An analysis of the features of successful written submissions to government inquiries.

OBJECTIVE: Government inquiries present a policy window for advocates to influence policy. Evidence on how to write influential submissions, however, is sparse. We aimed to identify features of successful written submissions to the Parliament of Australia's Inquiry into Food Pricing and Food Security in Remote Indigenous Communities (Inquiry). METHOD: A scoping review was conducted to identify influential features of written submissions to government inquiries. A content analysis of a sub-sample of government Inquiry submissions and their recommendations was then coded for influential features. The frequency of submission recommendations incorporated into the final Inquiry report was recorded, as was their link to influential features. RESULTS: Thirty features were identified. Results from 21 submissions indicate that when writing a submission to a government inquiry, advocates should: (1) ensure their submission is clear and concise; (2) convey the authority of both the writer and supporting evidence; and (3) where possible, align submission recommendations with the government agenda. CONCLUSIONS: We encourage future research to test the framework of influential features on other inquiry topics and in other countries to increase the reliability of results. IMPLICATIONS FOR PUBLIC HEALTH: This study consolidates and presents a list of features that advocates can consider incorporating when writing a submission to a government inquiry.

Patterns in assignment submission times: Analysis of factors contributing to undergraduate students' commitment to core-curriculum related course.

Co-curricular activities equip students with essential skills and knowledge for personal and professional growth. Despite their importance, many students exert minimal effort to complete the assigned tasks. Instructors perceive that the lack of emphasis on final exams in co-curricular subjects reduces student effort and commitment. Moreover, poor time management and lack of effort in completing tasks have increased across various subjects in recent years. Therefore, it is important to investigate the factors that contribute to student commitment towards co-curricular subjects. In this study, the submission status of 339 tasks was retrieved from the student learning system to measure student commitment based on whether tasks were submitted on time, delayed, or not submitted. A chi-square test f was used to investigate the relationship between students' demographic characteristics and their commitment. The findings revealed a significant association between student commitment and the type of task given (p < 0.001). Students were more likely to submit presentations on time compared to written assignments. Projects were more likely to be delayed, while written assignments had a high frequency of no submission. Age was a significant predictor of commitment (p < 0.05), with students over 20 more likely to submit on time and students under 20 more likely to ignore submission. Gender was also a significant predictor of commitment (p < 0.001), with female students having a higher percentage and frequency of on-time submissions while male students having a higher number of no submissions. However, no significant association was found between the study year and commitment (p > 0.05), indicating that the year of the study could not determine the level of commitment to the course. Overall, these findings could be used to guide the preparation of tasks and assignments in co-curricular subjects to enhance student commitment and holistic development.

COVID-19 as a chronic stressor and the importance of individual identity: A data-driven look at academic productivity during the pandemic.

The COVID-19 pandemic impacted personal and professional life. For academics, research, teaching, and service tasks were upended and we all had to navigate the altered landscape. However, some individuals faced a disproportionate burden, particularly academics with minoritized identities or those who were early career, were caregivers, or had intersecting identities. As comparative endocrinologists, we determine how aspects of individual and species-level variation influence response to, recovery from, and resilience in the face of stressors. Here, we flip that framework and apply an integrative biological lens to the impact of the COVID-19 chronic stressor on our endocrine community. We address how the pandemic altered impact factors of academia (e.g., scholarly products) and relatedly, how factors of impact (e.g., sex, gender, race, career stage, caregiver status, etc.) altered the way in which individuals could respond. We predict the pandemic will have long-term impacts on the population dynamics, composition, and landscape of our academic ecosystem. Impact factors of research, namely journal submissions, were altered by COVID-19, and women authors saw a big dip. We discuss this broadly and then report General and Comparative Endocrinology (GCE) manuscript submission and acceptance status by gender and geographic region from 2019 to 2023. We also summarize how the pandemic impacted individuals with different axes of identity, how academic institutions have responded, compile proposed solutions, and conclude with a discussion on what we can all do to (re)build the academy in an equitable way. At GCE, the first author positions had gender parity, but men outnumbered women at the corresponding author position. Region of manuscript origin mattered for submission and acceptance rates, and women authors from Asia and the Middle East were the most heavily impacted by the pandemic. The number of manuscripts submitted dropped after year 1 of the pandemic and has not yet recovered. Thus, COVID-19 was a chronic stressor for the GCE community.

We Welcome Findings from Further Afield.

For the past five years, the Journal of Appalachian Health has published timely, high-quality research from within Appalachia. We also welcome submissions from those working outside of Appalachia who produce quality research of direct relevance to our region.

