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  1. Article ; Online: Experiences and challenges with the new European Clinical Trials Regulation.

    Patrick-Brown, Thale D J H / Bourner, Josephine / Kali, Sabrina / Trøseid, Marius / Yazdanpanah, Yazdan / Olliaro, Piero / Olsen, Inge Christoffer

    Trials

    2024  Volume 25, Issue 1, Page(s) 3

    Abstract: Background: The new European Medicines Agency (EMA) Clinical Trials Information System (CTIS), based on the Clinical Trials Regulation (CTR EU 536/2014), came into full effect on 31 January 2022 and was intended to provide an easier, more streamlined ... ...

    Abstract Background: The new European Medicines Agency (EMA) Clinical Trials Information System (CTIS), based on the Clinical Trials Regulation (CTR EU 536/2014), came into full effect on 31 January 2022 and was intended to provide an easier, more streamlined approach to the registration of clinical trials taking place in Europe. Using the experience gained on the new regulatory framework from three multi-national European clinical research studies of outbreak-prone infectious diseases, this article describes the advantages and shortcomings of the new clinical trial submission procedure.
    Methods: We report the time to approval, size of the application dossier, and number of requests for information (RFIs) for each study. We also explore the experience of each study within the regulatory framework and its use of CTIS to document the real-world, practical consequences of the system on individual studies. The study assesses the experience of three multi-country studies conducted in Europe working within the EU and non-EU regulatory environments.
    Results: While the time to regulatory and ethical approval has improved since the implementation of the new regulation, the timelines for approvals are still unacceptably slow, particularly for studies being conducted in the context of an evolving outbreak. Within the new regulatory approval procedure, there is evidence of conflicting application requirements, increased document burden, barriers to submitting important modifications, and debilitating technical hurdles.
    Conclusions: CTIS promised to lower the administrative bar, but unfortunately this has not been achieved. There are challenges that need to be urgently confronted and addressed for international research collaborators to effectively manage health crises in the future. While the value of multi-national outbreak research is clear, the limitations and delays imposed by the system, which raise challenging ethical questions about the regulation, are prejudicial to all clinical research, especially publicly funded academic studies. This report is relevant to both regulators and clinical researchers. It is hoped that these findings can help improve pan-European clinical trials, especially for the purpose of epidemic preparedness and response.
    Trial registration: This paper references experiences gained during management of three pan-European trials: EU-SolidAct's Bari-SolidAct (CT No. 2022-500385-99-00 - 15 March 2022) and AXL-SolidAct (CT No. 2022-500363-12-00 - 19 April 2022), and MOSAIC (CT No. 2022-501132-42-00 - 22 June 2022).
    MeSH term(s) Humans ; Europe ; Forecasting ; Clinical Trials as Topic
    Language English
    Publishing date 2024-01-02
    Publishing country England
    Document type Journal Article
    ZDB-ID 2040523-6
    ISSN 1745-6215 ; 1468-6694 ; 1745-6215
    ISSN (online) 1745-6215
    ISSN 1468-6694 ; 1745-6215
    DOI 10.1186/s13063-023-07869-x
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  2. Article ; Online: Experiences and challenges with the new European Clinical Trials Regulation

    Thale D. J. H. Patrick-Brown / Josephine Bourner / Sabrina Kali / Marius Trøseid / Yazdan Yazdanpanah / Piero Olliaro / Inge Christoffer Olsen

    Trials, Vol 25, Iss 1, Pp 1-

    2024  Volume 9

    Abstract: Abstract Background The new European Medicines Agency (EMA) Clinical Trials Information System (CTIS), based on the Clinical Trials Regulation (CTR EU 536/2014), came into full effect on 31 January 2022 and was intended to provide an easier, more ... ...

