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1 – 10 of over 40000Examines a particular system for reporting clinical trials: the revised CONSORT system. Identifies its evolution and key components, indicating who may go on to use it, posting…
Abstract
Examines a particular system for reporting clinical trials: the revised CONSORT system. Identifies its evolution and key components, indicating who may go on to use it, posting its key strengths, and concludes by identifying its outstanding limitations.
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Afrooz Moatari-Kazerouni, Dinesh R. Pai, Alejandro E. Chicas and Amin Keramati
The authors propose a blockchain platform for managing clinical trial data to enhance data validity, integrity, trust and transparency in the pharmaceutical research process. The…
Abstract
Purpose
The authors propose a blockchain platform for managing clinical trial data to enhance data validity, integrity, trust and transparency in the pharmaceutical research process. The authors also provide an extensive review of how blockchain technology supports the business processes of clinical trials.
Design/methodology/approach
A systematic literature review was conducted to identify the existing applications of blockchain in pharmaceutical process management. A conceptual design for a blockchain infrastructure to address clinical trial challenges is developed by outlining the entire clinical trial value chain and identifying the coordination and communication among its stakeholders. A stakeholder analysis is conducted to ensure that the clinical trial processes satisfy the requirements and preferences of each stakeholder.
Findings
The proposed blockchain platform offers a promising solution for enhancing integrity, trust and transparency in the clinical trial process. Additionally, blockchain can help streamline communication and collaboration between stakeholders by enabling multiple parties to access and share data in real time, lowering the possibility of delays or errors in data analysis and reporting.
Practical implications
The proposed blockchain platform can benefit patients by empowering them to have better-controlled access to their data and by allowing researchers to maintain adherence to reporting requirements. Additionally, the platform can benefit granting agencies, researchers and decision-makers by ensuring the integrity of clinical trial data and streamlining communication and collaboration between stakeholders.
Originality/value
This study builds on existing blockchain applications in pharmaceutical process management by developing a blockchain framework that can address clinical trial concerns from an integrated perspective.
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Yaw A. Debrah and Ian G. Smith
Presents over sixty abstracts summarising the 1999 Employment Research Unit annual conference held at the University of Cardiff. Explores the multiple impacts of globalization on…
Abstract
Presents over sixty abstracts summarising the 1999 Employment Research Unit annual conference held at the University of Cardiff. Explores the multiple impacts of globalization on work and employment in contemporary organizations. Covers the human resource management implications of organizational responses to globalization. Examines the theoretical, methodological, empirical and comparative issues pertaining to competitiveness and the management of human resources, the impact of organisational strategies and international production on the workplace, the organization of labour markets, human resource development, cultural change in organisations, trade union responses, and trans‐national corporations. Cites many case studies showing how globalization has brought a lot of opportunities together with much change both to the employee and the employer. Considers the threats to existing cultures, structures and systems.
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David H.B. Bednall, Harmen Oppewal, Krongjit Laochumnanvanit and Cuc Nguyen
This paper aims to discover how consumers process an innovative set of systematically varied service trial offers and how this affects their learning and interaction as precursors…
Abstract
Purpose
This paper aims to discover how consumers process an innovative set of systematically varied service trial offers and how this affects their learning and interaction as precursors to customer engagement.
Design/methodology/approach
The research uses experiments that manipulate pricing, type of service and delivery method. A repeated-measures design was used with a sample of 396 participants.
Findings
Free (as opposed to cost or full price) service trials were more likely to be accepted, with perceived truthfulness of the trial offer and perceived obligation mediating the relationship. Credence service trials generate higher levels of perceived obligation than experience service trial offers, while personal services are more likely to lead to trial adoption.
Research limitations/implications
The research can be extended to well-recognized brands and further mixed service contexts.
Practical implications
Trial offers of new services are best targeted at buyers who are in the likely buyer group. The trial offer may accelerate time to purchase and relieve perceived risks. The trials of credence services need further signals of quality in the trial itself for consumers to adopt the full service. With personal service trials, skeptical consumers need assurance as to what will happen after the trial experience. Free trials may actually devalue a service, threatening engagement.
