scholarly journals Protecting Clinical Trials in Cystic Fibrosis; COVID-19 Mitigation Measures Crowd Sourced from the European Cystic Fibrosis Society Clinical Trials Network

2021 ◽  
Author(s):  
Silke van Koningsbruggen-Rietschel ◽  
Fiona Dunlevy ◽  
Veerle Bulteel ◽  
Kate Hayes ◽  
Anne Verbrugge ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Clinical Trials ◽  
Risk Mitigation ◽  
Study Drug ◽  
Home Delivery ◽  
Mitigation Measures ◽  
Site Location ◽  
Phone Calls ◽  
Source Data Verification ◽  
The Impact

Abstract The SARS-CoV-2 pandemic has disrupted clinical trials worldwide. The European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) has tracked clinical trial disruption by surveying its 58 trial sites across 17 European countries and collated information on measures to mitigate the impact of the pandemic and ensure trial continuity. Here we present recommendations on how to reduce the risk of SARS-CoV-2 exposure to patients and trial staff by implementing remote trial visits where possible, using home assessments, video and phone calls, electronic consent and home delivery of study drug. We discuss the practicalities of remote source data verification, protocol amendments, changing trial site location, and staff absences and home working. We outline how to protect trial outcomes, including home assessments, safety reporting, protocol deviations and recruitment challenges. Finally, we discuss the importance of continued access to study drug via extension trials for some patients. This guidance was co-created from the shared knowledge and experience of sites in our network and was re-distributed directly to all ECFS-CTN sites to help mitigate the impact of further waves of the SARS-CoV-2 pandemic. We will also use this guidance to assist companies, academia and consortia with future protocol design and risk mitigation plans.

scholarly journals Protecting clinical trials in cystic fibrosis during the SARS-CoV-2 pandemic: risks and mitigation measures

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Silke van Koningsbruggen-Rietschel ◽  
Fiona Dunlevy ◽  
Veerle Bulteel ◽  
Kate Hayes ◽  
Anne Verbrugge ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Clinical Trials ◽  
Risk Mitigation ◽  
Home Delivery ◽  
Mitigation Measures ◽  
Site Location ◽  
Phone Calls ◽  
Source Data Verification ◽  
The Impact

AbstractThe SARS-CoV-2 pandemic has disrupted clinical trials worldwide. The European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) has tracked clinical trial disruption by surveying its 58 trial sites across 17 European countries and collated information on measures to mitigate the impact of the pandemic and ensure trial continuity. Here, we present recommendations on how to reduce the risk of SARS-CoV-2 exposure to patients and trial staff by implementing remote trial visits where possible, using home assessments, video and phone calls, electronic consent, and home delivery of study drugs. We discuss the practicalities of remote source data verification, protocol amendments, changing trial site location, and staff absences and home working. We outline recommendations on how to protect trial outcomes, including home assessments, safety reporting, protocol deviations, and recruitment challenges. Finally, we discuss the importance of continued access to study drugs via extension trials for some patients. This guidance was co-created from the shared knowledge and experience of sites in our network and was re-distributed directly to all ECFS-CTN sites to help mitigate the impact of further waves of the SARS-CoV-2 pandemic. We will also use this guidance to assist companies, academia, and consortia with future protocol design and risk mitigation plans. This guidance can be applied to clinical trials in other diseases and could help sites that are not supported by clinical trial networks.

Technical Risks and Mitigation Measures in Combustion Turbine Project Development

2002 ◽  
Vol 125 (1) ◽  
pp. 228-235 ◽  
Author(s):  
D. Grace ◽  
J. Scheibel
Keyword(s):  
Power Plants ◽  
Development Process ◽  
Risk Mitigation ◽  
Mitigation Measures ◽  
Life Cycle Costs ◽  
Project Development ◽  
Technical Risk ◽  
Technical Risks ◽  
Interruption Costs ◽  
The Impact

