scholarly journals Introduction to the EQIPD quality system

eLife ◽  
2021 ◽  
Vol 10 ◽  
Author(s):  
Anton Bespalov ◽  
René Bernard ◽  
Anja Gilis ◽  
Björn Gerlach ◽  
Javier Guillen ◽  
...  
Keyword(s):  
Performance Standards ◽  
Quality System ◽  
Research Quality ◽  
Preclinical Research ◽  
Public And Private ◽  
Rigorous Research ◽  
Innovative Therapies ◽  
Core Requirements ◽  
Scientific Questions ◽  
Intended Use

While high risk of failure is an inherent part of developing innovative therapies, it can be reduced by adherence to evidence-based rigorous research practices. Numerous analyses conducted to date have clearly identified measures that need to be taken to improve research rigor. Supported through the European Union's Innovative Medicines Initiative, the EQIPD consortium has developed a novel preclinical research quality system that can be applied in both public and private sectors and is free for anyone to use. The EQIPD Quality System was designed to be suited to boost innovation by ensuring the generation of robust and reliable preclinical data while being lean, effective and not becoming a burden that could negatively impact the freedom to explore scientific questions. EQIPD defines research quality as the extent to which research data are fit for their intended use. Fitness, in this context, is defined by the stakeholders, who are the scientists directly involved in the research, but also their funders, sponsors, publishers, research tool manufacturers and collaboration partners such as peers in a multi-site research project. The essence of the EQIPD Quality System is the set of 18 core requirements that can be addressed flexibly, according to user-specific needs and following a user-defined trajectory. The EQIPD Quality System proposes guidance on expectations for quality-related measures, defines criteria for adequate processes (i.e., performance standards) and provides examples of how such measures can be developed and implemented. However, it does not prescribe any pre-determined solutions. EQIPD has also developed tools (for optional use) to support users in implementing the system and assessment services for those research units that successfully implement the quality system and seek formal accreditation. Building upon the feedback from users and continuous improvement, a sustainable EQIPD Quality System will ultimately serve the entire community of scientists conducting non-regulated preclinical research, by helping them generate reliable data that are fit for their intended use.

scholarly journals Introduction to the EQIPD Quality System

2020 ◽  
Author(s):  
Anton Bespalov ◽  
Rene Bernard ◽  
Björn Gerlach ◽  
Christoph Emmerich ◽  
Malgorzata Pietraszek ◽  
...  
Keyword(s):  
Performance Standards ◽  
Quality System ◽  
Research Quality ◽  
Preclinical Research ◽  
Public And Private ◽  
Training Support ◽  
Rigorous Research ◽  
Innovative Therapies ◽  
Core Requirements ◽  
Intended Use

While high risk of failure is an inherent part of developing innovative therapies, it can be reduced by adherence to evidence-based rigorous research practices. Numerous analyses conducted to date have clearly identified measures that need to be taken to improve research rigor. Supported through the European Union’s Innovative Medicines Initiative, the EQIPD consortium has developed a novel preclinical research quality system that can be applied in both public and private sectors and is free for anyone to use. The EQIPD Quality System was designed to be suited to boost innovation by ensuring the generation of robust and reliable preclinical data while being lean, effective and not becoming a burden that could negatively impact the freedom to explore scientific questions. EQIPD defines research quality as the extent to which research data are fit for their intended use. Fitness, in this context, is defined by the stakeholders, who are the scientists directly involved in the research, but also their funders, sponsors, publishers, research tool manufacturers and collaboration partners such as peers in a multi-site research project. The essence of the EQIPD Quality System is the set of 18 core requirements that can be addressed flexibly, according to user-specific needs and following a user-defined trajectory. The EQIPD Quality System proposes guidance on expectations for quality-related measures, defines criteria for adequate processes (i.e., performance standards) and provides examples of how such measures can be developed and implemented. However, it does not prescribe any pre-determined solutions. EQIPD has also developed tools (for optional use) to support users in implementing the system. Further, EQIPD is preparing training support and assessment services for those research units that successfully implement the quality system and would like to seek formal accreditation. Building upon the feedback from users and continuous improvement, a sustainable EQIPD Quality System will ultimately serve the entire community of scientists conducting non-regulated preclinical research, by helping them generate reliable data that are fit for their intended use.

scholarly journals The use of ball pits and playpens in laboratory Lister Hooded male rats induces ultrasonic vocalisations indicating a more positive affective state and can reduce the welfare impacts of aversive procedures

2022 ◽  
pp. 002367722110659
Author(s):  
Justyna K Hinchcliffe ◽  
Megan G Jackson ◽  
Emma SJ Robinson
Keyword(s):  
Emotional State ◽  
Affective State ◽  
Well Being ◽  
Male Rats ◽  
Research Quality ◽  
Environmental Complexity ◽  
Preclinical Research ◽  
Laboratory Rats ◽  
Rigorous Research ◽  
Positive Affective State

