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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…

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

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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

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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.

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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

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Book part
Publication date: 30 September 2020

Shivinder Nijjer, Kumar Saurabh and Sahil Raj

The healthcare sector in India is witnessing phenomenal growth, such that by the year 2022, it will be a market worth trillions of INR. Increase in income levels…

Abstract

The healthcare sector in India is witnessing phenomenal growth, such that by the year 2022, it will be a market worth trillions of INR. Increase in income levels, awareness regarding personal health, the occurrence of lifestyle diseases, better insurance policies, low-cost healthcare services, and the emergence of newer technologies like telemedicine are driving this sector to new heights. Abundant quantities of healthcare data are being accumulated each day, which is difficult to analyze using traditional statistical and analytical tools, calling for the application of Big Data Analytics in the healthcare sector. Through provision of evidence-based decision-making and actions across healthcare networks, Big Data Analytics equips the sector with the ability to analyze a wide variety of data. Big Data Analytics includes both predictive and descriptive analytics. At present, about half of the healthcare organizations have adopted an analytical approach to decision-making, while a quarter of these firms are experienced in its application. This implies the lack of understanding prevalent in healthcare sector toward the value and the managerial, economic, and strategic impact of Big Data Analytics. In this context, this chapter on “Predictive Analytics in Healthcare” discusses sources, areas of application, possible future areas, advantages and limitations of the application of predictive Big Data Analytics in healthcare.

Details

Big Data Analytics and Intelligence: A Perspective for Health Care
Type: Book
ISBN: 978-1-83909-099-8

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Article
Publication date: 1 August 2004

Catherine Dymoke‐Bradshaw and Benita Cox

This paper proposes an “innovative” approach to the evaluation of information systems projects to support pharmaceutical clinical trials. The IS evaluation process for…

Abstract

This paper proposes an “innovative” approach to the evaluation of information systems projects to support pharmaceutical clinical trials. The IS evaluation process for these projects closely follows that described in the Management of Innovation literature using methods which are highly iterative and are an integral component of the project. The development of organization‐technology fit is core and evaluation for this purpose can be thought of as a coupling mechanism between use and design and as a tool for continuous learning and improvement. This integrative, iterative approach is applied to a project undertaken at Glaxo Wellcome Research and Development.

Details

Journal of Enterprise Information Management, vol. 17 no. 4
Type: Research Article
ISSN: 1741-0398

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Article
Publication date: 1 December 2004

Elizabeth Murray, Rodney McAdam and Moira T. Burke

The objective of this paper is to critique emerging legislation in the pharmaceutical industry, focusing on the clinical trials sector. Possible changes are identified and…

Abstract

The objective of this paper is to critique emerging legislation in the pharmaceutical industry, focusing on the clinical trials sector. Possible changes are identified and discussed in relation to their impact on phase I clinical trials conducted in the UK. It is concluded that smaller contract research organisations, which have benefited in the past from European Union legislative variation, may have resource problems in trying to cope with the changing business environment created through legislative harmonization. These SMEs must use this opportunity to seek clinical trials research partnerships in a new harmonized EU market.

Details

International Journal of Health Care Quality Assurance, vol. 17 no. 7
Type: Research Article
ISSN: 0952-6862

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Article
Publication date: 23 November 2012

Maysoun Dimachkie Masri, Bernardo Ramirez, Cristina Popescu and Ed Michael Reggie

The aging of the population, high prevalence of chronic diseases, and increased need for evidence‐based practice are factors that have boosted a high demand for clinical

Abstract

Purpose

The aging of the population, high prevalence of chronic diseases, and increased need for evidence‐based practice are factors that have boosted a high demand for clinical trials in the United States. In recent years, an increasing number of clinical trials have shifted from academic medical centers, to community‐based practices, to global sites in different countries. Contract research organizations (CROs) are service organizations that provide research and support services to pharmaceutical, biotechnological, and health companies. This paper aims to explore the evolution of the CRO industry in the United States and worldwide, and to discuss the benefits and pitfalls of the globalization of CROs.

Design/methodology/approach

The organizational ecology framework is used to analyze the lifecycle of CROs in response to their environment including their emergence, growth, and evolution to date.

Findings

The authors discuss the drug development process, the role of CROs and outsourcing in clinical research. Pharmaceutical companies began outsourcing research activities to increase their profit margins and better position themselves in the rapidly‐changing healthcare environment. The paper analyzes the evolution of the CROs over time and the factor that affected it, including the current globalization stage with special emphasis in India, China and Central and Eastern Europe. Consequences of globalization include the stimulation of research collaboration, policy and issues related to quality.

Originality/value

The evolution of CROs over time points to transformation/evolution of these organizations, with challenges as they become an integral part of the drug development process in the USA and other countries.

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 6 no. 4
Type: Research Article
ISSN: 1750-6123

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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

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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Book part
Publication date: 19 September 2014

Abdullah A. Alshwer and Edward Levitas

This study empirically examines the relationship between institutional ownership and innovation activity in the unique setting of the clinical trials for US…

Abstract

This study empirically examines the relationship between institutional ownership and innovation activity in the unique setting of the clinical trials for US biopharmaceutical companies. We used multiple statistical techniques in the period from 1990 through 2006 for firms in the biopharmaceutical industry to examine this relationship. Contrary to the widely believed relationship discussed in the literature, our findings suggest that institutional investors vary in their reactions to innovative progress. Specifically, we find that institutional investors with a long-term investment horizon (i.e., dedicated owners) increase their holdings of a firm’s equity as the number of the firm’s products increases in phases I and II of FDA clinical trials. These findings are robust for heteroskedasticity and autocorrelation as well as for different operationalizations of the change of institutional ownership.

Details

Finance and Strategy
Type: Book
ISBN: 978-1-78350-493-0

Keywords

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