Project developers, insurers, financiers, and maintenance organizations have an interest in quantifying technical risks and evaluating risk mitigation alternatives for combustion turbine (CT) power plants. By identifying exposure to risk early in the project development process, optimal procurement decisions, and mitigation measures can be adopted for improved financial returns. This paper describes a methodology used to quantify all nonfuel O&M costs, including scheduled and unplanned maintenance, and business interruption costs due to unplanned outages. The paper offers examples that demonstrate the impact of technical risk on project profitability. An overview of activities required for addressing technical risk as part of the equipment selection and procurement process is provided, and areas of technical improvements for reducing life cycle costs are described.

scholarly journals Hands-On Experience of Crowdsourcing for Flood Risks. An Android Mobile Application Tested in Frederikssund, Denmark

2018 ◽  
Vol 15 (9) ◽  
pp. 1926 ◽  
Author(s):  
Simone Frigerio ◽  
Luca Schenato ◽  
Giulia Bossi ◽  
Matteo Mantovani ◽  
Gianluca Marcato ◽  
...  
Keyword(s):  
Emergency Response ◽  
Risk Mitigation ◽  
Weather Forecast ◽  
Relevant Information ◽  
Mitigation Measures ◽  
Exposed Population ◽  
Hands On ◽  
The Impact ◽  
Near Future ◽  
Design And Testing

There is evidence that the toll of death and destruction caused by natural hazards is rising. This is often ascribed to the impact of climate change that resulted in an increased frequency of extreme meteorological events. As a consequence, it is realistic to expect that the casualties and damages caused by floods will increase in the near future. Advanced weather forecast is a fundamental tool to predict the occurrence of floods and structural mitigation measures are crucial for flood protection. However, these strategies should be associate with tools to promote and increase natural-disaster awareness and nonstructural mitigation measures in the exposed population. To bridge this gap, we coupled innovative, ICT-based technologies with crowdsourcing. The idea is to exploit geospatial data gathered by citizens and volunteers with their own devices such as mobile phones to provide authorities with relevant information in case of flood emergencies. This paper describes the design and testing of an Android application named MAppERS (Mobile Applications for Emergency Response and Support), thought to enhance active participation and response of the population in territorial and flood-risk mitigation in Frederikssund, Denmark. The results of the piloting fully validate MAppERS as an effective tool to support the decision-making process during a crisis and to improve the awareness of the community and their disaster resilience.

A proposed analytic framework for determining the impact of an antimicrobial resistance intervention

2017 ◽  
Vol 18 (1) ◽  
pp. 1-25 ◽  
Author(s):  
Yrjo T. Grohn ◽  
Carolee Carson ◽  
Cristina Lanzas ◽  
Laura Pullum ◽  
Michael Stanhope ◽  
...  
Keyword(s):  
Antimicrobial Resistance ◽  
Food Supply ◽  
Risk Mitigation ◽  
Enteric Bacteria ◽  
Mitigation Measures ◽  
Biological Synthesis ◽  
Systems Science ◽  
Suitable Framework ◽  
The Impact ◽  
The Relationship

AbstractAntimicrobial use (AMU) is increasingly threatened by antimicrobial resistance (AMR). The FDA is implementing risk mitigation measures promoting prudent AMU in food animals. Their evaluation is crucial: the AMU/AMR relationship is complex; a suitable framework to analyze interventions is unavailable. Systems science analysis, depicting variables and their associations, would help integrate mathematics/epidemiology to evaluate the relationship. This would identify informative data and models to evaluate interventions. This National Institute for Mathematical and Biological Synthesis AMR Working Group's report proposes a system framework to address the methodological gap linking livestock AMU and AMR in foodborne bacteria. It could evaluate how AMU (and interventions) impact AMR. We will evaluate pharmacokinetic/dynamic modeling techniques for projecting AMR selection pressure on enteric bacteria. We study two methods to model phenotypic AMR changes in bacteria in the food supply and evolutionary genotypic analyses determining molecular changes in phenotypic AMR. Systems science analysis integrates the methods, showing how resistance in the food supply is explained by AMU and concurrent factors influencing the whole system. This process is updated with data and techniques to improve prediction and inform improvements for AMU/AMR surveillance. Our proposed framework reflects both the AMR system's complexity, and desire for simple, reliable conclusions.

scholarly journals ANALYSING DELAY IMPACT FROM POTENTIAL RISK FACTORS ON PROJECT DELIVERY OF OIL AND GAS PIPELINE: A CASE STUDY IN IRAQ