Clinical holds for cell and gene therapy trials: Risks, impact, and lessons learned.

The recent increase in cell and gene therapies being developed has been coupled with a disproportionate increase in Food and Drug Administration (FDA)-mandated clinical holds. Aiming to better understand causes and secondary effects of these clinical holds on biotechnology companies, we analyzed 33 clinical holds that were publicly announced from January 2020 to December 2022. Approximately 80% of the analyzed clinical holds were formally lifted by the close of our study after an average of 6.2 months, and several trials have had significant clinical success following a hold. CAR T cell therapies accounted for nine holds, Lentiviral and AAV-based gene therapies accounted for five and 15 holds, respectively, and other cell and gene therapies accounted for four holds. The most common trigger was an adverse event or patient death. To remove a hold, protocol amendments were the most requested resolution by FDA. While there is no way to guarantee a therapy will not be placed on clinical hold, especially following unexpected adverse events, some deficiencies are avoidable. Utilizing FDA-provided resources on regulations and expectations for cell and gene therapy investigational new drug applications, inclusion of an external safety monitoring board, and a proactive risk assessment plan may prevent a clinical hold or result in a shortened duration.

Gender Composition in Biomedical Research Grant Submissions and Grant Review Panels Before Versus During the COVID-19 Pandemic.

Purpose: This study examined the gender composition of career development award applicants and grant review panels during the pandemic compared with that beforehand. Methods: Data were collected from 14 Health Research Alliance (HRA) organizations, which fund biomedical research and training. HRA members provided the gender of grant applicants and grant reviewers during the pandemic (April 1, 2020, to February 28, 2021) and prepandemic (April 1, 2019, to February 29, 2020). The signed-rank test compared medians and the chi square test compared the overall gender distribution. Results: The total number of applicants was similar during the pandemic (N = 3,724) and prepandemic (N = 3,882) periods, as was the percentage of women applicants (45.2% pandemic vs. 44.9% prepandemic, p = 0.78). The total number of men and women grant reviewers declined during the pandemic (N = 856) compared with that pre-pandemic (N = 1,689); this decrease was driven by a change for the largest funder. Also driven by changes for this one funder, the percentage of total grant reviewers who were women increased significantly during the pandemic (45.9%) compared with that during prepandemic (38.8%; p = 0.001), but the median percentage of women grant reviewers across organizations remained similar during the pandemic (43.6%) and prepandemic periods (38.2%; p = 0.53). Conclusions: In a sample of research organizations, the gender composition of grant applicants and grant review panels remained similar, except for the review panel composition for one large funder. Given evidence from other studies that have revealed gender differences in other career and life experiences of scientists during the pandemic, ongoing evaluation of women's representation in grant submission and review mechanisms is essential.

Coverage and Representativeness of Passive Surveillance Components for Cattle and Swine in The Netherlands.

Common aims of animal health surveillance systems are the timely detection of emerging diseases and health status monitoring. This study aimed to evaluate the coverage and representativeness of passive surveillance components for cattle and swine in the Netherlands from 2015-2019. The passive surveillance components consisted of a telephone helpdesk for veterinary advice and diagnostic and postmortem facilities. Spatial analysis showed heterogeneity (range in RR = 0.26-5.37) of participation across the Netherlands. Generalized linear mixed models showed that distance to the diagnostic facility and farm density were associated with the number of contacts of farmers with the helpdesk and postmortem examination. The contact rate of veterinary practices was associated with their number of clients, ranging in RR from 0.39 to 1.59. We concluded that the evaluation indicated differences in coverage of the passive surveillance components across regions, farms and veterinary practices. Due to the absence of emerging infections in the study period, we were unable to estimate the consequences of the observed differences for the early detection of disease. Nevertheless, regions and veterinary practices with low participation in passive surveillance might be a risk for early detection, and consequently, further understanding of the motivation to participate in passive surveillance components is needed.

Irish farmers' interactions with regional veterinary laboratories- reasons, results, reactions: a survey.