    Abstract Abstract Background The new European Medicines Agency (EMA) Clinical Trials Information System (CTIS), based on the Clinical Trials Regulation (CTR EU 536/2014), came into full effect on 31 January 2022 and was intended to provide an easier, more streamlined approach to the registration of clinical trials taking place in Europe. Using the experience gained on the new regulatory framework from three multi-national European clinical research studies of outbreak-prone infectious diseases, this article describes the advantages and shortcomings of the new clinical trial submission procedure. Methods We report the time to approval, size of the application dossier, and number of requests for information (RFIs) for each study. We also explore the experience of each study within the regulatory framework and its use of CTIS to document the real-world, practical consequences of the system on individual studies. The study assesses the experience of three multi-country studies conducted in Europe working within the EU and non-EU regulatory environments. Results While the time to regulatory and ethical approval has improved since the implementation of the new regulation, the timelines for approvals are still unacceptably slow, particularly for studies being conducted in the context of an evolving outbreak. Within the new regulatory approval procedure, there is evidence of conflicting application requirements, increased document burden, barriers to submitting important modifications, and debilitating technical hurdles. Conclusions CTIS promised to lower the administrative bar, but unfortunately this has not been achieved. There are challenges that need to be urgently confronted and addressed for international research collaborators to effectively manage health crises in the future. While the value of multi-national outbreak research is clear, the limitations and delays imposed by the system, which raise challenging ethical questions about the regulation, are prejudicial to all clinical research, especially publicly funded ...
    Keywords Clinical trial ; Government regulation ; Pandemics ; Epidemics ; Multicenter trials ; Medicine (General) ; R5-920
    Subject code 320 ; 610
    Language English
    Publishing date 2024-01-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Determining a minimum data set for reporting clinical and radiologic data for pseudomyxoma peritonei.

    Patrick-Brown, Thale D J H / Mohamed, Faheez / Thrower, Andrew / Torgunrud, Annette / Cosyns, Sarah / Canbay, Emel / Villeneuve, Laurent / Flatmark, Kjersti / Brandl, Andreas

    Pleura and peritoneum

    2023  Volume 8, Issue 1, Page(s) 1–9

    Abstract: Objectives: Pseudomyxoma peritonei (PMP) is a rare cancer currently affecting over 11,736 patients across Europe. Since PMP is so uncommon, collaboration between scientific centers is key to discovering the mechanisms behind the disease, efficient ... ...

    Abstract Objectives: Pseudomyxoma peritonei (PMP) is a rare cancer currently affecting over 11,736 patients across Europe. Since PMP is so uncommon, collaboration between scientific centers is key to discovering the mechanisms behind the disease, efficient treatments, and targets pointing to a cure. To date, no consensus has been reached on the minimum data that should be collected during PMP research studies. This issue has become more important as biobanking becomes the norm. This paper begins the discussion around a minimum data set that should be collected by researchers through a review of available clinical trial reports in order to facilitate collaborative efforts within the PMP research community.
    Content: A review of articles from PubMed, CenterWatch, ClinicalTrials.gov and MedRxiv was undertaken, and clinical trials reporting PMP results selected.
    Summary: There is a core set of data that researchers report, including age and sex, overall survival, peritoneal cancer index (PCI) score, and completeness of cytoreduction, but after this, reports become variable.
    Outlook: Since PMP is a rare disease, it is important that reports include as large of a number of standardised data points as possible. Our research indicates that there is still much ground to cover before this becomes a reality.
    Language English
    Publishing date 2023-03-21
    Publishing country Germany
    Document type Journal Article ; Review
    ZDB-ID 2861909-2
    ISSN 2364-768X ; 2364-7671
    ISSN (online) 2364-768X
    ISSN 2364-7671
    DOI 10.1515/pp-2022-0200
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  4. Article ; Online: Ambient air quality and spatio-temporal patterns of cardiovascular emergency department visits

    Eun-Hye Yoo / Patrick Brown / Youngseob Eum

    International Journal of Health Geographics, Vol 17, Iss 1, Pp 1-

    2018  Volume 16

    Abstract: Abstract Background Air pollutants have been associated with various adverse health effects, including increased rates of hospital admissions and emergency room visits. Although numerous time-series studies and case-crossover studies have estimated ... ...

    Abstract Abstract Background Air pollutants have been associated with various adverse health effects, including increased rates of hospital admissions and emergency room visits. Although numerous time-series studies and case-crossover studies have estimated associations between day-to-day variation in pollutant levels and mortality/morbidity records, studies on geographic variations in emergency department use and the spatial effects in their associations with air pollution exposure are rare. Methods We focused on the elderly who visited emergency room for cardiovascular related disease (CVD) in 2011. Using spatially and temporally resolved multi-pollutant exposures, we investigated the effect of short-term exposures to ambient air pollution on emergency department utilization. We developed two statistical models with and without spatial random effects within a hierarchical Bayesian framework to capture the spatial heterogeneity and spatial autocorrelation remaining in emergency department utilization. Results Although the cardiovascular effect of spatially homogeneous pollutants, such as PM2.5 and ozone, was unchanged, we found the cardiovascular effect of NO$$_2$$ 2 was pronounced after accounting for the spatially correlated structure in emergency department utilization. We also identified areas with high ED utilization for CVD among the elderly and assessed the uncertainty associated with risk estimates. Conclusions We assessed the short-term effect of multi-pollutants on cardiovascular risk of the elderly and demonstrated the use of community multiscale air quality model-derived spatially and temporally resolved multi-pollutant exposures to an epidemiological study. Our results indicate that NO$$_2$$ 2 was significantly associated with the elevated ED utilization for CVD among the elderly.
    Keywords Cardiovascular disease (CVD) ; Emergency department (ED) visits ; Hierarchical Bayesian model ; Community multiscale air quality (CMAQ) ; Ambient air quality ; Spatial effects ; Computer applications to medicine. Medical informatics ; R858-859.7
    Subject code 333
    Language English
    Publishing date 2018-06-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Identifying the changing age distribution of opioid-related mortality with high-frequency data

