临床试验|概述
How do clinical trials work?
For most clinical trials a participant is assigned to either an intervention or a control group. Intervention group participants receive the intervention that is being tested. Control group participants do not receive the intervention. Instead they might receive the standard treatment for the disease or condition, or they might receive a placebo, which looks or feels like the intervention, but it is not an active medicine or treatment. The control group helps the researchers understand the effects of the experimental intervention.
您的小组分配通常会偶然发生。如果您参加临床试验，则可能不会获得正在测试的实验治疗方法。在某些情况下，您将不知道分配的组。
临床试验的潜在好处和风险
研究参与者有好处和风险。作为临床试验的一部分，参与者可以获得尚未向公众使用的实验治疗，同时还可以通过为新医疗或程序的开发做出贡献而帮助他人。其他好处包括：
- helping others by contributing to knowledge about new treatments or procedures
- 在广泛使用之前获得新的研究治疗
- receiving regular and careful medical attention for a research team that includes doctors and other health care professionals
研究参与者的风险包括：
- 当尚未完全了解其效果时，接受实验治疗
- 某些测试和程序的不愉快甚至严重的副作用
- minor discomfort
- 需要医疗的并发症
The specific risks associated with a research protocol are described in detail in the informed consent document, which participants are asked to consider and sign before participating in research. Also, a member of the research team will explain the study and answer any questions about the study. Before deciding to participate, it's important to carefully consider risks and possible benefits.
我在哪里可以找到临床试验？
一个好方法找出是否有任何临床trials that might help you is to ask your doctor. Other sources of information include:
- FDA Clinical Trials Search。搜索通过ClinicalTrials.gov获得联邦和私人支持的研究数据库。了解每个试验的目的，可以参与，位置以及与谁联系以获取更多信息。
- Clinicaltrials.gov.进行更高级的搜索
- 国家癌症研究所或致电800-4-Canter（800–422–6237）。了解针对癌症患者的临床试验。
临床试验安全吗？
The FDA works to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial. The Federal government has临床研究法规和指南to protect participants from unreasonable risks. Although efforts are made to control the risks to participants, some may be unavoidable because we are still learning more about the medical treatments in the study.
The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Before joining a particular study, you will be given an informed consent document that describes your rights as a participant, as well as details about the study, including potential risks. Signing it indicates that you understand that the trial is research and that you may leave at any time. The informed consent is part of the process that makes sure you understand the known risks associated with the study.
您和您的医生是您护理的团队。该材料仅用于信息目的，它不打算替代医疗建议。与您的医生交谈，为您决定正确的治疗方法。