| Clinical trials are experiments done in clinical research. |
临床试验是临床研究中开展的试验。 |
| 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. |
设计这些以人体受试者为研究对象的前瞻性生物医学或行为学研究的目的在于解决生物医学或行为学干预相关的特定问题，其中包括用于更深层研究和对比的新型治疗方式（如新开发的疫苗、药物、饮食选择、膳食补充和医疗器械）以及已知干预措施。 |
| Clinical trials generate data on safety and efficacy. |
通过临床试验会得出安全性和疗效相关数据。 |
| They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. |
临床试验只有在得到治疗已获批准的国家的卫生当局/伦理委员会批准后方可进行。 |
| 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. |
这些卫生当局负责审核试验的风险/获益比 - 他们批准试验能够进行并不意味着治疗是“安全”或有效的，而只意味着试验得以开展。 |
| 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. |
根据试验用药品类型及研发阶段，研究者最初会招募志愿者和/或患者进行小范围的试点研究，后续会逐渐进行更大规模的对照研究。 |
| 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. |
临床试验在规模和成本方面各有所异，其可在一个国家或多个国家的某一个研究中心或多个研究中心开展。 |
| Clinical study design aims to ensure the scientific validity and reproducibility of the results. |
临床试验设计旨在保证其科学性和研究结果的可重复性。 |
| Trials can be quite costly, depending on a number of factors. |
临床试验成本有时候相当高昂，具体取决于多个因素。 |
| The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company. |
临床试验申办方可以是政府机构，也可以是制药、生物技术或医疗器械公司。 |
| 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. |
临床试验中必要的某些功能，如监察和实验室工作，可由外包商管理，如合同研究组织或中心实验室。 |
