Insights into implementation planning for point-of-care testing to guide treatment of chronic obstructive pulmonary disease exacerbation: a mixed methods feasibility study

Frontiers in Health Services, Journal Year: 2024, Volume and Issue: 3

Published: Jan. 3, 2024

The purpose of this mixed methods feasibility study was to gain insights into unmet clinical needs, stakeholder preferences and potential barriers enablers adoption for planning the implementation point-of-care testing earlier detection guided treatment chronic obstructive pulmonary disease (COPD) acute exacerbation in NHS England. Exacerbations COPD cause considerable mortality morbidity. Earlier identification exacerbations would lead reduced duration, hospitalizations mortality, improve health-related quality life, reduce unnecessary treatments (including inappropriate antibiotic prescribing) which could save over £400 per patient. During early stages product design, we took a multi-disciplinary approach evidence generation, gaining from key stakeholders test concept inform evidence-based planning. Primary data collected 11 health care service professionals involved management exacerbations. Overall, participants agreed that by differentiation stable COPD, patients be started on appropriate treatment. To implement practice, is required demonstrate accuracy differentiating between etiologies provide information beneficial impact system terms optimized management, long-term side effects, admission avoidance, cost-effectiveness. This research provides an base future exacerbation. Moreover, technology developers can decide whether refine design value proposition thereby de-risking development.

Language: Английский

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Problems of creating an effective system of health technology assessment at the early stages of the drug life cycle

Social pharmacy in health care, Journal Year: 2024, Volume and Issue: 10(1), P. 11 - 20

Published: May 2, 2024

Aim. To study modern approaches to the formation and functioning of Horizon Scanning (HS) system early health technology assessment (HTА), in particular, for treatment rare diseases with significant unmet medical needs. Materials methods. The analysis, systematization synthesis data from scientific publications, analytical reports, guidelines, information official websites regulatory authorities, HTА HS agencies were used. Results. analysis theoretical foundations support processes forming an effective at stages life cycle has been performed. systems, so-called “early awareness alert systems”, are aimed identifying, filtering prioritizing new innovative technologies a predicted impact on health, costs, society healthcare order inform policy makers, purchasers providers or improve access. allows proactive planning decision-making use reimbursement medicines based preliminary assessments budgetary clinical efficacy. Conclusions. For national HTA system, which currently is stage development, it important adapt positive international experience this area provide functionality HS, assessment, dialogue, managed access development evidence base. It advisable apply “light” model join cooperation area.

Language: Английский

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EMERGINCaRE, le dispositif d’horizon scanning dédié aux médicaments anticancéreux développé par l’Institut national du cancer

Bulletin du Cancer, Journal Year: 2024, Volume and Issue: 111(9), P. 812 - 821

Published: June 24, 2024

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Immune-reactive tumor organoids system to determine the effects of microbial metabolites on cancer immunity and immunotherapies

Frontiers in Microbiomes, Journal Year: 2024, Volume and Issue: 3

Published: Oct. 7, 2024

Immunotherapies are a revolutionary approach to treating cancer by utilizing the body’s immune system target and combat cells. This offers promising alternatives traditional chemotherapies. Its potential induce long-lasting remissions specificity for cells, which minimizes side effects, makes it cutting-edge treatment with tremendous potential. With increase of clinical usage immunotherapy, evidence emerges microbiome’s impact on both tumor growth response immunotherapy. The proposed involvement microbiome can change efficacy altering drug metabolism reshaping response. Understanding specific interactions between is critical step in advancement To study complex interaction immunity microbiome, various preclinical vivo vitro models have been developed. We recently described use an ex model anti-cancer outcome prediction –tumor tissue equivalents (organoids). Specifically, immune-reactive organoids as novel tool understanding how influences More importantly, this platform utilize patient samples dissect patient-specific elements regulating influence. review presents rationale using It will discuss available components analyze their interplay, summarize relevant experimental data, assess validity. Additionally, explores personalized approaches. role immunotherapy outcomes lead transformative via simple diet or other manipulations. Ongoing research microbiome-cancer systems innovative strategies improved outcomes.

Language: Английский

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MedTech innovation identification: A rapid scoping review of patent research studies to inform horizon scanning methods (Preprint)