    Lauren A. Paul / Ye Li / Pamela Leece / Tara Gomes / Ahmed M. Bayoumi / Jeremy Herring / Regan Murray / Patrick Brown

    PLoS ONE, Vol 17, Iss

    2022  Volume 4

    Abstract: Background Opioid-related mortality continues to rise across North America, and mortality rates have been further exacerbated by the COVID-19 pandemic. This study sought to provide an updated picture of trends of opioid-related mortality for Ontario, ... ...

    Abstract Background Opioid-related mortality continues to rise across North America, and mortality rates have been further exacerbated by the COVID-19 pandemic. This study sought to provide an updated picture of trends of opioid-related mortality for Ontario, Canada between January 2003 and December 2020, in relation to age and sex. Methods Using mortality data from the Office of the Chief Coroner for Ontario, we applied Bayesian Poisson regression to model age/sex mortality per 100,000 person-years, including random walks to flexibly capture age and time effects. Models were also used to explore how trends might continue into 2022, considering both pre- and post-COVID-19 courses. Results From 2003 to 2020, there were 11,633 opioid-related deaths in Ontario. A shift in the age distribution of mortality was observed, with the greatest mortality rates now among younger individuals. In 2003, mortality rates reached maximums at 5.5 deaths per 100,000 person-years (95% credible interval: 4.0–7.6) for males around age 44 and 2.2 deaths per 100,000 person-years (95% CI: 1.5–3.2) for females around age 51. As of 2020, rates have reached maximums at 67.2 deaths per 100,000 person-years (95% CI: 55.3–81.5) for males around age 35 and 16.8 deaths per 100,000 person-years (95% CI: 12.8–22.0) for females around age 37. Our models estimate that opioid-related mortality among the younger population will continue to grow, and that current conditions could lead to male mortality rates that are more than quadruple those of pre-pandemic estimations. Conclusions This analysis may inform a refocusing of public health strategy for reducing rising rates of opioid-related mortality, including effectively reaching both older and younger males, as well as young females, with health and social supports such as treatment and harm reduction measures.
    Keywords Medicine ; R ; Science ; Q
    Subject code 310
    Language English
    Publishing date 2022-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article: Automatic mapping of planting year for tree crops with Landsat satellite time series stacks

    Chen, Bin / Yufang Jin / Patrick Brown

    International Society for Photogrammetry and Remote Sensing, Inc. (ISPRS) ISPRS journal of photogrammetry and remote sensing. 2019 May, v. 151

    2019  

    Abstract: California’s Central Valley faces serious challenges of water scarcity and degraded groundwater quality due to nitrogen leaching. Orchard age is one of the key determinants for fruit and nut production and directly affects consumptive water use and ... ...

    Abstract California’s Central Valley faces serious challenges of water scarcity and degraded groundwater quality due to nitrogen leaching. Orchard age is one of the key determinants for fruit and nut production and directly affects consumptive water use and fertilizer demand. However, regional and statewide spatially explicit information on orchard planting years in California is still lacking, despite some attempts to estimate tree ages using multi-temporal satellite imagery in other regions. Here we developed a robust detection method to track crop cover dynamics and identify the planting year through time series of Landsat imagery within the Google Earth Engine (GEE) platform. We used the full archive of Landsat data (Landsat-5 TM, Landsat-7 ETM+, and Landsat-8 OLI) from 1984 to 2017 as inputs and automated the GEE workflow for the on-fly-mapping. Preprocessing was initially performed using JavaScript to obtain high quality reflectance and Normalized Difference Vegetation Index (NDVI) time series for each Landsat pixel. Annual maximum NDVI was then aggregated to the orchard level based on the field boundary. Our change detection algorithm incorporated a set of decision rules, including adaptive identification of potential years with robust Z-score thresholds, elimination of false detections based on the post-planting growth curve, and estimation of planting year using the most recent minimum strategy. Our method showed a very high accuracy of estimating tree crop ages, with a R2 of 0.96 and a mean absolute error of less than half a year, when compared with 142 records provided by almond growers. We further evaluated the accuracy of the statewide mapping of planting years for all fruit and nut trees in California, and found an overall agreement of 89.2%. This automatic cloud-based application is expected to greatly strengthen our ability to forecast yield dynamics, estimate water use and fertilizer inputs, at individual field, county and statewide basis.
    Keywords Internet ; Landsat ; algorithms ; almonds ; computer software ; crops ; fertilizers ; fruits ; growers ; growth curves ; leaching ; nitrogen ; normalized difference vegetation index ; nut trees ; orchards ; planting date ; reflectance ; remote sensing ; time series analysis ; water quality ; water shortages ; California
    Language English
    Dates of publication 2019-05
    Size p. 176-188.
    Publishing place Elsevier B.V.
    Document type Article
    ZDB-ID 1007774-1
    ISSN 0924-2716
    ISSN 0924-2716
    DOI 10.1016/j.isprsjprs.2019.03.012
    Database NAL-Catalogue (AGRICOLA)

