A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa

Objectives: To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa. Design: Construction and analysis of a comprehensive database of completed randomised controlled clinical trials based on clinicaltrials.gov from 1 January 2005 to 31 December 2010 and drug approval data from 2006 until 2013 for India and South Africa. Setting: USA, the EU, India and South Africa. Main outcome measures: Percentage of completed randomised clinical trials for an Investigational Medicinal Product (IMP) leading to new drug approval in India and South Africa. Results: A total of 622 eligible randomised controlled trials were identified as per search criteria for India and South Africa. Clustering them for the same sponsor and the same Investigational New Drug (IND) resulted in 453 eligible trials, that is, 224 for India and 229 for South Africa. The distribution of the market application approvals between the EU/USA as well as India and South Africa revealed that out of clinical trials with the participation of test centres in India and/or South Africa, 39.6% (India) clinical trials and 60.1% (South Africa) clinical trials led to market authorisation in the EU/USA without a New Drug Application (NDA) approval in India or South Africa. Conclusions: Despite an increase in clinical trial activities, there is a clear gap between the number of trials conducted and market availability of these new drugs in India and South Africa. Drug regulatory authorities, investigators, institutional review boards and patient groups should direct their efforts to ensuring availability of new drugs in the market that have been tested and researched on their population.

Conceptualising public-private partnerships: a critical appraisal of approaches to meanings and forms

Purpose – The purpose of this paper is to survey various meanings attached to a public-private partnership (PPP) and related aspects in Western literature, and identify commonalities and differences between them. Additionally, the article intends to critically assess conflicting and overlapping views on contractual and institutional PPPs, their forms and models, and draw insights for transitional economies. Design/methodology/approach – The article contrasts and compares views on PPP meanings, forms and models within Western PPP literature, and also draws comparisons with understanding of partnership aspects in the Russian language sources. The paper examines theories underpinning PPPs, builds connections to PPP advantages and drawbacks, and provides critical assessment of net benefits that PPPs may bring along to the society. Findings – The article concludes that future PPP research in transitional countries such as Kazakhstan and Russia, particularly in the area of organisational and power arrangements in partnerships, may delineate new concepts such as government as a guarantor of a PPP project, social significance of a PPP project, and risk management in a country’s contextual environment. Practical implications – In transitional countries, in which PPPs are in their infancy, clarification of theoretical positions, and identification of commonalities and differences between meanings attached to the PPP terminology may enable better decisions by researchers and practitioners in their selection and further development of partnerships and related concepts. Originality/value – Research in the field of PPPs in transitional countries such as Russia and Kazakhstan is in its infancy. The paper intends to contribute to the body of knowledge about PPPs by providing detailed account and categorisation of their principal meanings, forms, models, underpinning theories, and drawing insights for future research in transitional countries.

A critical appraisal of the social entrepreneurship paradigm in an international setting : a proposed conceptual framework

'A load too heavy': Critical reflections on the child labor problem in Africa's small-scale mining sector

This paper provides an extended analysis of the child labor problem in the artisanal and small-scale mining (ASM) sector, focusing specifically on the situation in sub-Saharan Africa. In recent years, the issue of child labor in ASM has garnered significant attention from the International Labor Organization (ILO), which has been particularly active in raising public awareness of the problem; and, has proceeded to implement policies and collaborative project work aimed at Curtailing children's participation in ASM activities in a number of African countries. The analysis concludes with a critical appraisal of an ILO project recently launched in the Talensi-Nabdam District in the Upper East Region of Ghana, which sheds light on how the child labor problem is being tackled in practice in ASM communities in sub-Saharan Africa. (c) 2008 Elsevier Ltd. All rights reserved.

Rethinking public service media and citizenship : digital strategies for news and current affairs at Australia’s Special Broadcasting Service (SBS)

This article considers the concept of media citizenship in relation to the digital strategies of the Special Broadcasting Service (SBS). At SBS, Australia’s multicultural public broadcaster, there is a critical appraisal of its strategies to harness user-created content (UCC) and social media to promote greater audience participation through its news and current affairs Web sites. The article looks at the opportunities and challenges that user-related content presents for public service media organizations as they consolidate multiplatform service delivery. Also analyzed are the implications of radio and television broadcasters’ moves to develop online services. It is proposed that case study methodologies enable an understanding of media citizenship to be developed that maintains a focus on the interaction between delivery technologies, organizational structures and cultures, and program content that is essential for understanding the changing focus of 21st-century public service media.

Rethinking public service media and citizenship: digital strategies for news and current affairs at Australia’s Special Broadcasting Service

This article considers the concept of media citizenship in relation to the digital strategies of the Special Broadcasting Service (SBS). At SBS, Australia’s multicultural public broadcaster, there is a critical appraisal of its strategies to harness user-created content (UCC) and social media to promote greater audience participation through its news and current affairs Web sites. The article looks at the opportunities and challenges that user-created content presents for public service media organizations as they consolidate multiplatform service delivery. Also analyzed are the implications of radio and television broadcasters’ moves to develop online services. It is proposed that case study methodologies enable an understanding of media citizenship to be developed that maintains a focus on the interaction between delivery technologies, organizational structures and cultures, and program content that is essential for understanding the changing focus of 21st-century public service media.

The Maori social science academy and evidence-based policy

This paper focuses on recent moves to forge stronger linkages between the Māori social science academy and the policy industry. A critical appraisal of this development is offered, with particular attention given to the desirability of enhancing the academy’s role in the policy process, given the policy industry’s continued privileging of Eurocentric theory and research methodologies within the developing evidence-based environment. The paper ends with a discussion of the possibilities and problems associated with engagement with the policy industry, particularly as these relate to the various roles members can (or are forced to) take; either as ‘insiders’ (such as policy workers and contract researchers), or independent, critical ‘outsiders’. The author concludes that the best that insiders can hope for are incremental, largely ineffective changes to Māori policy, while independent members of the academy are best placed to speak on behalf of Māori, Māori communities, hapu and iwi.