2021 ◽  
Vol 2 (2) ◽  
Author(s):  
LAYTH A KRAIDI ◽  
Raj Shah ◽  
Wilfred Matipa ◽  
Fiona Fiona Borthwick
Keyword(s):  
Risk Factors ◽  
Oil And Gas ◽  
Risk Mitigation ◽  
Mitigation Measures ◽  
Project Delivery ◽  
Analysis Framework ◽  
Potential Risk Factors ◽  
South Of Iraq ◽  
The Impact

The aim of this paper is to present the design and specifications of an integrated Delay Analysis Framework (DAF), which could be used to quantify the delay caused by the Risk Factors (RFs) in Oil and Gas Pipelines (OGPs) projects in a simple and systematic way. The main inputs of the DAF are (i) the potential list of RFs in the projects and their impact levels on the projects and the estimated maximum and minimum duration of each task. Monte Carlo Simulation integrated within @Risk simulator was the key process algorithm that used to quantify the impact of delay caused by the associated RFs. The key output of the DAF is the amount of potential delay caused by RFs in the OGP project. The functionalities of the developed DAF were evaluated using a case study of newly developed OGP project, in the south of Iraq. It is found that the case study project might have delayed by 45 days if neglected the consideration of the RFs associated with the project at the construction stage. The paper concludes that identifying the associated RFs and analysing the potential delay in advance will help in reducing the construction delay and improving the effectiveness of the project delivery by taking suitable risk mitigation measures.  

scholarly journals Impact of COVID-19 pandemic on design and conduct of clinical trials: developing best practices based on lessons learned for risk and change management

2021 ◽  
Vol 8 (1) ◽  
pp. 79
Author(s):  
Marina A. Malikova
Keyword(s):  
Clinical Trials ◽  
Best Practices ◽  
Clinical Research ◽  
Risk Mitigation ◽  
Geographic Location ◽  
Study Drug ◽  
Lessons Learned ◽  
Drug Mechanism ◽  
Push Forward ◽  
Study Teams

<p class="abstract">The coronavirus disease 2019 (COVID- 19) pandemic is disrupting clinical research in most of the world. We have seen an immediate impact on clinical trials due to challenges coming from the COVID-19 travel bans, hospitals/clinics’ visitation restrictions, social distancing precautions and shifting operations to work remotely on a short notice. These factors have translated into the issues challenging clinical trials such as operations, milestones, budgets, data integrity, etc. Given the complex risk/benefit considerations associated with each specific clinical trial, there is no single solution to manage the risks in clinical trials conduct due to COVID-19. Each trial is unique with respect to patient population, study drug mechanism of action, concomitant medications, and geographic location needs. It is important to continue to engage the networks and communities to push forward with creative risk mitigation and develop solutions during this challenging time. Risk assessment should be a continuous and living process as the situation evolves over the coming weeks to months. Routine and ongoing cross checks with study teams are already proving to maintain alignment on key timelines, critical risk points and other study specific challenges as we are moving towards de-centralized settings in the conduct of clinical trials. We have analyzed lessons learned and attempted to develop best practices to mitigate risks and adjust clinical research operations during this unprecedented time.</p>

The changing atlas of clinical research in cancer: Measuring accessibility to clinical trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14123-e14123
Author(s):  
Luca Mazzarella ◽  
Giulia Tini ◽  
Pammolli Fabio ◽  
Righetto Lorenzo ◽  
Giuseppe Curigliano ◽  
...  
Keyword(s):  
Resource Allocation ◽  
Clinical Trials ◽  
Clinical Research ◽  
Phase 1 ◽  
Healthcare Research ◽  
Site Location ◽  
Middle Income ◽  
Trial Conduct ◽  
Global Economic Growth ◽  
The Impact

