临床试验

Clinical research is a type of study of clinical or biomedical questions through the use of human subjects. Clinical research studies do not necessarily all involve medical treatments or experimental therapies. Clinical research can include observational studies, in which people are followed over a period of time to determine health outcomes. Clinical research may also be used to determine the usefulness or safety of a new diagnostic procedure or drug treatment. Clinical research studies are planned in advance and follow a defined protocol. Epidemiologic studies examine specific populations to clarify how often a disease occurs or is found in a given group (theincidenceandprevalence），可能导致或恶化疾病进展的个体因素，以及人们做出的健康和生活方式决定的类型。临床试验（见下文）是临床研究的一种重要类型。

Clinical research is important in order to develop new therapies and diagnostic procedures as well as to understand how diseases begin and progress. Observational studies may help identify risk factors for thedevelopment特定疾病，例如协会betweensmokingandlung cancer。Outcomes-based research can help doctors identify the most effective therapies and treatments for a number of conditions. Another aspect of clinical research is the development of new technologies for use in health care, ranging from surgical tools and materials to听力艾滋病和人造四肢。在cancer治疗，几乎所有的护理中都取得了进步cancerpatients has occurred as a result of clinical research.

临床试验是一种临床研究的一种形式，遵循已定义的方案，该方案经过精心开发以评估临床问题。美国。National Institutes of Health（（NIH) defines a clinical trial as

• “A预期biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (such as drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)."

尽管人们通常将临床试验与药物试验相关联，但在这些试验中，对疾病的有效性进行了新的药物或药物组合的测试，但临床试验还可以评估诸如咨询或生活方式修改之类的干预措施是否对疾病进展有影响。可以对患有疾病或疾病的人进行临床试验healthy人们，取决于研究的目的。

美国NIH描述了以下类型的临床试验：

• Treatment trials test new treatments, new combinations of drugs, or new techniques in外科手术orradiation therapy。
• Preventiontrials are designed to identify ways to prevent disease through the use of medicines, lifestyle changes,膳食补充剂例如vitamins或免疫。
• 诊断试验的目标是识别的改进tests or methods used to diagnose disease.
• 筛查试验寻找在患者患有任何疾病症状之前检测特定疾病的方法。
• Quality of life trials（（also referred to as supportive-care trials) are trials that are designed to improve comfort and thequality of life对于患有chronicconditions or diseases.

临床试验分为阶段，每个阶段在试验中具有不同的目的。Phase I trials involve a small group of people (20-80) and are concerned with determining a safe dose of the drug being studied as well as its potential副作用。在第二阶段,治疗或药物测试more people (100-300) for further evaluation - this time, determining the time of the drug or treatment's effectiveness against the disease for which the patient is being treated. Even more people (1,000-3,000) are participants in Phase III of a trial, when theintervention将其与标准治疗方法进行比较，并收集有关安全性和副作用的更多信息。在第四阶段试验中，在治疗已批准了针对特定指示条件的处理后进行的FDA，，，，邮政- 进行市场研究以收集有关药物或治疗最佳使用的更多信息，并进一步评估其副作用。

临床试验可以在不同的位置进行，包括医院，诊所，个人physician实践，大学卫生中心或社区卫生中心。

The web sitehttp://clinicaltrials.govis a searchable database of federally and privately funded clinical trials being conducted in the U.S. and around the world. Yourdoctoror health-care team may also offer information about clinical trials that are currently under way for your specificcondition。

Before a clinical trial can be carried out, thorough preparation is necessary, including extensive reviews of the proposed trial, its methodology, and the goals of the trial. An Institutional Review Board (IRB) consisting of physicians, statisticians, researchers, patient advocates, and others must pre-approve every clinical trial in the U.S. The job of the IRB is to ensure that the trial is ethical, legal, and that the rights of those participating are fully protected. For example, individual participants' names are kept secret and not included in the results or publicly available information about a trial.

Every clinical trial has a strictly defined protocol that is approved by the IRB. A protocol describes what types of people may participate in the trial; outlines the exact the schedule of tests, procedures, medications, and/or dosages involved in the trial; and specifies the length of the study. Generally, doctors check the patient thoroughly at the start of the trial, provide instructions and directions for participation in the trial, monitor the patient during the actual trial, and remain in contact, sometimes with further monitoring after the trial is completed.

