临床研究有哪些不同类型？

What Are the Different Types of Clinical Research?

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Different types of clinical research are used depending on what the researchers are studying. Below are descriptions of some different kinds of clinical research.

Treatment Research generally involves an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy.

Prevention Research looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes.

Diagnostic Research refers to the practice of looking for better ways to identify a particular disorder or condition.

Screening Research aims to find the best ways to detect certain disorders or health conditions.

Quality of Life Research explores ways to improve comfort and the quality of life for individuals with a chronic illness.

Genetic studies aim to improve the prediction of disorders by identifying and understanding how genes and illnesses may be related. Research in this area may explore ways in which a person’s genes make him or her more or less likely to develop a disorder. This may lead to development of tailor-made treatments based on a patient’s genetic make-up.

Epidemiological studies seek to identify the patterns, causes, and control of disorders in groups of people.

An important note: some clinical research is “outpatient,” meaning that participants do not stay overnight at the hospital. Some is “inpatient,” meaning that participants will need to stay for at least one night in the hospital or research center. Be sure to ask the researchers what their study requires.

Phases of clinical trials: when clinical research is used to evaluate medications and devices Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as psychotherapy or medications. Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions.

Phase I trials Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects.

Phase II trials The experimental drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase III trials The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

Phase IV trials Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use.

Examples of other kinds of clinical research Many people believe that all clinical research involves testing of new medications or devices. This is not true, however. Some studies do not involve testing medications and a person’s regular medications may not need to be changed. Healthy volunteers are also needed so that researchers can compare their results to results of people with the illness being studied. Some examples of other kinds of research include the following:

A long-term study that involves psychological tests or brain scans

A genetic study that involves blood tests but no changes in medication

A study of family history that involves talking to family members to learn about people’s medical needs and history.

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根据研究人员正在研究的内容，使用不同类型的临床研究。以下是一些不同类型的临床研究的描述。

治疗研究通常涉及干预，例如药物，心理治疗，新设备或新的手术或放射治疗方法。

预防研究寻找更好的方法来预防疾病的发展或复发。不同类型的预防研究可以研究药物、维生素、疫苗、矿物质或生活方式的改变。

诊断研究是指寻找更好的方法来识别特定疾病或病症的做法。

筛查研究旨在找到检测某些疾病或健康状况的最佳方法。

生活质量研究探索了改善慢性病患者舒适度和生活质量的方法。

遗传学研究旨在通过识别和理解基因和疾病之间的关系来改善对疾病的预测。该领域的研究可能会探索一个人的基因使他或她或多或少地患上疾病的方式。这可能会导致根据患者的基因组成开发量身定制的治疗方法。

流行病学研究旨在确定人群中疾病的模式、原因和控制。

重要提示：一些临床研究是“门诊”的，这意味着参与者不会在医院过夜。有些是“住院”，这意味着参与者需要在医院或研究中心至少停留一晚。一定要问研究人员他们的研究需要什么。

临床试验阶段：当临床研究用于评估药物和设备时 临床试验是一种临床研究，旨在评估和测试新的干预措施，如心理治疗或药物。临床试验通常分四个阶段进行。每个阶段的试验都有不同的目的，帮助科学家回答不同的问题。

I期试验 研究人员首次在一小群人中测试实验性药物或治疗方法。研究人员评估治疗的安全性，确定安全剂量范围，并确定副作用。

二期试验 实验性药物或治疗被给予更多的人，看看它是否有效并进一步评估其安全性。

三期试验 实验研究药物或治疗给予大群人。研究人员确认其有效性，监测副作用，将其与常用治疗方法进行比较，并收集信息，使实验药物或治疗方法能够安全使用。

IV期试验 在FDA批准使用治疗后进行的上市后研究提供了额外的信息，包括治疗或药物的风险，益处和最佳用途。

其他种类的临床研究的例子 许多人认为，所有临床研究都涉及新药物或设备的测试。然而，事实并非如此。一些研究不涉及测试药物，一个人的常规药物可能不需要改变。还需要健康的志愿者，以便研究人员可以将他们的结果与正在研究的疾病患者的结果进行比较。其他类型的研究的一些例子包括：

一项涉及心理测试或脑部扫描的长期研究

一项涉及血液检查但没有药物变化的基因研究

一项家族史研究，涉及与家庭成员交谈以了解人们的医疗需求和病史。

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