临床试验

Clinical trials are research studies that test new therapeutic treatments or procedures. The goal of a clinical trial is to find better ways to prevent, diagnose and treat diseases. Experts carefully design and conduct clinical trials to advance medical care and improve outcomes for our patients. 

Clinical trials help us test whether new treatments are safe and effective. They also help us understand how new treatments compare to existing treatments. 我们使用临床试验来评估新的: 

• 医疗设备 
• 治疗或预防疾病的药物 
• 疾病的诊断和筛查方法
• 程序 

我们今天使用的许多标准治疗方法都是从临床试验开始的. These studies are a crucial tool for developing new and better approaches to medical care.

Besides advancing medical care, clinical trials can offer patients many benefits. 您可能受益于: 

• 当你积极治疗自己的疾病时，你会有控制感
• First-line access to treatments not available outside of clinical trials
• Satisfaction from knowing you’re helping improve medical care for future generations

临床试验治疗可能会产生副作用或其他健康风险. 因为临床试验研究新的治疗方法, 我们并不总是提前知道潜在的风险. 

Your doctor or nurse will explain the potential risks and benefits of a trial treatment. 您将签署一份知情同意书，说明这些风险. 询问你的医生或护士是否有不清楚的地方. Even if you sign the form, you can leave the trial at any time and receive other treatments. 

临床试验的资格各不相同. 这可能取决于以下因素: 

• 具体的试验标准由研究人员制定 
• 诊断的严重程度 
• 你的整体健康状况 

Your doctor or the research coordinator will help you determine if a clinical trial is right for you. 

一些临床试验还涉及“健康志愿者”.” Being a healthy volunteer means you have no significant health problems. You voluntarily participate in research to test a new drug, device or treatment. Healthy volunteers are essential for helping us compare how new techniques affect healthy patients versus sick patients. 这是定义什么是“正常”的一种方式.” 查看积极招募健康志愿者的试验.

目前, racial and ethnic minority groups make up less than 10% of all participants in clinical trials. This statistic is concerning because having diverse groups of people participating in clinical trials helps ensure new treatments work for everyone.

A person’s response to a disease or medication depends on multiple factors, including their: 

• 种族
• 基因
• 生活方式
• 出生时的性别 
• 社会经济背景 

Clinical trials follow strict rules that ensure every participant is treated equally, 不分种族, 种族, 性别或年龄. 皇冠hga025大学洛杉矶分校健康中心, we are committed to helping increase diversity in clinical trials so that we improve the lives of all our community members. 

研究人员将临床试验分为四个阶段: 

• 阶段1: 研究人员首次测试了一种新药或治疗方法. They give the treatment to a small group of people to study its safety, side effects and dosage. 
• 阶段2: 研究人员在更大的人群中测试这种药物或治疗方法. 这一阶段研究治疗的安全性和有效性. 
• 阶段3: 更多的人接受药物或治疗. 这个阶段再次测试治疗的有效性和副作用. 研究人员还将这种药物或治疗方法与现有的治疗方法进行了比较. 
• 阶段4: These studies occur after the drug or treatment has been approved by the U.S. 美国食品和药物管理局(FDA)，并向公众开放. Researchers collect information on how the treatment affects different groups and whether any problems arise with long-term use. 

一项随机研究将参与者随机分为不同的组. 这些组包括: 

• 对照组: People who receive standard treatments or a placebo (harmless treatment with no effects) instead of the trial treatment
• 治疗组: 接受试验治疗的人 

You don’t get to pick which group you’re in, and neither do the researchers. A computer places you in a group at random, like flipping a coin to make a decision. This process helps researchers avoid bias, or unfairness, in who gets put into a certain group.

In a blinded study, you don’t know whether you’re getting the trial treatment or a placebo. 盲法研究有两种: 

• 单盲研究: The study participants don’t know which treatment they’re getting, but the researchers do. 
• 双盲研究: Neither the study participants nor the researchers know who is getting the placebo and who is getting the trial treatment. 只有参与试验的药剂师知道. 

It is possible for you to find out which group you’re in if it’s medically necessary. 您可能会收到也可能不会收到研究结果. 如果你感兴趣，可以问研究小组. 

You may contact our clinical trial navigators to find out about trials that may be right for you. 呼叫 855-731-6040 或者要求回电话.

You may need to complete a pre-screening form to find out if you qualify for the trial. 您也可以填写我们的 匹配调查问卷 了解相关临床试验情况.

It’s important to ask questions if you’re considering a clinical trial, such as:  

• 本研究的目的是什么? 
• 这项研究将涉及哪些测试和治疗? 
• 这项研究将持续多长时间? 我是否需要长期的后续护理? 
• 这项研究对我的日常生活有何影响? 
• 如果我不参加研究，我还有什么其他治疗选择? 
• 这项研究的风险、益处和潜在副作用是什么? 
• 我需要支付治疗费用吗?

Informed consent is the process of giving you all the important details of a clinical trial before you decide to participate. 你的医生或护士会帮助你理解: 

• 试验所带来的好处 
• 试验的潜在风险 
• 在审判期间会有什么期待 
• 你作为试验参与者的权利

如果您同意参加本次研究，请签署一份同意书. 你不必同意参加或在表格上签名. Even after you sign the form, you can choose to leave the study at any time. 

在你参加临床试验之前, 我们的研究人员将解释试验并回答您的问题. 在庭审之前和庭审过程中，你要: 

• Learn about the study’s purpose, including the potential benefits and risks 
• 讨论治疗需要什么 
• 回顾您作为临床试验参与者的权利和保护 
• 获得额外的支持和监控，以确保您的安全 

参加临床试验是自愿的. 在整个研究过程中，你可以随时改变主意并退出. 无论你是否参加或退出试验, 我们为您提供先进的, 有效的治疗. 

Researchers follow rules to ensure you receive quality care and are always treated with respect. 他们有专门的培训来保护你的隐私和信息. 

参加临床试验将不会: 

• 改变你接受治疗的质量 
• 改变你和医生的关系
• 拒绝你在医疗机构的治疗 

Participating in a study is always up to you, and you can decide to leave a trial at any time. You should talk with your doctor about any concerns before leaving the study. Your doctor will explain whether there are any medical risks of opting out. 

Only the research staff will be able to see your information from a clinical trial. 这些工作人员经过特殊培训，可以保护您的隐私. 

在你加入研究之前, you may sign a consent form allowing researchers to store your information in a secure database. 该表单将列出可以查看该数据库的人员. Researchers keep information that identifies you separate from other information. 识别信息有额外的保护级别，以确保您的安全. 

有时研究人员会与其他研究人员分享研究细节. 即使他们知道，他们也不会分享任何能识别你身份的信息. 

你总是有权利: 

• Ask for information in the language of your choice, including through an interpreter 
• 决定不参加一项研究 
• 充分了解您的诊断和治疗方案 
• 随时离开书房 
• 得到安全和尊重的照顾

You will never be treated differently because of your 种族, sex or age. 如果有特殊需要，你可以得到额外的帮助. 这些都是您的权利，无论您是否参加这项研究.