scholarly journals Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group

Author(s):  
Alpha Diallo ◽  
Marius Trøseid ◽  
Victoria Charlotte Simensen ◽  
Anaïs Boston ◽  
Jacques DEMOTES ◽  
...  
ESMO Open ◽  
2021 ◽  
pp. 100237
Author(s):  
Luis Castelo-Branco ◽  
Ahmad Awada ◽  
George Pentheroudakis ◽  
Jose Luis Perez-Garcia ◽  
Joaquin Mateo ◽  
...  

2012 ◽  
Vol 33 (2) ◽  
pp. 291-297 ◽  
Author(s):  
Marlene H. Peters-Lawrence ◽  
Margaret C. Bell ◽  
Lewis L. Hsu ◽  
Ifeyinwa Osunkwo ◽  
Phillip Seaman ◽  
...  

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
◽  

Abstract The European Commission's State of Health in the EU (SoHEU) initiative aims to provide factual, comparative data and insights into health and health systems in EU countries. The resulting Country Health Profiles, published every two years (current editions: November 2019) are the joint work of the European Observatory on Health Systems and Policies and the OECD, in cooperation with the European Commission. They are designed to support the efforts of Member States in their evidence-based policy making and to contribute to health care systems' strengthening. In addition to short syntheses of population health status, determinants of health and the organisation of the health system, the Country Profiles provide an assessment of the health system, looking at its effectiveness, accessibility and resilience. The idea of resilient health systems has been gaining traction among policy makers. The framework developed for the Country Profiles template sets out three dimensions and associated policy strategies and indicators as building blocks for assessing resilience. The framework adopts a broader definition of resilience, covering the ability to respond to extreme shocks as well as measures to address more predictable and chronic health system strains, such as population ageing or multimorbidity. However, the current framework predates the onset of the novel coronavirus pandemic as well as new work on resilience being done by the SoHEU project partners. This workshop aims to present resilience-enhancing strategies and challenges to a wide audience and to explore how using the evidence from the Country Profiles can contribute to strengthening health systems and improving their performance. A brief introduction on the SoHEU initiative will be followed by the main presentation on the analytical framework on resilience used for the Country Profiles. Along with country examples, we will present the wider results of an audit of the most common health system resilience strategies and challenges emerging from the 30 Country Profiles in 2019. A roundtable discussion will follow, incorporating audience contributions online. The Panel will discuss the results on resilience actions from the 2019 Country Profiles evidence, including: Why is resilience important as a practical objective and how is it related to health system strengthening and performance? How can countries use their resilience-related findings to steer national reform efforts? In addition, panellists will outline how lessons learned from country responses to the Covid-19 pandemic and new work on resilience by the Observatory (resilience policy briefs), OECD (2020 Health at a Glance) and the EC (Expert Group on Health Systems Performance Assessment (HSPA) Report on Resilience) can feed in and improve the resilience framework that will be used in the 2021 Country Profiles. Key messages Knowing what makes health systems resilient can improve their performance and ability to meet the current and future needs of their populations. The State of Health in the EU country profiles generate EU-wide evidence on the common resilience challenges facing countries’ health systems and the strategies being employed to address them.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aldo Badano

AbstractImaging clinical trials can be burdensome and often delay patient access to novel, high-quality medical devices. Tools for in silico imaging trials have significantly improved in sophistication and availability. Here, I describe some of the principal advantages of in silico imaging trials and enumerate five lessons learned during the design and execution of the first all-in silico virtual imaging clinical trial for regulatory evaluation (the VICTRE study).


2014 ◽  
Vol 12 (1-2) ◽  
pp. 90-91
Author(s):  
L. Kindler ◽  
C. McMullen ◽  
A. Owen-Smith ◽  
S. Honda ◽  
A. Firemark ◽  
...  

2011 ◽  
Vol 32 (5) ◽  
pp. 614-619 ◽  
Author(s):  
Lemuel A. Moyé ◽  
Shelly L. Sayre ◽  
Lynette Westbrook ◽  
Beth C. Jorgenson ◽  
Eileen Handberg ◽  
...  

2012 ◽  
Vol 3 (4) ◽  
pp. 477-487 ◽  
Author(s):  
Katja Biedenkopf

This article argues that European Union (EU) risk regulation of hazardous substances in electrical and electronic equipment (EEE) was both a trigger and formative factor in the development of similar Chinese regulation. The attractiveness and global interdependence of the EU market in EEE impelled a response from Chinese policy-makers. Fostering the domestic industry's global competitiveness was one of the driving factors behind Chinese substance restriction regulation. Additionally, symbolic emulation and growing domestic environmental problems related to waste EEE infl uenced the Chinese policy agenda. Chinese substance restriction rules are not, however, a mere copy of EU regulation. The limited domestic capacity of the Chinese economy, administration, and legal structure to adopt policies similar to those of the EU explains, to a large extent, the emergence and partial persistence of differences between EU and Chinese risk regulation. In the course of the implementation and evaluation of Chinese substance restriction regulation, lessons learned from the EU’s experience increasingly contributed to shaping the policy, leading to growing convergence.


2018 ◽  
Vol 16 (4) ◽  
pp. 211-212 ◽  
Author(s):  
Trijn Israels ◽  
◽  
Elizabeth M. Molyneux

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