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Copyright of Unternehmung: Swiss Journal of Business Research & Practice is the property of Nomos Verlagsgesellschaft mbH & Co. KG and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

We aim to characterize industry-funded trials that have posted the informed consent forms (ICFs), and to assess whether the role played by industry as 'sponsor' or 'collaborator' could impact several relevant variables. A cross-sectional study was conducted on ClinicalTrials.gov on all industry-funded trials registered on or before 25 February 2023. We registered types of intervention, current recruitment status, design, enrollment, and countries involved. For trials with special interest to potential participants and investigators and/or clinicians an analysis of the role played by industry as 'sponsor' or 'collaborator' was performed. Of 116,281 industry-funded trials registered, 741 (0.6%) had posted ICFs. Most of these trials were categorized as 'completed' (n = 408) or 'terminated' (n = 107). The review of a sample of 359 trials showed that most were on drugs and/or biologics (59%), were randomized (51%), conducted exclusively in the USA (72%), and had posted results (79%), protocols (92%), and statistical analysis plans (SAPs) (89%). Trials in which industry participated as 'collaborator' were significantly more likely to post ICFs when trials were in the 'active, not recruiting' phase (OR 4.70, 99.71% CI 1.59–13.9, p < 0.001) than industry-sponsored trials. This was also the case when assessing drugs/biologics (OR 2.64, 99.71% CI 1.25–5.58, p < 0.001). Conversely, companies acting as 'sponsors' were significantly more likely to post ICFs with trials assessing devices, radiation interventions and/or diagnostic tests (OR 0.37, 99.71% CI 0.17–0.79, p < 0.001) than when participating as 'collaborators'. While industry-funded trials rarely post ICFs, when they do, they are highly compliant with transparency requirements. Regulations and ethics codes should consider requiring posting of protocols, SAPs, and ICFs for all clinical trials, regardless the type of sponsor. [ABSTRACT FROM AUTHOR]

The editors' request to reflect on one's career is a daunting one. There is an inherent implication that some pivotal point has been achieved, and usually, it's the point of retirement. There is also an assumption that the author can be impartial, though some writers will be laudatory and others excessively critical. I tend to fall in the latter group, and I firmly believe that it stems from my experience as an immigrant. What follows will be my thoughts about my experiences as a mentee and eventual mentor framed in the context of my upbringing. [ABSTRACT FROM AUTHOR]

Simple Summary: In the present framework of constraints on healthcare budgets, an assessment of costs of antineoplastic drugs is a crucial step in contributing to the sustainability of public-payer systems. This study evaluated the characteristics of cancer clinical trials and potential drug cost avoidance in a large population of adult cancer patients with solid tumors enrolled in clinical trials over a 10-year period (2010–2019). These trials were conducted at the Medical Oncology Department of Vall d'Hebron University Hospital in Barcelona (Spain), one of the largest tertiary care centers in the country. Based on the data of 2930 clinical trials with 10,488 participants, it was found that the total cost of antineoplastic drugs supplied by sponsors in the clinical trials setting was EUR 107,306,084, with a potential cost savings of EUR 92,662,609. Participation in sponsored clinical trials in which drugs are provided free of charge yields considerable cost savings, with benefits in clinical strategies to reduce drug expenditures. The objective of this single-center retrospective study was to describe the clinical characteristics of adult patients with solid tumors enrolled in cancer clinical trials over a 10-year period (2010–2019) and to assess drug cost avoidance (DCA) associated with sponsors' contributions. The sponsors' contribution to pharmaceutical expenditure was calculated according to the actual price (for each year) of pharmaceutical specialties that the Vall d'Hebron University Hospital (HUVH) would have had to bear in the absence of sponsorship. A total of 2930 clinical trials were conducted with 10,488 participants. There were 140 trials in 2010 and 459 in 2019 (228% increase). Clinical trials of high complexity phase I and basket trials accounted for 34.3% of all trials. There has been a large variation in the pattern of clinical research over the study period, whereas, in 2010, targeted therapy accounted for 79.4% of expenditure and cytotoxic drugs for 20.6%; in 2019, immunotherapy accounted for 68.4%, targeted therapy for 24.4%, and cytotoxic drugs for only 7.1%. A total of four hundred twenty-one different antineoplastic agents were used, the variability of which increased from forty-seven agents in 2010, with only seven of them accounting for 92.8% of the overall pharmaceutical expenditure) to three hundred seventeen different antineoplastic agents in 2019, with thirty-three of them accounting for 90.6% of the overall expenditure. The overall expenditure on antineoplastic drugs in clinical care patients not included in clinical trials was EUR 120,396,096. The total cost of antineoplastic drugs supplied by sponsors in a clinical trial setting was EUR 107,306,084, with a potential DCA of EUR 92,662,609. Overall, clinical trials provide not only the best context for the progress of clinical research and healthcare but also create opportunities for reducing cancer care costs. [ABSTRACT FROM AUTHOR]

