在评估2018-2021年期间欧盟风险最小化措施的有效性时报告的局限性:对行业赞助的授权后安全研究的定性分析

Renske J Grupstra1, Thomas Goedecke2, Helga Gardarsdottir1,3,4

  • 1Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.

概括

许多评估药物风险最小化措施 (RMM) 的授权后安全研究 (PASS) 面临挑战. 这项研究强调了局限性,特别是关于二次数据的使用,影响了对RMM有效性的结论.

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