Academic Research Organizations Research Articles

Editorial introductions.

Current Opinion in Anesthesiology was launched in 1988. It is one of a successful series of review journals whose unique format is designed to provide a systematic and critical assessment of the literature as presented in the many primary journals. The field of anesthesiology is divided into 15 sections that are reviewed once a year. Each section is assigned a Section Editor, a leading authority in the area, who identifies the most important topics at that time. Here we are pleased to introduce the Editors of the journal and the Section Editors for this issue. SECTION EDITORS Jill MhyreJill MhyreJill Mhyre is The Dola S Thompsom Professor and Chair of Anesthesiology at the University of Arkansas for Medical Sciences, Arkansas, USA. She is Executive Section Editor of Obstetric Anesthesiology for Anesthesia & Analgesia, and Associate Editor for the textbook, Chestnut's Obstetric Anesthesia: Principles & Practice. Her academic interests include maternal safety systems such as early warning systems, cardiopulmonary resuscitation, and morbidity and mortality. Christiane BeckChristiane BeckDr Christiane Beck is the leading senior consultant at the Clinic of Anesthesiology and Intensive Care Medicine at Hannover Medical School, Germany. She has studied medicine at the Universities of Göttingen, Germany, Johannesburg, South Africa, and Madison, USA. She received her degree in 1997 from the University of Göttingen, Germany. She completed her anesthesiology residency training in 2003 and is a certified anesthesiologist, intensivist and emergency physician. She achieved her doctoral degree at the Center for Radiologic Diagnostics, University of Göttingen, Germany in 2000. Dr Christiane Beck habilitated in 2021 at the Hannover Medical School, Germany. Besides clinical duties, she implemented and coordinates to date preoperative fasting guidelines for children. She is co-author of the actual ESAIC Fasting Guideline and coordinator of the German fasting guidelines on this subject. She specializes in pediatric anesthesia, anesthesia for complex congenital cardiac surgery and transplant surgery in children. She is a member of the German Society of Anesthesiology and Intensive Care Medicine (DGAI), the Professional Association of German Anesthesiologists (BDA), the European Society of Anesthesiology and Intensive Care Medicine (ESAIC), the Scientific Working Group for Pediatric Anesthesia and since 2021, Speaker of the Scientific Working Group for Pediatric Cardiac Anesthesia of the German Society of Anesthesiology. Her focus is on the research of pediatric anesthesia. She coordinated a national study on preoperative fasting in children for the Scientific Working Group for Pediatric Anesthesia and is part of the research group of Prof. Robert Sümpelmann. She has published several journal articles and book chapters, mainly on the field of pediatric anesthesia. She is a passionate mentor for trainees and early career junior residence in building a clinical or scientific career. Dr Christiane Beck has been involved on a voluntary basis as the leading anesthetist to pediatric cardiac missions to Moldova, Bosnia Herzegovina, Cyprus and Romania. She is in close contact and provides support to an innovative project MOHKI – the mobile kinderherzen clinic of kinderherzen - Fördergemeinschaft deutscher Kinderherzzentren e.V. to provide excellent medical infrastructure for cardiac missions in low-income countries. Wolfgang BuhreWolfgang BuhreWolfgang Buhre is Anaesthesiologist and Medical Director of the Division of Anesthesiology, Perioperative Medicine, Emergency Medicine and Critical Care Medicine at Maastricht University Medical Centre (MumC), The Netherlands. He is also Professor of Anesthesiology at Maastricht University, The Netherlands. At Maastricht, he is a member of the School Council and a research fellow in the School of Mental Health and Neurosciences (MhenS). He is also an associated research fellow in the Care and Public health Research Institute (CAPHRI), Maastricht University. He earned his medical degree at the University of Göttingen, Germany, where he also completed his residency training. He is trained in intensive care medicine and pain medicine. His areas of research are outcome research, artificial intelligence, and modern technology to support decision making in clinical practice. Wolfgang Buhre is leading the Research Mentorship Program of the European Society of Anaesthesiology and Intensive Care Medicine (ESAIC). Moreover, he is coordinating investigator in the Academic Research Organization of ESAIC and serves within the society also as industrial liaison member for the Academic Research Organization (A-CRO).

