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BACKGROUND Onychomycosis is the most common nail disease seen in clinical practice. Inclusion of diverse groups in onychomycosis clinical trials subjects is necessary to generalise efficacy data. OBJECTIVES We aimed to systematically review race and ethnicity reporting and representation, as well as, treatment outcomes in onychomycosis clinical trials. METHODS A PubMed search for onychomycosis clinical trials was performed in August 2020. Primary clinical trial data were included and post hoc analyses were excluded. Categorical variables were compared using chi-squared and Fisher's exact tests. Statistical significance was set at p

Background There has been limited progress in the development of novel therapeutics for the treatment of sarcomas. A review of phase I and II clinical trials for sarcomas may give insight into factors influencing sarcoma drug development. Methods An exhaustive analysis of phase I and II clinical trials testing drugs for human sarcoma patients between 1 January 2000 and 1 June 2018 was performed using the PubMed search engine, the Thomson Web of Science, and the National Clinical Trials registry. Recorded outcomes included tested drugs, tested histological subtypes, whether the drug was initially developed for sarcoma, reported funding sources, and whether studies led to phase III trials. Results Out of 238 studies meeting inclusion criteria, 87% (207 studies) reported funding sources. Of these, 59.9% (124/207) reported industry funding, 52.7% (109/207) reported government funding, and 27.5% (57/207) reported private funding. Only 5% (12/238) of phase I and II trials resulted in phase III trials, with 11 of 12 studies funded by industry. Approximately 90% (214/238) of studies tested drugs that were not initially tested in sarcoma, and 60.1% (143/238) of studies grouped different sarcoma histological subtypes together in the same study. Conclusion Industry has funded the majority of phase I and II sarcoma clinical trials that have led to phase III trials. There was a high rate of drugs approved for other cancers and then secondarily tested in sarcoma. Most trials tended to group different sarcoma subtypes rather than studying each subtype separately.

Hip and knee arthroplasty are increasingly common surgical procedures in Australia, with more than 85,000 expected to be performed this year. Compared to the general public, people who undergo a hip or knee arthroplasty are at an increased risk of developing blood clots (also known as a venous thromboemboli or VTE) as both procedures activate all three aspects of Virchow’s risk triad during the pre-, peri- and postoperative period. Importantly, VTE are considered one of the most common causes of preventable death in Australian hospitals. Whilst there are mechanical and pharmacological measures that can be employed to prevent VTE (known collectively as thromboprophylaxis), and many national and international bodies have released thromboprophylaxis guidelines over the years, previous studies have reported consistent underutilisation of thromboprophylaxis both in Australia and overseas. The overarching objective of this thesis was to examine thromboprophylaxis prescribing patterns in Australia, and the factors that influence them. To achieve this aim, a number of complementary studies were conducted, including both qualitative and quantitative work. Retrospective reviews were conducted at six hospitals across three states to explore prescribing patterns; the results indicated that while anticoagulant thromboprophylaxis is routinely used in hospital, its continuation at discharge is not habitual – despite recommendations by contemporary guidelines to extend therapy usually beyond the inpatient period. Interestingly, prescribing patterns were generally found to be more aligned with recent contemporary recommendations than recommendations existent at the time of prescribing, indicating practice preceded guidelines. A survey exploring hospital protocols and local prescribing practices identified that only 50% of the 143 Australian hospitals surveyed had thromboprophylaxis protocols and that their alignment with published literature varied considerably. Surprisingly, private hospitals tended to base their guidelines on the National Health and Medical Research Council (NHMRC) Guideline, whereas public hospitals were more likely to favour individual or collective surgeon preferences. Where they existed, adherence to hospital protocols was apparently high (86%), and predictably trended to increase in hospitals with adherence strategies in place (91% vs. 79%). Two online surveys were conducted with orthopaedic surgeons practising in Australia. Whilst the first survey was limited by its small number of respondents (25), it identified that individual prescribing preferences vary significantly, with many surgeons perceiving guideline recommendations (including those of the NHMRC Guideline) as inappropriate. Although few respondents believed that pharmacological prophylaxis prevents fatal pulmonary emboli, and many responded that VTE risk is low following arthroplasty, all participants routinely prescribed pharmacological prophylaxis postoperatively. In addition to bleeding concerns and a perceived low VTE risk, the third strongest barrier to thromboprophylaxis use was the belief that study evidence is not applicable to real-world inpatient populations. Along this line, a number of surgeons expressed suspicions that industry funding was heavily biasing guideline recommendations, either directly by sponsoring guideline authors or indirectly by sponsoring associated research. The second survey had a significantly larger number of respondents (221), and maintained the results of the first study. Semi-structured interviews were used to explore surgeons’ preferences, opinions and experiences in greater detail. Moreover, to complement these views and to gain a better understanding of real practice, these interviews were supplemented by interviews with Tasmanian based orthopaedic interns, general practitioners (GPs) and clinical pharmacists. While a surgeon’s opinion was identified to be greatly moulded by their training and collective experience, and not by contemporary guidelines, other health professionals’ opinion were more inclined to be shaped by guidelines. The interviews also identified that even though participants differed in their thromboprophylaxis preferences and opinions, they all strongly agreed that thromboprophylaxis should be tailored to the individual patient. All surgeons expressed familiarity with at least one contemporary guideline; however, other health professionals generally did not. This lack of knowledge and familiarity naturally impairs their ability to contribute to postoperative care. Additionally, hospital to community communication was described as slow and unreliable by participants, further disadvantaging GPs from being able to effectively contribute to VTE prevention after discharge. Rather than awaiting the formulation of a Tasmanian based protocol (which was attempted by an outside group early on in the research), another strategy to optimise thromboprophylaxis use would be to instigate a statewide strategy to increase the uptake of the NHMRC Guideline. One of the biggest barriers identified in this research to the adoption of guidelines such as the NHMRC Guideline is the perception that they impose a ‘one size fits all’ approach to thromboprophylaxis by making ‘carte blanche recommendations’. In reality, the NHMRC Guideline takes a comprehensive approach to VTE prophylaxis and, unbeknown to many health professionals, actually addresses the many concerns they expressed in the studies in this thesis. A quick ready-reference tool developed from the NHMRC Guideline could assist greatly in overcoming communication and knowledge obstacles described in this thesis; and a suggestion of what this ready-reference tool could look like is included. Passively disseminating clinical practice guidelines has been ineffective at optimising thromboprophylaxis use to date, both in Tasmania and interstate, potentially leaving many patients exposed to a higher risk of VTE. A clear understanding of the factors that influence thromboprophylaxis prescribing and guideline adoption is essential. Together, the studies contained in this thesis identified many barriers to thromboprophylaxis use and guideline adoption, including: concerns over bleeding complications (and associated potential underreporting), the scope of industry influence, and the threat of guidelines being too prescriptive, threatening professional autonomy and thereby posing a potential medico-legal liability to surgeons. These barriers should be addressed in forthcoming editions of the NHMRC Guideline to encourage uptake of its recommendations and ensure optimal outcomes for patients.