Why evolutionary realism underpins evolutionary economic analysis and theory

This paper offers a reply to Jochen Runde's critical appraisal of the ontological framework underpinning Dopfer and Potts's (2008) General Theory of Economic Evolution. We argue that Runde's comprehensive critique contains several of what we perceive to be misunderstandings in relation to the key concepts of ‘generic’ and ‘meso’ that we seek here to unpack and redress.

The Biodex Isokinetic Dynamometer for knee strength assessment in children : advantages and limitations

Objective: To critically appraise the Biodex System 4 isokinetic dynamometer for strength assessment of children. Methods: Appraisal was based on experiences from two independent laboratories involving testing of 213 children. Issues were recorded and the manufacturer was consulted regarding appropriate solutions. Results: The dynamometer had insufficient height adjustment for alignment of the knee for some children, requiring the construction of padding to better fit the child within the dynamometer. Potential for entrapment of the non-testing leg was evident in the passive and eccentric modes and a leg bracket restraint was constructed. Automated gravity correction did not operate when protocols were linked or data was exported to an external device. Conclusions: Limitations were noted, some of which were applicable to knee strength testing in general and others which were specific to use with children. However, most of these obstacles could be overcome, making the Biodex System 4 suitable for assessment of knee strength in children.

The politicization of youth crime in Scotland and the rise of the 'Burberry Court'

In 2003, the youth justice system in Scotland entered a new phase with the introduction of a pilot youth court. The processing of persistent 16 and 17 year old (and serious 15 year olds) represented a stark deviation from a ‘child centred’ and needs-oriented state apparatus for dealing with young offenders to one based on deeds and individual responsibility. This article, based on an evaluation funded by the Scottish Executive, is the first to provide a critical appraisal of this youth justice reform. It examines the views of the judiciary and young offenders and reveals that the pilot youth court in Scotland represents a punitive excursion that poses serious concerns for due process, human rights and net widening.

Defining standards for modelling the biomechanics of the foot and ankle : a systematic review

The complex interaction of the bones of the foot has been explored in detail in recent years, which has led to the acknowledgement in the biomechanics community that the foot can no longer be considered as a single rigid segment. With the advance of motion analysis technology it has become possible to quantify the biomechanics of simplified units or segments that make up the foot. Advances in technology coupled with reducing hardware prices has resulted in the uptake of more advanced tools available for clinical gait analysis. The increased use of these techniques in clinical practice requires defined standards for modelling and reporting of foot and ankle kinematics. This systematic review aims to provide a critical appraisal of commonly used foot and ankle marker sets designed to assess kinematics and thus provide a theoretical background for the development of modelling standards.

A Systematic Review of kinematic models used in foot & ankle biomechanics

Over the past decade our understanding of foot function has increased significantly[1,2]. Our understanding of foot and ankle biomechanics appears to be directly correlated to advances in models used to assess and quantify kinematic parameters in gait. These advances in models in turn lead to greater detail in the data. However, we must consider that the level of complexity is determined by the question or task being analysed. This systematic review aims to provide a critical appraisal of commonly used marker sets and foot models to assess foot and ankle kinematics in a wide variety of clinical and research purposes.

Defining standards for modelling the biomechanics of the foot and ankle: A systematic review

The complex interaction of the bones of the foot has been explored in detail in recent years, which has led to the acknowledgement in the biomechanics community that the foot can no longer be considered as a single rigid segment. With the advance of motion analysis technology it has become possible to quantify the biomechanics of simplified units or segments that make up the foot. Advances in technology coupled with reducing hardware prices has resulted in the uptake of more advanced tools available for clinical gait analysis. The increased use of these techniques in clinical practice requires defined standards for modelling and reporting of foot and ankle kinematics. This systematic review aims to provide a critical appraisal of commonly used foot and ankle marker sets designed to assess kinematics and thus provide a theoretical background for the development of modelling standards.

An overview of level I evidence for the management of radiation dermatitis literature

Background: Despite the technologic advances, radiation dermatitis is still a prevalent and distressing symptom in patients with cancer undergoing radiotherapy. Systematic reviews (SRs) are regarded as level I evidence providing direction for clinical practice and guidelines. This overview aims to provide a critical appraisal of SRs published on interventions for the prevention/management of radiation dermatitis. Methodology: We searched the following electronic databases: MEDLINE, CINAHL, EMBASE, and the Cochrane Library (up to Feb 2012). We also hand-searched reference lists of potentially eligible articles and a number of key journals in the area. Two authors screened all potential articles and included eligible SRs. Two authors critically appraised and extracted key findings from the included reviews using the “A Measurement Tool to Assess Systematic Reviews” (AMSTAR). Results: Of 1837 potential titles, six SRs were included. A number of interventions have been reported to be potentially beneficial for managing radiation dermatitis. Interventions evaluated in these reviews included skin care advice, steroidal/non-steroidal topical agents, systematic therapies, modes of radiation delivery, and dressings. However, all the included SRs reported that there is insufficient evidence supporting any single effective intervention. The methodological quality of the included studies varied, and methodological shortfalls in these reviews may create biases to the overall results or recommendations for clinical practice. Conclusions and implications: An up-to-date high quality SR in preventing/managing radiation dermatitis is needed to guide practice and direction for future research. Clinicians or guideline developers are recommended to critically evaluate the information of SRs in their decision making.