Today, the key to the success of an organization and society is earning money for its survival. Without a secure income, society and various organizations will be dissolved and destroyed and cannot survive in a competitive environment. Income is a financial source that is injected into an organization in different ways and the organization can use it to produce goods and services. Reliable and stable income can provide the necessary facilities to meet the costs and expenses of organizations. In fact, income and financial resources are known as the driving force of sports organizations, clubs and leagues. Generating income is necessary for the development, effective planning and maintaining these organizations' independence. Research has shown that financial resources are vital for non-profit organizations such as sports federations and clubs. Non-profit sports organizations need financial support from the government and private institutions, but they prefer to organize sports activities independently (Iskandar et al, 2019). Every sports organization needs financial support to advance its programs and projects. These supports help the sports organization reach its goals (Solntsev, 2021). An important part of these resources is provided by the government. Other forms of income can be obtained from international organizations, marketing income, membership fees and donations. Nowadays, to introduce their company's name and provide their financial resources, many sports organizations refer to the companies which are interested in volunteering. In addition, clubs are capable of generating value and their revenue structure for buying and selling players, sales of secondary products (shirts, sports equipment, etc.), fan sponsorship, television rights, ticket sales and advertising are such that they can generate financial resources (Ljumović et al, 2022). Financing is one of the important issues in the field of financial management. Over the years, various methods have been developed in this field, the existence of various financial instruments can increase market efficiency and optimal allocation of resources (Dróżdż, 2021). Today, many professional clubs are well capable of playing an important role in the strategic performance of countries. Furthermore, the development and sustainable performance and especially the acquisition of financial resources and stable income have been given a lot of attention in today's football. The lack of balance and non-realization of sustainable incomes in different organizations of the football industry, such as clubs and different leagues, have been confirmed by various studies and reports from reputable institutions (Dunbar & Middleton, 2022).Meanwhile, managers of clubs and economic enterprises can play an essential role in strategic performance. Upon accepting the responsibility of financing, financial managers of companies or clubs must know the financial markets and financing methods in order to consider the most economical way of financing by using appropriate inancial tools in the financial markets.Therefore, considering the importance of income generation for clubs and the issue of financing development of football clubs, and due to the fact that the relationship between football clubs' financing methods and their strategic performance has not been discussed so far, this scientific challenge seems to strongly require regular, codified and organized scientific research. It is clear that by carrying out such researches, suggestions can be given to governments and non-government policy makers so that they can take basic steps to develop the financing of football clubs and the ways to overcome the strategic performance of their organizations with research-based decisions and establish a financially successful break - even point in their clubs. With this approach, the researchers in this study intend to answer the following question: what are the financing methods and their relationship with the strategic performance of Iraq football clubs? This research is descriptive and correlational in terms of purpose and application. Its statistical population includes a selection of physical education professors of Iraq higher education institutions, managers and members of the physical education faculty of the Ministry of Science, coaches and referees and expert football experts, managers of public and private institutions active in the field of Iraq clubs who specialize in sports activities, especially football including 153 people who were selected as samples. The tools used in the current research include the researcher-made questionnaire and the standard strategic performance questionnaire of Slater et al. (2010). After confirming the validity of the questionnaires, the reliability of the questionnaires was obtained using Cronbach's alpha method, the financing questionnaire (0.89), and the strategic performance questionnaire (0.82). The data analysis of this research was done in the descriptive part by means of percentage frequency, average and standard deviation and in the inferential part including Pearson's correlation coefficient and regression tests using SPSS22 software. The results after the analysis showed that the income from holding competitions, sponsorship and commercial income, broadcast rights and infrastructure, and monetary and financial markets can significantly predict the strategic performance of Iraq football clubs. Based on the findings of the research and since earning more money can significantly predict the strategic performance of Iraq football clubs, it is suggested to increase the size of the sports market in Iraq by increasing the participation of economic enterprises, supporting large companies and financial sponsors, advertising and promoting products, goods and services, so that clubs can go through the commercialization process more easily. On the other hand, it seems that for the successful financing and commercialization of football clubs, a series of technical, economic and financial activities should be carried out in the light of the commercial registration of clubs as a commercial enterprise, so that clubs become institutions with a legal aspect and follow the rules of business. As a result, if the mechanism is well defined, clubs can achieve better financial success as also mentioned by other researchers (Szymanski & Weimar, 2019). They can continue to achieve sports success, and the club's sports success will also guarantee financial success and cause dynamism in clubs. [ABSTRACT FROM AUTHOR]