University research provides valuable inputs to industrial innovation. It is therefore not surprising that private sector firms increasingly seek direct access through funding public R&D. This development, however, spurred concerns about possible negative long-run effects on scientific performance. While previous research has mainly focused on a potential crowding-out of scientific publications through commercialization activities such as patenting or the formation of spin-off companies, we study the effects of direct funding from industry on professors’ publication and patenting efforts. Our analysis of a sample of 678 professors at 46 higher education institutions in Germany shows that a higher share of industry funding of a professor’s research budget results in a lower publication outcome both in terms of quantity and quality in subsequent years. For patents, we find that industry funding increases their quality measured by patent citations.

The contribution of women to the economy as investors has an increasing profile, but sources of information on women's economic activity in the nineteenth century are limited. However, shipping registers provide new avenues for exploring this largely hidden perspective. Women investors in shipping are revealed here to be more consistently active across the century with a close involvement with their investment. They were a significant factor in enabling smaller port communities to remain self-sufficient in their industry funding until the dominance of steam in the 1880s caused the sailing vessel to become increasingly obsolete.

Objective Investigators in trials of glucosamine report a range of estimates for efficacy, making conclusions difficult. We undertook this study to identify factors that explain heterogeneity in trials of glucosamine. Methods We searched for reports of trial results in Ovid Medline, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and proceedings of scientific conferences. We selected reports of randomized, double-blind, placebo-controlled trials of glucosamine for pain from osteoarthritis of the knee or hip. We extracted data regarding features of design, subjects, and markers of industry involvement, including industry funding, whether a drug was supplied by industry, industry participation, and industry-affiliated authorship. We examined which factors best accounted for differences in the effect sizes of studies grouped by these characteristics, and we examined changes in I2, a measure of heterogeneity. Results Fifteen trials met our inclusion criteria. The summary effect size was 0.35 (95% confidence interval 0.14, 0.56). I2 was 0.80. Except for allocation concealment, no feature of study design explained this substantial heterogeneity. Summary effect sizes ranged from 0.05 to 0.16 in trials without industry involvement, but the range was 0.47–0.55 in trials with industry involvement. The effect size was 0.06 for trials using glucosamine hydrochloride and 0.44 for trials using glucosamine sulfate. Trials using Rottapharm products had an effect size of 0.55, compared with 0.11 for the rest. Conclusion Heterogeneity among trials of glucosamine is larger than would be expected by chance. Glucosamine hydrochloride is not effective. Among trials with industry involvement, effect sizes were consistently higher. Potential explanations include different glucosamine preparations, inadequate allocation concealment, and industry bias.