Development of a risk assessment and risk management tool for an academic research organization

BackgroundIn the past decade, regulatory agencies have released guidance around risk-based management with the goal of focusing on risks to critical aspects of a research study. Several tools have been developed aimed at implementing these guidelines. We designed a risk management tool to meet the demands of our academic data coordinating center. MethodsWe developed the Risk Assessment and Risk Management (RARM) tool on three fundamental criteria of our risk/quality program: (1) Quality by Design concepts applies to all employees, regardless of the employee's role; (2) the RARM process must be economically feasible and dynamically flexible during the study startup and implementation process; and (3) responsibility of the RARM lay with the entire study team as opposed to a single quality expert. ResultsThe RARM tool has 20 elements for both risk assessment and risk management. The incorporation of both aspects of risk management allow for a seamless transition from identifying risks to actively monitoring risks throughout enrollment. ConclusionThe RARM tool achieves a simplified, seamless approach to risk assessment and risk management. The tool incorporates the concept of Quality by Design into daily work by having every team member contribute to the RARM tool. It also combines the risk assessment and risk management processes into a single tool which allows for a seamless transition from identifying risks to managing the risks throughout the life of the study. The instructions facilitate documentation of de-risking protocols early in development and the tool can be implemented in any platform and organization.

Advances in Stroke: Digital Health.

HomeStrokeVol. 53, No. 3Advances in Stroke: Digital Health No AccessArticle CommentaryRequest AccessFull TextAboutView Full TextView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toNo AccessArticle CommentaryRequest AccessFull TextAdvances in Stroke: Digital Health Gisele Sampaio Silva, MD, MPH, PhD and Lee H. Schwamm, MD Gisele Sampaio SilvaGisele Sampaio Silva Correspondence to: Gisele Sampaio Silva, MD, MPH, PhD, Universidade Federal de São Paulo, Albert Einstein Ave 627, Suite 218, São Paulo 05652, Brazil. Email E-mail Address: [email protected] https://orcid.org/0000-0002-3247-3123 Universidade Federal de São Paulo, Department of Neurology and Neurosurgery, Brazil (G.S.S.). Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo, Brazil (G.S.S.). Search for more papers by this author and Lee H. SchwammLee H. Schwamm https://orcid.org/0000-0003-0592-9145 Virtual Care, Mass General Brigham Digital, Boston, MA (L.H.S.). Massachusetts General Hospital, Boston (L.H.S.). Harvard Medical School, Boston, MA (L.H.S.). Search for more papers by this author Originally published18 Feb 2022https://doi.org/10.1161/STROKEAHA.121.036974Stroke. 2022;53:1004–1007FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.For Sources of Funding and Disclosures, see page 1006.Correspondence to: Gisele Sampaio Silva, MD, MPH, PhD, Universidade Federal de São Paulo, Albert Einstein Ave 627, Suite 218, São Paulo 05652, Brazil. Email [email protected]com

The Path Forward - Designation as a Cooperative Academic Research Organization of the Science Council of Japan

The Path Forward - Designation as a Cooperative Academic Research Organization of the Science Council of Japan

Reviewing my career as a hematologist-oncologist and a quality control specialist in clinical trials

After a long-term hospitalization following a ski accident in college, I decided to choose a specialty in hematology and oncology. In graduate school, after learning the basics of biostatistics and the methodology of clinical trials, I had the opportunity to go through a series of clinical trial tasks, from launching to writing a clinical study report, which led to the study drug approval. This has greatly motivated me to be actively involved in this field. At the Dana-Farber Cancer Institute, I studied outcomes research under a supervisor, and at a time of difficulty, my good role model, Dr. Stephanie Lee, had urged me, saying, "That which does not kill you makes you stronger." Subsequently, I devoted myself to the establishment of a data center for a Japanese pediatric leukemia/lymphoma study group, currently a subcommittee of the Japan Children's Cancer Group, and to develop an academic research organization for conducting ICH-GCP-compliant international clinical trials, including the originally developed EDC system. I was struggling in balancing work and parenting. Fortunately, I was supported by my encounters with respectable people.

