Article
Energy & Fuels
Agnieszka Janik, Adam Ryszko, Marek Szafraniec
Summary: This study conducted a comprehensive analysis on the factors determining EU citizens' attitudes towards the European Energy Union priorities, revealing significant variations in support for specific energy policy priorities based on different perceptions and demographic variables. The awareness of the importance of environment, climate, and energy at the EU level was found to strongly influence attitudes towards energy policy priorities. Additionally, factors such as political orientation, gender, occupation, and place of residence were identified as important determinants of attitudes towards the European Energy Union priorities, with age and educational level playing predictive roles in limited cases.
Article
Health Care Sciences & Services
Richard Hooper
Summary: A stepped wedge trial is an evaluation method of implementing interventions over a staggered timetable, usually cluster randomized, with various designs and conduct practices. The analysis of this trial assumes a constant intervention effect and the need to adjust for period effects, underlying trends, and clustering of outcomes. The advantage lies in practicality or statistical efficiency.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2021)
Review
Pharmacology & Pharmacy
Vida Terzic, Lea Levoyer, Melanie Figarella, Elisabetta Bigagli, Noemie Mercier, Lucie De Gastines, Severine Gibowski, Marius Troseid, Jacques Demotes, Inge Christoffer Olsen, Maya Hites, Florence Ader, Jose Ramon Arribas Lopez, France Mentre, Helene Esperou, Dominique Costagliola, John-Arne Rottingen, Julien Poissy, Jean-Christophe Roze, Adilia Warris, Jackie O'Leary, Ricardo M. Fernandes, Lambert Assoumou, Regis Hankard, Mark A. Turner, Yazdan Yazdanpanah, Alpha Diallo
Summary: To ensure the safety of participants and regulatory compliance in academic trials, a centralized pharmacovigilance system was established, allowing sponsors to delegate work. This system consisted of key procedures, a local safety officer network, and centralized safety activities. Lessons learned from four trials demonstrated the ability to manage diverse European requirements and communicate effectively with trial teams.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2023)
Editorial Material
Clinical Neurology
Lucy Farrimond, Kevin Talbot
Summary: This scientific commentary discusses the paper by Ezer et al. that investigates the infantile SOD1 deficiency syndrome caused by a homozygous SOD1 variant with a lack of enzyme activity.
Article
Clinical Neurology
Jessica B. Langbaum, Julie Zissimopoulos, Rhoda Au, Niranjan Bose, Chris J. Edgar, Evan Ehrenberg, Howard Fillit, Carl Hill, Lynne Hughes, Michael Irizarry, Sarah Kremen, Darius Lakdawalla, Nancy Lynn, Kristina Malzbender, Tetsuyuki Maruyama, Holly A. Massett, Deep Patel, Desi Peneva, Eric M. Reiman, Klaus Romero, Carol Routledge, Michael W. Weiner, Stacie Weninger, Paul S. Aisen
Summary: Clinical trials for Alzheimer's disease face challenges in recruiting study participants, with slow enrollment, long completion time, and high costs. In 2020, an advisory panel of experts from various fields convened to assess the critical challenges in recruitment and develop recommendations to accelerate the development of novel therapies for AD.
ALZHEIMERS & DEMENTIA
(2023)
Review
Biochemistry & Molecular Biology
Bernadett Nagy, Julia Szekeres-Bartho, Gabor L. Kovacs, Endre Sulyok, Balint Farkas, Akos Varnagy, Viola Vertes, Kalman Kovacs, Jozsef Bodis
Summary: Progesterone plays crucial roles in gestation, menstrual cycle, and reproduction, acting as a precursor to various hormones. Progesterone and its derivatives have significant functions in contraception, treatment, immunity, and cancer prevention.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2021)
Article
Biotechnology & Applied Microbiology
Terra A. Manca, Manish Sadarangani, Scott A. Halperin, Joanne M. Langley, Elisabeth McClymont, Shannon E. MacDonald, Karina A. Top
Summary: Exclusion of pregnant and breastfeeding women from COVID-19 vaccine trials has led to knowledge gaps, vaccine hesitancy, and misinformation. Inclusion of these populations in trials should be prioritized and regulatory authorities can play a crucial role.
HUMAN VACCINES & IMMUNOTHERAPEUTICS
(2022)
Review
Biochemistry & Molecular Biology
Yuncong Shi, Huanji Zhang, Suli Huang, Li Yin, Feng Wang, Pei Luo, Hui Huang
Summary: Epigenetics plays a significant role in cardiovascular diseases, involving various mechanisms such as DNA methylation, histone modification, and noncoding RNA. Targeting epigenetic key enzymes could be a promising approach for the diagnosis and treatment of cardiovascular diseases.