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  7. Article ; Online: Estimating the Prevalence of Pseudomyxoma Peritonei in Europe Using a Novel Statistical Method.

    Patrick-Brown, Thale Dawn J H / Carr, Norman John / Swanson, David M / Larsen, Stein / Mohamed, Faheez / Flatmark, Kjersti

    Annals of surgical oncology

    2020  Volume 28, Issue 1, Page(s) 252–257

    Abstract: Background: The determination of the incidence and prevalence of rare diseases is important for economists and health-care providers. Pseudomyxoma peritonei (PMP) is a rare, slow-growing abdominal cancer that represents a substantial burden on both ... ...

    Abstract Background: The determination of the incidence and prevalence of rare diseases is important for economists and health-care providers. Pseudomyxoma peritonei (PMP) is a rare, slow-growing abdominal cancer that represents a substantial burden on both patients and health-care systems. The incidence rate was previously approximated at 1-2 people per million per year; this incidence has never been challenged, and the prevalence has not been estimated.
    Methods: Epidemiological data from Norway and England were obtained and analysed to calculate a minimum incidence rate based on the number of patients having a first surgical intervention for PMP. A novel method was then used to determine a prevalence rate for PMP, incorporating incidence, death, and cure rates in a multi-year analysis that accounted for the increasing population of Europe over a 10-year period.
    Results: An incidence rate of 3.2 people per million per year was calculated, with a corresponding estimated prevalence rate of 22 people per million per year. By this calculation, 11,736 people in Europe were estimated to be living with PMP in 2018.
    Conclusion: Incidence and prevalence are essential tools for assessment of the financial and human cost of a disease. For rare diseases, such as PMP, the lack of accurate registries presents a particular challenge in determining such health-related statistical parameters. Based on our calculations, a significant number of people are living with PMP in Europe, underlining the need for appropriate resource allocation to ensure that adequate health-care measures are provided.
    MeSH term(s) Europe/epidemiology ; Humans ; Norway ; Peritoneal Neoplasms/epidemiology ; Prevalence ; Pseudomyxoma Peritonei/epidemiology
    Language English
    Publishing date 2020-06-02
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1200469-8
    ISSN 1534-4681 ; 1068-9265
    ISSN (online) 1534-4681
    ISSN 1068-9265
    DOI 10.1245/s10434-020-08655-8
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    In stock of ZB MED Cologne/Königswinter

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  8. Article ; Online: Collaboration for Impact

    Juliet Rayment / Manbinder Sidhu / Polly Wright / Patrick Brown / Sheila Greenfield / Stephen Jeffreys / Nicola Gale

    International Journal of Integrated Care, Vol 20, Iss

    Co-creating a Workforce Development Toolkit Using an Arts-based Approach

    2020  Volume 2

    Abstract: Introduction: The identification, communication and management of health risk is a core task of Community Health Workers who operate at the boundaries of community and primary care, often through not-for-profit community interest companies. However, ... ...

