Clinical Research in Resource-poor Settings

Solbakk, Jan Helge; Vidal, Susana

doi:10.1007/978-94-007-2512-6_102

Cited by 6 publications

(4 citation statements)

References 23 publications

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“…Ensuring appropriate ethical conduct, as discussed in depth by Solbakk and Vidal, is essential and they point out the importance of a robust local ethics review. 3 Condo et al. 23 noted a key challenge for setting locally relevant clinical trial priorities for Rwanda was that local ethics and regulatory institutions lacked the local capacity and expertise to follow through the ethics, design, and integrity of clinical trials.…”

Section: Resultsmentioning

confidence: 99%

“…Ensuring appropriate ethical conduct, as discussed in depth by Solbakk and Vidal, is essential and they point out the importance of a robust local ethics review. 3 Condo et al 23 noted a key challenge for setting locally relevant clinical trial priorities for Rwanda was that local ethics and regulatory institutions lacked the local capacity and expertise to follow through the ethics, design, and integrity of clinical trials. 23 In our experience, during the implementation of the ATTEND trial, 18 the ethics and regulatory environment in India were suited to behavioral intervention trials but not for pharmaceutical trials, due to onerous requirements to compensate healthcare costs in drug trials (regulations that have now been changed to facilitate more drug trials in India).…”

Section: Research Question and Methodologymentioning

confidence: 99%

“…2 Furthermore, it has been estimated that 90% of medical research is targeted on the health needs of the richest 10% of the world. 3 1 As stroke is occurring at an earlier age in LMICs, there is a disproportionate loss of DALYs in these countries. This has major implications for families, as those with stroke are often the breadwinners of the family, and thus stroke commonly leads to catastrophic financial hardship.…”

Section: Introductionmentioning

confidence: 99%

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Clinical stroke research in resource limited settings: Tips and hints

Pandian

Liu

Gandhi

et al. 2017

International Journal of Stroke

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Background Most stroke research is conducted in high income countries, yet most stroke occurs in low- and middle-income countries. There is an urgent need to build stroke research capacity in low- and middle-income countries. Aims To review the global health literature on how to improve research capacity in low- and middle-income countries, provide additional data from the recently completed ATTEND Trial and provide examples from our own experience. Summary of review The main themes from our literature review were: manpower and workload, research training, research question and methodology and research funding. The literature and our own experience emphasized the importance of local stakeholders to ensure that the research was appropriate, that there were robust local ethics and regulatory processes, and research was conducted by trained personnel. Research training opportunities can be developed locally, or internationally, with many international schemes available to help support new researchers from low- and middle-income country settings. International collaboration can successfully leverage funding from high income countries that not only generate data for the local country, but also provide new data appropriate to high income countries. Conclusions Building stroke research capacity in low- and middle-income countries will be vital in improving global health given the huge burden of stroke in these countries.

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Section: Resultsmentioning

confidence: 99%

Section: Research Question and Methodologymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Clinical stroke research in resource limited settings: Tips and hints

Pandian

Liu

Gandhi

et al. 2017

International Journal of Stroke

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“…The research stands on the building blocks of tension between the philosophical ethos of medical research concerning the development and production of effective diagnostic, therapeutic and preventive techniques versus the ethical imperative of the same enterprise that attempts to protect the well being and interests of the healthy individuals benefitting from breakthrough or innovations in research, patients, exposed workers and the public at large. The absence of firm ethical standards may lead to epistemic blindness and violation of human rights [91]. Since most of the human clinical trials of nanomedicines are carried out on patients at an advanced stage of disease with no other alternative therapy, the trials may offer no propitious effects or may even deteriorate the present state of the patient [92].…”

Section: Ethical Challenges: Paving Way For Moral Blindnessmentioning

confidence: 99%

An Elucidative Review to Analytically Sieve the Viability of Nanomedicine Market

et al. 2020

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The advent of the twenty-first century marked a paradigm shift in the healthcare sector with coming of automated, sensitive, targeted medicines and technologies having diagnostic, prophylactic and therapeutic effects. Nanomedicines also attained wide acclamation in their initial years, but the transformation from being the proof of concept to successfully marketed products seems very daunting. Although the reason for this may be attributed to slow but incremental character of many present-day technologies, the review asserts that there are other significant facets that may purvey a thorough explanation of this scenario. The article elaborately discusses the hurdles hindering clinical translation of nanomedicines including scale-up challenges, in vitro in vivo cascade of toxicology assays, along with unrefined manufacturing guidelines, inadequate regulatory approvals, competitive conventional market, etc., leading to hesitant investments by pharmaceutical giants. The paper also explores the economic viability of nanobiotechnology sector through an empirical investigation of the revenue data of various pharmaceutical industries manufacturing nano-based drugs, which indicates minor commercial importance of these medicines. We also laid down a comprehensive set of recommendations to smoothen the translational pathway of nanomedicines from an idea to reality, efface the consumer distrust and push boundaries for development and launching of safe, efficient and commercially successful products. Keywords Nanobiotechnology. Nanomedicines. Nanopharmaceuticals. Clinical translation For the past few decades, nanobiotechnology has been proclaimed as the 'revolution in making' with the potential Highlights • Nanomedicines are extensively researched for their highly claimed efficacy, biocompatibility and unexplored potential. • The clinical translation of nanopharmaceuticals from laboratory to market undergoes many challenges on their pathway. • Major hurdles restricting the market dominance of nanomedicines includes limited investments by pharmaceutical, toxicological assays, biocompatibility risks, scale-up issues, regulatory limitations, etc. • Comparative analysis of annual reports of big pharmaceutical companies for gross sales and revenue contributed by nanomedicines. Recommendations to improve the research, development, manufacture and sales of nanopharmaceuticals.

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Development and Bioethics

Solbakk¹

2015

Encyclopedia of Global Bioethics

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Clinical Research in Resource-poor Settings

Cited by 6 publications

References 23 publications

Clinical stroke research in resource limited settings: Tips and hints

Clinical stroke research in resource limited settings: Tips and hints

An Elucidative Review to Analytically Sieve the Viability of Nanomedicine Market

Development and Bioethics

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