scholarly journals Globalization of clinical trials: ethical and regulatory implications

2016 ◽  
Vol 3 (1) ◽  
pp. 1 ◽  
Author(s):  
Ricardo Eccard da Silva ◽  
Angélica Amorim Amato ◽  
Dirce Bellezi Guilhem ◽  
Maria Rita Carvalho Garbi Novaes

The globalization of clinical research is a relatively recent phenomenon, in which many of these studies are taking place on a global scale, with a significant increase of clinical trials in developing countries. The largest clinical trials average annual growth from 2005–2012 occurred in Asian (30%), and Latin American/Caribbean (12%) regions; other geographic regions had growth rates less than the world average (8%). The largest average annual growth occurred in lower-middle income (33%) and low-income (21%) regions. Emerging economies from low-middle income countries (Iran, China, Egypt) had the largest country-specific growth; other countries included South Korea, Japan, India, Brazil, and Turkey. With the globalization of clinical trials, it becomes necessary to strengthen legal and ethical guidelines for guaranteeing the research participants’ integrity. Some observers noted, more than a decade ago, that studies were being run in developing countries without concerns regarding adherence to the international ethical principles. The process of globalization of clinical trials, therefore, can be advantageous because, for example, it gives to access to new treatments to participants; however, it requires discussion and the monitoring of ethical questions related mainly to ensuring the integrity, welfare and safety of the research participant; to the frames of reference of bioethics, such as autonomy, nonmaleficence, beneficence, justice and fairness.

2013 ◽  
pp. 1554-1570
Author(s):  
Nicoletta Corrocher ◽  
Anna Raineri

This chapter aims at investigating the evolution of the digital divide within a set of developing countries between the years 2000 and 2005. In doing so, it moves away from the traditional analysis of the digital divide, which compares developed countries and developing countries, and examines the existing gap within a relatively homogeneous group of countries. On the basis of the theoretical and empirical contributions from scholars in different disciplines, we select a series of socioeconomic and technological indicators and provide an empirical assessment of the digitalization patterns in a set of 51 low income and lower-middle income countries. By means of cluster analysis techniques, we identify three emerging patterns of the digital divide and derive a series of policy implications, related to the implementation of an effective strategy to reduce digital backwardness. The characteristics of each pattern of digitalization can be also usefully employed to understand whether past interventions, especially in the area of competition policy, have been successful in addressing country-specific issues.


2018 ◽  
Vol 09 (03) ◽  
pp. 1850010 ◽  
Author(s):  
Sudeshna Ghosh

This paper explores the causal association between globalization and carbon dioxide emanations in a panel set of 17 low- and low-middle-income countries and 12 upper-middle and high-income countries of Asia, respectively. The time series of observations run from 1974 to 2014. The Westerlund (2007) panel cointegration test reveals that there exists a long-run cointegrating relationship in both the panel set of observations between globalization and CO2 emissions. For the panel of upper-middle and high-income countries of Asia the long-run panel (heterogeneous elasticities) shows that globalization does not cause environmental damage, contrary to the observation based on lower- and lower-middle-income countries. The study is in conformity with the Environmental Kuznets Curve Hypothesis. The Granger causality between the variables is explored by utilizing the Dumitrescu and Hurlin (2012) Granger Causality tests. The empirical observation shows that globalization-led environmental causality is valid for lower- and lower-middle-income countries of Asia. So proper sustainable green and clean technology must be adopted for the low-income countries to stop the negation of the growth process in the near future.


2000 ◽  
Vol 6 (4) ◽  
pp. 17-20
Author(s):  
Philip D. Harvey

Social marketing programs that market and distribute subsidized contraceptives in developing countries do not make money, nor are they intended to. Indeed, attempts to make them profitable have generally undermined the effectiveness of such programs, particularly in very poor countries (Harvey, 1999, pp. 213-225). The purpose of such programs is to make contraceptives available to even the lowest-income people in developing country markets and, as such, subsidization of overall project activities will always be required. Indeed, contraceptive services, along with health services in general, are subsidized for low-income people in industrialized countries, leading one expert to suggest that it is “patently absurd” to withdraw contraceptive subsidies “for people who struggle to survive on a dollar a day” (The Lancet Eds., 1990, p. 659). However, there are numerous parties involved in contraceptive social marketing (CSM) projects in the countries of Asia, Africa, and Latin American that do make money from their role in social marketing, and these businesses and entrepreneurs benefit significantly from the parts they play. Such private businesses include, most prominently, advertising agencies, product distribution firms, market research firms, and ancillary businesses like vehicle manufacturers and importers, makers of promotional paraphernalia - from calendars to pens to T-shirts, and others.


2019 ◽  
pp. bmjspcare-2019-001871
Author(s):  
Sarah Barry Lincoln ◽  
Enrique Soto-Perez-de-Celis ◽  
Yanin Chavarri-Guerra ◽  
Alfredo Covarrubias-Gomez ◽  
Mariana Navarro ◽  
...  

