A Guide to Understanding Clinical Trials

临床试验是利用人类志愿者来确定有效性的科学研究, safety and tolerability of an intervention. 在开始试验之前，志愿者被告知可能存在的风险. Before a clinical trial can begin for a treatment, 药物或设备, it must show promising results in laboratory or animal tests.

Below are some common questions about clinical trials:

What happens during a clinical trial?

At the beginning of a clinical trial, 一组医生, 护士, 社会工作者和其他保健专业人员检查拟参加人员的健康状况, identifies those that are eligible for the trial, and gives specific instructions for using the treatment, 药物或设备 throughout the trial. Participants sign an informed consent prior to enrollment. 知情同意是在您决定参加临床试验之前向您提供有关临床试验的关键信息的过程. 随着试验的进行，研究小组对参与者进行监控，并在试验结束后的一到两周内保持联系. All clinical trials follow a detailed plan, 称为协议, 其中包括研究沙巴足球体育平台长短的信息以及将收集哪些信息.

临床试验安全吗??

在很大程度上，是的. 然而, 有时，临床试验是针对患有某种疾病的人的研究性药物. In those cases, there may be more risks involved. 在知情同意文件中，参与者将始终被告知试验的潜在风险和益处. 所有的你.S. 临床试验必须得到机构审查委员会(IRB)的批准和监督，以确保它们符合伦理，并保护研究参与者的权利.

Who can participate in a clinical trial?

所有临床试验方案都包括谁有资格参加的定义. 标准可能包括年龄, 性别, the type and stage of a disease, previous treatment history and other medical conditions. Some participants may be healthy volunteers, who serve as control groups.

Why participate in a clinical trial?

Your participation may help others by contributing to medical research. 在新的研究治疗方法被广泛应用之前，你也可以接触到它们.

Do I have to stay in a hospital or leave my home for a clinical trial?

参与者通常被要求在一个可进入的临床试验地点进行定期的办公室访问, 哪个可能是医生的办公室, university medical center or community hospital or clinic. 一些试验可能涉及偶尔的过夜住院或需要比正常疾病或状况更多的医生访问. 许多试验包括入组前的体格检查或病史回顾. 在签署知情同意文件之前，应该提供对参与者期望的描述.

What kind of paperwork or legal agreements do I have to sign?

临床试验研究小组的一名成员将解释风险和潜在的益处. This information is also provided in an informed consent document, 参与者在参加试验前需要签署哪些文件. 根据 食品及药物管理局(链接在新窗口中打开), minimum required elements of an informed consent include the following:

1. 研究目的
2. 可预见的风险
3. 潜在的好处
4. Disclosure of alternative procedures
5. 保密
6. Course of action if more than minimal risk involved
7. 联系谁
8. 参与是自愿的

Can you quit after a clinical trial starts?

Entering a clinical trial is voluntary. 如果你开始学习，你可以在任何时候停止，你不需要给出理由.

How long do clinical trials typically last?

它们差别很大. Some last just a few days while others take years.

If I decide to take part in a clinical trial, what should I do to prepare?

在签署知情同意文件之前，您应该尽可能多地了解试验. Helpful questions to ask the trial directors include:

• What is the 目的 of the study?
• 为什么研究人员相信正在测试的实验性治疗可能有效? 以前测试过吗?
• Who has reviewed and approved the study?
• 研究治疗可能存在的风险、副作用和益处是什么?
• What other options do people with my disease have?
• How might this trial affect my daily life?
• 审判将持续多久?
• What will be my responsibilities if I participate?
• What kinds of tests and experimental treatments are involved?
• Will they hurt, and if so, for how long?
• Will I be able to take my regular medications while in the clinical trial?
• Will hospitalization be required?
• Who will pay for the experimental treatment, or is sponsoring the trial?
• 我的其他费用如交通费或托儿费会得到报销吗?
• Who can help answer questions from my insurance company or health plan?
• What type of long-term follow-up care is part of this study?
• How will I know that the experimental treatment is working? Will results of the trials be provided to me?
• Who will be in charge of my care?

我在哪里可以找到临床试验中使用的一些科学术语的理解定义?

的 美国国立卫生研究院 临床试验术语表(链接在新窗口中打开) lists more than 80 terms commonly used in clinical trials.

Where can I get more detailed information about clinical trials?

Helpful informational sources include:

• 临床试验.政府(链接在新窗口中打开)
• CenterWatch(链接在新窗口中打开)
• Office for Human Research Protections(链接在新窗口中打开)
• 美国国立卫生研究院(链接在新窗口中打开)
• 美国国立卫生研究院 HIPAA Privacy Rule(链接在新窗口中打开)
• 研究匹配(链接在新窗口中打开)

How can I be sure a clinical trial is legitimate?

担保人或研究协调员应该能够回答你所有的问题, 比如试验方案是否被批准，是否会受到IRB的监督, what is the 目的 of the trial, what are the possible risks and how long the trial is expected to last.

另一个资源是美国国立卫生研究院临床试验注册 http://clinicaltrials.政府(链接在新窗口中打开). This site lists more than 200,000 trials in at least 190 countries. 您可以使用治疗条件或疾病等条件搜索试验, 使用的药物或治疗, 或者地点国家. Each entry includes a trial description, 赞助商, 目的, 预计完工日期, eligibility criteria and contact information.

的 世界卫生组织国际临床试验注册平台(链接在新窗口中打开) 提供有关世界各地试验的类似背景信息.

What are the different types of clinical trials?

的re are several kinds of trials, each with a different 目的:

• 行为试验 看看如何检查行为改变如何改善健康和结果. 
• 治疗试验 试验处理, 新的药物组合或新的手术或放射治疗方法.
• 预防试验 寻找更好的方法来预防从未患过疾病的人的疾病或防止疾病复发.
• 诊断试验 evaluate tests or procedures for diagnosing a disease or condition.
• 筛选试验 evaluate methods of detecting a disease or health condition.
• 生活质量试验 (或支持性护理试验)评估改善慢性疾病患者舒适度和生活质量的方法.

Are there different phases of clinical trials?

经美国批准.S. 美国食品药品监督管理局, 一种实验性药物或治疗必须经过几个临床试验阶段.

• 一期试验 首次在一小群人(20-80人)中测试一种实验性药物或治疗方法，以评估其安全性并确定副作用.
• II期试验 在更大的人群(100-300人)中测试实验性药物或治疗，以确定其有效性并继续评估安全性.
• III期试验 test the experimental drug or treatment in a large group of people (1,000-3,000) to confirm its effectiveness, 监测副作用, 将其与标准或同等治疗方法进行比较，并继续评估安全性.
• IV期试验 在获得食品及药物管理局批准并向公众开放后，跟踪有关实验性药物或治疗的安全性和最佳使用的其他信息.

谁赞助临床试验?

临床试验可以由组织或个人赞助，如医生, 医疗机构, 基金会, voluntary groups and pharmaceutical companies, 除了美国国立卫生研究院等联邦机构, the Department of Defense and the Department of Veterans Affairs.