新藥臨床試驗受試者招募廣告、新聞宣傳之法規限制

Abstract

新藥臨床試驗對於受試者健康上的影響並不確定，而且越是前期的臨床試驗，其不確定性可能越高。因此，為了避免臨床試驗藉由易導致誤解的招募廣告文字，或甚至以高額的報酬作為訴求來利誘民眾參與，使民眾忽略應考量的風險，現行法規遂對於相關廣告與宣傳加以限制，主管機關亦多次函釋相關的審查原則與執法原則，值得注意。

In order to protect potential participants, regulations on clinical trial recruitment advertising are necessary. For examples, no claims should be made that the investigational drug is safe or effective, or that it is equivalent or superior to existing treatments. The content of advertising should be pre-reviewed by an IRB, in determining whether it is misleading or too promissory. The advertising should not promote “free medical treatment” or emphasize the trial is paid. When preparing to advertise clinical trials, failing to keep in mind these regulations and relevant guidelines may cause serious consequences to the research.