BACKGROUND: Animal health surveillance is important in ensuring optimal animal health and welfare. Monitoring of diagnostic submissions, including post-mortem examination of carcasses, at the Department of Agriculture Food and the Marine laboratories, provides the basis for this type of passive surveillance in Ireland. The process requires engagement from veterinarians and farmers from all sectors of the agricultural spectrum. This study aims to identify the reasons why farmers engaged in dairy, beef, sheep, and mixed farming enterprises submit carcasses or not to the Regional Veterinary Laboratories. RESULTS: Surveys were distributed in hard copy format at Regional Veterinary Laboratories, and fifty Teagasc facilitated farmer discussion groups. There were 1179 responses collected in 54 locations. The top reasons participants submitted to the laboratories were 1) to guide treatment/ vaccination, 2) fear of a contagious disease, and 3) if their veterinarian advised them to. The top reasons for not submitting were 1) the vet making a diagnosis on the farm, 2) the distance from the laboratory, and 3) lack of time and labour. Implementation of vaccination protocols was the main change implemented based on results, followed by management changes and the use of different treatments, e.g., switching from antibiotic to parasite treatment. Sheep enterprises were more likely than dairy to choose distance and cost as a reason not to submit. Dairying enterprises were more likely than other enterprise types to submit if they feared a contagious or zoonotic disease. CONCLUSION: Positively, this survey shows the desire of participants to submit to the laboratories to guide treatment and vaccination protocols, potentially indicating that positive engagement between stakeholders and the RVLs will help promote optimal animal health and promote responsible antimicrobial use. Results also show the critical role of veterinarians in continued disease surveillance on farms. Maintaining engagement with all farming sectors will be essential in promoting successful animal health surveillance.

Effects of the COVID-19 Pandemic on Authors and Reviewers of American Geophysical Union Journals.

The COVID-19 pandemic affected the scientific workforce in many ways. Many worried that stay-at-home orders would disproportionately harm the productivity and well-being of women and early-career scientists, who were expected to shoulder more childcare, homeschooling, and other domestic duties while also interrupting field and lab research, essential for career advancement. AGU journal submission and author and reviewer demographic data allowed us to investigate the effect the pandemic may have had on many Earth and space scientists, especially on women and early career scientists. However, we found that submissions to AGU journals increased during the pandemic as did total submissions from women (with no difference in the proportion). Although the rate at which women agreed to review decreased slightly (down 0.5%), women still made up a larger proportion of agreed reviewers during the pandemic compared to 2 years earlier. Little difference was seen overall in median times to complete reviews except with women in their 40s and 70s, suggesting that they were affected more during the pandemic than other age and gender groups. Although AGU's data do not show that the effects of the pandemic decreased women's participation in AGU journals, the lag between research and writing/submitting may still be seen in later months, which we will continue to report on as we analyze the data. The stay-at-home orders may also have allowed people to devote time to writing up research conducted prepandemic; writing too can be done during down-time hours, which may have supported the increase in submissions to and reviews for AGU journals.

Successful regulatory agency interaction - A nonclinical regulatory strategist's perspective.

Regulatory agency interaction occurs from before a candidate drug enters clinical development and all the way to marketing approval and beyond. This paper presents ways to enable successful interaction by avoiding issues, with an emphasis on nonclinical testing aspects. Strategic thinking as to whether an early regulatory agency meeting should occur is discussed and if yes, how to make it a success by generating relevant questions with proper preparation including a robust Briefing Document. Examples of unfavourable regulatory agency feedback during meetings is given which may have been avoided. Similarly, ways for successful regulatory submission in the form of a Clinical Trials Application (CTA) in Europe or an Investigational New Drug (IND) application in the US are considered with examples of comments that can be received from regulatory agencies. At marketing application stage with submission of a Marketing Authorisation Application (MAA) in Europe and a New Drug Application (NDA) or a Biologic License Application (BLA) in the US, a key document is the Nonclinical Overview and suggested content and potential deficiencies are presented to allow avoidance of adverse regulatory agency responses and time delay. Successful regulatory agency interaction involves robust scientific thinking, proper planning and well-written documentation.

Geographic Trends in Publications and Submissions in Radiology Journals: Decade Report (2010 - 2020).