BackgroundPain control is an essential component of high-quality palliative care. Unfortunately, many low-income and middle-income countries lack an appropriate infrastructure to provide palliative care and suffer from a severe lack of access to opioid analgesics to alleviate pain from various conditions such as cancer.ObjectivesWe aimed to review the history and current status of cancer pain management in Mexico, a middle-income Latin American country. Our objective was to identify existing barriers to proper, effective opioid use, as well as provide practical recommendations for improvement.MethodsUsing a search of EBSCOhost database, PubMed and Google, we found official documents and peer-reviewed articles related to health legislation, opioid consumption, palliative care infrastructure and palliative care training in Mexico.ResultsDespite advances in palliative care and access to opioids in Mexico, there are still several barriers that undermine effective pain management, showing a major gap between policy and practice. Although Mexican legislation and guidelines include adequate palliative care and pain control as a right for all patients with cancer, the lack of adequate infrastructure and trained personnel severely hampers the implementation of these policies. Additionally, there are important barriers to prescribing opioids, many of which are related to attempts at reducing the consumption of recreational drugs.ConclusionsAlthough Mexico has made significant improvements in pain control and palliative care, much needs to be done. Expansion of drug availability, improvement of palliative care training, and constant oversight of regulations and guidelines will help to strengthen Mexico’s palliative care services.


2019 ◽  
Vol 7 (2) ◽  
pp. 66-72
Author(s):  
Mohammad Omar Faruq ◽  
ARM Nooruzzaman ◽  
Rownak Jahan Tamanna ◽  
Amina Sultana ◽  
Uzzwal Kumar Mallick ◽  
...  

Background : This study is a sub analysis of data submitted on behalf of Bangladesh in an International study ( ACME 2012) involving physicians working in Asian ICUs. Objective : To describe attitude of physicians of ICUs of Bangladesh toward withholding and withdrawal of life sustaining treatments in end of life care, to assess factors associated with these observations and to compare the findings especially with those of physicians of low – middle income Asian ICUs. Method : Self-administered pre-set structured and scenario based survey conducted among 101 physicians working in 38 ICUs of Bangladesh. Results : For patients with no real chance of recovering a meaningful life, 20 of 101 respondents reported that they almost always or often withheld life-sustaining treatments and 18 of 101 respondents almost always or often withdrew life-sustaining treatments.44 respondents in our study reported that they almost always or often withheld life sustaining treatments whereas 10 respondents almost always or often withdrew life sustaining treatments. 72% of all our respondents would implement DNR orders. In Bangladesh, religion (Islam) does not influence decision of complying with DNR order requested by family. Our study showed 71% of physicians were more likely to “do everything” if a patient with hypoxic-ischaemic encephalopathy developed septic shock. In our study, physicians were more ready to withdraw vasopressors and hemo dialysis than enteral feeding and intravenous fluids. Physicians from Bangladesh generally perceived more legal risk with limitation of life sustaining treatments because of lack of legislation for such practices. When it comes to limit aggressive lifesaving treatments, Bangladeshi physicians were less likely accede to families request to withdraw them on financial ground. Conclusion : Like physicians of low-middle income countries of Asia, Bangladeshi ICU physicians’ self-reported practice of limiting life sustaining treatments, role of families and surrogates and perception of legal rights were significantly different than physicians of high income countries of Asia. However unlike physicians from other low income Asian countries, physicians from Bangladesh were less likely to accede to families request to withdraw life sustaining treatments on financial ground. Bangladesh Crit Care J September 2019; 7(2): 66-72


2021 ◽  
pp. bmjinnov-2021-000837
Author(s):  
Hariharan Subbiah Ponniah ◽  
Viraj Shah ◽  
Arian Arjomandi Rad ◽  
Robert Vardanyan ◽  
George Miller ◽  
...  

ObjectiveThis systematic review aims to provide a summary of the use of real-time telementoring, telesurgical consultation and telesurgery in surgical procedures in patients in low/middle-income countries (LMICs).DesignA systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement and the Cochrane Collaboration published guidelines.Data sourcesEMBASE, MEDLINE, Cochrane, PubMed and Google Scholar were searched for original articles and case reports that discussed telementoring, telesurgery or telesurgical consultation in countries defined as low-income or middle-income (as per the World Banks’s 2021–2022 classifications) from inception to August 2021.Eligibility criteria for selecting studiesAll original articles and case reports were included if they reported the use of telemedicine, telesurgery or telesurgical consultation in procedures conducted on patients in LMICs.ResultsThere were 12 studies which discussed the use of telementoring in 55 patients in LMICs and included a variety of surgical specialities. There was one study that discussed the use of telesurgical consultation in 15 patients in LMICs and one study that discussed the use of telesurgery in one patient.ConclusionThe presence of intraoperative telemedicine in LMICs represents a principal move towards improving access to specialist surgical care for patients in resource-poor settings. Not only do several studies demonstrate that it facilitates training and educational opportunities, but it remains a relatively frugal and efficient method of doing so, through empowering local surgeons in LMICs towards offering optimal care while remaining in their respective communities.


