COVID-19新冠大流行已經將世界的關(guan) 注點從(cong) 經濟和全球關(guan) 係部分轉向了醫療保健和疫苗生產(chan) 。如此大規模的大流行病首次衝(chong) 擊了現代社會(hui) ，確診病例接近7億(yi) 。生命危在旦夕，時間與(yu) 我們(men) 賽跑，科學家們(men) 正在全球範圍內(nei) 竭盡全力開發有效的治療方法和疫苗。今天，我們(men) 將從(cong) 表現和合法性的角度審視疫苗發展的快速過程。我們(men) 將深入探討生物學進步背後的道德性，回顧過去一些臭名昭著的錯誤，並揭示導致我們(men) 現在的COVID-19疫苗的複雜過程。
The COVID-19 pandemic has turned the world’s attention partially away from economic and global relationships into healthcare and vaccine production. For the first time, such an extensive pandemic had crushed modern society, growing close to 700 million positive cases. With life hanging in the balance and time running against us, scientists are racing to develop effective treatment and vaccines has become a topic of global interest. Today, we question the rapid process of vaccine development under the scope of its performance and legality. We will delve into the ethicality behind advancement in biology, examining some infamous missteps from the past, and shedding light to the complex process that has led to our present-day COVID-19 vaccines.
人類臨(lin) 床試驗：拯救生命的機會(hui) 遊戲 The Human Clinical Trials: A Lifesaving Game of Chance
人類臨(lin) 床試驗是確定潛在新治療方法是否安全有效的關(guan) 鍵實驗，遵循嚴(yan) 格的多階段過程。它們(men) 是任何新的醫療手段的最終檢驗場，雖然它們(men) 可能會(hui) 帶來拯救生命的突破，但有時也可能出錯。兩(liang) 個(ge) 例子生動地說明了這一點。
Human clinical trials, the crucial experiments that determine whether a potential new treatment is safe and effective, follow a rigorous, multi-phase process. They are the ultimate proving ground for any new medical intervention and, while they can lead to life-saving breakthroughs, they can sometimes go disastrously wrong. Two examples, one from the past and another more recent, illustrate this starkly.
大象人的悲劇故事 The Tragic Tale of the Elephant Man
可能在悲劇結果方麵引發了最多關(guan) 注的臨(lin) 床試驗是使參與(yu) 者變得畸形腫脹的試驗，讓他們(men) 看起來像約瑟夫·梅裏克，人們(men) 通常稱他為(wei) "大象人"。2006年，為(wei) 治療白血病開發的TGN1412藥物的第一階段臨(lin) 床試驗導致了災難性的結果。在接受藥物幾分鍾後，參與(yu) 的六名健康誌願者開始出現頭痛，然後迅速進入嚴(yan) 重疾病。這種藥物觸發了他們(men) 免疫係統的災難性過度反應，這種反應在動物試驗中未見，突顯了早期臨(lin) 床試驗的潛在不可預測性。
The clinical trial that has arguably garnered the most publicity in terms of tragic outcomes was the one that left participants with grotesque swelling, likening them to Joseph Merrick, famously known as the "Elephant Man". In 2006, a phase I clinical trial for the drug TGN1412, developed to treat leukemia, led to disastrous results. Within minutes of receiving the drug, the six healthy volunteers involved started experiencing headaches, followed by a rapid spiral into critical illness. The drug triggered a catastrophic overreaction of their immune systems, a reaction not seen in animal trials, highlighting the potential unpredictability of early-phase clinical trials.
現代警世故事：BIA 10-2474 A Modern-Day Cautionary Tale: BIA 10-2474
快進十年，我們(men) 在2016年遇到了另一個(ge) 警世故事，這次是用於(yu) 治療一係列神經疾病的實驗性藥物BIA 10-2474。在法國進行的第一階段試驗中，一名參與(yu) 者死亡，另外五人出現嚴(yan) 重的神經症狀。試驗後的調查顯示，在測試階段采取的防範措施不足，進一步強調了人類臨(lin) 床試驗中嚴(yan) 格安全措施的重要性。
Fast forward a decade, and we encounter another cautionary tale from 2016, this time with the experimental drug BIA 10-2474, aimed to treat a range of neurological conditions. During a phase I trial in France, one participant died, and five others suffered severe neurological symptoms. The trial's subsequent investigation revealed insufficient precautions during the testing phase, further emphasizing the importance of rigorous safety measures in human clinical trials.