Originality/value
Uniquely, service trial offers are systematically manipulated using experience versus credence and personal versus impersonal trials to determine their effect on acceptance of the trial offer and the full service. Additionally, the study compares free, cost price and full price trial offers.
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Ethnic minority people are frequently under‐represented in clinical trials. This potentially affects the generalisability/external validity of the trial findings. This not only…
Abstract
Ethnic minority people are frequently under‐represented in clinical trials. This potentially affects the generalisability/external validity of the trial findings. This not only has important repercussions regarding the safety and the efficacy of new drug use in ethnic minority groups, but also reduces opportunities for subgroup analysis. There can be no scientific basis for excluding this group of people from clinical trials. Aims to provide a mix of theoretical and empirical debates, in order to make sense of ethnic minority exclusion from clinical trials, and suggest possibility of change. Recommends that educational programmes should be directed at clinical trial investigators and funding bodies, to increase their awareness of under‐representation of ethnic minority people in clinical trials. Ethics committees could also redress this inequality by providing guidance for investigators, and by being more rigorous about reviewing clinical trial protocols. Provides a set of guidelines to “enlighten” and aid health professionals in working with ethnic, linguistic and culturally diverse populations. The guidelines require additional work and have cost implications. Argues that cost should not be allowed as an acceptable excuse for excluding ethnic minority people from clinical trials.
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Risk management is becoming an increasingly important topic in healthcare. The dangers of conducting clinical trials were brought to the attention of the public by the media in…
Abstract
Purpose
Risk management is becoming an increasingly important topic in healthcare. The dangers of conducting clinical trials were brought to the attention of the public by the media in 2006 with the TGN1412 phase 1 clinical trial. Clinical trials are however important for the development of new drugs. There are a number of gatekeepers for the safety of trials but risk assessment is now becoming an important aspect. This paper aims to focus on clinical trials.
Design/methodology/approach
A new risk assessment tool was developed to collect data relating to the contributory factors and control measures associated with clinical trials. The responses to a series of 29 questions are then scored to inform a risk rating for the clinical trial
Practical implications
The theoretical model was converted into a Microsoft Excel spreadsheet with drop down boxes for the responses to the questions. Research management staff have found the tool simple and quick to use. A printout of the assessment can be placed in the study folder as evidence. Highlighted risks are then flagged up to the organisation's corporate risk register and an action plan developed.
Originality/value
The tool has been utilised to assess risks of all research projects from educational studies such as MSc, PhD to medical device trials and drug trials. Furthermore it has assessed risks in the acute, primary care and mental health sectors.
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Beth Ann Fiedler and Robert J. Bebber
The purpose of this paper is to establish historic regulatory conditions and priority national characteristics eliciting outstanding best practices in clinical trial regulatory…
Abstract
Purpose
The purpose of this paper is to establish historic regulatory conditions and priority national characteristics eliciting outstanding best practices in clinical trial regulatory systems, towards global health objectives through targeted economic development.
Design/methodology/approach
Exploratory review of clinical trial processes of three industrialized nations with similar democratic processes – Japan, the UK and the USA – in order to determine the efficacy of international clinical trials.
Findings
Outstanding best practices in national vaccine clinical trials can guide the international economic development, manufacturing and distribution policy strategies necessary to form the basis of a cross‐cultural global delivery system.
Originality/value
This study's contribution to academic literature is threefold: first, it reviews established fundamental clinical trial processes for Japan, the UK and the USA; second, it distinguishes similarities and differences to determine best practices; and third, it suggests changes in regulatory vaccine clinical trials towards achieving global health objectives.
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Jiaqing Xu, Weiling Jiao, Hao Chen and Yufei Yuan
Free trial is an effective strategy to gaining users’ data so as to strengthen and optimize product design. The purpose of this paper is to understand the IT companies' dynamic…
Abstract
Purpose
Free trial is an effective strategy to gaining users’ data so as to strengthen and optimize product design. The purpose of this paper is to understand the IT companies' dynamic decision-making behavior in the free trial of IT products and services context based on a three-stage theoretical framework and users' decision-making behavior in the respective stage.