Clinical events classification (CEC) in clinical trials: Report on the current landscape and future directions — proceedings from the CEC Summit 2018

Clinical events adjudication is pivotal for generating consistent and comparable evidence in clinical trials. The methodology of event adjudication is evolving, but research is needed to develop best practices and spur innovation. A meeting of stakeholders from regulatory agencies, academic and contract research organizations, pharmaceutical and device companies, and clinical trialists convened in Chicago, IL, for Clinical Events Classification (CEC) Summit 2018 to discuss key topics and future directions. Formal studies are lacking on strategies to optimize CEC conduct, improve efficiency, minimize cost, and generally increase the speed and accuracy of the event adjudication process. Major challenges to CEC discussed included ensuring rigorous quality of the process, identifying safety events, standardizing event definitions, using uniform strategies for missing information, facilitating interactions between CEC members and other trial leadership, and determining the CEC's role in pragmatic trials or trials using real-world data. Consensus recommendations from the meeting include the following: (1) ensure an adequate adjudication infrastructure; (2) use negatively adjudicated events to identify important safety events reported only outside the scope of the primary endpoint; (3) conduct further research in the use of artificial intelligence and digital/mobile technologies to streamline adjudication processes; and (4) emphasize the importance of standardizing event definitions and quality metrics of CEC programs. As novel strategies for clinical trials emerge to generate evidence for regulatory approval and to guide clinical practice, a greater understanding of the role of the CEC process will be critical to optimize trial conduct and increase confidence in the data generated.

Research data management and services: Resources for different data practitioners

The emergence of data-driven research and demands for the establishment of Research Data Management (RDM) has created interest in academic institutions and research organizations globally. Some of the libraries especially in developed countries have started offering RDM services to their communities. Although lagging behind, some academic libraries in developing countries are at the stage of planning or implementing the service. However, the level of RDM awareness is very low among researchers, librarians and other data practitioners.
 The objective of this paper is to present available open resources for different data practitioners particularly researchers and librarians. It includes training resources for both researchers and librarians, Data Management Plan (DMP) tool for researchers; data repositories available for researchers to freely archive and share their research data to the local and international communities. 
 A case study with a survey was conducted at the University of Dodoma to identify relevant RDM services so that librarians could assist researchers to make their data accessible to the local and international community.
 The study findings revealed a low level of RDM awareness among researchers and librarians. Over 50% of the respondent indicated their perceived knowledge as poor in the following RDM knowledge areas; DMP, data repository, long term digital preservation, funders RDM mandates, metadata standards describing data and general awareness of RDM. Therefore, this paper presents available open resources for different data practitioners to improve RDM knowledge and boost the confidence of academic and research libraries in establishing the service.

Clinical Data Management in Japan Past, Present, and Future

In this article, we summarize 1) the history of clinical data management (CDM), 2) how different sectors function,3) educational activities for CDM professionals, and 4) the role of data management in biomedical research in Japan. Here, we explain the differences inroles of clinical data managers among those practicing in academic research organizations, pharmaceutical companies, and contract research organizations.The current status and issues of CDM in Japan are discussed, including training, education, and career paths for CDM professionals.

International Consortium to Advance Cross-Species Extrapolation of the Effects of Chemicals in Regulatory Toxicology.

International Consortium to Advance Cross-Species Extrapolation of the Effects of Chemicals in Regulatory Toxicology.

