Design and Analysis of Multinational Clinical Trials

Ho, Hsin‐Tsung; Chow, Shein‐Chung

doi:10.1177/00928615980320s126

“…This approach would be straightforward if efficacy/effectiveness data were generated from RCT(s) conducted in a single country where the economic evaluation was conducted. However, multi-regional clinical trials (MRCT) in global development programs have gained popularity in recent decades (Ho and Chow, 1998), especially after the release of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidance E5 addressing ethnic factors for acceptability of foreign data in the drug registration evaluation (Guideline, 2016a). The rising prevalence of MRCT has introduced new questions about CEA methods, especially surrounding data related to clinical evidence.…”

Section: Introductionmentioning

confidence: 99%

Challenges from Variation across Regions in Cost Effectiveness Analysis in Multi-Regional Clinical Trials

Chu

¹

,

Dai

²

,

Qi

³

et al. 2016

Front. Pharmacol.

0

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Economic evaluation in the form of cost-effectiveness analysis has become a popular means to inform decisions in healthcare. With multi-regional clinical trials in a global development program becoming a new venue for drug efficacy testing in recent decades, questions in methods for cost-effectiveness analysis in the multi-regional clinical trials setting also emerge. This paper addresses some challenges from variation across regions in cost effectiveness analysis in multi-regional clinical trials. Several discussion points are raised for further attention and a multi-regional clinical trial example is presented to illustrate the implications in industrial application. A general message is delivered to call for a depth discussion by all stakeholders to reach an agreement on a good practice in cost-effectiveness analysis in the multi-regional clinical trials. Meanwhile, we recommend an additional consideration of cost-effectiveness analysis results based on the clinical evidence from a certain homogeneous population as sensitivity or scenario analysis upon data availability.

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Multinational (Global) Trial

Snapinn

¹

2007

Wiley Encyclopedia of Clinical Trials

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Multinational clinical trials are trials conducted in more than one country using a common protocol. They have become increasingly common and have many advantages, such as access to a large patient population and the potential to obtain a broadly generalizable conclusion. However, these trials also have a number of practical difficulties, such as differences among the countries in language, import/export procedures, and regulatory and legal requirements. In addition, country‐by‐treatment interactions have frequently been found in these trials, leading to difficulties in interpreting the results. For example, the MERIT‐HF trial, which evaluated metoprolol in patients with heart failure, found an overall hazard ratio for total mortality of 0.66, but a hazard ratio of 1.05 in the United States. There is particular concern that differences among countries hinder the ability to evaluate the cost effectiveness of an experimental treatment.

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Multinational (Global) Trial

Snapinn

¹

2014

Wiley StatsRef: Statistics Reference Online

0

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Multinational clinical trials are trials conducted in more than one country using a common protocol. They have become increasingly common and have many advantages, such as access to a large patient population and the potential to obtain a broadly generalizable conclusion. However, these trials also have a number of practical difficulties, such as differences among the countries in language, import/export procedures, and regulatory and legal requirements. In addition, country‐by‐treatment interactions have frequently been found in these trials, leading to difficulties in interpreting the results. For example, the MERIT‐HF trial, which evaluated metoprolol in patients with heart failure, found an overall hazard ratio for total mortality of 0.66, but a hazard ratio of 1.05 in the United States. There is particular concern that differences among countries hinder the ability to evaluate the cost effectiveness of an experimental treatment.

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Design and Analysis of Multinational Clinical Trials

Cited by 5 publications

References 6 publications

Challenges from Variation across Regions in Cost Effectiveness Analysis in Multi-Regional Clinical Trials

Challenges from Variation across Regions in Cost Effectiveness Analysis in Multi-Regional Clinical Trials

Multinational (Global) Trial

Multinational (Global) Trial

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