Based on the analysis of the results of two measurement episodes in February 2021/22 and calculations using the LSM SPONSOR model, we obtained estimates of the variability of the snow surface thermal balance components and the thermal regime of the snowpack in the ablation zone of the Garabashi glacier on the southern slope of Mount Elbrus at 3850 m above sea level. A quantitative assessment of the sensitivity of the heat balance components to variations in key physical parameters has been performed. It is shown that the optimal value of the emissivity coefficient of snow cover in mountainous areas is 0.98: the absolute error in calculating the radiation temperature of the snow surface at this value does not exceed 1°С, in addition, the model adequately reproduces the thermal regime of deep layers of snow cover. It is also shown that a change in snow density by ±100 kg/m3 can lead to deviations in the temperature of the snow mass by several degrees. This indicates an urgent need to solve the methodological problem of measurements with thermocouples, in which the integrity of the snow mass is inevitably violated. A good agreement between the results of calculations of turbulent sensible heat fluxes in the SPONSOR model with direct measurements (correlation coefficient > 0.9) is demonstrated. Based on the measurement data, the fact of a fairly high frequency of high values of turbulent fluxes under conditions of intense radiative heating in combination with high wind speeds was revealed, which apparently turns out to be typical for high-mountain regions in winter (unlike the plains). For cases of strongly stable stratification in the surface layer, the model systematically overestimates the absolute values of heat fluxes. This may be due to the well-known problem of implementing the calculation scheme based on the Monin-Obukhov theory under conditions of temperature inversions. The inaccuracy in determining the snow surface roughness parameter, which in high mountain conditions is characterized by significant temporal variability, can contribute to the error.

This is the first study examining the key role played by venture capital and private equity (VCPE) firms in the private debt market. Private debt funds invest in companies owned (sponsored) by VCPEs and in other companies without VCPE sponsors. Using novel data, we find that private debt without VCPE sponsors generates a premium. Further analysis shows that this sponsorless premium compensates for higher risk and costs of risk mitigation as sponsorless lenders adopt a more hands-on approach emulating VCPE sponsors' roles. Our results are robust and provide important lessons for investors and investee firms in private debt, venture lending, and VCPE. This paper was accepted by Victoria Ivashina, finance. Supplemental Material: The data files and online appendix are available at https://doi.org/10.1287/mnsc.2022.4664. [ABSTRACT FROM AUTHOR]