ЕФЕКТИВНІСТЬ НАУКОВОЇ Й ІННОВАЦІЙНОЇ ДІЯЛЬНОСТІ УНІВЕРСИТЕТІВ УКРАЇНИ У КОНТЕКСТІ РЕАЛІЗАЦІЇ ФІНАНСОВОГО ПОТЕНЦІАЛУ ТА АКАДЕМІЧНОЇ РЕПУТАЦІЇ

The main features of the modern educational and scientific space are the rapid realization of knowledge, the ability to effectively operate scientific results, the development of new technologies and their spread in the world, the competition for intellectual and financial resources. Under such conditions, the ability of universities not only to disseminate but also to create new knowledge through research, to ensure their social and economic efficiency, are the main criteria of global competitiveness. Transforming the domestic science, education and production, defining strategic guidelines for innovative development, ensuring economic growth and the most effective distribution of available resources, especially through the improvement of the universities efficiency in the context of their intellectual, financial potential and academic reputation realization are important tasks of the state on the way to building a competitive national economy. The purpose of the article is to identify and evaluate the relationship between the results of research activities at Ukrainian universities, their financial potential and academic reputation. In accordance with the objectives, the article describes the existing sources and organization of academic research financing at Ukrainian state higher education institutions (HEIs), the scientific and innovative activity efficiency indicators are systematized, the comparative analysis of results of research work of universities of Ukraine taking into account sources and volumes of their financing is carried out and the interrelation between these indicators of scientific and innovative activity is estimated. The object of the study are the classical universities of Ukraine, which occupy leading positions in the national rankings of HEIs, in particular the ranking of universities according to Scopus. Analyzing with the help of information posted on the websites of the HEIs, the sample indicators of scientific and innovative activities of universities, their staffing and financial support, it was found that not always the scale of HEIs in its quantitative dimension affects efficiency. The analysis showed that there is no direct relationship between the financial potential of universities and the achievement of the highest scientific results. Thus, the amount of funding for scientific activities has a significant impact on the level of achievement of HEIs and its employees, but is not always used effectively. Important in the market environment is effective financial management, diversification of funding sources, targeted use of financial resources provided for research and innovation of universities, which in globalization allows to ensure a high level of research, an important place of Ukrainian universities in world science and international rankings, their competitiveness, among others, as well as the innovative development of the country as a whole.

Assessment of North American Clinical Research Site Performance During the Start-up of Large Cardiovascular Clinical Trials

Randomized clinical trials (RCTs) are critical in advancing patient care, yet conducting such large-scale trials requires tremendous resources and coordination. Clinical site start-up performance metrics can provide insight into opportunities for improved trial efficiency but have not been well described. To measure the start-up time needed to reach prespecified milestones across sites in large cardiovascular RCTs in North America and to evaluate how these metrics vary by time and type of regulatory review process. This cohort study evaluated cardiovascular RCTs conducted from July 13, 2004, to February 1, 2017. The RCTs were coordinated by a single academic research organization, the Duke Clinical Research Institute. Nine consecutive trials with completed enrollment and publication of results in their target journal were studied. Data were analyzed from December 4, 2019, to January 11, 2021. Year of trial enrollment initiation (2004-2007 vs 2008-2012) and use of a central vs local institutional review board (IRB). The primary outcome was the median start-up time (from study protocol delivery to first participant enrollment) as compared by trial year and type of IRB used. The median start-up time for the top 10% of sites was also reported. Secondary outcomes included time to site regulatory approval, time to contract execution, and time to site activation. For the 9 RCTs included, the median site start-up time shortened only slightly over time from 267 days (interquartile range [IQR], 185-358 days) for 2004-2007 trials to 237 days (IQR, 162-343 days) for 2008-2012 trials (overall median, 255 days [IQR, 177-350 days]; P < .001). For the top 10% of sites, median start-up time was 107 days (IQR, 95-121 days) for 2004-2007 trials vs 104 days (IQR, 84-118 days) for 2008-2012 trials (overall median, 106 days [IQR, 90-120 days]; P = .04). The median start-up time was shorter among sites using a central IRB (199 days [IQR, 140-292 days]) than those using a local IRB (287 days [IQR, 205-390 days]; P < .001). This cohort study of North American research sites in large cardiovascular RCTs found a duration of nearly 9 months from the time of study protocol delivery to the first participant enrollment; this metric was only slightly shortened during the study period but was reduced to less than 4 months for top-performing sites. These findings suggest that the use of central IRBs has the potential to improve RCT efficiency.

