Dataset Information

The EU one-stop-shop collection of publicly available information on COVID-19 in vitro diagnostic medical devices.

ABSTRACT: The JRC COVID-19 In Vitro Diagnostic Devices and Test Methods Database, aimed to collect in a single place all publicly available information on performance of CE-marked in vitro diagnostic medical devices (IVDs) as well as in house laboratory-developed devices and related test methods for COVID-19, is here presented. The database, manually curated and regularly updated, has been developed as a follow-up to the Communication from the European Commission "Guidelines on in vitro diagnostic tests and their performance" of 15 April 2020 and is freely accessible at https://covid-19-diagnostics.jrc.ec.europa.eu/.

SUBMITTER: Petrillo M

PROVIDER: S-EPMC7851715 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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The EU one-stop-shop collection of publicly available information on COVID-19 in vitro diagnostic medical devices.

Petrillo Mauro M Querci Maddalena M Tkachenko Olga O Siska Ioana-Raluca IR Ben Enrico E Angers-Loustau Alexandre A Bogni Alessia A Brunetto Antonino A Fabbri Marco M Garlant Linda L Lievens Antoon A Munoz Amalia A Paracchini Valentina V Pietretti Danilo D Puertas-Gallardo Antonio A Raffael Barbara B Sarno Eleonora E Tregoat Virginie V Zaro Fabrizio F Van den Eede Guy G

F1000Research 20201103

The JRC COVID-19 In Vitro Diagnostic Devices and Test Methods Database, aimed to collect in a single place all publicly available information on performance of CE-marked in vitro diagnostic medical devices (IVDs) as well as in house laboratory-developed devices and related test methods for COVID-19, is here presented. The database, manually curated and regularly updated, has been developed as a follow-up to the Communication from the European Commission "Guidelines on in ...[more]

PMID: 33564397

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Project description:OBJECTIVES:To assess the sources of publicly available evidence supporting withdrawal, revocation or suspension of marketing authorisations ('regulatory actions') due to safety reasons in the EU since 2012 and to investigate the time taken since initial marketing authorisation to reach these regulatory decisions. SETTING:This investigation examined the sources of evidence supporting 18 identified prescription medicinal products which underwent regulatory action due to safety reasons within the EU in the period 1 July 2012 to 31 December 2016. RESULTS:Eighteen single or combined active substances ('medicinal products') withdrawn, revoked or suspended within the EU for safety reasons between 2012 and 2016 met the inclusion criteria. Case reports were most commonly cited, supporting 94.4% of regulatory actions (n=17), followed by randomised controlled trial, meta-analyses, animal and in vitro, ex vivo or in silico study designs, each cited in 72.2% of regulatory actions (n=13). Epidemiological study designs were least commonly cited (n=8, 44.4%). Multiple sources of evidence contributed to 94.4% of regulatory decisions (n=17). Death was the most common adverse drug reaction leading to regulatory action (n=5; 27.8%), with four of these related to medication error or overdose. Median (IQR) time taken to reach a decision from the start of regulatory review was found to be 204.5 days (143, 535 days) and decreased across the study period. Duration of marketing prior to regulatory action, from the medicinal product's authorisation date, increased across the period 2012-2016. CONCLUSIONS:The sources of evidence supporting pharmacovigilance regulatory activities appear to have changed since implementation of Directive 2010/84/EU and Regulation (EU) No. 1235/2010. This, together with a small improvement in regulatory efficiency, suggests progress towards more rapid regulatory decisions based on more robust evidence. Future research should continue to monitor sources of evidence supporting regulatory decisions and the time taken to reach these decisions over time.

Project description:One of the most valuable initiatives on massive availability of biodiversity data is the Global Biodiversity Information Facility, which is creating new opportunities to develop and test macroecological knowledge. However, the potential uses of these data are limited by the gaps and biases associated to large-scale distributional databases (the so-called Wallacean shortfall). Describing and quantifying these limitations are essential to improve knowledge on biodiversity, especially in poorly-studied groups, such as mosses. Here we assess the coverage of the publicly-available distributional information on Iberian mosses, defining its eventual biases and gaps. For this purpose, we compiled IberBryo v1.0, a database that comprises 82,582 records after processing and checking the geospatial and taxonomical information. Our results show the limitations of data and metadata of the publicly-available information. Particularly, ca. 42% of the records lacked collecting date information, which limits data usefulness for time coverage analyses and enlarges the existing knowledge gaps. Then we evaluated the overall coverage of several aspects of the spatial, temporal and environmental variability of the Iberian Peninsula. Through this assessment, we demonstrate that the publicly-available information on Iberian mosses presents significant biases. Inventory completeness is strongly conditioned by the recorders' survey bias, particularly in northern Portugal and eastern Spain and the spatial pattern of surveys is also biased towards mountains. Besides, the temporal pattern of survey effort intensifies from 1970 onwards, encompassing a progressive increase in the geographic coverage of the Iberian Peninsula. Although we just found 5% of well-surveyed cells of 30' of resolution over the 1970-2018 period, they cover about a fifth of the main climatic gradients of the Iberian Peninsula, which provides a fair - though limited - coverage. Yet, the well-surveyed cells are biased towards anthropised areas and some of them are located in areas under intense land-use changes, mainly due to the wood-fires of the last decade. Despite the overall increase, we found a noticeable gap of information in the south-west of Iberia, the Ebro river basin and the inner plateaus. All these gaps and biases call for a careful use of the available distributional data of Iberian mosses for biogeographical and ecological modelling analysis. Further, our results highlight the necessity of incorporating several good practices to increase the coverage of high-quality information. These good practices include digitalisation of specimens and metadata information, improvement on the protocols to get accurate data and metadata or revisions of the vouchers and recorders' field notebooks. These procedures are essential to improve the quality and coverage of the data. Finally, we also encourage Iberian bryologists to establish a series of re-surveys of classical localities that would allow updating the information on the group, as well as to design their future surveys considering the most important information gaps on IberBryo.

Dataset Information

The EU one-stop-shop collection of publicly available information on COVID-19 in vitro diagnostic medical devices.

Publications

The EU one-stop-shop collection of publicly available information on COVID-19 <i>in vitro</i> diagnostic medical devices.

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