SIGNAL TRANSDUCTION AND TARGETED THERAPY
(2022)
Editorial Material
Biotechnology & Applied Microbiology
Valentina Mantua, Celso Arango, Pavel Balabanov, Florence Butlen-Ducuing
Summary: Digital health technologies can help address challenges in the clinical development of drugs for central nervous system disorders. This article discusses strategies for developing such tools within the European regulatory environment.
NATURE REVIEWS DRUG DISCOVERY
(2021)
Review
Medicine, Research & Experimental
Patrick Savage, Brian Cox, Katie Linden, Jaimie Coburn, Michael Shahmohammadi, Ian Menown
Summary: This article summarizes key clinical cardiology trials from 2021, covering interventional cardiology data, trials in acute coronary syndromes, structural intervention trials, heart failure data, prevention trials, and electrophysiology data.
ADVANCES IN THERAPY
(2022)
Review
Medicine, Research & Experimental
Patrick Savage, Brian Cox, Michael Shahmohammadi, Johnathan Foster, Ian Menown
Summary: This article provides a summary of important clinical cardiology trials that were published or presented at major international conferences in 2022, aiming to summarize these trials and reflect on their clinical context.
ADVANCES IN THERAPY
(2023)
Review
Medicine, Research & Experimental
Aileen Kearney, Katie Linden, Patrick Savage, Ian B. A. Menown
Summary: This article summarizes key clinical cardiology trials from 2020, covering interventional and structural cardiology data, preventative cardiology data, antiplatelet therapy, and heart failure data. These trials are relevant to both clinicians and cardiology researchers.
ADVANCES IN THERAPY
(2021)
Article
Medicine, General & Internal
Neil Mackillop, Jayesh Shah, Michael Collins, Thomas Costelloe, Daniel Ohman
Summary: The objective of this study was to quantify the carbon footprint of pharma industry sponsored phase III trials and develop an approach for future trials. Through life cycle assessment, the study confirmed that phase III trials result in significant carbon emissions and proposed a plan for addressing the carbon footprint.
Article
Geriatrics & Gerontology
Christopher Delude, Ivan H. Abi-Elias, Charlene C. Quinn, Alyce S. Adams, Jay S. Magaziner, Kouta Ito, Paavani Jain, Jerry H. Gurwitz, Kathleen M. Mazor
Summary: This study aims to identify key factors for conducting clinical trials in nursing homes. The attributes of the research team, the diversity of residents and facilities, and communication among participants were identified as key factors. Future clinical trials in nursing homes will require a supportive environment and a reconsideration of the relationships involved.
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY
(2022)
Review
Pediatrics
H. W. Dalrymple
Summary: This paper explores the impact of GDPR on paediatric trials, highlighting the need to consider additional considerations and respect the rights of children. It also suggests that conducting paediatric clinical trials within GDPR requirements is possible with careful consideration during protocol drafting.
EUROPEAN JOURNAL OF PEDIATRICS
(2021)
Editorial Material
Medicine, General & Internal
Mark Flear, Anniek de Ruijter, Martin McKee
BMJ-BRITISH MEDICAL JOURNAL
(2020)
Article
Health Care Sciences & Services
Tamara Hervey, Ivanka Antova, Mark L. Flear, Jean McHale, Elizabeth Speakman, Matthew Wood
Summary: This article focuses on the external effects (Brexternalities) of Brexit on health and healthcare. The EU plays a significant role in managing economic and political externalities in health policy, and the manner in which a state leaves the EU can affect the management of relevant externalities. Health Brexternalities are not evenly distributed across all EU countries, with some countries more impacted due to close ties with UK health policies.
JOURNAL OF HEALTH POLITICS POLICY AND LAW
(2021)
Editorial Material
Ethics
Mark L. Flear, Richard Ashcroft
JOURNAL OF LAW AND THE BIOSCIENCES
(2021)
Article
Ethics
Mark L. Flear
Summary: Expectations and imaginaries shaped by organizations play a crucial role in the public legitimation of their governance and regulatory activities. These constructs tend to marginalize broader systemic issues, particularly those related to social justice.
JOURNAL OF LAW AND THE BIOSCIENCES
(2021)
Article
Ethics
Aurelie Mahalatchimy, Pin Lean Lau, Phoebe Li, Mark L. Flear
Summary: Gene-editing technologies are the subject of global competition and regulatory race, with EU-level legal regulation focusing on tensions around naturalness, morality and ethics, and medical objectives. Despite strong EU competence in the internal market, concerns around eugenics and human enhancement have shaped a multifaceted imaginary in relation to the use of gene-editing technologies. This imaginary not only limits EU-level regulation, but also seeks to ensure its legitimacy.