우리나라 수산자원 연구 동향의 분석적 연구

This study is to quantitatively analyze research trends of fisheries resources in Korea, based on the literature analysis and keywords analysis of research papers which were published by academic societies and research organizations for six decades from 1961 to 2020. The contents of this study include quantitative analysis of changes in the research production for six decades, research trends by research area(survey, assessment, management), and research contents by decade. Based on the literature analysis using a total of 1,680 research papers, the pattern of increase in research production revealed a typical logistic type, showing a rapid increase in the earlier years and then a gradual slower increase afterwards to reach the asymptotic level. The keywords analysis showed that there were apparent changes in research contents by decades. The earlier years’ research focused mainly on the resource survey than resource assessment or resource management. However, researches after 1990s were dominantly conducted on the resource assessment. It is recommended that an integrated ecosystem-based fisheries resource management system should be established in the near future, based on the scientific assessment and GIS-based spatio-temporal management of the aquatic ecosystems as well as fisheries resources. To effectively carry out this task, it will be necessary to adopt a customized integrated education system, which should be closely interacting with integrated research of fisheries resources by facilitating fisheries education.

Development of university research potential as the basis of competitive quality of higher education in the United States: experience for Ukraine

The development of University research potential (URP) in the USA during 1950-2020 in view of achieving competitive quality of higher education is analysed in the article.&#x0D; The national deterministic context and components of this potential by the types of activity (educational, research) and by the resources (personnel, financial, organizational) as well as component impact on the highest excellence quality of education (according to the criteria of the Academic Ranking of World Universities, ARWU) are identified. It is proved that the context of URP development is dichotomous and consists of national spheres of education and research. This assertion corresponds to the duality of higher education (as an integrated intersection of education and research) and the composition and structure of higher education mission (list of interrelated keywords and the order of their priority: education, research, creativity / innovation).&#x0D; It is substantiated that URP is first actualized within study programmes of the highest level of complexity (Master's, PhD and Postdoctoral), research activity of academic staff (especially professors) and research organizations associated with Universities (institutes, centres, laboratories, clinics). This reasoning conforms to the concept and criteria for research and doctoral Universities in line with the Carnegie Classification. These components are integrated into the educational process to varying degrees, so they have a different impact on the quality of education. For the first 30 top US Universities, there is no probable correlation between ranking achievements and the amount of research and developments (R&amp;D) funding as well as the number of researchers in institutions. Instead, such correlation is strong for the number of Postdoctorates in an institution.&#x0D; In general, there is a steady trend of downward in the share of the higher education sector within R&amp;D performance in the US that amounted to 12.0 % in 2019. Although scale of higher education sector share is still growing quantitatively and is the basis for modernizing education content. At the same time, Master's, PhD and Postdoctoral programmes are spreading at a significant pace. In the 1959/60 academic year, the ratio of the number of awarded Bachelor's, Master's and PhD degrees was 1 : 27 : 7.5, in 2018/19 – 1 : 41 : 9.3 under multiple times increased graduation. Between 1979 and 2019, the number of Postdoctorates increased 3.7 times. Salaries of academic staff, especially professors, are increased, academic staff workload is minimized and subject-oriented, a system of permanent employment is proposed, and a modern educational, research, and information infrastructure is created for effective research and research-based education activity.&#x0D; The national context of the development of URP is stably favourable given the increase in the share of GDP for the funding of education institutions in general, higher education institutions in particular, and R&amp;D especially. The corresponding expenditures reached 7.1 %, 3.0 % and 3.1 % GDP and are the largest ones quantitatively in the world. Purposeful and consolidated (federal, business, university, public) support for education and R&amp;D has been and is provided in critical periods of the country's competitive struggle for leadership in an innovatively progressive world. The state of these spheres, in particular higher education, and URP, is systematically examined. The decades of the 1960s of the last century and the twenties of the present century are significant. In the 1960s, the share of GDP for the higher education institutions funding was doubled, the number of awarded Master's degrees was increased almost tripled, and the award of PhD degrees was increased six times to overcome the threat of educational and scientific backwardness. R&amp;D funding reached 2.8 % of GDP, of which 1.9 % came from the federal budget. Funding for Universities’ R&amp;D has increased 3.6 times. The super-powerful public University of California, San Diego (1960), 9 other world-class Universities, and 6 subworld-class Universities according to the ARWU, the National Academy of Engineering (1964), and the National Academy of Education (1965) were established.&#x0D; The characteristics of state, monitoring and development policy of the URP and educational and research context in the US is a guideline for the improvement of Ukrainian Universities.