Published: Dec. 19, 2024

This study investigates the role of and methods for patent analysis in advancing medical technology (MedTech) innovation, a sector characterized by diverse, non-pharmacological or non-immunological healthcare technologies significant research investment. Patents are critical early indicators supporting horizon scanning weak signal detection. The aimed to identify intellectual property sources, evaluate retrieval analysis, outline objectives using data anticipate trends inform strategies. It also offered methodological framework support stakeholders adopting innovative MedTech solutions. A rapid review (RR) was conducted Cochrane Rapid Review Methods PRISMA guidelines, with pre-registered protocol on Open Science Framework. Searches Embase, IEEE Xplore, Web targeted records from 2020 onwards. Three independent reviewers screened studies Rayyan. We included any type, published since that provided sufficient tools applied MedTech. Our extraction bibliographic details, characteristics, information. Risk bias assessments were not undertaken. Narrative tabular methods, supplemented visual charts, employed synthesise findings. searches identified 1,741 studies, which 124 after title, abstract, full-text screening, 54% being original research, 44% reviews, remainder conference abstracts. Most (68%) relied solely databases, while others searched grey literature. Research grouped into nine themes, trend (50%) policy recommendations (20%) most common. analysed 199 27% multiple sources. Time horizons averaged 24.6 years, ranging 1900 2019. Automated approaches, 33% frequently utilised like Gephi network visualization. Disease mapping, based NICE classification, indicated cancer (19%) respiratory conditions (16%), particularly COVID-19, key areas, digital health dominated "health social care delivery" category. highlights value its broader shaping policies While patents provide crucial insights emerging technologies, inconsistent de-duplication practices across pose risk inflation, accentuating need transparency rigour. Finally, this emphasized importance transformation visualization detecting Python R commonly used programming languages developing custom tools. N/A

Language: Английский

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Platform Technology in Global Vaccine Regulation: Development, Applications, and Regulatory Strategies with Insights from China

Vaccines, Journal Year: 2024, Volume and Issue: 12(12), P. 1436 - 1436

Published: Dec. 20, 2024

The concept of "platform technology" gained prominence after the Ebola outbreak and since then has become essential to international vaccine (prophylactic vaccines against infectious disease) regulatory frameworks. Its significance was further amplified during COVID-19 pandemic, where platform technology enabled rapid development approval vaccines, optimizing processes, enhancing global public health responses. As a transformative tool, streamlines product development, allowing for reduction in number clinical trials or exemption from certain facilitating cross-referencing submissions. Despite significant efforts establish standardized procedures, challenges remain, particularly achieving unified definition application across regions. This paper explores evolution, applications, strategies technology, with focus on China's experience this field. approach, encompassing risk assessment, expedited emergency offers valuable insights into coordination. By analyzing contributions practices, highlights potential address future pandemics, including "Pathogen X", underscores importance harmonizing strengthen preparedness response.

Language: Английский

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Methodological approaches to assessing digital maturity of logistics activities of pharmaceutical enterprises

ScienceRise Pharmaceutical Science, Journal Year: 2023, Volume and Issue: 4(44), P. 76 - 88

Published: Aug. 31, 2023

The aim: development of methodological approaches to assessing the digital maturity logistics activity a pharmaceutical enterprise and elaboration proposed methodology on example those domestic enterprises that have developed system some experience in implementation technologies activities. Materials methods: Research was conducted using databases Internet: European Center for Information Systems Research, Medicines Agency, scientific metric - Scopus, Web Science. Logical, systematic analysis synthesis, graphic methods research, mathematical statistical (expert, pair correlation taxonomic) were used. results. An state carried out enterprises, which been leaders market recent years. It is substantiated assessment mandatory prerequisite transformation entities. existing models are analyzed, their shortcomings identified. Based this, activities proposed. algorithm practical application taxonomic method, calculation integral indicator level out. priorities determined depending degree maturity. Conclusions. has proven complex process must consider many factors internal external environment enterprise. impossible form strategy make decisions about investing without first your real opportunities weak points That why an important step way digitalization methodical will allow holistic view certain its deviation from desired state, determine priority directions increasing maturity, based specifics particular enterprise, develop sound improve performance both individual business supply chain

Language: Английский

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Pharmaceuticals, toxicity and antimicrobial resistance. Advancing human health and environmental risk assessment

Published: Sept. 25, 2023

Pharmaceuticals are an indispensable tool against disease and morbidity in humans animals. However, their use also poses some challenges can lead to undesirable consequences, of the most concerning which increased environmental pollution antimicrobial resistance. The assessment human health risks posed by pharmaceuticals is a critical exercise help make best available knowledge identify data gaps prioritize strategies holding promise. goal this dissertation was assess pharmaceutical aquatic system via exposure. concentrations activities transboundary European Vecht River were used demonstrate idea. In addition, selective pressure potential antibiotics over antibiotic-resistance genes investigated artificial natural environments. Taken together, we how risk remains resourceful support targeted emission exposure reduction (local) responsible authorities. Using, statistical mathematical modelling, contributed advancement tailored resistance environment.

Language: Английский

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Recent Advances in Regulatory Science for Pharmaceutical Development and Approval

Journal of Pharmaceutical Research, Journal Year: 2023, Volume and Issue: 8(2)

Published: July 18, 2023

Regulatory science is a vital component of pharmaceutical development and approval processes, ensuring the safety, efficacy, quality drugs. This article provides an overview background importance regulatory in industry. It highlights critical role plays supporting innovation creating predictable transparent environment. Recent advances are discussed, including use real-world evidence, innovative trial designs, advancements gene cell therapies. These developments have potential to revolutionize drug approval, offering new treatment options improving patient outcomes. However, they also introduce challenges that need be addressed, such as reliability evidence adapting complex landscape Understanding evolving field crucial for professionals navigate bring safe effective therapies patients.

Language: Английский

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