This article reports the results of a national survey that examines the concerns of American faculty about close university industry collaboration and explores how these concerns may impinge upon their participation in industrial innovation. The data show that while academics are generally, but cautiously, in favor of close collaboration, they live with deep tension that is caused by two powerfully competing realities: the instrumental need for industry funding, and the intrinsic need to preserve intellectual freedom. A challenge to public policy is to fashion a positive-sum strategy (e.g., tax incentives) in which firms would be encouraged to increase funding for their academic collaborators, who then may fulfill their research mission better while contributing to industrial innovation.

This paper discusses the history of the changing relationship between research and industrial funding, using the tobacco industry as its example. It seeks to explain why funding which was once acceptable is now unacceptable. The hypotheses advanced include: the changing nature of the industry's interest in research and the role of marketing; the rise of the 'new public health' alliance focused on abstention rather than on harm minimization; the role of government funding and control of research; and the changing meaning of tobacco and especially nicotine.

Purpose: CT automatic exposure control (AEC) systems adjust tube current output in response to changes in patient attenuation. Some have interpreted this to mean that the use of AEC results in constant size-specific dose estimates (SSDE) across patient sizes. The purpose of this work was to derive the AEC parameters that yield constant SSDE across patient sizes and compare these conditions with clinical implementations of AEC. Methods: The relationship between tube current output and patient attenuation within AEC systems is governed by a modulation parameter (b-value), which controls the strength of the tube current adjustment. In order for SSDE to be constant over patient sizes, this b-value needs to yield tube current values, for a given patient size, that are inversely proportional to the AAPM Report 204 CTDIvol-to-SSDE conversion coefficients. A mathematical framework was developed to determine the b-value that produces constant SSDE across patient sizes. Using that b-value, along with b-values used in clinical practice (0.33, 0.5 and 1.0), theoretical estimates of SSDE as a function of water equivalent diameter (WED) were determined, and the range of SSDE values (max-min) was quantified over WED ranging from 10 to 50 cm. Results: A b-value of 0.185 was determined to yield constant SSDE across patient sizes. For this b-value, the range of SSDE was 0.11 mGy. Ranges of 10.27 mGy, 22.05 mGy and 97.00 mGy were determined for SSDE calculated using b-values of 0.33, 0.5 and 1.0, respectively. Conclusion: Current clinical implementations of AEC do not yield constant SSDE across patient sizes. A b-value was calculated that would yield constant SSDE across patient sizes, but this value is much less than b-values used clinically. We conclude that constant SSDE should not be the goal of tube current adaption, as it would not yield clinically acceptable tube current adaption with patient size. CH McCollough is supported by industry funding from Siemens Healthcare

This paper examines the relationship between basic and applied pharmaceutical research. We focus on three stages of research and development (R & D): government-funded basic research; publication in medical journals; and industry-finded applied R&D. We estimate that a one percent increase in basic research in a particular therapeutic category causes a 0.76 percent increase in industry R&D in that category, and a 1.71 percent increase in other categories, mer seven years. We also find that research incentives differ across government, academic and industry researchers. For example, government funding favors diseases that are less prevalent and more debilitating than industry funding.

Introduction: The literature suggests that there is concern about the relationship between industry and doctors. Whilst industry sponsorship of education and research activities is highly valued, evidence suggests that promotional activities may influence doctors in ways that are not always beneficial to patients. The industry-doctor relationship must therefore be transparent and comply with ethical standards of the community to preserve professional integrity and maintain patients’ trust. The aims of this study are 1) to determine the opinions of patients on the ethics of various practical aspects of urologists’ relationship with industry; 2) to compare these opinions to those of urologists. Methods: A questionnaire comprising 22 aspects of the industry-urologist relationship was formulated. Approval was obtained from the hospital ethics unit to distribute the questionnaire to urology outpatients. The questionnaire was also given to patients at private practices of urologists, and distributed to urologists and trainees in Australia and New Zealand. Results: Over 200 questionnaires were returned for analysis. Urologists and their patients were found to hold very similar views on the ethics of the industry-urologist relationship. Whilst industry funding for education and research activities was generally looked upon favourably, other promotional activities and conditional funding were generally not approved of. Notably, there was also a wide variation of opinion amongst urologists on several specific aspects of the industry-urologist relationship. Conclusions: Australian and New Zealand urologists’ standard of ethics regarding their relationship with industry appears to be in line with that of their patients. Such concordance of opinion is desirable as it may help to preserve professional integrity and maintain patients’ trust.