How to Do Business with DHS S&T

Established by Congress in 2003 as the research and development (R&D) arm of the Department of Homeland Security (DHS), the Science and Technology Directorate (S&T) focuses on providing technology solutions and knowledge products to mitigate the adverse consequences resulting from the release of chemical, biological, and agricultural threats.DHS S&T research areas include chemical and biological defense, borders and maritime security and port of entry screening, critical infrastructure and resilience, cybersecurity, explosives detection and aviation screening, first responders, unmanned aerial systems, and tests, evaluations, standards, and systems engineering. In addition, S&T partners with academic, national laboratory, and other research organizations to address specific homeland security topics and threats and funds DHS S&T Technology Centers with subject matter experts in sensors and platforms, modeling and simulation, data analytics, hazard awareness and characterization, biometrics and identity, social sciences, and interoperability and compatibility.Innovation is the driving force behind S&T’s work. Because potential solutions may exist outside the homeland security arena, S&T casts a wide, inclusive net to find and use the best technology available. During her presentation, Dr. Angela M. Ervin will outline the current work of DHS S&T and explain the process for requirements gathering for initiation of projects and programs. She will also discuss opportunities available for academia and industry to work with S&T as well as mechanisms to apply for funding.

Canagliflozin and Kidney-Related Adverse Events in Type 2 Diabetes and CKD: Findings From the Randomized CREDENCE Trial

