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Clinical trials Hironobu TOKUMASU 1 1Clinical Research Support Center, Kurashiki Central Hospital pp.543-549
Published Date 2022/7/1
DOI https://doi.org/10.11477/mf.3102200996
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A “clinical trial” is a clinical study conducted to obtain approval for a drug or medical device. Since clinical trials (PhaseⅢ) are generally conducted as randomized controlled trials (RCT), there are issues such as how to deal with situations that are difficult to be targeted by an RCT, such as patients with rare diseases or multiple complications. There are also issues regarding the role of companies, such as lengthy duration of a clinical trial and the high cost associated with conducting a clinical trial. To deal with these problems, evidence generated using real-world data (real-world evidence) is expected to be used in regulatory agency approval applications. The era of utilizing real-world evidence for drug discovery is just around the corner.


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電子版ISSN 2186-7852 印刷版ISSN 1883-4833 メディカル・サイエンス・インターナショナル

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