Regulating international clinical research: an ethical framework for policy-makers

Aguilera, Bernardo; DeGrazia, David; Rid, Annette

doi:10.1136/bmjgh-2020-002287

Cited by 9 publications

(8 citation statements)

References 35 publications

(31 reference statements)

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“…They also reported lengthy or ill-defined approval processes, significant bureaucracy, and lack of regulatory staff with expertise in reviewing. Similar findings have been reported in several studies around the globe especially in developing countries reporting ( 37 , 38 ). Complex and unreasonably strict government regulatory systems could worsen the negative feedback loop between limited research capacity and small numbers of trials conducted.…”

Section: Discussionsupporting

confidence: 92%

Harnessing Clinical Trial Capacity to Mitigate Zoonotic Diseases: The Role of Expert Scientists in Ethiopia

Belay

Giday

Manyazewal

2021

Front. Public Health

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Background: The emergence and resurgence of zoonotic diseases have continued to be a major threat to global health and the economy. Developing countries are particularly vulnerable due to agricultural expansions and domestication of animals with humans. Scientifically sound clinical trials are important to find better ways to prevent, diagnose, and treat zoonotic diseases, while there is a lack of evidence to inform the clinical trials' capacity and practice in countries highly affected with the diseases. This study aimed to investigate expert scientists' perceptions and experiences in conducting clinical trials toward zoonotic diseases in Ethiopia.Methods: This study employed a descriptive, qualitative study design. It included major academic and research institutions in Ethiopia that had active engagements in veterinary and public health researches. It included the National Veterinary Institute, the National Animal Health Diagnostic and Investigation Center, the College of Veterinary Medicine at Addis Ababa University, the Ethiopian Public Health Institute, the Armauer Hansen Research Institute, and the College of Health Sciences at Addis Ababa University. In-depth interviews were conducted with expert scientists. Data were collected from October 2019 to April 2020. Data analysis was undertaken using open code 4.03 for qualitative data analysis.Results: Five major themes, with 18 sub-themes, emerged from the in-depth interviews. These were: challenges in the prevention, control, and treatment of zoonotic diseases; One Health approach to mitigate zoonotic diseases; personal and institutional experiences in conducting clinical trials on zoonotic diseases; barriers in conducting clinical trials toward zoonotic diseases; and strategies that promote conducting clinical trials on zoonotic diseases. Conducting clinical trials on zoonotic diseases in Ethiopia is hampered by a lack of clearly articulated ethics and regulatory frameworks, trial experts, financial resources, and good governance.Conclusion: In Ethiopia, conducting clinical trials on zoonotic diseases deserves due attention. Strengthening institutional and human resources capacity is a pre-condition to harness effective implementation of clinical trials on zoonotic diseases in the country. In Ethiopia where skilled human resource is scarce, One Health approach has the potential to form multidisciplinary teams to systematically improve clinical trials capacity and outcomes in the country.

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Section: Discussionsupporting

confidence: 92%

Harnessing Clinical Trial Capacity to Mitigate Zoonotic Diseases: The Role of Expert Scientists in Ethiopia

Belay

Giday

Manyazewal

2021

Front. Public Health

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“…Justice : The geographical distribution of clinical trials has shifted to LMICs and emerging economies where costs are lower, markets are expanding, and participants are plentiful and more easily recruited [ 40 ]. This is positive as under-represented populations are now included within research.…”

Section: Types Of Trials Using Adaptive Designsmentioning

confidence: 99%

“…Concerns have arisen in LMICs where clinical trial governance and regulatory systems and processes are not yet aligned with global standards. In response, some LMICs have introduced stringent regulatory protections for clinical trial participants [ 40 ]. Thus, research is becoming more challenging to undertake in some LMICs because of complex trial regulations and increased administrative burdens.…”

Section: Types Of Trials Using Adaptive Designsmentioning

confidence: 99%

The critical need to accelerate cerebral palsy research with consumer engagement, global networks, and adaptive designs