Canagliflozin reduced the risk of kidney failure and related outcomes in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) in the CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) trial. This analysis of CREDENCE trial data examines the effect of canagliflozin on the incidence of kidney-related adverse events (AEs).A randomized, double-blind, placebo-controlled, multicenter international trial.4,401 trial participants with T2DM, CKD, and urinary albumin-creatinine ratio >300-5,000 mg/g.Participants were randomly assigned to receive canagliflozin 100 mg/d or placebo.Rates of kidney-related AEs were analyzed using an on-treatment approach, overall and by screening estimated glomerular filtration rate (eGFR) strata (30-<45, 45-<60, and 60-<90 mL/min/1.73 m2).Canagliflozin was associated with a reduction in the overall incidence rate of kidney-related AEs (60.2 vs 84.0 per 1,000 patient-years; hazard ratio [HR], 0.71 [95% CI, 0.61-0.82]; P < 0.001), with consistent results for serious kidney-related AEs (HR, 0.72 [95% CI, 0.51-1.00]; P = 0.05) and acute kidney injury (AKI; HR, 0.85 [95% CI, 0.64-1.13]; P = 0.3). The rates of kidney-related AEs were lower with canagliflozin relative to placebo across the 3 eGFR strata (HRs of 0.73, 0.60, and 0.81 for eGFR 30-<45, 45-<60, and 60-<90 mL/min/1.73 m2, respectively; P = 0.3 for interaction), with similar results for AKI (P = 0.9 for interaction). Full recovery of kidney function within 30 days after an AKI event occurred more frequently with canagliflozin versus placebo (53.1% vs 35.4%; odds ratio, 2.2 [95% CI, 1.0-4.7]; P = 0.04).Kidney-related AEs including AKI were investigator-reported and collected without central adjudication. Biomarkers of AKI and structural tubular damage were not measured, and creatinine data after an AKI event were not available for all participants.Compared with placebo, canagliflozin was associated with a reduced incidence of serious and nonserious kidney-related AEs in patients with T2DM and CKD. These results highlight the safety of canagliflozin with regard to adverse kidney-related AEs.The CREDENCE trial and this analysis were funded by Janssen Research & Development, LLC, and were conducted as a collaboration between the funder, an academic steering committee, and an academic research organization, George Clinical.The CREDENCE trial was registered at ClinicalTrials.gov with identifier number NCT02065791.

Research Support Services in STEM Libraries: A Scoping Review

As science and technology libraries continue to evolve, specialized research support services are developed and offered at academic institutions or research organizations. Making sense of this changing landscape and determining the best programs for an institution can be a daunting task, especially for early-career librarians. This article aims to provide an overview of various small to medium size non-traditional or specialized research support services in academic and special libraries serving Science, Technology, Engineering and Mathematics (STEM) disciplines. A systematic search of five databases was conducted for articles that described the development and implementation of research support services. Non-traditional or specialized research support services identified in this scoping review fall in the following areas: bibliometrics/altmetrics, data management services, geographic information systems, patents, and systematic reviews. The paper provides a detailed foundation for novice and experienced STEM librarians to offer innovative library services or enhance existing research support services.

Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research.

The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs. Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.

Preface: International Conference on Innovations in Mechanical Sciences (ICIMS’21)

Preface: International Conference on Innovations in Mechanical Sciences (ICIMS’21)

Science Coordination that Promote Co-creations in Academic Research Organizations:Backgrounds on disturbing coexistence between research and support activities

Science Coordination that Promote Co-creations in Academic Research Organizations:Backgrounds on disturbing coexistence between research and support activities

Blockchain in Engineering Education: The Teaching Factory Paradigm

The research work presented in this paper is related to the design and development of a framework based on the Blockchain technology for the upscaling of modern academic education. The goal is to securely and successfully connect the multiple stakeholders involved in the academic education, including students, universities, research organizations and industries as well. Based on the concept of the distributed ledger, each stakeholder maintains a copy of the Blockchain locally, ensuring valuable information, such as achievements, projects, intellectual property, and patents/inventions. By extension, the proposed framework can act as a reward system for the academic stakeholders, i.e. the universities and the students. On the one hand, students via the creation of a virtual wallet can gather reward points based on their performance, their achievements as well as their participation in Teaching Factories (TF). On the other hand, universities can benefit from this framework as regards their accreditation, in worldwide basis. Concretely, with the participation in TF, award points are provided to these organizations, which act as a proof of the educational quality they provide to the students. Similarly, industries and research foundations, are also rewarded for their participation in such TF. The TF in the proposed framework can be realized as Smart contracts created by the industries and undertaken by the academic or research organizations. Furthermore, with the proposed framework human resources managers are facilitated in selecting competent and adequately qualified professionals. The selection of the professionals is based on their academic portfolio, which is part of the distributed ledger. Therefore under the scope of this research work, a group of young engineers was formed. The students had the opportunity to get familiar with the concept of Blockchain and assisted in the conceptualization and development of a distributed Teaching Factory platform based on the Blockchain Technology.