嚴重不良事件

在從事人體藥物臨床試驗中，所謂嚴重不良事件 (英語：serious adverse event，SAE) 的定義為在使用任何劑量下，所產的任何不良醫學事件，包括有：

造成死亡
危及生命
需要住院治療，或是導致既有住院時間因而延長
導致持續或嚴重的失能/官能不全
可能會導致先天性障礙（先天缺陷）發生
需要用到干預手段，以防止永久性傷害或是損害^[1]

「life-threatening（危及生命）」表達的就是「嚴重」的定義，是指患者在事件發生時就面臨死亡的風險；並非指假設當情況更為嚴重時，才可能會導致死亡。^[2]^[3] 不良事件（英語：Adverse event）被進一步定義為「患者或是臨床研究對象攝取藥物後發生的任何不良醫學事件，並且不一定與治療有因果關係。」^[2]

研究

人體臨床試驗的研究人員有義務為這些事件提出報告。^[4]而根據研究顯示，在公開報告之中，對這些事件通常並未做充分的報導。^[5]由於缺乏數據，以及在整合資料時有不確定性，對治療干預進行系統綜述和綜合分析的人往往會不經意，而過分強調藥物對於健康的益處。^[6]為針對過分強調益處提供平衡的報導，學者們呼籲對臨床試驗時發生的危害要做更完整的報告。^[7]

參見

^ What is a Serious Adverse Event?. FDA. 9 September 2020 [2021-12-20]. （原始內容存檔於2018-01-25）.
^ ^2.0 ^2.1 Expert Working Group (Efficacy) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guideline for Industry - Clinical safety data management: definitions and standards for expedited reporting. (PDF). FDA Center for Drug Evaluation and Research. August 25, 2007 [2021-12-20]. （原始內容存檔 (PDF)於2009-05-11）.
^ CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING ICH Harmonised Tripartite Guideline (PDF). European Medicines Agency. June 1995 [5 October 2021]. （原始內容存檔 (PDF)於2022-07-28）. NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.
^ Expert working group (efficacy) of the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Guideline for Industry Structure and Content of Clinical Study Reports. (PDF). FDA Center for Drug Evaluation and Research. August 25, 2007 [2021-12-20]. （原始內容存檔 (PDF)於2009-05-25）.
^ Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas.. JAMA. 2001, 285 (4): 437–43. PMID 11242428. doi:10.1001/jama.285.4.437 .
^ Chou R, Helfand M. Challenges in systematic reviews that assess treatment harms.. Ann Intern Med. 2005, 142 (12 Pt 2): 1090–0. PMID 15968034. doi:10.7326/0003-4819-142-12_part_2-200506211-00009 .
^ Ioannidis JP, Evans SJ, Gøtzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D, CONSORT Group. Better reporting of harms in randomized trials: an extension of the CONSORT statement.. Ann Intern Med. 2004, 141 (10): 781–8. PMID 15545678. doi:10.7326/0003-4819-141-10-200411160-00009.

參考文獻

不良事件（英語：Adverse event）, 包括溫和/不嚴重
臨床試驗
良好藥品臨床試驗規範(GCP)
臨床數據及安全檢測委員會（英語：Data Monitoring Committee）
藥物安全檢測（英語：Pharmacovigilance）
歐盟藥物安全檢測機構（英語：EudraVigilance）
歐盟臨床試驗法規（英語：Clinical Trials Directive）
Theralizumab（英語：Theralizumab），一種在臨床試驗時發生嚴重不良事件的免疫治療藥物
BIA 10-2474（英語：BIA 10-2474）,一種脂肪酸酰胺水解酶（英語：Fatty acid amide hydrolase）藥物，在臨床試驗中發生嚴重不良事件，包含一起死亡案例。

外部連結

What Is A Serious Adverse Event? （頁面存檔備份，存於互聯網檔案館） (MedWatch)
ClinicalTrials.gov （頁面存檔備份，存於互聯網檔案館） from US National Library of Medicine
ICH Website （頁面存檔備份，存於互聯網檔案館）

[1] What is a Serious Adverse Event?. FDA. 9 September 2020 [2021-12-20]. （原始內容存檔於2018-01-25）.

[Defs-2] 2.0 ^2.1 Expert Working Group (Efficacy) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guideline for Industry - Clinical safety data management: definitions and standards for expedited reporting. (PDF). FDA Center for Drug Evaluation and Research. August 25, 2007 [2021-12-20]. （原始內容存檔 (PDF)於2009-05-11）.

[3] CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING ICH Harmonised Tripartite Guideline (PDF). European Medicines Agency. June 1995 [5 October 2021]. （原始內容存檔 (PDF)於2022-07-28）. NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.

[4] Expert working group (efficacy) of the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Guideline for Industry Structure and Content of Clinical Study Reports. (PDF). FDA Center for Drug Evaluation and Research. August 25, 2007 [2021-12-20]. （原始內容存檔 (PDF)於2009-05-25）.

[5] Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas.. JAMA. 2001, 285 (4): 437–43. PMID 11242428. doi:10.1001/jama.285.4.437 .

[6] Chou R, Helfand M. Challenges in systematic reviews that assess treatment harms.. Ann Intern Med. 2005, 142 (12 Pt 2): 1090–0. PMID 15968034. doi:10.7326/0003-4819-142-12_part_2-200506211-00009 .

[7] Ioannidis JP, Evans SJ, Gøtzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D, CONSORT Group. Better reporting of harms in randomized trials: an extension of the CONSORT statement.. Ann Intern Med. 2004, 141 (10): 781–8. PMID 15545678. doi:10.7326/0003-4819-141-10-200411160-00009.

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研究

相關名詞

參見

參考文獻

外部連結