    Abstract Introduction: The identification, communication and management of health risk is a core task of Community Health Workers who operate at the boundaries of community and primary care, often through not-for-profit community interest companies. However, there are few opportunities or resources for workforce development. Publicly funded researchers have an obligation to be useful to the public and furthermore, university funding is increasingly contingent on demonstrating the social impact of academic research. Collaborative work with participants and other stakeholders can have reciprocal benefits to all but may be daunting to some researchers, unused to such approaches. Methods: This case study is an account of the co-creation of a (freely accessible) workforce development toolkit, as part of a collaboration between academics, community interest companies, patients and services users and arts practitioners. Results: Our collaborative group produced three short films, fictionalising encounters between Community Health Workers and their clients. These were used within a series of five discussion-led workshops with facilitator guidance to explore issues generated by the films. Two collaborating community-based, not-for-profit organisations piloted the toolkit before its launch. Conclusion: We aim to encourage other academics to maximise the impact of their own research through collaborative projects with those outside of academia, including research participants and to consider the potential value of arts-based approaches to explore and facilitate reflection on complex tasks and tensions that make up daily work practices. Whilst publication of findings from such projects may be commonplace, accounts of the process are unusual. This detailed account highlights some of the benefits and challenges involved.
    Keywords risk ; arts-based methods ; community health workers ; collaboration ; workforce ; Medicine (General) ; R5-920
    Subject code 306
    Language English
    Publishing date 2020-06-01T00:00:00Z
    Publisher Ubiquity Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  9. Article ; Online: Development and validation of the Trust in Government measure (TGM)

    Kathleen E. Burns / Patrick Brown / Michael Calnan / Paul R. Ward / Jerrica Little / Gustavo S. Betini / Christopher M. Perlman / Helena Godinho Nascimento / Samantha B. Meyer

    BMC Public Health, Vol 23, Iss 1, Pp 1-

    2023  Volume 14

    Abstract: Abstract Background Trust in government is associated with health behaviours and is an important consideration in population health interventions. While there is a reported decline in public trust in government across OECD countries, the tools used to ... ...

    Abstract Abstract Background Trust in government is associated with health behaviours and is an important consideration in population health interventions. While there is a reported decline in public trust in government across OECD countries, the tools used to measure trust are limited in their use for informing action to (re)build trust, and have limitations related to reliability and validity. To address the limitations of existing measures available to track public trust, the aim of the present work was to develop a new measure of trust in government. Methods Fifty-six qualitative interviews (Aug-Oct 2021; oversampling for equity-deserving populations) were conducted to design a national survey, including factor analyses and validation testing (N = 878; June 1-14th 2022) in Canada. Results The measure demonstrated strong internal consistency (α = 0.96) and test validity (CFI = 0.96, RMSEA = 0.09, SRMR = 0.03), suggesting that trust in government can be measured as a single underlying construct. It also demonstrated strong criterion validity, as measured by significant (p < 0.0001) associations of scores with vaccine hesitancy, vaccine conspiracy beliefs, COVID-19 conspiracy beliefs, trust in public health messaging about COVID-19, and trust in public health advice about COVID-19. We present the Trust in Government Measure (TGM); a 13-item unidimensional measure of trust in Federal government. Conclusions This measure can be used within high-income countries, particularly member countries within the OECD already in support of using tools to collect, publish and compare statistics. Our measure should be used by researchers and policy makers to measure trust in government as a key indicator of societal and public health.
    Keywords Trust ; OECD ; Measure ; Federal ; Government ; Validation ; Public aspects of medicine ; RA1-1270
    Subject code 336
    Language English
    Publishing date 2023-10-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  10. Article ; Online: Determining a minimum data set for reporting clinical and radiologic data for pseudomyxoma peritonei

    Patrick-Brown Thale D.J.H. / Mohamed Faheez / Thrower Andrew / Torgunrud Annette / Cosyns Sarah / Canbay Emel / Villeneuve Laurent / Flatmark Kjersti / Brandl Andreas

    Pleura and Peritoneum, Vol 8, Iss 1, Pp 1-

    2023  Volume 9

    Abstract: Pseudomyxoma peritonei (PMP) is a rare cancer currently affecting over 11,736 patients across Europe. Since PMP is so uncommon, collaboration between scientific centers is key to discovering the mechanisms behind the disease, efficient treatments, and ... ...

    Abstract Pseudomyxoma peritonei (PMP) is a rare cancer currently affecting over 11,736 patients across Europe. Since PMP is so uncommon, collaboration between scientific centers is key to discovering the mechanisms behind the disease, efficient treatments, and targets pointing to a cure. To date, no consensus has been reached on the minimum data that should be collected during PMP research studies. This issue has become more important as biobanking becomes the norm. This paper begins the discussion around a minimum data set that should be collected by researchers through a review of available clinical trial reports in order to facilitate collaborative efforts within the PMP research community.
    Keywords biobanking ; data science ; investigative techniques ; neoplasm ; peritoneum ; pseudomyxoma peritonei ; Medicine ; R ; Specialties of internal medicine ; RC581-951
    Language English
    Publishing date 2023-03-01T00:00:00Z
    Publisher De Gruyter
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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