Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials.

Nahathai Dukaew,Mingkwan Na Takuathung,Wannachai Sakuludomkan, Kanyarat Chairaksa,Preeyaporn Klinjan,Nimit Morakote,Nut Koonrungsesomboon

Clinical trials (London, England)（2023）

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摘要

The informed consent forms in industry-sponsored drug development clinical trials were long but incomplete. Our findings draw attention to ongoing challenges in industry-sponsored drug development clinical trials, where deficient informed consent form quality continues to exist.

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关键词

consent forms,regulatory compliance,drug development,trials,industry-sponsored

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