RATIONALE AND OBJECTIVE: The Radiology Research Alliance (RRA) of the Association of University Radiologists (AUR) organized a task force to quantify geographic changes in submissions to and publications within radiology journals over time. MATERIALS AND METHODS: Twenty journals were selected: 7 US-based general, 4 European-based general, and 9 subspecialty radiology journals. Journals were solicited for submissions and publications based on country of origin from 2010 -2020. Regression models assessed changes over time across countries, and by continent, with an emphasis on the US and China, for each journal category. RESULTS: There were 104,679 publications and 92,446 submissions from 149 countries. Overall, there were significant increases in numbers of publications from Asia (R2 = 0.66, p <0.01), and specifically, China (R2 = 0.87, p <0.01). For US journals, there were increased numbers of publications from Asia (R2 = 0.72, p <0.01) and China (R2 = 0.98, p <0.01), but decreased numbers from North America (R2 = 0.41, p = 0.03). For European journals, there were increased numbers of publications from Asia (R2 = 0.79, p <0.01), North America (R2 = 0.75, p <0.01), and China (R2 = 0.82, p <0.01). For subspecialty journals, there were increased numbers of publications from North America (R2 = 0.38, p = 0.04) and China (R2 = 0.73, p <0.01). There was an acute COVID spike in submissions during 2020, with a continuous increase most notable in China (R2 = 0.96, p <0.01). CONCLUSION: In the last decade, the numbers of submissions to and publications within general and subspecialty US and European radiology journals have generally increased around the world, with the largest growth in Asia and in particular China.

COVID-19 Pandemic-Related Arguments in Polish Civil Litigation.

The aim of this paper is to analyse the legal record on civil litigation from mid-March 2020 to mid-July 2021 and examine COVID-19 pandemic-related arguments in a sample of litigated cases heard in Polish courts, more precisely 41 cases. In an attempt to establish the number and types of court cases in which such arguments have been raised, the population of individual case records was accessed electronically from the Ordinary Courts Judgments Portal (Pol. Portal Orzeczen Sadów Powszechnych). The analysed research material consists of texts of written justifications published along with rulings of courts of the first instance in the Portal, except for texts regarding criminal cases and widely understood labour cases. This paper refers to certain theoretical aspects of argument and argumentation. Then, it sheds light on the use of COVID-19 pandemic-related arguments by the parties involved in litigation-as reported by the courts in written justifications-considering, amongst others, whether those arguments were found convincing by the courts. Based on a survey of relevant cases, an attempt was made to identify categories of COVID-19 pandemic-related arguments of the parties involved in litigation, raised in their legal submissions. Also a look into the tendencies in this regard was taken to see whether any patterns emerge and it is possible (or not) to discern different trends in the analysed phenomena. The point of the analysis in this article is both descriptive and normative.

Using a Modified Delphi Method to Reach Consensus on Best Practices for Medical Education Abstract Submissions to Multiple Conferences.

PURPOSE: Medical education researchers are often uncertain whether they should submit abstracts to certain conferences. Therefore, we aimed to elicit consensus among medical education conference organizers to answer the question: what are best practices for research abstract submissions to multiple conferences? METHODS: Using a 44-question online survey, we conducted a modified Delphi process to identify best practices for abstract submissions to medical education conferences. Consistent with the Delphi process, we identified conference representatives from non-specialty medical education conferences and across four conference types (institutional, regional, national, and international) to serve as panelists. RESULTS: Eleven expert panelists, representing all four conference types-two institutional conferences, five regional conferences, two national conferences, and two international conferences-completed three rounds of the survey. After three rounds, panelists reached consensus on 39/44 survey items-26 items in round 1, 10 items in round 2, and three items in round 3. Panelists' consensus and rationale indicated that it is most appropriate to resubmit abstracts to conferences with a larger or different audience, but not to more homogeneous audiences. Among the four conference types, abstract resubmission from institutional conferences to other conference types was the most widely accepted. Panelists agreed that abstracts using data and results submitted or accepted for publication could be submitted to any conference type. CONCLUSION: The results of this study provide best practices for presenting scholarship to medical education conferences. We recommend that guidelines for medical education conference abstract submissions provide consistent, clear instructions regarding the appropriate life cycle of an abstract.

Physiologically Based Pharmacokinetics Model in Pregnancy: A Regulatory Perspective on Model Evaluation.

Physiologically based pharmacokinetics (PBPK) modelling is widely used in medicine development and regulatory submissions. The lack of clinical pharmacokinetic data in pregnancy is widely acknowledged; therefore, one area of current interest is in the use of PBPK modelling to describe the potential impact of anatomical and physiological changes during pregnancy on the medicine's pharmacokinetics. PBPK modelling could possibly represent a predictive tool to support the medicine benefit-risk decision and inform dose adjustment in this population and also to investigate medicine levels in the foetus to support the risk assessment to the foetus. In the context of regulatory application, there are, however, a number of considerations around model evaluation, and this should be tailored to the model purpose, in order to inform the confidence in the model for the intended application. A number of gestational age-related physiological changes are expected to alter the pharmacokinetics of medicines during pregnancy, and there are uncertainties on some parameters; therefore, well-qualified models are needed to improve assurance in the model prediction before this approach can be used to inform with confidence high-impact decisions as part of regulatory submissions.

