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Bibliometric Assessment of European and Sub-Saharan African Research Output on Poverty-Related and Neglected Infectious Diseases from 2003 to 2011  [PDF]
J. Gabrielle Breugelmans?,Michael M. Makanga?,Ana Lúcia V. Cardoso?,Sophie B. Mathewson?,Bethan R. Sheridan-Jones?,Karen A. Gurney?,Charles S. Mgone
PLOS Neglected Tropical Diseases , 2015, DOI: 10.1371/journal.pntd.0003997
Abstract: Background The European & Developing Countries Clinical Trials Partnership (EDCTP) is a partnership of European and sub-Saharan African countries that aims to accelerate the development of medical interventions against poverty-related diseases (PRDs). A bibliometric analysis was conducted to 1) measure research output from European and African researchers on PRDs, 2) describe collaboration patterns, and 3) assess the citation impact of clinical research funded by EDCTP. Methodology/Principal Findings Disease-specific research publications were identified in Thomson Reuters Web of Science using search terms in titles, abstracts and keywords. Publication data, including citation counts, were extracted for 2003–2011. Analyses including output, share of global papers, normalised citation impact (NCI), and geographical distribution are presented. Data are presented as five-year moving averages. European EDCTP member countries accounted for ~33% of global research output in PRDs and sub-Saharan African countries for ~10% (2007–2011). Both regions contributed more to the global research output in malaria (43.4% and 22.2%, respectively). The overall number of PRD papers from sub-Saharan Africa increased markedly (>47%) since 2003, particularly for HIV/AIDS (102%) and tuberculosis (TB) (81%), and principally involving Southern and East Africa. For 2007–2011, European and sub-Saharan African research collaboration on PRDs was highly cited compared with the world average (NCI in brackets): HIV/AIDS 1.62 (NCI: 1.16), TB 2.11 (NCI: 1.06), malaria 1.81 (NCI: 1.22), and neglected infectious diseases 1.34 (NCI: 0.97). The NCI of EDCTP-funded papers for 2003–2011 was exceptionally high for HIV/AIDS (3.24), TB (4.08) and HIV/TB co-infection (5.10) compared with global research benchmarks (1.14, 1.05 and 1.35, respectively). Conclusions The volume and citation impact of papers from sub-Saharan Africa has increased since 2003, as has collaborative research between Europe and sub-Saharan Africa. >90% of publications from EDCTP-funded research were published in high-impact journals and are highly cited. These findings corroborate the benefit of collaborative research on PRDs.
The National Drug Abuse Treatment Clinical Trials Network: forging a partnership between research knowledge and community practice
Tai B,Sparenborg S,Liu D,Straus M
Substance Abuse and Rehabilitation , 2011,
Abstract: Betty Tai, Steven Sparenborg, David Liu, Michele StrausCenter for the Clinical Trials Network, National Institute on Drug Abuse, National Institutes of Health, United States Department of Health and Human Services, Bethesda, MD, USAAbstract: The National Drug Abuse Treatment Clinical Trials Network (CTN) has faced many challenges over its first eleven years. This review explores some of these challenges and the paths the CTN took to meet these challenges, including: designing clinical trials that reflect the CTN’s mission and changing public health needs, finding the synergies in the varied expertise of clinical treatment providers and academic researchers, promoting evidence-based practices and expanding the Network into mainstream medical practices to reach a broader patient population. Included in this exploration are specific examples from CTN clinical trials.Keywords: Clinical Trials Network, drug abuse, addiction
Schizophrenia trials conducted in African countries: a drop of evidence in the ocean of morbidity?