Introduction: To safeguard the safety and interests of subjects participating in clinical trials, their conduct is heavily regulated. The EU Clinical Trials Regulation (CTR) 536/2014 brings fundamental changes that will require sponsors to adapt their current way of working. One major change is the significant shortening of the permitted reply timelines to requests for information (RFI), which may require adaptations to established processes within an organisation. This study aimed to assess these reply timelines at the European Organisation for Research and Treatment of Cancer (EORTC), a non-commercial sponsor. Additionally, it aimed to investigate how the impact of the different CTR requirements is perceived by the organisation's staff. Methods: A retrospective analysis was performed to assess the length of reply to grounds of non-acceptance (GNA) timelines. Questionnaires were circulated to internal staff to assess their views on the impact of important changes the CTR introduces on the organisation's processes. Results: The average reply time to comments from regulators was 27.5 days, which is longer than the 12-day time limit required by CTR, which indicates that the organisation's processes require re-optimization to allow efficient activation of trials compliant with the new legislation. The majority of the staff that completed the questionnaire assessed the impact the CTR would have on the organisation to be positive. Finally, there was a large consensus about the changes related to the submission timelines, transition period and the user management of the Clinical Trial Information System (CTIS) having a very important impact on the organisation as a whole. Participants referred to the streamlined process of a clinical trial in different countries as foreseen in the CTR, as an aspect that would benefit the organisation. Discussion: For all retrospectively studied timelines, the average timelines to reply combined for competent authorities (CA) and ethics committees (EC) were longer than the 12 days allowed under the CTR. EORTC will have to adapt internal processes to meet the time limit imposed by the CTR without compromising its scientific integrity. The questionnaire respondents had the required expertise to provide an opinion on the CTR's impact on the organisation. There was a large consensus about the changes relating to the submission timelines having a very important impact on the organisation. This observation is in line with the results of the retrospective part of this study. Conclusion: Based on the results of the retrospective and prospective parts of the study, it is clear that the shorter reply timelines are the main factor that will affect the organisation. EORTC has spent significant resources in adapting its processes to comply with the CTR's new requirements. Experience with the first studies under the new regulation can be utilized to implement further process adaptations. [ABSTRACT FROM AUTHOR]

In 1935–1936 Konstantin Dmitrievich Balmont (1867–1942) suffered a serious nervous disease that interrupted his literary activity. The treatment, which required large expenses, deprived him of his livelihood, and Russian emigrants joined in helping the sick poet. A well-known public figure Vladimir Feofilovich Zeeler (1874–1954), secretary of the Union of Russian Writers and Journalists in Paris, the driving force and treasurer of the Committee to commemorate the 50th anniversary of Balmont’s literary activity (official English translation: the Committee for the Recognition of the 50 years long literary activity of Constantin Balmont) established at the end of 1935, was particularly active in fundraising. The history of his relationship with the poet is generally known from Balmont’s published letters and poems addressed to Zeeler, and from Zeeler’s memoirs. This paper complements it with the text of the Committee’s appeal, most likely compiled by Zeeler, re-printed in full for the first time, and with the materials of Zeeler’s correspondence with sponsors published for the first time.

To examine whether and how the different levels of regional economic incentives would have an effect on underwriters' market share in general. Drawing on Chinese IPO firms during the period 2006-2016, this study examines the impact of different levels of regional economic incentives on underwriters' market share. The authors find that regional economic incentives have a positive impact on underwriters' market share and that local economic incentives have a significantly stronger impact than central economic incentives. Furthermore, the authors find that IPO firms with underwriters driven by regional economic incentives experience worse post-IPO performance than firms with underwriters driven by central economic incentives, which do not experience a significant decline in post-IPO performance. Taken together, the authors’ findings are consistent with the notion that performance assessment motivates officials at various levels of government to bring companies in their jurisdiction to the IPO market prematurely. In addition, the results indicate that central economic incentives play a significant role in driving China's macroeconomic development and market-oriented system reforms. As such, they are one of the major driving forces behind China's market-oriented system reforms.

How do interactions between institutional investors and sponsors affect the quotations in IPOs? This paper provides evidence that connections between the above two agencies result in variations in the institutional investors' quoted prices and quotation frequency in China stock market. Using a Bartik-style identification strategy that links shocks to connections between institutional investors and sponsors in China, we find that a stronger connection between a sponsor and an institutional investor lowers the quoted price to a realistic level and increases the probability that the investor joins the quotation of the sponsor's main-board IPO during the "three highs" period in which the "favor quotation" is common. This relationship will be more significant for quotation frequency when more investors are connected to sponsors within a city. Moreover, the mouth-to-mouth effect tends to be weaker in cities with more investors. [ABSTRACT FROM AUTHOR]