e14123 Background: The recent global economic growth produced dramatic social changes that impacted healthcare. Private industries, low and middle income countries increased their interest in clinical research. How these changes impact on accessibility to clinical trials has not been sufficiently studied, an issue becoming more relevant as trials increasingly constitute a relevant source of access to innovative drugs. Methods: We analyzed changes related to funding source, phase and locations involved in all interventional clinical trials on cancer extracted from clinicaltrials.gov from 2005 to 2019. We studied the evolution of accessibility to clinical trials on worldwide scale, by developing a family of indexes weighted on population, distance from the site location, numbers of trials. These indexes were also used to simulate different resource allocation models. Results: The absolute involvement of industry in clinical trials consistently increased (~6 fold over 2005), with a significant bias for phase 1 trials; however, its relative impact has globally remained the same. The geographical distribution of trial sites changed dramatically: some nations (China, Korea) increased their total number of trials 50 fold. The number of countries with ≥10 multicentric studies grew from 3 to 16. Our accessibility index (Table, relative increment on 2005 in parenthesis) shows that Asia had the highest improvement, with Korea and Taiwan as leading countries. The analysis captures significant trends associated with changing policies on trial conduct, such as the introduction in 2012 and abandonment in 2015 of centralized ethical committees in Brazil, or the introduction of EUdract in Europe in 2015. Simulations allowed to identify specific resource allocations to maximize accessibility. Conclusions: Accessibility to clinical trials is improving worldwide, but with important differences across continents and countries, which follow social, economic and political changes. Our accessibility indexes can inform national and continental healthcare/research policies, as they predict the impact of different resource allocation models, representing useful tools to facilitate access to innovative treatments. [Table: see text]

Residents’ perceptions of risk towards residential property in Canterbury NZ subsequent to the earthquakes

2015 ◽  
Vol 6 (3) ◽  
pp. 234-267 ◽  
Author(s):  
Sandy Bond
Keyword(s):  
Online Survey ◽  
Risk Mitigation ◽  
Mitigation Measures ◽  
Residential Property ◽  
Content Type ◽  
Perceptions Of Risk ◽  
Transient Nature ◽  
The Media ◽  
The Impact ◽  
Market Behaviour

Purpose – This paper aims to investigate residents’ perceptions of risk towards owning and living in residential property in Christchurch subsequent to the 2010 and 2011 Canterbury earthquakes to identify how these perceptions impact on the price residents are willing to pay for affected property. Such market behaviour can motivate homeowners to adopt risk mitigation measures. Design/methodology/approach – An online survey was developed and the Web link distributed to Canterbury residents via the media. This method of distribution was adopted, as a postal survey was not possible due to the number of homes that had been destroyed by the earthquakes and the highly transient nature of the community as a result. Findings – The results indicate that with the recent earthquake experience, residents are demonstrating risk mitigation behaviours through an aversion to investing in properties affected by, or with a risk of, liquefaction. Specifically, the majority of respondents had strong reservations about buying Technical Category 3 property, and would be prepared to pay 20 per cent (or > 20 per cent) less for it, indicating some stigma towards affected property. Further, most respondents would now prefer the construction of their home to be of a type that fared better in the earthquakes: lightweight, single-storey, with a concrete slab foundation. These housing preferences will likely drive the market towards the adoption of risk mitigation measures in the retrofit of existing homes as well as in the design and construction of new homes. Research limitations/implications – Due to the number of homes that had been destroyed by the earthquakes and the highly transient nature of the community as a result, probability sampling was not possible. This, together with the low response rate, means that the respondents surveyed may not be representative of the Christchurch population. Practical implications – The outcomes of this research will be of interest not only to homeowners wanting to know how their home’s value has been impacted by market perceptions towards earthquake and liquefaction damage, particularly in the worst-affected areas, but also the rating valuers tasked with assessing property values for rating purposes. Property developers and builders involved in the repair of existing homes and construction of new homes will also want to know current market preferences. Government bodies will find the results informative of how the media has, and can be used, to motivate market behaviour towards risk mitigation, particularly in regard to “material risk” (as described in Solberg et al., 2010), that is risk from a scientific and technical viewpoint of probability of future risk, and as related to what has become known about these risks in terms of building structure, height, age, soil type/land categories and flood zones. Further, the results provide a gauge of how the community perceived the handling of the recovery process, so that the weaknesses highlighted can be addressed, which will help restore community trust. Originality/value – This study fills a research void on the impact of residents’ perceptions of risk towards home ownership in a city impacted by significant earthquakes and resulting liquefaction.

