[英中] 一小段翻譯回顧,歡迎前輩指正~
最近開始回顧、訂正以前的翻譯作業,
這次內容來自一本講授臨床試驗的教科書。
還請各位前輩指正~
Fundamental Point 根本要點
A properly planned and executed clinical trial is a powerful experimental
technique for assessing the effectiveness of an intervention.
一次規畫和執行恰當的臨床試驗,為一項評估介入效果的強力實驗技術。
What Is a Clinical Trial? 何謂臨床試驗?
We define a clinical trial as a prospective study comparing the effect
and value of intervention(s) against a control in human beings.
我們定義臨床試驗是一種前瞻性研究,
用於和人體內的控制組比較介入的效果和其重要性。
Note that a clinical trial is pro- spective, rather than retrospective.
要注意臨床試驗是「預期性」,而非回溯性。
Study participants must be followed forward in time.
而研究受試者必須被及時追蹤,
They need not all be followed from an identical calendar date.
但不必從相同的日期開始進行追蹤。
In fact, this will occur only rarely.
實務上,這很少發生。
Each participant however, must be followed from a well-defined point
in time, which becomes time zero or baseline for the study.
然而每位受試者須從一個定義清楚的時間點開始被追蹤,
以成為研究的計時起點或基線。
This contrasts with a case-control study, a type of retrospective
observational study in which participants are selected on the basis of
presence or absence of an event or condition of interest.
這和病例對照研究相反。
病例對照研究為一種回溯性觀察研究,
其受試者是依據某事件,或我們有興趣的症狀之存在與否,作為挑選的基準。
By definition, such a study is not a clinical trial.
根據定義,此項研究不是一項臨床試驗。
People can also be identified from hospital records or other data sources,
and subsequent records can be assessed for evidence of new events.
若受試者的身份可以從醫院紀錄或其它資料來源得知,
且後續紀錄可用於評估新事件發生的證據,
This is not considered to be a clinical trial since the participants
are not directly observed from the moment of initiation of the study
and at least some of the follow-up data are retrospective.
則該試驗不應視為一項臨床試驗。
因為受試者的身分並非直接從研究初始之際就進行觀察,
且至少有部分受試者的追蹤資料為回溯性。
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