The advancement and quality of science rely on research that is robust and unbiased in its experimental design, execution, analysis, and reproducibility. In preclinical research, a better understanding of animal emotions and refinement of their husbandry, housing, and handling are important goals in providing good animal welfare in a laboratory setting which underpins rigorous research quality. Induction of positive emotional state in animals is a key component of their well-being, and one approach is to increase their environmental complexity using, for example, ball pits or playpens in rats. In this study, we recorded 50 kHz ultrasonic vocalisations (USVs) during animals’ exposure to the ball pit and playpen. We have previously shown that 50 kHz USVs provide a graded and quantifiable measure of an animal’s emotional state, and here find that access to the ball pit and playpen increases 50 kHz USVs, indicative of a more positive affective state. Using our affective bias test (ABT) we next quantified the animals’ emotional response to an aversive intervention and whether this could be attenuated by access to a playpen. The playpen exposure completely mitigated the negative affective state induced by an anxiogenic drug when compared with animals who experienced the drug in the home cage. Together, these findings suggest ball pits and playpens provide a simple and effective method to improve the welfare of laboratory rats and reduce the cumulative suffering they experience from their housing conditions and minor, aversive procedures.

scholarly journals Limitations and Flaws of Preclinical Pulmonary Hypertension Studies

2020 ◽  
Vol 19 (2) ◽  
pp. 47-54
Author(s):  
Tsukasa Shimauchi ◽  
François Potus ◽  
Sébastien Bonnet ◽  
Steeve Provencher ◽  
Roxane Paulin ◽  
...  
Keyword(s):  
Animal Ethics ◽  
Preclinical Studies ◽  
Preclinical Research ◽  
Funding Agencies ◽  
Need Support ◽  
Innovative Therapies ◽  
Peer Reviewers ◽  
Delayed Translation ◽  
Rigorous Study ◽  
Pulmonary Arterial

Despite advances in our understanding of the disease, significant therapeutic gaps remain for pulmonary arterial hypertension (PAH). Indeed, no cure exists yet for this devastating disease, and very few innovative therapies beyond the traditional pathways of endothelial dysfunction have reached late clinical trial phases in PAH. While there are inherent limitations to the currently available animal models of PAH, the delayed translation of innovative therapies to the clinic may also relate to flawed preclinical research methodologies. The present article discusses the limitations and flaws in the design of preclinical PH trials and discusses opportunities to create preclinical studies with improved predictive value in identifying key mechanisms involved in PAH development and progression and guiding early phase drug development in PAH patients. The implementation of rigorous study design will need support not only from researchers, peer reviewers, and editors, but also from academic institutions, funding agencies, and animal ethics authorities.

Regulating Medical Devices in the European Union

2020 ◽  
Author(s):  
Aurélie Mahalatchimy
Keyword(s):  
European Union ◽  
Medical Devices ◽  
The United States ◽  
The European Union ◽  
Public And Private ◽  
European Regulatory ◽  
Notified Body ◽  
Private Actors ◽  
Intended Use ◽  
The Eu

This chapter addresses the regulation of medical devices in the European Union. The overall goals of the European regulatory framework for medical devices are the same as the goals of the framework for medicines. It aims to protect public health by ensuring that medical devices are of good quality and safe for their intended use. However, the regulation of medical devices in Europe is very different from the regulation of medicines in two regards. First, unlike medicines, there is no pre-market authorisation by a regulatory authority for medical devices to lawfully enter the EU market. Second, unlike in the United States where the Food and Drug Administration is the primary regulator of devices throughout the nation, the European Union does not have a single regulator of medical devices. Instead, several organisations may be involved, and mainly a notified body in specific cases. The chapter then explains what constitutes a medical device in the EU and how devices are classified according to their level of risk in the EU. It then discusses how medical devices reach the market, how their risks are managed all along their lifecycle, and what kinds of incentives are provided for innovation and competition. The chapter also analyses the balance between public and private actors in the regulation of medical devices. It then concludes with case studies of innovative medical technologies that have challenged the traditional European regulatory scheme and that have led to many revisions in the 2017 device regulations.

scholarly journals Conceptualizing centers of excellence: A global evidence

2021 ◽  
Author(s):  
Tsegahun Manyazewal ◽  
Yimtubezinash Woldeamanuel ◽  
Claire Oppenheim ◽  
Asrat Hailu ◽  
Mirutse Giday ◽  
...  
Keyword(s):  
Scoping Review ◽  
The United States ◽  
Healthcare Research ◽  
Research Quality ◽  
Main Theme ◽  
List Type ◽  
Centers Of Excellence ◽  
Eligibility Criteria ◽  
Public And Private ◽  
Global Evidence