在many clinical trials, patients will berandomly分配给测试组或controlgroup. The control group receives the standard and accepted treatment for a given condition, while the test group receives the experimentalmedicationor treatment to be evaluated. When a trial is "double-blinded," neither the participants nor the treating doctors know if an individual patient is receiving the standard treatment versus the experimental treatment. Double-blinded trials offer the advantage of allowing the treating health-care team and the patient to make unbiased observations about patient progress and the effectiveness of the treatment being evaluated. Adouble-blindstudy is also referred to as a双面具study. Results obtained from a随机， 双倍的瞎的临床试验are considered the most accurate and reliable types of results, and help those conducting the trial to draw the most accurate conclusions.

在formed consent is giving your consent to participate in the clinical trial after having learned about the trial and having had the opportunity to ask questions. You should be fully aware of all the details, risks vs. benefits, and expectations of the trial before agreeing to participate. When you give informed consent, yousigna document - which should be in a language that you understand - that describes the rights of the participants as well as gives details of the study and names of the investigators who are conducting the study and contact information for these people.

Clinical trials are required to maintain strict patient privacy. Your name will not be published anywhere thatdataabout the trial are published or included in any publicly available information. Some clinical trials may require that you be seen and examined by a larger treatment team than would typical medical care. For example, this may include research nurses who only see patients enrolled on clinical trials.

每个试验都有特定的包含和排除标准，以确定可能参与的确切患者人群。在dividuals who fit the predefined and preapproved inclusion criteria for a trial may participate if the trial is currently accepting participants. Inclusion criteria are based on factors such as patient age, gender, the type and阶段of a disease, previous treatment history, and other medical conditions. Some clinical trials seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants.

Some clinical trials offer monetary compensation for participants. Other trials may offer their participants free health care that is related to the condition being studied, or screening examinations. There are no requirements for those who sponsor clinical trials to pay or otherwise compensate participants.

The benefits of clinical trials are many andrange通过在管理自己的医疗保健中发挥积极作用，通过帮助他人来帮助他人processof knowledge acquisition and development of enhanced treatments, being cared for by - or in accordance with the protocol which has been developed by - leading health care teams in a given field, and in some cases, receiving使用权to new treatments before they are approved. However, there are also risks, including side effects of drugs and risks of any procedures that may be performed. In some cases, clinical-trial participation may require more frequent doctor visits or hospitalizations than standard care, and you may have to travel to a study site that is farther away than your local health-care practitioner's office.

Some questions you may want to ask before participating in a clinical trial include the following:

• 试验的目的是什么？
• 是否正在测试一种新型的治疗方法？这与接受或标准有何不同therapyfor my condition?
• Has the drug or treatment ever been tested before?
• How will participation影响my daily life and schedule? Will it be necessary to be in thehospital？
• What are the risks and possible side effects of the treatment?
• Who will pay for the treatments? Will I receive reimbursement or any type of compensation for my time or expenses?
• 预计审判将持续多长时间？
• How will I receive results of the trial, and how will I know if the treatment is successful?

知情同意文件不是需要参与研究时间研究的法律合同。A参与者is free to leave a clinical trial at any time without prejudice to their ongoing medical care. They will not have access to the experimental medicine being studied if they leave the trial.

临床试验可以由各种组织或个人赞助或资助。联邦机构，例如国立卫生研究院（NIH），国防部（DOD）和退伍军人事务部（VA）经常资助和赞助商临床试验。此外，医疗机构，慈善基金会，倡导组织，医师和/或生物技术或制药公司可能会赞助临床试验。

The researchers in the trial will stay in contact with participants and inform them of the conclusions of the trial. In some cases, you may be asked to provide long-term follow-up in the form of patient surveys or periodic health examinations. Since most clinical trials provide short-term treatments related to a specific condition, they are not a substitute forprimaryhealth care. Your regular health-care provider should be aware of the trial and will work with the researchers during the trial. When the trial is over, you will continue to receive care through yourprimary care provider以及您病情所需的任何其他从业者。