临床试验Resource Center

A clinical trial is a research study to answer specific questions about vaccines, new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.

为了促进所有人的健康，研究人员需要志愿者来测试不同药物和程序的安全性和功效beplay苹果手机能用吗。临床试验或研究旨在回答有关在受控环境中可以观察到的新疗法或新理论的具体问题。我们今天所享有的大多数医学突破和进步始于与志愿者有关的临床研究。

参与者in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about a new treatment, its risks and how well it may or may not work.

主要团队成员是：

• the Principal Investigator (PI) who is usually a physician and who is responsible for the design of the clinical trial and how it is conducted
• the Research Nurse or Coordinator who coordinates the patient care while you are part of the study
• sometimes Research Associates who work with the physician-scientist and the research nurse to assist in data collection and scheduling and who are part of the development of the clinical trial.

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.

A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

一个控制实验ob是标准的servations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

Treatment trialstest new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials寻找更好的方法来预防从未患有这种疾病或预防疾病回来的人的疾病。这些方法可能包括药物，维生素，疫苗，矿物质或改变生活方式。

Screening trialstest the best way to detect certain diseases or health conditions.

生活质量试验(or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

In第一阶段trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In第一阶段Itrials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In第一阶段IItrials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In第一阶段Vtrials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

所有临床试验均具有研究协调员和管理临床试验日常运作的个人。这包括与参与者联系并跟踪数据。如果您想参加临床试验，则将使用您感兴趣的特定研究的联系信息。然后，研究协调员将引导您进入该过程的下一步。

我们共同的l trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

知情同意是在决定是否参与之前学习有关临床试验的关键事实的过程。在整个研究中，这也是为参与者提供信息的持续过程。为了帮助某人决定是否参加，参与试验的医生和护士解释了研究的细节。如果参与者的母语不是英语，则可以提供翻译协助。然后，研究团队提供beplay苹果手机能用吗了一份知情同意文件，其中包括有关研究的详细信息，例如其目的，持续时间，所需程序和关键联系人。知情同意文件中解释了风险和潜在利益。然后，参与者决定是否签署文档。知情同意不是合同，参与者可以随时退出审判。

• Plan ahead and write down possible questions to ask.
• Ask a friend or relative to come along for support and to hear the responses to the questions.
• Bring a tape recorder to record the discussion to replay later.

People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

• What is the purpose of the study?
• Who is going to be in the study?
• 为什么研究人员beplay苹果手机能用吗认为正在测试的新治疗方法可能有效？以前有过测试吗？
• What kinds of tests and treatments are involved?
• 与我目前的治疗相比，研究中可能的风险，副作用和益处如何？
• 这个试验将如何影响我的日常生活？
• 审判将持续多长时间？
• Will hospitalization be required?
• Who will pay for the treatment?
• Will I be reimbursed for other expenses?
• 本研究是什么类型的长期后续护理？
• How will I know that the treatment is working? Will results of the trials be provided to me?
• Who will be in charge of my care?

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

Side effects are any undesired actions or effects of drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

Clinical trials that are well-designed and well-executed are the best treatment approach for eligible participants to:

• Play an active role in their own health care. Gain access to new research treatments before the treatments are widely available.
• 在试验期间，在领先的医疗机构中获得专家医疗服务。
• 通过为医学研究做出贡献来帮助他人。beplay苹果手机能用吗

Risks
There are risks to participating in a clinical trial:

• There may be unpleasant, serious or even life-threatening side effects to treatment.
• The treatment may not be effective for the participant.
• The protocol may require more of the participant’s time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

管理医学实践的道德和法律法规也适用于临床试验。此外，大多数临床研究都受到内置保障措施的联邦监管，以保beplay苹果手机能用吗护参与者。该试验遵循精心控制的协议，该计划详细介绍了研究人员在研究中将要做的事情。beplay苹果手机能用吗随着临床试验的进行，研究人员将科学会议，医学期刊和各个政府机构的beplay苹果手机能用吗试验结果报告。个人参与者的名字将保持秘密，并且不会在这些报告中提及。

美国的每项临床试验都必须得到机构审查委员会（IRB）的批准和监控，以确保风险尽可能低，并且值得任何潜在的收益。IRB是医师，统计学家，社区倡导者和其他人的独立委员会，以确保临床试验具有道德和研究参与者的权利受到保护。所有进行或支持涉及人民的生物医学研究的机构必须通过联邦法规必须具有最初批准并定期审查研究的IRB。beplay苹果手机能用吗

Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.