临床研究:它是什么?
你的医生可能已经说过你有资格进行临床试验, 或者你可能见过临床研究的广告. 什么是临床研究，它适合你吗?
Clinical research is the comprehensive study of the safety and effectiveness of the most promising advances in patient care. 临床研究不同于实验室研究. 它包括自愿帮助我们更好地了解医学和健康的人. Lab research generally does not involve people — although it helps us learn which new ideas may help people.
Every drug, device, tool, diagnostic test, technique and technology used in medicine today was once tested in volunteers who took part in clinical research studies.
At Johns Hopkins Medicine, we believe that clinical research is key to improve care for people in our community and around the world. 一旦你更了解临床研究, 你可能会明白为什么参与对你自己和社区都很重要.
临床研究有哪些类型?
临床研究主要有两种:
Observational Studies
Observational studies are studies that aim to identify and analyze patterns in medical data or in biological samples, 比如研究参与者提供的组织或血液.
Clinical Trials
Clinical trials, 也被称为介入性研究, 测试医疗干预措施(如药物)的安全性和有效性, 程序和工具——在活人身上.
临床研究需要各个年龄段的人, health status, race, gender, 种族和文化背景的参与. This will increase the chances that scientists and clinicians will develop treatments and procedures that are likely to be safe and work well in all people. Potential volunteers are carefully screened to ensure that they meet all of the requirements for any study before they begin. Most of the reasons people are not included in studies is because of concerns about safety.
Both healthy people and those with diagnosed medical conditions can take part in clinical research. 参与始终是完全自愿的, 参与者可以在任何时候因为任何原因离开研究.
“The only way medical advancements can be made is if people volunteer to participate in clinical research. The research participant is just as necessary as the researcher in this partnership to advance health care.”
利兹·马丁内斯，约翰·霍普金斯大学医学研究参与者倡导者
Types of Research Studies
在这两种主要的临床研究中，有许多类型的研究. 它们根据研究目标、参与者和其他因素而有所不同.
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生物储存库是一种收集, 对血液等生物材料标本进行分类和储存, tissue, 或用于实验室研究的细胞. A person’s medical information and/or written consent to use the samples in research may go along with the samples to be studied.
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People with no known major health issues — also called normal volunteers — are needed for some studies. 对于新的药物，从健康的个体开始更安全，也更容易. These studies look at how the study drug affects people and how it is absorbed and removed from the body.
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调查通常用于研究健康行为、实践和意见.
Clinical Trials
Clinical trials study the safety and effectiveness of interventions and procedures on people’s health. Interventions may include medications, radiation, foods or behaviors, such as exercise. Usually, the treatments in clinical trials are studied in a laboratory and sometimes in animals before they are studied in humans. 临床试验的目的是寻找新的更好的预防方法, 诊断和治疗疾病. They are used to test:
Drugs or medicines
New types of surgery
Medical devices
使用现有治疗方法的新方法
改变健康行为的新方法
改善推荐十大正规网赌平台生活质量的新方法
因为每个临床试验都是为了回答一个或多个医学问题, 不同的试验有不同的目标. Those goals include:
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治疗试验测试新疗法的安全性和有效性, such as medications, surgical procedures, 以及结合现有治疗方法的新方法.
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预防试验研究诸如疫苗等卫生干预措施, 药物和生活习惯, 以及医生认为可能影响疾病风险的习惯. 这些研究寻找预防疾病或疾病复发的最佳方法, 通常发生在患此病的高风险人群中.
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Screening trials look for the most effective ways to detect, diagnose and monitor disease. For example, studies of mammography show that women of a certain age who had mammograms were less likely to die of breast cancer. These trials are important for developing ways to detect a disease or condition in its earliest stage, when it is most treatable.
一般来说，一种新药需要经过四种类型的临床试验. 这有助于研究人员证明这种药物是安全有效的. 随着研究进入每个阶段, 研究人员对药物有了更多的了解, 包括它的风险和收益.
这种药物安全吗?正确的剂量是多少? 第一阶段试验涉及少量参与者，通常是正常的志愿者.
新药有效吗?有什么副作用? 第二阶段试验在更多的参与者身上测试治疗或程序. These participants usually have the condition or disease that the treatment is intended to remedy.
新药是否比现有的治疗方法更有效? 第三阶段的试验招募了更多的人. Some may get a placebo (a substance that has no medical effect) or an already approved treatment, 这样新的药物就可以和原来的治疗进行比较.
新药长期有效且安全吗? 第四阶段发生在治疗或程序被批准之后. Information about patients who are receiving the treatment is gathered and studied to see if any new information is seen when given to a large number of patients.
“Johns Hopkins has a comprehensive system overseeing research that is audited by the FDA and the Association for Accreditation of Human Research Protection Programs to make certain all research participants voluntarily agreed to join a study and their safety was maximized.”
Gail Daumit, M.D., M.H.S.约翰霍普金斯大学医学院临床研究副院长
参与临床研究安全吗?
There are several steps in place to protect volunteers who take part in clinical research studies. 临床研究受联邦政府监管. In addition, the institutional review board (IRB) and Human Subjects Research Protection Program at each study location have many safeguards built in to each study to protect the safety and privacy of participants.
Clinical researchers are required by law to follow the safety rules outlined by each study's protocol. 协议是研究人员在研究期间将做什么的详细计划.
In the U.S., every study site's IRB — which is made up of both medical experts and members of the general public — must approve all clinical research. 内部审查委员会成员也审查所有临床研究的计划. And, they make sure that research participants are protected from as much risk as possible.
Earning Your Trust
但情况并非总是如此. Many people of color are wary of joining clinical research because of previous poor treatment of underrepresented minorities throughout the U.S. 这包括在未经奴隶同意的情况下对其进行医学研究, or not giving treatment to Black men who participated in the Tuskegee Study of Untreated Syphilis in the Negro Male. Since the 1970s, numerous regulations have been in place to protect the rights of study participants.
Many clinical research studies are also supervised by a data and safety monitoring committee. 这是一个由所研究领域的专家组成的小组. 这些生物医学专业人员定期监测临床研究的进展. If they discover or suspect any problems with a study, they immediately stop the trial. 此外，约翰霍普金斯医学院 研究参与者倡导小组 专注于改善参与临床研究的人的体验.
Clinical research participants with concerns about anything related to the study they are taking part in should contact Johns Hopkins Medicine’s IRB or our 研究参与者倡导小组.
Video 健康明天的临床研究:一个家庭分享他们的故事
健康明天的临床研究:一个家庭分享他们的故事