Utilizing technology to enhance laboratory-client interaction while encouraging best behavior.

As client interactions with veterinary diagnostic laboratories have evolved, so have client expectations: faster results, enhanced accessibility to cases, and more seamless data transfer from the laboratory database; all of these factors have encouraged the evolution of diagnostic laboratory systems. This evolution started with 24-h access to laboratory results via the web, yet data quality remained at the mercy of the person filling out the form. If bad (incomplete) information was flowing in, then the data coming out was equally bad (incomplete or inconsistent). By designing a web-based system integrated into our existing reporting platform, the Iowa State University Veterinary Diagnostic Laboratory (ISU-VDL) set out to improve the quality of submission data by including the premises identification number (PIN) and obtaining consistent location data, all while presenting to the client an easy-to-use interface. Efforts continued by incentivizing the use of this tool and client submission practices. As clients transitioned, data have become more complete, resulting in easier queries and an improved ability to leverage the diagnostic data. To further enhance the client experience, a streamlined daily reporting summary was designed to communicate laboratory results succinctly. The use of these web-based tools had a positive impact on the quality and consistency of the diagnostic data. As new ideas develop, the ISU-VDL strives to foster continuous improvement and positively impact the clients' experience.

Pitfalls in Article Submissions for Publication.

The aim of every academician and clinical dermatologist is to publish their research in reputed biomedical journals. But from conceptualization to completion, myriad shortcomings creep into the article and by the time it is ready for publication, by default and certainly not by design, the article discourse gets flawed, sometime fatally so. The endeavor of this article is to discuss these pitfalls from conceptualization, statistical machinations, authorial misconcepts, article structuring, and final journal selection. The article can function as a prophylactic checklist, albeit not comprehensive, by any prospective author and is an appreciation of the most oft repeated fallacies usually detected in publication submissions.

Mitigating Deficiencies in Evidence during Regulatory Assessments of Advanced Therapies: A Comparative Study with Other Biologicals.

Advanced therapy medicinal products (ATMPs) comprising cell therapy, gene therapy, and tissue-engineered products, offer a multitude of novel therapeutic approaches to a wide range of severe and debilitating diseases. To date, several advanced therapies have received marketing authorization for a variety of indications. However, some products showed disappointing market performance, leading to their withdrawal. The available evidence for quality, safety, and efficacy at product launch can play a crucial rule in their market success. To evaluate the sufficiency of evidence in submissions of advanced therapies for marketing authorization and to benchmark them against more established biological products, we conducted a matched comparison of the regulatory submissions between ATMPs and other biologicals. We applied a quantitative assessment of the regulatory objections and divergence from the expected data requirements as indicators of sufficiency of evidence and regulatory flexibilty, respectively. Our results demonstrated that product manufacturing was challenging regardless of the product type. Advanced therapies displayed critical deficiencies in the submitted clinical data. The submitted non-clinical data packages benefited the most from regulatory flexibility. Additionally, ATMP developers need to comply with more commitments in the post-approval phase, which might add pressure on market performance. Mitigating such observed deficiencies in future product development, may leverage their potential for market success.

Exploration of the visibility of patient input in final recommendation documentation for three health technology assessment bodies.

Health technology assessment (HTA) recommendations informed by patient concerns are seen to ensure democracy and legitimacy. We explored how written and oral patient involvement in two HTAs was reported on in publicly available final recommendations and discussion summaries of appraisal committees from three HTA bodies. We aimed to gain insights into how patient input was utilized by appraisal committees to better understand the goals of patient involvement and how these are being achieved. In each of the three HTA bodies, templated submission questionnaires provide a formal process for seeking written patient group input. Additionally, the National Institute for Health and Care Excellence (NICE) selects patient experts to provide a templated submission and attend appraisal committee meetings. For Scottish Medicines Consortium (SMC), a patient advocate and clinician combined meeting (PACE) discussed the cancer drug, referred to in the final recommendation. The discussion summaries of all appraisal committees contained references to patient involvement. Where two mechanisms for patient involvement were provided, oral input from the expert patients and PACE were more clearly documented than information from written patient group submissions. NICE reports focused on the perspective of the patient expert. The SMC report highlighted feedback from the PACE throughout. We suggest that the lack of clear reporting on the use of patient group input in deliberations and therefore accountability to patient groups limits progress in patient involvement in HTA. Patient groups may therefore not have a clear understanding of what information they can best provide to inform deliberations, and in reporting back to members.