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Article
Publication date: 21 June 2013

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

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.

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 7 no. 2
Type: Research Article
ISSN: 1750-6123

Keywords

Article
Publication date: 26 April 2011

Anthony Scott Brown

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…

1818

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.

Details

Clinical Governance: An International Journal, vol. 16 no. 2
Type: Research Article
ISSN: 1477-7274

Keywords

Article
Publication date: 1 September 2001

Alan Earl Slater

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…

1561

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.

Details

British Journal of Clinical Governance, vol. 6 no. 3
Type: Research Article
ISSN: 1466-4100

Keywords

Article
Publication date: 27 January 2012

Céline Bérard, L. Martin Cloutier and Luc Cassivi

If the use of information technology (IT) supporting clinical trial projects offers opportunities to optimize the underlying information management process, the intricacy…

Abstract

Purpose

If the use of information technology (IT) supporting clinical trial projects offers opportunities to optimize the underlying information management process, the intricacy of the identification and evaluation of relevant IT options is generally seen as a complex task in healthcare. Hence, the purpose of this paper is to examine the problem of ex ante information system evaluation, and assess the impact of IT on the information management process underlying clinical trials.

Design/methodology/approach

Combining Unified Modeling Language (UML) and system dynamics modeling, a simulation model for evaluating IT was developed. This modeling effort relies on a case study conducted in a clinical research organization, which, at that time, faced an IT investment dilemma.

Findings

Some illustrative results of sensitivity analyzes conducted on error rates in clinical data transmission are presented. These simulation results allow for quantifying the impact of different IT options on human resources' efforts, time delays and costs of clinical trials projects. Notably, the results show that although the technology has no real influence on the duration of a clinical trial project, it impacts the number of projects that can be carried out simultaneously.

Originality/value

The research provides insights into the development of an innovative approach appropriate to the evaluation of IT supporting clinical trials, through the use of a mixed‐method based on qualitative and quantitative modeling. The results illustrate two critical issues addressed in the IS literature: the necessity to extend IT evaluation beyond the quantitative‐qualitative dichotomy; and the role of evaluation in organizational learning, and in learning about business dimensions.

Article
Publication date: 12 April 2011

Lyn Murphy and William Maguire

The purpose of this paper is to report on the decision process that the authors follow in applying mixed methods research to evaluate the benefits and costs of conducting…

1847

Abstract

Purpose

The purpose of this paper is to report on the decision process that the authors follow in applying mixed methods research to evaluate the benefits and costs of conducting sponsored clinical trials in a publicly funded New Zealand hospital.

Design/methodology/approach

A simultaneous parallel mixed method design was adopted. This design builds on a health outcomes study that involves a retrospective cohort study of changes in participants' health status and mortality rates. Although a team of medical researchers conducted that study (i.e. the current authors were not involved), it is one of the three strands of the current research as it forms the platform for the other two strands, namely the multiple stakeholder perception strand and the economic outcomes strand. In the multiple stakeholder perceptions strand, qualitative methods were used to explore the benefits and costs perceived by stakeholders. In the economic outcomes strand, quantitative methods were used to estimate the benefits and costs of clinical trials.

Findings

The economic outcomes strand and the multiple stakeholder perceptions strand are complementary. Each strand delivers dimensions to the analysis that are not apparent from the other.

Originality/value

The value of the paper lies in improved understanding of the process of mixed method research through communicating choices and decisions made in response to the challenges faced.

Details

Qualitative Research in Accounting & Management, vol. 8 no. 1
Type: Research Article
ISSN: 1176-6093

Keywords

Book part
Publication date: 12 November 2018

Bernice Davies, Anona Armstrong and Maree Fitzpatrick

In 2013, the National Mutual Acceptance (NMA) of single ethical review was introduced into the Australian public health sector to address the timeliness of multisite…

Abstract

In 2013, the National Mutual Acceptance (NMA) of single ethical review was introduced into the Australian public health sector to address the timeliness of multisite clinical trials. A clinical trial is usually designed to test the effects of an experimental therapeutic product. While all research involving humans must comply with ethical guidelines, clinical trials testing products in Australia are also subject to stringent regulatory controls making the need to meet trial milestones critically import. Commercial clinical trials offer participating research sites substantial financial and clinical advantages. Concerns that bureaucratic processes have impeded commercial investment have influenced countries, including Australia, to introduce single ethical review, where one ethics review is accepted at multiple sites participating in the same research project. Although a central tenet of the NMA is the standardization of the behaviors and procedures of research review, concerns of inconsistency remain. This raises the question of whether the NMA does lead public healthcare agencies to adopt similar research governance practices.

A questionnaire survey was undertaken to explore the current experiences (n = 149) of the NMA in Victorian public health agencies, and 21 semi-structured interviews were conducted to explore expectations of the future of the NMA. The findings indicated that, while there was conformity to many of the process requirements of the NMA, a persistent focus on the needs of each individual healthcare agency rather than on complying with the national system weakened pressure on agencies to adopt standardization.

The NMA has the capacity to be a powerful tool in delivering quality clinical trial outcomes, maximize research resources and create dependable performance metrics if consistent policies and governance are followed.

