临床研究基础

Clinical trials are research studies performed that aim to evaluate a medical, surgical, or behavioral intervention. They help researchers evaluate a new drug or medical device to determine if it is:

• 安全
• 有效的
• Better than the standard or current treatment

Clinical trials also test methods of early detection of diseases, prevention of 健康状况s, and may also look at ways to improve the quality of life for people living with a life-threatening disease or a chronic 健康状况. Clinical trials may also study the role of caregivers 或者支持小组.

There are two main types of clinical research studies:

• 观察性研究 observe people in normal settings. 病人 are treated based on normal 必要时的临床决策. Participants are monitored over a period of time and the study team collects and reviews the data gathered. 为 example, for a set period of time, researchers may collect data of older adults through medical exams, tests, or questionnaires to learn more about the effects of different lifestyles on cognitive health.
• 介入性临床试验 take action to prevent, better understand, or treat a disease. 研究人员 test the safety and effectiveness of a new drug or other treatment. 介入 clinical trials follow strict rules to protect patients.

临床试验是如何进行的?

The idea for a clinical trial often starts in the laboratory. 后研究人员 test new treatments or procedures in the lab, the most promising treatments 是否进入临床试验. As new treatments move through a series of steps called phases, more information is gained about the treatment, 它的风险和有效性.

Clinical trials are done in four phases to test a treatment or, in the case of a new drug, find the appropriate dosage, and look for side effects. The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for clinical use and continue 监测其效果.

临床试验的阶段

第一阶段:安全吗?

The main goal is to see if the treatment is safe.

People in Phase I studies can be healthy or have a disease.

第二阶段:有效吗?

Once a treatment is safe, then a Phase II study is done to see if the treatment works.

Phase II studies usually have more participants than Phase I studies.

Phase III: Is it better than what we currently have?

A Phase III study compares a new treatment with a current treatment to see which is safer and works better.

Phase III studies have a large number of participants, sometimes thousands.

After a Phase III study shows that a treatment works and is safe, then the Food and Drug Administration (FDA) reviews it for approval.

第四阶段:还会发生什么?

After FDA approval and the treatment is being used, researchers may do IV期研究.

Phase IV studies look at whether the treatment is useful for other conditions or if it has any long-term side effects.