The present work aims to examine how the Life Cycle Canvas® visual model influences the performance of the governance function performed by the project sponsor in the project life cycle of a public educational institution. A research with case study procedures was carried out, where the subjects of this research comprised the members of the institution's project office and the sponsors themselves. Data collection was carried out through individual semi-structured interviews and the analysis was carried out through content analysis. The previously defined data analysis categories represented the six dimensions of sponsor roles in the context of project governance pointed out by Crawford et al. (2008). As a result, it was identified that the Life Cycle Canvas® visual model can contribute to the performance of this role in the six dimensions suggested by Crawford et al. (2008), and taking into account the list of identified codes, it can be argued that it helps, mainly, in the dimensions “govern the project”, “guide and make decisions” and “critically review progress”. Relationships with the main governance theories linked to project management were also identified. In this way, the work suggests that the Life Cycle Canvas® visual model can be an important tool to improve the governance performance that the sponsor must have, allowing him to see his role throughout the life cycle of a project.

This has been the case not only regarding ED but also surrounding other male sexual dysfunctions (eg, premature ejaculation[5]) and women's sexual health.[6] Last but not least, pharma have played a major role in supporting national and international scientific societies in the area of sexual medicine. Keywords: industry; sponsor; research; sexual medicine EN industry sponsor research sexual medicine 422 425 4 06/15/23 20230401 NES 230401 Introduction The debate around the role of pharmaceutical industries (hereinafter "pharma") in the field of sexual medicine over the course of my (A.S.) nearly 30 years of clinical and translational research on this amazing topic has been harsh and sometimes unproductive. Google Scholar Crossref Search ADS PubMed WorldCat 2 Salonia A, Rigatti P, Montorsi F. Sildenafil in erectile dysfunction: a critical review. In the specific and relatively narrow context of sexual medicine, pharma have played a primary role throughout the last 50 years, with an incredible peak in the late 1990s and early 21st century in (1) the discovery, development, and implementation of drugs for the treatment of erectile dysfunction (ED) that have drastically revolutionized the field; (2) the way that we treat patients; (3) our way of approaching medicine; and (4) the way in which research, at least clinical research, has been conducted from 1998 onward. [Extracted from the article]

Context and background Infusion of technologies such as Geographical Information Systems into organizations has in most cases been associated with the concept of championing. Geographical Information Systems when developed across countries and/or regions, are integrable to create Spatial Data Infrastructure (SDI). In the Southern African Customs Union (SACU) region, the concept of SDI at national level have been acknowledged and/or kick-started by each member country. The efforts by these countries in development of National SDIs are evaluated with the aim of advancing a Southern African Customs Union Regional Spatial Data Infrastructure. SACU was incepted in 1889 and has metamorphosed into a collaborative trade block of five Southern African countries. In the context of geospatial information, it is advanced that as a region, it has discoverable opportunities and organizational platform for developing and hosting Spatial Data Infrastructure. A consideration is made that spatial data is capable of strengthening operational, tactical and strategic endeavors of SACU by providing evidence-based support to decisions and policy making. Goal and Objectives: The objective being interrogated in this paper, is the discoverability of geospatial data and information systems in Southern African Customs Union that can be integrated with its trade data and championed into Regional Spatial Data Infrastructure. Methodology: Mixed method of both quantitative and qualitative was used. In qualitative form, documents, questionnaires, interviews and workshop attendance have been utilized to decipher the attitudes of various stakeholders within Southern African Customs Union towards a Regional Spatial Data Infrastructure Concept. In a quantitative form, discoverable data has been found then further processed in line with the goal and objectives stated above. Results: Results obtained have enabled an elementary geodatabase proposition and maps of the region with a number of macroeconomic indicators. Furthermore, a discussion has been done to advance a preliminary determination of sponsor and champion of Southern African Customs Union Regional Spatial Data Infrastructure. [ABSTRACT FROM AUTHOR]

