收藏|临床研究常用术语表中英文对照

Glossary of Common Terms常用术语表

Clinical Research临床研究
Clinical research is medical research that involves people to test new treatments and therapies.临床研究是涉及人们测试新疗法和疗法的医学研究。

Clinical Trial临床试验
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
前瞻性地将一项或多项人类受试者分配给一项或多项干预措施（可能包括安慰剂或其他对照）的研究，以评估这些干预措施对健康相关的生物医学或行为结局的影响。

Healthy Volunteer健康志愿者(又称：健康受试者)
A Healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention.健康志愿者是指没有已知重大健康问题的人，他们参与临床研究以测试新药，新设备或新干预措施。

Inclusion/Exclusion Criteria纳入/排除标准
Inclusion/Exclusion Criteria are factors that allow someone to participate in a clinical trial are inclusion criteria. Those that exclude or not allow participation are exclusion criteria.纳入/排除标准是允许某人参加临床试验的因素，是纳入标准。那些排除或不允许参加的人是排除标准。

Informed Consent知情同意
Informed consent explains risks and potential benefits about a clinical trial before someone decides whether to participate.知情同意书可在某人决定是否参加之前解释有关临床试验的风险和潜在收益。

Patient Volunteer患者志愿者(又称：患者受试者)
A patient volunteer has a known health problem and participates in research to better understand, diagnose, treat, or cure that disease or condition.患者志愿者具有已知的健康问题，并参与研究以更好地理解，诊断，治疗或治愈该疾病或状况。

Phases of Clinical Trials临床试验阶段
Clinical trials are conducted in “phases.” The trials at each phase have a different purpose and help researchers answer different questions.临床试验是分阶段进行的。每个阶段的试验都有不同的目的，可以帮助研究人员回答不同的问题。
Phase I trials — An experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.I期试验-首次在少数人群中（20-80）进行实验性药物或治疗。目的是评估其安全性并确定副作用。
Phase II trials — The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.II期试验-将试验性药物或治疗药物用于更大范围的人群（100-300），以确定其有效性并进一步评估其安全性。
Phase III trials — The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments.III期试验-将实验性药物或治疗药物用于大批人群（1,000-3,000），以确认其有效性，监测副作用并将其与标准或等效治疗方法进行比较。
Phase IV trials — After a drug is licensed and approved by the FDA researchers track its safety, seeking more information about its risks, benefits, and optimal use.IV期试验-在药物获得FDA许可并批准后，研究人员跟踪其安全性，以寻求有关其风险，益处和最佳用法的更多信息。

Placebo安慰剂
A placebo is a pill or liquid that looks like the new treatment but does not have any treatment value from active ingredients.安慰剂是一种药丸或液体，看起来像新疗法，但没有任何有效成分的治疗价值。

Protocol协议
A Protocol is a carefully designed plan to safeguard the participants’ health and answer specific research questions.协议是精心设计的计划，旨在保护参与者的健康并回答特定的研究问题。

Principal Investigator首席研究员
A Principal Investigator is a doctor who leads the clinical research team and, along with the other members of the research team, regularly monitors study participants’ health to determine the study’s safety and effectiveness.首席研究员是领导临床研究团队的医生，并与研究团队的其他成员一起定期监视研究参与者的健康状况，以确定研究的安全性和有效性。

Randomization随机化
Randomization is the process by which two or more alternative treatments are assigned to volunteers by chance rather than by choice.随机化是通过偶然而非选择将两种或多种替代疗法分配给志愿者的过程。

Single- or Double-Blind Studies单盲或双盲研究
Single- or double-blind studies (also called single- or double-masked studies) are studies in which the participants do not know which medicine is being used, so they can describe what happens without bias.单盲或双盲研究（也称为单掩蔽或双掩蔽研究）是参与者不知道正在使用哪种药物的研究，因此他们可以描述发生的情况而不会产生偏见。

Types of Clinical Trials临床试验的类型
Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition.诊断试验确定用于诊断特定疾病或状况的更好测试或程序。
Natural history studies provide valuable information about how disease and health progress.自然史研究提供了有关疾病和健康进展的宝贵信息。
Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning.预防试验正在寻找更好的方法来预防从未患过该病的人或预防该病的复发。
Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with a chronic illness.生活质量试验（或支持性护理试验）探索和衡量改善慢性病患者的舒适度和生活质量的方法。
Screening trials test the best way to detect certain diseases or health conditions.筛选试验是检测某些疾病或健康状况的最佳方法。
Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.治疗试验测试新疗法，新药物组合或外科手术或放射疗法的新方法。

注：以上中文翻译仅为参考，请以英文内容为主

       文章来源：famai618 法迈医讯

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