新冠時期的試驗：平衡的藝術 Trials in the Time of COVID-19: A Balancing Act
隨著COVID-19大流行的展開，對有效疫苗的迫切需要使臨(lin) 床試驗的世界麵臨(lin) 前所未有的壓力。形勢的緊迫性要求在速度和安全之間找到微妙的平衡。研究人員肩負了在不危害試驗參與(yu) 者安全的情況下尋找解決(jue) 方案的任務。
As the COVID-19 pandemic unfurled, a desperate need for effective vaccines put the world of clinical trials under unprecedented pressure. The urgency of the situation demanded a delicate balance between speed and safety. Researchers were tasked with finding a solution without compromising the safety of trial participants.
為(wei) 此，傳(chuan) 統的試驗階段通常是連續進行的，但在保證安全標準的同時進行。在早期的小規模試驗中表現出前景的疫苗候選者迅速轉移到大規模試驗，有時涉及數千名參與(yu) 者。同時，進行了大規模生產(chan) 的準備工作，這是一個(ge) 通常會(hui) 延遲到最後批準之後才進行的步驟，以避免如果疫苗證明無效而產(chan) 生不必要的成本。
In response to this, traditional trial phases, typically sequential, were conducted simultaneously, while ensuring safety standards. Vaccine candidates that showed promise in early-phase small-scale trials were quickly moved to large-scale trials, sometimes with thousands of participants. Concurrently, preparations for mass production were set in motion, a step that normally would be delayed until after the final approval to avoid unnecessary costs if the vaccine proved ineffective.
這個(ge) 加速過程的一個(ge) 例子是輝瑞-生物NTech COVID-19疫苗。在涉及超過43,000名參與(yu) 者的大型臨(lin) 床試驗中，這種疫苗展示了約95%的效果。由於(yu) 階段重疊，COVID-19發病率高，需求緊迫，試驗加速了。在仔細檢查試驗數據後，該疫苗在2020年12月被FDA授予緊急使用授權(EUA)，許多其他全球監管機構也做出了相同的決(jue) 定。
One example of this expedited process was the Pfizer-BioNTech COVID-19 vaccine. Tested in a large clinical trial involving over 43,000 participants, the vaccine demonstrated an efficacy of around 95%. The accelerated trial was a result of overlapping phases, high COVID-19 incidence, and urgent need. After careful examination of trial data, the vaccine was granted emergency use authorization (EUA) by the FDA in December 2020, a decision mirrored by many other global regulatory bodies.
總結 Conclusion
從(cong) 構思到部署的臨(lin) 床試驗之旅，證明了科學的奉獻精神，嚴(yan) 謹性和無數誌願參與(yu) 者的勇氣。這是一條充滿潛在陷阱的道路，正如TGN1412和BIA 10-2474的故事提醒我們(men) 的。然而，在COVID-19大流行中，我們(men) 實時看到了這個(ge) 過程的展開，結果是我們(men) 恢複正常生活的最大希望的疫苗。盡管存在試驗本身，但這些試驗的勝利為(wei) 我們(men) 在這個(ge) 充滿挑戰的時期提供了希望的燈塔。
The journey of a clinical trial, from conception to deployment, is a testament to scientific dedication, rigor, and the courage of countless volunteer participants. It's a path fraught with potential pitfalls, as the stories of TGN1412 and BIA 10-2474 remind us. Yet, amid the COVID-19 pandemic, we've seen this process unfold in real-time, resulting in vaccines that are our best hope for returning to a sense of normalcy. The triumph of these trials, despite the trials themselves, offers a beacon of hope in these challenging times.
參考文獻
1. National Institutes of Health (NIH) resources on clinical trials: Clinical Trials - NIH
2. The "Elephant Man" clinical trial case: “Elephant Man” Drug Trial Leaves Six Fighting for their Lives - The Guardian
3. The BIA 10-2474 clinical trial case: Death in France renews concerns about drug trial safety - Nature
4. The Pfizer-BioNTech COVID-19 vaccine development: Pfizer-BioNTech COVID-19 Vaccine - FDA
5. Bioethics and COVID-19 vaccine distribution: Fairly Prioritizing Groups for Access to COVID-19 Vaccines - JAMA
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