| Clinical trials are experiments done in clinical research. |
臨床試驗即臨床研究領域進行的實驗。 |
| Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. |
如此的以人類受試者為前瞻性的生物醫學或是行為研究的試驗，乃設計來解答特定的關於生醫或是行為介入的問題，包括了新的治療(像是新穎的疫苗、藥物、飲食選擇、飲食補充品以及醫療器械)，以及需要進一步研究和比較的已知的介入方式。 |
| Clinical trials generate data on safety and efficacy. |
臨床試驗提供安全性和有效性的數據。 |
| They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. |
臨床試驗唯有在獲得尋求治療許可的所在國的醫療管理機構/倫理委員會的許可之後方可進行。 |
| These authorities are responsible for vetting the risk/benefit ratio of the trial - their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted. |
這些管理當局負責審度試驗的風險/受益比，他們的許可不表示治療是安全或有效的，而僅只是試驗是可以進行的。 |
| Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. |
依產品的類型和發展的階段，試驗主持人剛開始先招募志願者或是病人參與前導研究，後續接著進行規模漸增的比較性研究。 |
| Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. |
臨床試驗的規模和花費差異很大，他們可以牽涉單一研究中心或是多中心、在單一國家或是多國進行。 |
| Clinical study design aims to ensure the scientific validity and reproducibility of the results. |
臨床研究設計目標在確保結果在科學上的有效性以及再現性。 |
| Trials can be quite costly, depending on a number of factors. |
試驗可能所費不貲，其與一些因素相關。 |
| The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company. |
試驗委託者可以是政府機構，或是製藥、生技或醫療器械的公司。 |
| Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory. |
某些試驗必要的功能，像是監測和實驗室的工作，可以交由外包公司比方說受託研究機構或是中心實驗室來處理。 |