2009 ◽  
Vol 15 (2) ◽  
Author(s):  
Tor A. Strand ◽  
Maria Mathisen

Zinc is an essential nutrient particularly important for growing children and for those who experience frequent infections. Many children in developing countries have inadequate zinc nutrition that impairs their immune system. Diarrhea and pneumonia are among the leading causes of morbidity and mortality in children of low-income countries. Zinc deficiency increases the susceptibility to these infections and administration of zinc to children with diarrhea and, possibly, pneumonia speeds up recovery. Furthermore, zinc given to otherwise healthy children also reduces the incidence of diarrhea and pneumonia. Thus, thousands of lives can be saved every year by giving zinc to prevent childhood infections or by providing zinc to children with ongoing infections. This paper gives a brief outline of the history of zinc research and reviews existing evidence from clinical trials on the prophylactic and therapeutic effect of oral zinc on childhood pneumonia and diarrhea


2021 ◽  
Vol 8 (10) ◽  
pp. 3228
Author(s):  
Vethunan Tamalvanan

Advancement in tele surgery or long distance telerobotic surgery is an intriguing prospect achieve equitable reach of global surgical services. In realization of this dream there are multiple of challenges as to telesurgery establishment and operation in low-and middle-income countries (LMIC). As of current market status, telesurgery is costly and not practical for the austere settings in these countries. “Telesurgery for a truly global surgery” is a realisable dream for the fore coming future. Affordable robotic surgical platforms, assistance from manufacturing companies to establish robotic platforms, introduction of 5G networking technology, international collaboration to unify efforts in telesurgery, and secure networking framework for a hassle free telesurgery network; are few formidable suggestions for implementing telesurgery in a global scale.


BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e048423
Author(s):  
Andrew George Lim ◽  
Sean Kivlehan ◽  
Lia Ilona Losonczy ◽  
Srinivas Murthy ◽  
Enrico Dippenaar ◽  
...  

IntroductionCritical care in low-income and low-middle income countries (LLMICs) is an underdeveloped component of the healthcare system. Given the increasing growth in demand for critical care services in LLMICs, understanding the current capacity to provide critical care is imperative to inform policy on service expansion. Thus, our aim is to describe the provision of critical care in LLMICs with respect to patients, providers, location of care and services and interventions delivered.Methods and analysisWe will search PubMed/MEDLINE, Web of Science and EMBASE for full-text original research articles available in English describing critical care services that specify the location of service delivery and describe patients and interventions. We will restrict our review to populations from LLMICs (using 2016 World Bank classifications) and published from 1 January 2008 to 1 January 2020. Two-reviewer agreement will be required for both title/abstract and full text review stages, and rate of agreement will be calculated for each stage. We will extract data regarding the location of critical care service delivery, the training of the healthcare professionals providing services, and the illnesses treated according to classification by the WHO Universal Health Coverage Compendium.Ethics and disseminationReviewed and exempted by the Stanford University Office for Human Subjects Research and IRB on 20 May 2020. The results of this review will be disseminated through scholarly publication and presentation at regional and international conferences. This review is designed to inform broader WHO, International Federation for Emergency Medicine and partner efforts to strengthen critical care globally.PROSPERO registration numberCRD42019146802.


2020 ◽  
Vol 10 (3) ◽  
pp. 20
Author(s):  
Ikenna Samuel Umezurike ◽  
Ibraheem Salisu Adam

Despite the recent economic growth in Nigeria, poverty remains a social problem. One of the strategies employed by the Nigerian government and some development partners towards solving this problem is the deployment of social protection instruments, such as Conditional Cash Transfers (CCTs), which aim at stemming the tide of poverty and vulnerability. This study uses the secondary research method to examine the extent to which the Latin American CCT model influenced the design and operation of the Nigerian CCT programme. The policy diffusion model adopted for the study posits that the success of CCT programmes in Latin America has stimulated its extension to many developing countries outside the region. The findings from the review of selected literature explain the rationale for CCTs as short-term poverty reduction and long-term human capital development. Admittedly, a nexus exists between the Latin American and Nigerian strategies. Yet the study concludes that the Latin American model cannot adequately serve as a blueprint for the Nigeria strategy, given that underlying conditions in upper middle-income Latin American countries are clearly different from those present in low income or lower middle-income African countries like Nigeria. The study recommends urgent implementation of the National Social Protection Policy; a review of the current CCT programme in Nigeria every two years and extensive research into social protection strategies.


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