retention, and safety-what does the industry have to lose in pursuing a simpler, more straightforward path? [...]the industry decides to reduce the number of necessary (versus desired) data points for a given interventional study, sponsors, CROs, sites, and ultimately the patients we all serve will bear the resulting costs.

Investigative Site Placement Practices to Support Operation Warp Speed

Data from ClinicalTrials.gov was supplemented by press releases, news articles, and other publicly available information to segment investigative sites into five categories;site networks (SN), academic medical centers (AMC), health systems, independent medical practices (IMP), and government entities (GE). [...]a lack of diversity has already been documented in both the NIAID Adaptive COVID-19 Treatment Trial (ACTT-1) and the Gilead-funded remdesivir study.5 It is interesting to note the very low percentage of investigative sites from health systems and independent medical centers participating in these late stage COVID-19 clinical trials. Similar to pre-pandemic conditions, these entities have been less attractive settings when compared to site networks and academic medical centers that offer larger numbers and more dedicated personnel;higher levels of experience and competency;and substantially greater research infrastructure.6 Hospitals and independent medical centers were also the slowest to respond during the early stages of lockdowns throughout the US, and these sites were among the most likely to suspend their clinical trials at the outset of the pandemic.7 Community hospitals often find themselves being passed over during site selection in favor of academic medical centers which boast experienced investigators and specialized researchers.8 This is another reason why new investigators and health systems are not participating in COVID-19 clinical trials: sponsors place a high value on prior experience rather than total potential for accessing and attracting a large and diverse patient population. The integrated research organization (IRO) is an emerging model that is allowing multi-specialty practices and community health systems to be involved in clinical trials as a research care option for their patients.

Shifting Perspectives on Site Networks to Create Positive Change

In the short-term, however, there have been more immediate and acute concerns about the ability of clinical development to continue in the face of widespread infection;how will patients continue participation when leaving home poses a significant risk?;what happens to patients who are relying on speedy development of life-changing, even life-saving, treatments? [...]it is essential to develop therapeutic network strategies in specialist areas, such as rare disease and cell and gene therapy. Because of the access to large numbers of potentially qualified patients onsite, staffing levels may be a limited concern in quickly contacting and qualifying patients within its systems.

Integrating Technology and Expertise

Phase I/II study in cancer patients showcases eClinical effectiveness Complex study designs are fast becoming the norm-but integrated clinical trial technology can make even the more complicated of data collection requirements a breeze. Solution The sponsor selected IDDI as its biometric partner, and we provided our fully integrated eClinical suite, which features electronic data capture (EDC) and RTSM, as well as data collection, data cleaning, and data analysis. [...]resources were planned on almost real-time trial status, thus reducing timeand resource-wasting activities.

ePRO and Ensuring Data Integrity

An increased focus on patient engagement and the 21st Century Cures Act, regulatory authorities, i.e., the FDA, are embracing the need for more patient-centric drug development and wider access to assure accurate data collection as trials become more decentralized. The focus on improved visibility and oversight of data collection, faster trial implementation, sharing of real-time data and patient comfort and collaboration has led to a variety of eClinical applications. ePRO and other eCOA approaches can transform trials to make them more pragmatic, patient-centric and efficient by maximizing the potential to quickly access data through electronic health records, and especially to assist trial managers to make reliable data-driven decisions, and to mitigate risks. In the area of event prediction, a trial manager can look into a company's historical clinical trial data and provide data guidance when for example, writing new protocols, i.e., for dosages that may need to be increased/ reduced for trials in different geographic areas or age groups.

The Evolution of Site Selection

Whether it was recognition, for a very long time pre-pandemic, that industry needed new ways to recruit and retain patients, or the success realized last year during the global SARS-CoV-2 vaccine trials, when pharma said we have no choice but to adopt in situ-or both reasons-the clinical trial industry is doing a 180, site-selection speaking. Syneos has the clinical trial networks;Elligo has access to Cerner and other EHR systems, said Maria Fotiu, executive vice president, decentralized solutions, Syneos Health. Healthcare, said Keith Fern, vice president, corporate development, Elligo, has become a heterogenous business. According to the Curebase website, its technology propelled the start of a COVID trial in two weeks.