Agents, race-organisers, and sponsors have a key influence in shaping the world of elite professional distance running. Yet to date this important but hard-to-reach stakeholder group has been omitted from the global research landscape of doping and anti-doping. The purpose of this study is to address this gap in the literature and explore the systematic contributors to doping in elite long-distance running, along with potential solutions to this issue, from this influential perspective. Thirteen in-depth interviews were conducted with agents (n = 8) of world-class long-distance runners, major race organisers (n = 3), and sports marketing managers for global brands (n = 2). The interviews were conducted via the phone, audio-recorded, and transcribed verbatim. Reflexive thematic analysis generated three themes which focused on: 1) The framework of professional distance running and the contextual aspects which may contribute to doping risk, 2) the impact of various recruitment strategies on doping and anti-doping, and 3) the lessons that can be learnt from the participants' first-hand experiences with doping cases and/or managing anti-doping requirements. Reflecting on the sector rather than the sample, the results highlighted that not all commercial stakeholders feel responsible for anti-doping. Collective responsibility from all stakeholders, which is currently borne by some and not others, is necessary to minimise doping in distance running. The challenge is how to convince all stakeholders of their share of the responsibility. [ABSTRACT FROM AUTHOR]

Objective: To explore challenges and opportunities for supporting midcareer women otolaryngologists in the areas of negotiation and sponsorship. Study Design: Qualitative approach using semistructured interviews. Setting: Online multi‐institutional interviews. Methods: This study was performed from June to August 2021. Women otolaryngologists representing diverse subspecialties, training, and practice environments were recruited via a purposive criterion‐based sampling approach. Semistructured interviews were transcribed, coded, and analyzed via an inductive‐deductive approach to produce a thematic content analysis. Results: Among the 12 women interviewees, who represented 7 subspecialties, the majority were Caucasian (58%) and in academic practice (50%). The median residency graduation year was 2002 (range, 1982‐2013). Participants expressed several challenges that women otolaryngologists face with respect to negotiation, including the absence of systematic formal negotiation training, gendered expectations that women experience during negotiations, and a perceived lack of power in negotiations. Obstacles to effective sponsorship included difficulty in the identification of sponsors and the influence of gender and related systemic biases that hindered sponsorship opportunities. Conclusion: Notable gender disparities exist for negotiation and sponsorship in the midcareer stage for women otolaryngologists. Women start at a disadvantage due to a lack of negotiation training and access to sponsors, which is exacerbated by systemic gender bias and power differentials as women advance in their careers. This study highlights opportunities to improve negotiation and sponsorship for women, with the goal of promoting a more diverse workforce. [ABSTRACT FROM AUTHOR]

Assessment of new research topics and emerging technologies in any branch of knowledge is important for researchers, universities and research institutes, research investors, industry sectors, and scientific policymakers for a variety of reasons. The basic premise of this research is that the topics of interest for academic research are those that are yet underdeveloped, but are relatively well sponsored by investors. This paper proposes a method to identify and evaluate topics for their research, industrial and commercial potential based on development, investment and investment-to-development ratio (investment appeal). Since the target audience of this paper is researchers in all fields of knowledge who are mostly unfamiliar with scientometric schemes, the proposed method is aimed to be simple, based on meta-databases with easy access, without any need to clustering on keywords. The development index is defined as the keyword link strength obtained from the keyword co-occurrence network, and investment is introduced as the number of sponsors associated with each keyword. From the qualitative analysis of the development-investment diagram, six sets of keywords, entitled as: for Research, for Industry, for Commerce, Matured, Academic and Chaotic, are identified. Due to uncertain membership of research topics to these sets and their relative overlapping, they are defined as fuzzy sets. A fuzzy model, called as Fuzzy Research Ranking System (FRRS), is designed to characterize the fuzzy behavior of research topics and their potential assessment, the output of which is the membership of keywords to any of the six predefined fuzzy sets. The proposed method has been implemented for a sample knowledge domain, Geo-Engineering, which is an interdisciplinary field with significant technological capacity. Expert review of the results shows that the method is relatively well qualified for its ability to identify research topics with technological and industrial perspectives from purely scientific keywords, and may efficiently introduce a ranked list of research topics to the researchers. [ABSTRACT FROM AUTHOR]