Details

Applied Ethics in the Fractured State
Type: Book
ISBN: 978-1-78769-600-6

Keywords

Article
Publication date: 1 June 2001

Alan Earl‐Slater

Increasing attention is being placed on clinical trials as a source of evidence. Presents thoughts about the advantages and disadvantages of clinical trials and their…

2526

Abstract

Increasing attention is being placed on clinical trials as a source of evidence. Presents thoughts about the advantages and disadvantages of clinical trials and their influence on thinking and clinical practice.

Details

British Journal of Clinical Governance, vol. 6 no. 2
Type: Research Article
ISSN: 1466-4100

Keywords

Article
Publication date: 11 April 2008

Martin Grossman and Stephen Bates

The purpose of this paper is to provide an overview of knowledge capture in the biopharmaceutical industry, focusing primarily on the transition from paper‐based to

Abstract

Purpose

The purpose of this paper is to provide an overview of knowledge capture in the biopharmaceutical industry, focusing primarily on the transition from paper‐based to electronic data capture (EDC) systems.

Design/methodology/approach

The paper draws on biopharmaceutical industry literature and data from example clinical studies to describe the issues involved in transitioning to EDC in the clinical trials environment.

Findings

While electronic data capture systems provide greater efficiencies along the clinical trial supply chain, the industry is still far from achieving wide scale utilization of such technologies. The barriers to successful implementation are multifaceted, involving not only the information technology itself, but also user acceptance issues, lack of interoperability standards, and regulatory compliance. Major shifts in organizational culture and a unified effort within the industry will be necessary in order to derive full benefits from electronic capture systems in the future.

Research limitations/implications

This study was limited in that case data from only one company was used to supplement the literature review. Further research is warranted to better understand the factors that facilitate adoption of electronic knowledge capture systems in the biopharmaceutical industry.

Originality/value

While the need for knowledge management in the healthcare industry is indisputable, there has been remarkably slow progress in this area, and a dearth of research exploring implementation issues. The value of this type of inquiry is profound as it will help us better understand the issues in implementation and adoption, and ultimately to deliver more effective and safe drugs to the public in a more efficient manner.

Details

VINE, vol. 38 no. 1
Type: Research Article
ISSN: 0305-5728

Keywords

Article
Publication date: 29 March 2013

Beth Ann Fiedler, Robert J. Bebber and Reid M. Oetjen

Global health objectives have stimulated changes to the international vaccine market. The authors seek to suggest that modern vaccine categories will aid in the formation…

Abstract

Purpose

Global health objectives have stimulated changes to the international vaccine market. The authors seek to suggest that modern vaccine categories will aid in the formation of standardized clinical trial processes through the implementation of suggested policy strategies.

Design/methodology/approach

A systematic review of literature for the period of 2000‐2010 was conducted by searching academic databases of peer‐reviewed articles (e.g. Medline, PsychInfo, and Social Science Citation Index) for multiple keywords, namely: clinical trial, regulatory standards, vaccine development, vaccine manufacturing, and vaccine distribution. The search yielded surprisingly few items that were able to provide an adequate baseline of clinical trial processes for fundamental analysis. Consequently, additional material was obtained through an exploratory literature review. The method included hand‐searching reference lists and tables of contents and search engines (Google Scholar) for national and international clinical trial regulatory processes, global health organizations, and trends in vaccine marketing.

Findings

Establishing modern vaccine designations is essential towards addressing the current trends of vaccine development. Identification of the market drivers will aid in the goal of establishing international protocols that can better position industry to streamline response in several areas including research, economic development, manufacturing, and distribution.

Practical implications

Categorization of modern vaccine development can guide the international formulation of manufacturing and distribution policy strategies to elicit a cross‐cultural global delivery system.

Originality/value

This paper contributes to academic literature threefold. It categorizes vaccines, depicts the fundamental clinical trial phases vital to global health, and provides policy options driven by modern vaccine production designations.

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 7 no. 1
Type: Research Article
ISSN: 1750-6123

Keywords

Article
Publication date: 11 April 2008

Joyce Riedinger

The purpose of this paper is to demonstrate how a learning centre can be designed as a transformational vehicle to align the culture with the organization's mission and

469

Abstract

Purpose

The purpose of this paper is to demonstrate how a learning centre can be designed as a transformational vehicle to align the culture with the organization's mission and vision to achieve competitive advantage.

Design/methodology/approach

In the setting of international clinical development in a major pharmaceutical company, this paper first describes the change strategy and tactics used in designing a learning centre. Then, the overall framework for integrating learning into day‐to‐day work is described as well as the specific methods used for bringing about this integration.

Findings

The patient‐centered approach and continuous learning and improvement environment result in exploring, managing, and mitigating risks and optimizing benefits to the patient. Clearly, this change strategy is pivotal to achieving the company mission, and it enables international clinical development to exceed industry standards.

Originality/value

The paper shows how to design and implement a learning centre as a vehicle for culture change.

Details

VINE, vol. 38 no. 1
Type: Research Article
ISSN: 0305-5728

Keywords

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