Key challenges faced by Chinese contractors in Malaysian construction industry

2019 ◽  
Vol 18 (3) ◽  
pp. 705-726
Author(s):  
Jeffrey Boon Hui Yap ◽  
Sin Yi Cheah
Keyword(s):  
Factor Analysis ◽  
Performance Management ◽  
Construction Industry ◽  
Exploratory Factor Analysis ◽  
Construction Projects ◽  
Risk Mitigation ◽  
Mitigation Measures ◽  
Research Approach ◽  
Content Type ◽  
The Impact

Purpose The purpose of this paper is to investigate the major challenges faced by Chinese international contractors (CICs) in the Malaysian construction industry. Design/methodology/approach An exploratory sequential mixed-methods research approach was adopted where following a detailed literature review and semi-structured interviews with local professionals, 20 prevalent challenges experienced by CICs are identified. Subsequently, a questionnaire survey was used to elicit the views of 100 construction practitioners. Descriptive statistics were used to prioritise the challenges, while exploratory factor analysis was conducted to uncover the underlying factors. Findings The five most crucial challenges identified relate to: changes of regulation, cost control, contract clauses, language barrier and quality control. Exploratory factor analysis revealed four major underlying dimensions of these challenges, in connection to financial and government policy management, organisational performance management, supplier relationship management and cross-cultural management. Research limitations/implications The challenges are considered primarily involving CICs in the context of Malaysia; further work can be extended to Western or other East Asian, such as Japanese and Korean, international contractors undertaking construction projects in Malaysia or selected developing countries around the region. Practical implications This study will benefit professionals involved with China-backed construction projects in countries sharing demographics and socio-economic characteristics akin to Malaysia. The outcome of the study is expected to facilitate project managers to devise proactive risk-mitigation measures to reduce the impact of these challenges and to improve project delivery. Originality/value The paper examined the challenges faced by CICs in the Malaysian context. This is a timely study, as China’s Belt and Road Initiative will provide considerable opportunities for Chinese companies in Malaysia.

Observational Study of Food Safety Practices in Retail Deli Departments

2010 ◽  
Vol 73 (10) ◽  
pp. 1849-1857 ◽  
Author(s):  
M. B. LUBRAN ◽  
R. POUILLOT ◽  
S. BOHM ◽  
E. M. CALVEY ◽  
J. MENG ◽  
...  
Keyword(s):  
Food Safety ◽  
Risk Mitigation ◽  
Surface Cleaning ◽  
Hand Washing ◽  
Mitigation Measures ◽  
Chain Stores ◽  
Frequency Of Contact ◽  
State And Local ◽  
The Impact ◽  
Retail Establishments

In order to improve the safety of refrigerated ready-to-eat food products prepared at retail deli departments, a better understanding of current practices in these establishments is needed. Food employees in deli departments at six chain and three independent retail establishments in Maryland and Virginia were observed, using notational analysis, as they prepared deli products for sale. The frequency of contact with objects and deli products before sale, hand washing and glove changing during preparation, and equipment, utensil, and surface cleaning and sanitizing was determined. Compliance with the U.S. Food and Drug Administration's 2005 model Food Code recommendations, which must be adopted by the individual state and local jurisdictions that are responsible for directly regulating retail establishments, was also assessed. Observations indicated there were a large number of actions for which hand washing was recommended at independent and chain stores (273 recommended of 1,098 total actions and 439 recommended of 3,073 total actions, respectively). Moreover, 67% (295 of 439) of the actions for which hand washing was recommended at the chain stores and 86% (235 of 273) of those at the independent stores resulted from employees touching non–food contact surfaces prior to handling ready-to-eat food. Compliance with hand washing recommendations was generally low and varied depending on store type with independent stores exhibiting lower compliance than chain stores (5 instances of compliance for 273 recommended actions and 73 instances of compliance for 439 recommended actions, respectively). Potential risk mitigation measures that may reduce the frequency of hand washing actions needed during ready-to-eat food preparation in retail deli departments are discussed. More research is needed to determine the impact of such measures on food safety.

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