Marianna Purgato, Clive Adams, Corrado Barbui
International Journal of Mental Health Systems , 2012, DOI: 10.1186/1752-4458-6-9
Abstract: We searched the Cochrane Schizophrenia Group Register, which contains 16,000 citations to 13,000 studies relating only to people with schizophrenia or schizophrenia-like illness, to identify schizophrenia trials conducted in Africa without time limitation.A total of 38 trials met the inclusion criteria and were included in our analysis. Of the 54 countries of Africa, only 8 produced at least one trial: South Africa produced the majority of trials (20 out of 38 trials, 53%), followed by Nigeria (7 out of 38 trials, 18%) and Egypt (4 out of 38 trials, 11%). The majority of studies investigated the efficacy of pharmacological interventions, were short in duration, and employed a double-blind design. The quality of reporting was generally poor. We found six trials comparing antipsychotics from the WHO Essential List of Medicine versus new generation antipsychotics. In terms of efficacy and acceptability, these studies failed to show any advantage of newer antipsychotics over first-generation agents.We observed an impressive mismatch between the number of individuals with schizophrenia living in African countries, estimated to be around 10 million, and the overall number of patients included in African trials, which is less than 2,000. These few trials were of low quality and appeared not to reflect the real needs of the population. We argue that the concept of pragmatism should be introduced into the design of randomized trials in African countries. Pragmatic trials should investigate whether treatments, given in real-world circumstances, really have clinically meaningful effects.
Biopharmaceutical industry-sponsored global clinical trials in emerging countries
Alvarenga, Lenio Souza;Martins, Elisabeth Nogueira;
Revista da Associa??o Médica Brasileira , 2010, DOI: 10.1590/S0104-42302010000400015
Abstract: objective: to evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in brazil. methods: data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on february 2nd 2009. proportions of sites in each country were compared among emerging countries. multiple logistic regressions were performed to evaluate whether trial placement in brazil could be predicted by trial location in other countries and/or by trial features. results: a total of 8,501 trials were then active and 1,170 (13.8%) included sites in emerging countries (i.e., argentina, brazil, china, czech republic, hungary, india, mexico, poland, russia, south korea, and south africa). south korea and china presented a significantly higher proportion of sites when compared to other countries (p<0.05). multiple logistic regressions detected no negative correlation between placement in other countries when compared to brazil. trials involving subjects with less than 15 years of age, those with targeted recruitment of at least 1,000 subjects, and seven sponsors were identified as significant predictors of trial placement in brazil. conclusion: no clear direct competition between brazil and other emerging countries was detected. south korea showed the higher proportion of sites and ranked third in total number of trials, appearing as a major player in attractiveness for biopharmaceutical industry-sponsored clinical trials.
Moral imperialism and multi-centric clinical trials in peripheral countries
Garrafa, Volnei;Lorenzo, Claudio;
Cadernos de Saúde Pública , 2008, DOI: 10.1590/S0102-311X2008001000003
Abstract: moral imperialism is expressed in attempts to impose moral standards from one particular culture, geopolitical region or culture onto other cultures, regions or countries. examples of direct moral imperialism can be seen in various recurrent events involving multi-centric clinical trials promoted by developed (central) countries in poor and developing (peripheral) countries, particularly projects related to the theory of double standards in research. after the wma general assembly refused to change the helsinki declaration - which would have given moral recognition to the above mentioned theory - the usa abandoned the declaration and began to promote regional seminars in peripheral countries with the aim of "training" researchers on ethical perspectives that reflect america's best interests. individuals who received such training became transmitters of these central countries' ideas across the peripheral countries, representing a form of indirect moral imperialism. the paper proposes the establishment of regulatory and social control systems for clinical trials implemented in peripheral countries, through the formulation of ethical norms that reflect the specific contexts of these countries, along with the drawing up and validation of their own national norms.
Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries
K Mystakidou, I Panagiotou, S Katsaragakis, E Tsilika, E Parpa
SAHARA J (Journal of Social Aspects of HIV/AIDS Research Alliance) , 2009,
Abstract: Background/rationale: Ethical issues regarding HIV/AIDS human research in the developing world remain under continuous evaluation; a critical area of concern includes informed consent. This paper reviews several of the most important ethical and practical aspects of informed consent in HIV research in developing countries. Enhancement of overall understanding of such key issues might promote higher ethical standards of future research. Objectives: The major objective was to address informed consent in human research in non-Western societies, and specifically in HIV clinical trials of affected adults. Secondary end-points included the consent complexities in HIV research involving vulnerable patient populations in resource-limited nations, such as children, adolescents and women. Methods: A systematic review of the published literature using MEDLINE and EMBASE from 1998 until December 2008 was performed, using the search terms ‘HIV/AIDS’, ‘informed consent’, ‘clinical trials’, ‘developing world’. Results: Ethical complexities such as participants’ diminished autonomy, coercion or monetary inducement, language difficulties, illiteracy or lack of true understanding of the entire study, cultural barriers mainly due to communitarianism and social diversities were identified in the 44 studies reviewed. Informed consent of vulnerable patient populations must be tailored to their sex and developmental age, while counselling is fundamental. Children and adolescents’ assent must be ensured. Local language is to be used, while trusted community leaders and local cultural representatives may convey information. Discussion: Despite the heterogeneity of studies, similarities were identified. Providing adequate and comprehensive information and assessing the true understanding of the research represent fundamental prerequisites. Potential solutions to the critical areas of concern include peer counselling and meetings with local community leaders or local cultural representatives. Conclusions: International investigators of HIV human research should bear in mind these ethical issues and their potential solutions, when trying to ensure ethical research conduct, based on a truly informed and culturally relevant consent.
Quality of life in infants and children with atopic dermatitis: Addressing issues of differential item functioning across countries in multinational clinical trials
Stephen P McKenna, Lynda C Doward, David M Meads, Alan Tennant, Gemma Lawton, Jens Grueger
Health and Quality of Life Outcomes , 2007, DOI: 10.1186/1477-7525-5-45
Abstract: The 45 items were included in three clinical trials designed to test the efficacy of a new topical treatment (pimecrolimus, Elidel cream 1%) in the treatment of AD in infants and children and in validation studies in the UK, US, Germany, France and the Netherlands. Rasch analyses were undertaken to determine whether an internationally valid, unidimensional scale could be developed that would inform on the direct impact of AD on the child.Rasch analyses applied to the data from the trials indicated that the draft measure consisted of two scales, one assessing the QoL of the carer and the other (consisting of 12 items) measuring the impact of AD on the child. Three of the 12 potential items failed to fit the measurement model in Europe and five in the US. In addition, four items exhibiting differential item functioning (DIF) by country were identified. After removing the misfitting items and controlling for DIF it was possible to derive a scale; The Childhood Impact of Atopic Dermatitis (CIAD) with good item fit for each trial analysis. Analysis of the validation data from each of the different countries confirmed that the CIAD had adequate internal consistency, reproducibility and construct validity.The CIAD demonstrated the benefits of treatment with Elidel over placebo in the European trial. A similar (non-significant) trend was found for the US trials.The study represents a novel method of dealing with the problem of DIF associated with different cultures. Such problems are likely to arise in any multinational study involving patient-reported outcome measures, as items in the scales are likely to be valued differently in different cultures. However, where all items in a scale fit both a single theoretical construct and the Rasch measurement model, it is feasible to conceive of outcome measures with a different set of items in each language.Paediatric atopic dermatitis (AD) is a common skin condition affecting 12–15% of children in early childhood [1]. There is a w
EUROPEAN EXPERIENCE OF SOCIAL PARTNERSHIP IN THE LABOUR FIELD: PERSPECTIVES FOR THE REPUBLIC OF MOLDOVA  [PDF]
Irina Nicolaescu,Valentina Teosa
CES Working Papers , 2012,
Abstract: European integration is not a slogan, a political discourse or a foundation for the political platform of political parties. European integration includes concrete directives of action to be taken into account by all states. One of the most important of them might be considered the social partnership in the labour field. Under current circumstances, the need to study relations established within social partnership, factors contributing to social dialogue development and fulfillment of social partnership potential within existing political and socio-economic reforms increased. Analysis of European dimension of Moldovan social partnership evolution is essential for further democratization of labour field and European perspectives of the country.