Background: The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) began collaboration on Good Clinical Practice (GCP) inspections for marketing applications since 2009. The main characteristics of the GCP inspection processes between FDA and EMA were never evaluated. This is the first analysis comparing the GCP inspection processes between the two agencies. Methods: We examined and analyzed the key characteristics of the GCP inspection processes, including the geographical distribution, inspection types and timelines from application submission to final inspection reporting for marketing applications from September 2009 through December 2015. Results: Fifty-five shared applications were included for analysis. For these applications, a total of 433 GCP inspections were conducted in 47 countries. Most clinical investigator (CI) inspections were conducted in regions outside of each agency's own regulatory jurisdiction, while most sponsor/contract research organization (CRO) inspections were conducted in the U.S. by both agencies. Twenty-eight shared applications included common sites inspected by both agencies. There were 15 joint inspections conducted for seven of these applications and the remaining applications had common sites inspected by both agencies at separate times. Of the joint inspections, 73% were conducted in the U.S and 20% in the E.U. The median time from submission of an application to generation of final inspection reports was 232 days for FDA and 204 days for EMA, with no significant differences noted among applications with and without common sites. Conclusion: The inspection processes and timelines between the two agencies were similar, providing support for continued FDA-EMA GCP collaboration. [ABSTRACT FROM AUTHOR]

This paper sets out the working party's view that for a defined benefit pension scheme's commutation rate the appropriate starting point should be to set it in line with the scheme's cash equivalent transfer value basis. We recognise that there may be several reasons why an actuary in their advice may deviate from that starting point and we explore these in detail, giving our views on when deviation is and is not justified, noting that many common reasons used such as selection risk are often used without (in our view) adequate justification. We also cover frequency of review -- our view is that commutation rates should be reviewed at least every 3 years and actuaries should consider performing a high-level review of commutation rates annually. We suggest that actuaries should consider proposing market-related commutation rates especially in periods of volatile market conditions. In terms of timing, there are good arguments to review commutation terms either following or during a valuation. Finally, we set out some considerations on how actuaries should present their advice, such as clearly setting out all the information required to take key decisions, following up with any actuarial certification in writing (if necessary) and illustrating the impact on members for changing commutation rates. [ABSTRACT FROM AUTHOR]

Copyright of Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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Background: The United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) have collaborated in good clinical practice (GCP) inspections since September 2009. The two agencies operate under different regulatory frameworks for GCP oversight. No systematic assessments of GCP inspection findings have been reported. Methods: We identified common inspections of clinical investigators, sponsors, and contract research organizations conducted by both agencies in support of marketing applications that had the same trial data submitted between 2009 and 2015. We grouped inspection findings into deficiency areas. We reviewed and compared these findings and calculated concordance rate for each deficiency area. Results: Twenty-six clinical investigator sites and 23 sponsors/contract research organizations were inspected by both agencies in support of 31 marketing applications during this period. For FDA, the most common GCP findings were deficiencies related to Protocol Compliance for clinical investigator inspections and Trial Management issues for sponsor/contract research organization inspections. For EMA, deficiencies related to Documentation (including Trial Master File) were the most common findings for both clinical investigator and sponsor/contract research organization inspections. There was high concordance, of approximately 90%, for deficiencies related to Protocol Compliance for clinical investigator inspections and Trial Management for sponsor/contract research organization inspections between the two agencies. There was a concordance rate of about 70% for Documentation deficiencies for both clinical investigator and sponsor/contract research organization GCP inspections. Conclusion: GCP inspection findings from 49 common clinical investigator and sponsor/contract research organization inspections were comparable, providing support for continued FDA-EMA GCP collaboration. [ABSTRACT FROM AUTHOR]

Research in survey methodology indicates that survey attributes, such as topic and sponsor influence survey participation and data quality. This paper primarily aims to examine whether such attributes influence socially desirable responding in an online survey setting, a setting which is less studied in the literature than face-to-face interview settings with regards to social desirability. To achieve this aim, it empirically tests the effects of survey topic, survey sponsor, introduction interest, and perceived topic sensitivity on socially desirable responding (SDR) across a range of items in a questionnaire. The survey experiment is based on a convenience sample of higher education students who filled out an online self-administered questionnaire, which also included a short version of the Marlowe-Crowne SDR scale. The findings showed that the tendency to SDR does not significantly differ by survey topic and sponsor. However, it varies by introduction interest, and intriguingly, more interested respondents demonstrated a higher tendency to SDR. Also, the tendency to SDR marginally differed by the perceived topic sensitivity. [ABSTRACT FROM AUTHOR]

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