AbstractObjectiveGlobally, interest in excellence has grown exponentially, with public and private institutions shifting their attention from meet targets to achieving excellence. Centers of Excellence (CoEs) are standing at the forefront of healthcare, research, and innovations responding to the world’s most complex problems. However, their potential is hindered by conceptual ambiguity. We conducted a global synthesis of the evidence to conceptualize CoEs.DesignScoping review, following Arksey and O’Malley’s framework and methodological enhancement by Levac et al to analyze the evidence and the PRISMA-ScR to guide the retrieval and inclusion of the evidence.Data sourcesPubMed, Scopus, CINAHL, Google Scholar, and the Google engine from their inception to 01 January 2021.EligibilityPapers that describe CoE as the main theme, which could be defining, theorizing, implementing, or evaluating a CoE.ResultsThe search resulted in 52,161 potential publications, with 78 articles met the eligibility criteria. The 78 articles were from 33 countries, of which 35 were from the United States of America, 3 each from Nigeria, South Africa, Spain, and India, and 2 each from Ethiopia, Canada, Russia, Colombia, Sweden, Greece, and Peru. The rest 17 were from various countries. The articles involved six thematic areas - healthcare, education, research, industry, information technology, and general concepts on CoE. The analysis documented success stories of using the brand “Center of Excellence” - an influential brand to stimulate technical skills, innovation, and technology. We identified 12 essential foundations of CoE - specialized expertise; infrastructure; innovation; high-impact research; quality service; accreditation or standards; leadership; organizational structure; strategy; collaboration and partnership; sustainable funding or financial mechanisms; and entrepreneurship.ConclusionsCoEs have significant scientific, political, economic, and social impacts. A comprehensive framework is needed to guide and inspire an institution as a CoE and to help government and funding institutions shape and oversee CoEs.Strengths and limitations of this study-To the best of our knowledge, this is the first scoping review to conceptualize centers of excellence based on global evidence.-The study followed Arksey and O’Malley’s framework and methodological enhancement by Levac et al to and the PRISMA-ScR methodological frameworks.-Five databases were systematically searched to identify scientific and gray literature-The study was limited by language restrictions.

FinTech in the Kingdom of Bahrain

2021 ◽  
pp. 174-190
Author(s):  
Hayat Ali ◽  
Reem Al Kaabi ◽  
Hussain Mansoor Ali ◽  
Hussain Sami Ahmed ◽  
Mohammed Naser
Keyword(s):  
Service Quality ◽  
User Satisfaction ◽  
Information Quality ◽  
Quality System ◽  
Ease Of Use ◽  
Significant Positive Effect ◽  
System Quality ◽  
Public And Private ◽  
Positive Effect ◽  
Financial Technology

Financial technology (FinTech) has developed rapidly over the last decade. In the Kingdom of Bahrain, both public and private sectors have adopted FinTech in different ways. The objective of this research is to explore and assess Bahraini users' adoption of and satisfaction with FinTech services. A model was built to quantify FinTech users' satisfaction. and a questionnaire was used to collect data; 319 responses were returned. The outcome was that all the factors investigated, accessibility, ease of use, completeness, accuracy, security, reliability, responsiveness, service quality, system quality, and information quality, have a significant positive effect on user satisfaction. The contribution of this research is the model of satisfaction for FinTech that can be applied in different countries. The proposals recommended by the authors will also inform government and concerned organizations about FinTech in Bahrain for greater user satisfaction.

Patients Suffer While the Science Establishment Resists Innovative Therapies

2018 ◽  
Vol 24 (2) ◽  
Author(s):  
Henry I. Miller
Keyword(s):  
Public Policy ◽  
Gene Therapy ◽  
Recombinant Dna ◽  
Germ Line ◽  
Human Gene ◽  
Future Generations ◽  
Preclinical Research ◽  
Human Gene Therapy ◽  
Innovative Therapies ◽  
Heritable Change

Human gene therapy has been up to now of a type that affects only the patient being treated; it has not modified sperm or eggs cells or embryos in a way that would constitute “germ line gene therapy” (GLGT) by creating a heritable change and affecting future generations.  Preclinical research has progressed almost to the point where GLGT interventions will be possible with a reasonable likelihood of success, but such clinical trials are currently prohibited: NIH's Recombinant DNA Advisory Committee is not permitted even to consider such proposals, and the FDA cannot use appropriated funds to review such trials.  Such absolute prohibitions are bad for patients and bad public policy.  

scholarly journals The RCCM 2009 Survey: Mapping Doctoral and Postdoctoral CAM Research in the United Kingdom