Thomas,

Novak,

Ritterband-Rosenbaum

et al. 2024

PRM

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The prevalence of cerebral palsy (CP) varies globally, with higher rates and burden of disease in low- and middle-income countries. CP is a lifelong condition with no cure, presenting diverse challenges such as motor impairment, epilepsy, and mental health disorders. Research progress has been made but more is needed, especially given consumer demands for faster advancements and improvements in the scientific evidence base for interventions. This paper explores three strategies to accelerate CP research: consumer engagement, global clinical trial networks, and adaptive designs. Consumer engagement involving individuals with lived experience enhances research outcomes. Global clinical trial networks provide efficiency through larger and more diverse participant pools. Adaptive designs, unlike traditional randomized controlled trials, allow real-time modifications based on interim analyses, potentially answering complex questions more efficiently. The establishment of a CP Global Clinical Trials Network, integrating consumer engagement, global collaboration, and adaptive designs, marks a paradigm shift. The Network aims to address consumer-set research priorities. While challenges like ethical considerations and capacity building exist, the potential benefits for consumers, clinicians, researchers, and funding bodies are substantial. This paper underscores the urgency of transforming CP research methodologies for quicker translation of novel treatments into clinical practice to improve quality of life for those with CP.

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“… 1 3 4 This trajectory coincides with clinical trial sponsors and trial coordinators primarily being based in HICs without equal data sharing or capacity building in recruiting regions. 5 Often, recruitment for these global trials occurs solely in low-income countries (LICs) and lower middle-income countries (LMICs), yet analysis is conducted solely in HICs. 6–8 This appears to follow a common, extractive pattern from Global South to benefit the Global North, which may be attributed to traditional power imbalances, and the ongoing colonial model of global health research.…”

Section: Introductionmentioning

confidence: 99%

Data flow within global clinical trials: a scoping review

Kwok

Sati²,

Dron³

et al. 2022

BMJ Glob Health

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ObjectiveTo document clinical trial data flow in global clinical trials published in major journals between 2013 and 2021 from Global South to Global North.DesignScoping analysisMethodsWe performed a search in Cochrane Central Register of Controlled Trials (CENTRAL) to retrieve randomised clinical trials published between 2013 and 2021 from The BMJ, BMJ Global Health, the Journal of the American Medical Association, the Lancet, Lancet Global Health and the New England Journal of Medicine. Studies were included if they involved recruitment and author affiliation across different country income groupings using World Bank definitions. The direction of data flow was extracted with a data collection tool using sites of trial recruitment as the starting point and the location of authors conducting statistical analysis as the ending point.ResultsOf 1993 records initially retrieved, 517 studies underwent abstract screening, 348 studies underwent full-text screening and 305 studies were included. Funders from high-income countries were the sole funders of the majority (82%) of clinical trials that recruited across income groupings. In 224 (73.4%) of all assessable studies, data flowed exclusively to authors affiliated with high-income countries or to a majority of authors affiliated with high-income countries for statistical analysis. Only six (3.2%) studies demonstrated data flow to lower middle-income countries and upper middle-income countries for analysis, with only one with data flow to a lower middle-income country.ConclusionsGlobal clinical trial data flow demonstrates a Global South to Global North trajectory. Policies should be re-examined to assess how data sharing across country income groupings can move towards a more equitable model.

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Regulating international clinical research: an ethical framework for policy-makers

Cited by 9 publications

References 35 publications

Harnessing Clinical Trial Capacity to Mitigate Zoonotic Diseases: The Role of Expert Scientists in Ethiopia

Harnessing Clinical Trial Capacity to Mitigate Zoonotic Diseases: The Role of Expert Scientists in Ethiopia

The critical need to accelerate cerebral palsy research with consumer engagement, global networks, and adaptive designs

Data flow within global clinical trials: a scoping review

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