Design/methodology/approach
A three-stage methodology is proposed to clarify relevant decision problems and actions in each stage from IT companies' and users' perspectives, respectively. It then investigates relating variables on IT companies' decision-making based on extant research and users' decision-making.
Findings
In this study, the authors argue that the IT companies have to make the offering, implementation and retention decision in different stage during the whole free trial process. Each decision is determined by several variables from their own and users, namely the offering decision is determined by product characteristics, network effects, product life cycle and WOM (word of mouth); the implementation decision is determined by the quality of products and services, trial type, incentive measures on user's usage and communication strategy; and the retention decision is determined by the product and price strategy.
Practical implications
The results are practical and can be used by IT companies as a decision basis or reference to make reliable decisions so that IT companies can take target measures to ensure the effectiveness of their free trial strategy so as to meet their users' needs based on products designed by data driven. Thus, the ultimate goal of supply chain management is achieved.
Originality/value
In this study, the decision-making process in the free trial of IT products and services context is investigated as a whole for the first time. From the IT companies' perspective, the process includes offering, implementation and retention decision stages, which are continuous and inseparable. The variables that determine IT companies' decision-making are identified based on users' decision and action. Hence, it represents a brand-new whole process perception to clearly understand the dynamic of the IT companies' decision-making. Considering users' decision and action, the final decisions of the IT companies will be more practical in respect of motivating, retaining and upgrading users.
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Yingying Hu, Ling Zhao, Xin (Robert) Luo, Sumeet Gupta and Xiuhong He
The purpose of this paper is twofold: first, to clarify what specific behaviors are involved in consumers' partial switching in mobile application (app) usage, and, second, to…
Abstract
Purpose
The purpose of this paper is twofold: first, to clarify what specific behaviors are involved in consumers' partial switching in mobile application (app) usage, and, second, to explore the common and differential motivations of these behaviors.
Design/methodology/approach
This paper specified two behaviors in consumers' partial switching in mobile app usage, trialing and combining behaviors, and conceptualized them as different types of variety seeking behaviors. A theoretical model contrasting intrinsic motivations and extrinsic motivations on the two behaviors was developed and tested with a sample of 561 mobile app users in China.
Findings
The findings showed that both trialing and combining behaviors could be motivated by intrinsic individual-related and extrinsic technology-related factors. Besides, intrinsic individual-related factors were more effective in motivating trialing behavior, whereas extrinsic technology-related factors were more effective in motivating combining behavior. All these findings are applicable and consistent in both hedonic and utilitarian apps.
Originality/value
This study extends and advances the literature on information technology switching by investigating consumer use behaviors from a new perspective of partial switching and multiple competing apps usage. This study also contributes to variety seeking literature by extending the understanding of variety seeking to the context of mobile app usage. Finally, by investigating the associations and distinctions of trialing and combining behavior, this study not only helps to fully understand the partial switching but also enriches the understanding of different types of variety seeking behaviors.
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Niraj Kumar Jha and Udo Nackenhorst
The purpose of this paper is to develop a progressive damage framework to predict the fatigue life of cord-reinforced rubber composite under cyclic loadings. Special attention has…
Abstract
Purpose
The purpose of this paper is to develop a progressive damage framework to predict the fatigue life of cord-reinforced rubber composite under cyclic loadings. Special attention has been paid to failure mechanisms, like cord–rubber interfacial debonding, and rubber matrix damage.
Design/methodology/approach
The constitutive modeling is based on the continuum damage mechanics (CDMs) and the thermodynamics of irreversible process. The damage in rubber is described by an istropic law, whereas elasto-plastic continuum model has been proposed for cord–rubber interphase layer. The numerical framework is implemented into commercial finite element code Abaqus/Standard via user subroutine (UMAT).
Findings
One of the most important findings obtained from reviewing various techniques is that meso-level fatigue damage modeling based on developed framework can simulate competitive damage scenarios, e.g. debonding, delamination or matrix failure.
Originality/value
A systematic framework for predicting failure in cord-reinforced rubber composite is formulated within the context of CDMs that can also be applied for industrial components, such as tires and airsprings.
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