JOURNAL OF LAW AND THE BIOSCIENCES
(2021)
Article
Health Policy & Services
Nick Fahy, Tamara Hervey, Mark Dayan, Mark Flear, Michael J. Galsworthy, Scott Greer, Holly Jarman, Martha McCarey, Martin McKee, Matthew Wood
Summary: This article examines the likely impacts on the National Health Service (NHS) in the UK of the EU-UK Trade and Cooperation Agreement and the Withdrawal Agreement through a 'building blocks' framework. While there are positive impacts in trade, cooperation, and regulatory aspects, only one of the 17 NHS 'building blocks' supports positive health and care outcomes.
HEALTH ECONOMICS POLICY AND LAW
(2022)
Review
Psychiatry
Emer Galvin, Shane Desselle, Blanaid Gavin, Etain Quigley, Mark Flear, Ken Kilbride, Fiona McNicholas, Shane Cullinan, John Hayden
Summary: Remote consultations have become a necessary and acceptable form of mental healthcare provision, although concerns about care quality and the therapeutic relationship persist. Increased accessibility and convenience are key facilitators, while lack of infrastructure and patient comfort and competence pose significant barriers. This study emphasizes the importance of patient preferences and provider buy-in for the future of remote consultations.
JOURNAL OF PSYCHIATRIC RESEARCH
(2022)
Article
Health Care Sciences & Services
Emer Galvin, Shane Desselle, Blanaid Gavin, Etain Quigley, Mark Flear, Ken Kilbride, Fiona McNicholas, Shane Cullinan, John Hayden
Summary: Remote mental health consultations were swiftly implemented as a response to the COVID-19 pandemic, and research has begun to inform the future design and delivery of these services. This study aimed to explore the perspectives and experiences of stakeholders involved in the implementation of remote mental health consultations in Ireland.
BMC HEALTH SERVICES RESEARCH
(2023)
Article
Political Science
Matthew Wood, Ivanka Antova, Mark Flear, Tamara Hervey
Summary: Recent political support for populist parties worldwide can be attributed to the changing preferences of marginalized communities. Existing research on left behind communities' policy preferences is inconclusive due to methodological challenges. To address this, our study uses an innovative photo elicitation methodology to investigate the policy preferences of left behind communities in the UK regarding Brexit. Through 418 interviews with 489 participants, we find that interviewees reject elite framings and instead articulate policy preferences based on personal experiences.
AMERICAN POLITICAL SCIENCE REVIEW
(2023)
Article
Political Science
Mark Dayan, Tamara Hervey, Nick Fahy, Elizabeth Vlachakis, Martha McCarey, Mark Flear, Scott Greer, Holly Jarman
Summary: EU laws have had a significant impact on various aspects of the products essential for national health systems, including research, manufacturing, supply, sale, and procurement. Although there has been a rhetoric of competitive divergence since Brexit, the actual UK policy divergence has been limited so far. It remains uncertain whether the UK, as a small market, genuinely seeks a higher risk, industry-friendly regulatory paradigm. Additionally, the UK's attempt to remain within the EU's research funding programme has faced involuntary divergence due to ongoing negotiations on Northern Ireland's unique partial status.
JOURNAL OF EUROPEAN PUBLIC POLICY
(2023)
Article
Health Policy & Services
Nick Fahy, Tamara Hervey, Mark Dayan, Mark Flear, Mike Galsworthy, Scott Greer, Holly Jarman, Martin McKee
Summary: While policy focus is on COVID-19, the UK's post-Brexit 'transition period' is still set to end on 31 December 2020. Various aspects of the future EU-UK relationship are expected to have negative impacts on healthcare, especially in terms of NHS staffing, funding, and global influence. The UK seeks to maintain continuity in key areas like pharmaceuticals and medical devices, but will miss out on the economies of scale that come with EU membership.
HEALTH ECONOMICS POLICY AND LAW
(2021)
Article
Economics
Jean McHale, Elizabeth M. Speakman, Tamara Hervey, Mark Flear
Summary: Brexit has significant implications for UK healthcare, requiring a multilevel governance approach to address the challenges. Understanding the diverse impacts on healthcare in devolved nations and various aspects of health governance is crucial in navigating the post-Brexit landscape.
Article
Law
Kai P. Purnhagen, Anniek De Ruijter, Mark L. Flear, Tamara K. Hervey, Alexia Herwig
EUROPEAN JOURNAL OF RISK REGULATION
(2020)
Article
Law
Mark L. Flear
EUROPEAN JOURNAL OF RISK REGULATION
(2019)
Article
Education & Educational Research
Mark L. Flear, Daithi Mac Sithigh