Homefluencers' endorsement of millennial consumers' purchase intention in new normal

PurposeThe purpose of this study is to examine how "homefluencers" sponsored posts on millennial consumers' purchase intention in the international marketing sphere can be impacted in the new normal by drawing on source credibility, parasocial interaction (PSI) and persuasion knowledge model (PKM) theory.Design/methodology/approachThis research applies structural equation modeling (SEM) and mediation analysis as the data analysis method using non-probability purposive sampling of a total of 217 local millennial Instagram and Facebook users, who have followed homefluencers sponsored posts in fashion-beauty, yoga-fitness and food sectors.FindingsBased on hypothesis testing, advertising recognition strongly mediates purchase intention with the indirect effects of expertise and trustworthiness than attractiveness.Research limitations/implicationsThis research extends the international marketing literature on source credibility, PSI, PKM and purchase intention theory in the new normal by proposing "Homefluencer's Endorsement Model for Purchase Intention" (HEMPI). Specifically, the mediating role of ad recognition of homefluencers sponsorship disclosure (#paidad, #sponsored), positively affects "change-of-persuasion meaning" on Instagram and Facebook, where research is rare.Practical implicationsThis research provides valuable suggestions for global brand owners, consumers and authorities of Instagram and Facebook to consider post-COVID consumer behavior highlighting homefluencers sponsored collaboration.Originality/valueThe authors have contributed to the use of the source credibility model and PSI to identify the antecedents in determining how the homefluencer's effective sponsorship disclosure can positively activate ad recognition on millennial consumers' purchase intention in a crisis period from an international standpoint with the practical implications in post-COVID.

Editors' Introduction Neoliberalism in Higher Education: Practices, Policies, and Issues

While the working and middle classes have faced the challenges brought about by job layoffs resulting from corporate mergers and the lack of an economic support system to provide a survivable quality of life, the top one percent has enjoyed the benefits of increasing monetary gains from tax cuts and stock market investments. Reduced state funding and the infusion of marketplace principles and practices have resulted in the treatment of students as a revenue stream for raising tuition, which, in turn, increases student dependence on loans benefiting primarily Wall Street private lenders. [...]higher education has become the victim of a hostile takeover by neoliberal principles that utilize higher education as a laboratory for economic practices and redesign work roles to monetize the value of higher education. [...]they argue that for the last fifty years, neoliberalism has penetrated the academy and intercollegiate athletics and has been speeding toward a separation of the university and athletics by prioritizing business and profit interests as well as private and corporate sponsorships, and by increasing reliance on governance by the NCAA rather than universities (including academic standards and compliance).

Gambling in football: How much is too much?

Football and gambling have a long, intertwined history. This commentary seeks to explore the changing nature and implications of this relationship, how the relationship has been affected by COVID-19, and how the relationship may change in the future. No new data were collected for this commentary. The commentary identifies some recent examples, and some examples from the more distant annals of football history, of the often-controversial history between football and gambling before discussing the increased prevalence of gambling industry shirt sponsors. Research highlighting the saturation of gambling in football is then discussed, and the implications of this. Different Government and Football Association responses to gambling in football, and the potential impact of COVID-19 related legislation are examined, before recommendations from the recent Lord Gambling Industry Committee are considered. The discussion of research in gambling and football highlights some of the ethical considerations facing clubs and legislators. This commentary brings together some of the issues surrounding the close relationship between gambling and football.

Research on Development of Sponsorship Effect Analysis Module Using Text Mining Technique

To expand the sponsorship market, sponsorship activities based on sponsorship effect analysis data through scientific and systematic analysis must be carried out. As the development of the media industry and the COVID-19 pandemic have caused many changes in the method of broadcasting professional sports, it is necessary to upgrade the analysis of sponsorship effects. In a crisis situation where the sponsorship effect analysis market is shrinking due to the COVID-19 pandemic, the development of brand exposure analysis programs that can be used based on online platforms will expand the sponsorship market and promote changes in the domestic analysis market that relies on overseas analysis programs. In this study, more than 200,000 online sports media data were collected to analyze the sponsorship effect by minimizing the omission of sponsor brands exposed through online media and detecting sophisticated data. A commercial dictionary in the sports field was established and a sponsorship effect analysis module was developed by quantifying text data using morpheme analysis and TF-IDF. A module based on UI was implemented to analyze the results of the custom morpheme analyzer and Elasticsearch Term Vectors AP. © 2023, The Author(s), under exclusive license to Springer Nature Switzerland AG.