The case for conducting first-in-human (phase 0 and phase 1) clinical trials in low and middle income countries
Lydia Kapiriri, James V Lavery, Peter A Singer, Hassan Mshinda, Lorne Babiuk, Abdallah S Daar
BMC Public Health , 2011, DOI: 10.1186/1471-2458-11-811
Abstract: There are scientific and pragmatic arguments that support conducting FIH trials in LMIC. Furthermore, the changing product-development and regulatory landscape, and the likelihood of secondary benefits such as capacity building for innovation and for research ethics support our argument. These arguments take into account the critical importance of protecting human subjects of research while developing capacity to undertake FIH trials.While FIH trials have historically not been conducted in LMICs, the situation in some of these countries has changed. Hence, we have argued that FIH should be conducted in LMICs for products meant primarily for conditions that are most prevalent in those contexts; provided the necessary protections for human subjects are sufficient.Despite the sustained proliferation of clinical trials in low and middle income countries (LMICs), [1] there has been little examination of whether First in Human (FIH; phase 0 and phase 1) clinical trials should be conducted in LMICs, and if so, under what conditions. Most of the discussion has focused on later phases of clinical trials. The purpose of this paper is to stimulate debate on the merits of FIH trials in LMICs: the default option should be to do the trials where the relevant health conditions present the greatest public health challenge, if, and only if, the necessary capacities exist for participant safety and scientific rigor. We argue, further, that the default presumptions against performing FIH trials in LMICs may be quietly impeding progress in the evolution of the very capacities that these trials require.Interest in FIH clinical trials has grown recently, in part because of the disastrous experience of the phase I clinical trial of the superagonistic anti-CD28 antibody TGN1412 in the United Kingdom. The drug was developed with the intention to stimulate a specific kind of T-cell while at the same time controlling the production of other T-cells in order to suppress the immune system. In t
Randomised trials relevant to mental health conducted in low and middle-income countries: a survey
Rebecca Sheriff, Clive E Adams, Prathap Tharyan, Mahesh Jayaram, Lelia Duley, the PRACTIHC Mental Health Group
BMC Psychiatry , 2008, DOI: 10.1186/1471-244x-8-69
Abstract: 6107 electronic records, most with full text copies, were available following extensive searches for randomised or potentially randomised trials from low and middle-income countries published in 1991, 1995 and 2000. These records were searched to identify studies relevant to mental health. Data on study characteristics were extracted from the full text copies.Trials relevant to mental health were reported in only 3% of the records. 176 records reporting 177 trials were identified: 25 were published in 1991, 45 in 1995, and 106 in 2000. Participants from China were represented in 46% of trials described. 68% of trials had <100 participants. The method of sequence generation was described in less than 20% of reports and adequate concealment of allocation was described in only 12% of reports. Participants were most frequently adults with unipolar depression (36/177) or schizophrenia (36/177). 80% of studies evaluated pharmacological interventions, a third of which were not listed by WHO as essential drugs. 41% of reports were indexed on PubMed; this proportion decreased from 68% in 1991 to 32% in 2000.In terms of overall health burden, trial research activity from low and middle-income countries in mental health appears to be low, and in no area adequately reflects need.Most of the global burden of mental illness falls to the poorest nations, where 80% of world's population live [1]. On average low and middle-income countries devote less than 1% of their health expenditure to mental health and have poorly developed mental health policies and legislation. Treatment provision is often dismally under resourced [2]. Randomised trials are the gold-standard for evaluation of care, and systematic reviews of randomised trials increasingly provide the basis for health care practice and policy. Most trials, however, are conducted in high-income countries [3]. The interventions assessed may be unaffordable, unavailable or inappropriate for people in other cultures and settings [4
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