2011 ◽  
Vol 2011 ◽  
pp. 1-4 ◽  
Author(s):  
Nicola Robinson ◽  
George Lewith
Keyword(s):  
Research Capacity ◽  
Research Quality ◽  
Research Assessment ◽  
Full Time ◽  
Research Activity ◽  
High Quality Research ◽  
Strategic Approach ◽  
Rigorous Research ◽  
The Usa ◽  
The Uk

Complementary and Alternative Medicine (CAM) is widely available in the UK and used frequently by the public, but there is little high quality research to sustain its continued use and potential integration into the NHS. There is, therefore, a need to develop rigorous research in this area. One essential way forward is to train and develop more CAM researchers so that we can enhance academic capacity and provide the evidence upon which to base strategic healthcare decisions. This UK survey identified 80 research active postgraduates registered for MPhils/PhDs in 21 universities and were either current students or had completed their postgraduate degree during the recent UK Research Assessment Exercise (RAE) 2001–2008. The single largest postgraduate degree funder was the university where the students registered (26/80). Thirty-two projects involved randomized controlled trials and 33 used qualitative research methods. The UK RAE also indicates a significant growth of postdoctoral and tenured research activity over this period (in 2001 there were three full time equivalents; in 2008 there were 15.5) with a considerable improvement in research quality. This mapping exercise suggests that considerable effort is currently being invested in developing UK CAM research capacity and thus inform decision making in this area. However, in comparative international terms UK funding is very limited. As in the USA and Australia, a centralized and strategic approach by the National Institute of Health Research to this currently uncoordinated and underfunded activity may benefit CAM research in the UK.

scholarly journals Small Dimension—Big Impact! Nanoparticle-Enhanced Non-Invasive and Intravascular Molecular Imaging of Atherosclerosis In Vivo

Molecules ◽  
2020 ◽  
Vol 25 (5) ◽  
pp. 1029 ◽  
Author(s):  
Tobias Lenz ◽  
Philipp Nicol ◽  
Maria Isabel Castellanos ◽  
Leif-Christopher Engel ◽  
Anna Lena Lahmann ◽  
...  
Keyword(s):  
Molecular Imaging ◽  
Targeted Drug Delivery ◽  
Molecular Level ◽  
Small Dimension ◽  
Secondary Effects ◽  
Preclinical Research ◽  
Targeted Nanoparticles ◽  
Non Invasive ◽  
Intended Use

Extensive translational research has provided considerable progress regarding the understanding of atherosclerosis pathophysiology over the last decades. In contrast, implementation of molecular in vivo imaging remains highly limited. In that context, nanoparticles represent a useful tool. Their variable shape and composition assure biocompatibility and stability within the environment of intended use, while the possibility of conjugating different ligands as well as contrast dyes enable targeting of moieties of interest on a molecular level and visualization throughout various imaging modalities. These characteristics have been exploited by a number of preclinical research approaches aimed at advancing understanding of vascular atherosclerotic disease, in order to improve identification of high-risk lesions prior to oftentimes fatal thromboembolic events. Furthermore, the combination of these targeted nanoparticles with therapeutic agents offers the potential of site-targeted drug delivery with minimized systemic secondary effects. This review gives an overview of different groups of targeted nanoparticles, designed for in vivo molecular imaging of atherosclerosis as well as an outlook on potential combined diagnostic and therapeutic applications.

scholarly journals What Affects The Ability To Accumulate The Best Applicants By Russian Universities? The Application Of Quantile Regression Model

2017 ◽  
Vol 19 (5) ◽  
pp. 81-98
Author(s):  
Edyta Łaszkiewicz ◽  
Stepan Zemstov ◽  
Vera Barinova
Keyword(s):  
Higher Education ◽  
Quantile Regression ◽  
Regression Model ◽  
Higher Education Institutions ◽  
Research Quality ◽  
Related Factors ◽  
Public And Private ◽  
Quantile Regression Model ◽  
The Impact ◽  
Russian Universities

The aim of this paper is to evaluate which university’s characteristics have the greatest impact on the competitiveness of universities in their ability to attract better students in Russia. We examined the impact of three groups of factors,related to teaching, research and entrepreneurial activities of universities. The quantile regression model was applied for the subsample of public and private higher education institutions localized in Russia. The results prove that not only traditional, teaching-related factors affect the attractiveness of the universities. We found that the research quality and entrepreneurial experience both increase the ability to accumulate the best applicants by Russian universities. However, the synergy between training, research and business activities is not always achieved. The importance of science and business-oriented activities varies between public and private institutions. According to the results from the quantile regression the importance of the certain factors differs between the quantiles of the dependent variable distribution. Our findings might be useful for the governmental authorities during the universities’ assessment as well as for the higher education institutions themselves – in order to define their strategic development and attract better students.

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