Regional Treatment Effects in Studies of Cardiorenal Drugs

Lawrence, John; Bai, Steve; Hung, H. M. James; O’Neill, Robert T.

doi:10.1016/j.jacc.2012.04.051

Cited by 8 publications

(4 citation statements)

References 4 publications

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“…Empirical evidence indicated the existence of country specific effects of medical interventions. For example, studies conducted in the United States (US) on average reported smaller treatment effects of cardiorenal drugs compared with studies in the non-US countries 103 . A meta-epidemiological study found that RCTs conducted in less developed countries tended to report more favourable results than trials in more developed countries 12 .…”

Section: Discussionmentioning

confidence: 99%

An assessment of randomized controlled trials (RCTs) for non-communicable diseases (NCDs): more and higher quality research is required in less developed countries

Hong

2015

Sci Rep

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Research is crucial to implement evidence-based health interventions for control of non-communicable diseases (NCDs). This study aims to assess main features of randomized controlled trials (RCTs) for control of NCDs, and to identify gaps in clinical research on NCDs between high-income and less developed countries. The study included 1177 RCTs in 82 Cochrane Systematic reviews (CSRs) and evaluated interventions for adults with hypertension, diabetes, stroke, or heart diseases. Multivariate logistic regression analyses were conducted to explore factors associated with risk of bias in included RCTs. We found that 78.2% of RCTs of interventions for major NCDs recruited patients in high-income countries. The number of RCTs included in the CSRs was increasing over time, and the increasing speed was more noticeable for RCTs conducted in middle-income countries. RCTs conducted in less developed countries tended to be more recently published, less likely to be published in English, with smaller sample sizes, and at a higher risk of bias. In conclusion, there is still a lack of research evidence for control of NCDs in less developed countries. To brace for rising NCDs and avoid waste of scarce research resources, not only more but also higher quality clinical trials are required in low-and-middle-income countries.

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Section: Discussionmentioning

confidence: 99%

An assessment of randomized controlled trials (RCTs) for non-communicable diseases (NCDs): more and higher quality research is required in less developed countries

Hong

2015

Sci Rep

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“…A meta‐analysis of 24 cardiovascular and renal drug trials submitted to the FDA in the past 15 years was conducted 45 . In these trials, the percentage of US patients ranged from 3 to 90.…”

Section: Clinical and Statistical Experience Reviewing Clinical Trialsmentioning

confidence: 99%

Regulatory and Scientific Issues Regarding Use of Foreign Data in Support of New Drug Applications in the United States: An FDA Perspective

Khin

Yang

Hung

et al. 2013

Clin Pharmacol Ther

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Globalization of clinical research has led to an increase in clinical trials conducted outside of the United States that are submitted to the US Food and Drug Administration (FDA) in new drug applications. This article discusses the FDA's experience with these submissions in specific therapeutic areas, including the extent of this practice, differences between the effectiveness and safety outcomes of studies conducted inside and outside the United States, and the FDA's approach to acceptance of these trials.

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“…Generalizability or external validity of findings from RCTs is often context dependent, and questionable across different settings or countries [ 56 , 57 ]. For example, studies in the United States on average reported smaller effects of cardiorenal drugs compared with those conducted in other countries [ 58 ]. A study found that RCTs from less developed countries tended to report more favorable results than those from developed countries [ 53 ].…”

Section: Discussionmentioning

confidence: 99%

An assessment of factors associated with quality of randomized controlled trials for smoking cessation

Hong

Wang

et al. 2016

Oncotarget

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To reduce smoking-related diseases, a research priority is to develop effective interventions for smoking cessation, and evidence from randomized controlled trials (RCTs) is usually considered to be the most valid. However, findings from RCTs may still be misleading due to methodological flaws. This study aims to assess the quality of 1083 RCTs of smoking cessation interventions in 41 relevant Cochrane Systematic Reviews (CSRs). Logistic regression analysis was performed to identify significant variables associated with the quality of RCTs. It was found that evidence for smoking cessation from RCTs was predominantly from high income countries, and the overall quality was high in only 8.6% of the RCTs. High quality RCTs tended to have a larger sample size, to be more recently published, and conducted in multiple countries belonging to different income categories. In conclusion, the overall quality of RCTs of smoking cessation interventions is far from perfect, and more RCTs in less developed countries are required to generate high grade evidence for global tobacco control. Collaboration between researchers in developed and less developed countries should be encouraged.

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Regional Treatment Effects in Studies of Cardiorenal Drugs

Abstract: Studies are listed in order from top to bottom by percent of U.S. enrollment (shown in the column on right). Circles indicate the point estimate of the difference between log-hazard ratios (U.S. compared with non-U.S.), and arrows represent the 95% confidence interval for this difference.

Cited by 8 publications

References 4 publications

An assessment of randomized controlled trials (RCTs) for non-communicable diseases (NCDs): more and higher quality research is required in less developed countries

An assessment of randomized controlled trials (RCTs) for non-communicable diseases (NCDs): more and higher quality research is required in less developed countries

Regulatory and Scientific Issues Regarding Use of Foreign Data in Support of New Drug Applications in the United States: An FDA Perspective

An assessment of factors associated with quality of randomized controlled trials for smoking cessation

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