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What is ClinicalTrials.gov and who uses it?
什么是 ClinicalTrials.gov？哪些人会使用它？
ClinicalTrials.gov is a website and online database of clinical research studies and information about their results. The purpose of ClinicalTrials.gov is to provide information about clinical research studies to the public, researchers, and health care professionals. The U.S. government does not review or approve the safety and science of all studies listed on this website.
ClinicalTrials.gov 是一个网站和在线数据库，收录临床研究及其结果信息。其宗旨是向公众、研究人员和医疗专业人员提供临床研究信息。美国政府不对本网站所列所有研究的安全性和科学性进行审查或批准。
ClinicalTrials.gov: ClinicalTrials.gov：
- Relies on sponsors or investigators to submit and update information about studies
依赖研究发起者或研究者提交并更新研究信息 - Lists up-to-date information on clinical research studies and their results with new studies added almost every day
提供临床研究及其结果的最新信息，几乎每天都有新研究加入 - Includes studies that take place in all 50 states and over 200 countries
包括在美国所有 50 个州及全球 200 多个国家开展的研究 - Supports laws, regulations, and policies that require sponsors and investigators to publicly share information about clinical trials, including results
支持要求申办方和研究者公开分享临床试验信息（包括结果）的法律、法规和政策
Does the U.S. Government approve all studies listed in the ClinicalTrials.gov database?
美国政府是否批准 ClinicalTrials.gov 数据库中列出的所有研究？
No. The U.S. government does not review or approve the safety and science of all studies listed in the ClinicalTrials.gov database. The National Institutes of Health (NIH) and other U.S. agencies only approve the studies that they fund. U.S. government agencies do not fund all the studies listed on ClinicalTrials.gov.
不。美国政府不会审查或批准 ClinicalTrials.gov 数据库中所有研究的安全性和科学性。美国国立卫生研究院（NIH）及其他美国机构仅批准其资助的研究。美国政府机构并不资助 ClinicalTrials.gov 上列出的所有研究。
The National Library of Medicine (NLM) does a limited review of the study information that sponsors and investigators submit to be included in the study record in the ClinicalTrials.gov database. The study sponsor or investigator is responsible for the safety, science and accuracy of any study they list on ClinicalTrials.gov. They are also responsible for ensuring that their study follows all relevant laws and regulations.
美国国家医学图书馆（NLM）会对申办方和研究者提交至 ClinicalTrials.gov 数据库研究记录中的信息进行有限审查。研究申办方或研究者需对其在 ClinicalTrials.gov 上列出的任何研究的安全性、科学性和准确性负责。他们还需确保其研究遵循所有相关法律法规。
What clinical studies can be listed in the ClinicalTrials.gov database?
哪些临床研究可以列入 ClinicalTrials.gov 数据库？
ClinicalTrials.gov lists studies that involve people, have health-related research questions, and follow ethics review and other health authority rules and laws. The ClinicalTrials.gov database includes these types of studies:
ClinicalTrials.gov 收录的研究需符合以下条件：涉及人类受试者、提出健康相关研究问题，并遵循伦理审查及其他卫生主管部门的规则和法律。该数据库包含以下类型的研究：
- Clinical trials: research studies in which researchers assign participants to get one or more interventions (such as a drug, behavior, or medical device) to test what happens in people.
临床试验：研究人员将参与者分配接受一种或多种干预措施（如药物、行为或医疗器械）的研究，以测试这些干预措施在人体中的效果。 - Observational studies: research studies in which researchers simply collect information (called data) from participants or look at data that was already collected. The data may be about participants’ health, habits, or environments. In observational studies, researchers do not assign participants to get an intervention. If there is an intervention, participants were already using it as part of their regular health care or daily life.
观察性研究：研究人员仅从参与者处收集信息（称为数据）或查看已收集数据的研究。这些数据可能涉及参与者的健康状况、习惯或环境。在观察性研究中，研究人员不会分配参与者接受干预措施。如果存在干预措施，参与者已将其作为常规医疗保健或日常生活的一部分在使用。
Learn more about types of clinical research studies on the Learn About Studies page.
在“了解研究”页面了解更多关于临床研究类型的信息。
Expanded access 扩大使用
ClinicalTrials.gov also lists expanded access. Expanded access is a possible way for a patient with a serious illness who is unable to take part in a clinical trial to get an intervention (such as a drug or medical device) that isn’t approved for treatment. Expanded access is not available for all interventions being tested. The study record includes who to contact to learn more. Read more about expanded access on the FDA’s website.
ClinicalTrials.gov 还收录了扩大使用计划。对于患有严重疾病且无法参与临床试验的患者，扩大使用计划是一种可能获得未经批准用于治疗的干预措施（如药物或医疗器械）的途径。并非所有正在测试的干预措施都提供扩大使用计划。研究记录中包含了解更多信息的联系方式。有关扩大使用计划的更多信息，请访问美国食品药品监督管理局（FDA）的网站。
Is every research study listed in the ClinicalTrials.gov database?
ClinicalTrials.gov 数据库中是否列出了每一项研究？
No. Sponsors and investigators list studies in the ClinicalTrials.gov database based on laws and policies or by choice. Laws and policies around the world have set the expectation that clinical trials be listed on public databases, such as ClinicalTrials.gov. The U.S. has laws, regulations and policies requiring sponsors and investigators to submit certain types of clinical trials to ClinicalTrials.gov. Few policies require sponsors and investigators to list observational studies on public databases.
不是。申办者和研究者根据法律、政策或自愿选择在 ClinicalTrials.gov 数据库中列出研究。世界各地的法律和政策都期望临床试验能在公共数据库（如 ClinicalTrials.gov）中列出。美国有法律、法规和政策要求申办者和研究者向 ClinicalTrials.gov 提交特定类型的临床试验。很少有政策要求申办者和研究者在公共数据库中列出观察性研究。
For research studies that aren’t required to be submitted by law or policy, sponsors and investigators can choose to submit to ClinicalTrials.gov or not. If they choose to list the study on ClinicalTrials.gov, they must keep the study record up-to-date.
对于法律或政策未强制要求提交的研究，申办者和研究者可选择是否向 ClinicalTrials.gov 提交信息。若选择在 ClinicalTrials.gov 上登记研究，则必须保持研究记录的及时更新。
Learn more about the rules and laws for submitting studies on the Clinical Trial Reporting Requirements page.
了解更多关于提交研究的规则和法律，请访问临床试验报告要求页面。
Who submits information about a clinical study to the ClinicalTrials.gov database?
谁向 ClinicalTrials.gov 数据库提交临床试验信息？
Study sponsors and investigators submit the information to ClinicalTrials.gov. Sponsors and investigators are responsible for ensuring that their studies follow all relevant laws, regulations, and policies.
研究申办方和研究者向 ClinicalTrials.gov 提交信息。申办方和研究者有责任确保其研究遵守所有相关法律、法规和政策。
What information about clinical studies can be found in the ClinicalTrials.gov database?
在 ClinicalTrials.gov 数据库中能找到哪些临床试验信息？
The ClinicalTrials.gov database includes information about clinical research studies that are happening now, will happen soon, or happened in the past. Information about each study is permanently available in the database, even after the study ends.
ClinicalTrials.gov 数据库包含正在进行、即将进行或过去已完成的临床研究信息。每项研究的信息在数据库中将永久保存，即使研究结束后仍可查阅。
Information submitted about the study can be viewed in one place, called the study record. Each version of the study record is also permanently available. A study record includes:
关于研究提交的信息可以在一个称为研究记录的地方查看。每个版本的研究记录也会永久保存。研究记录包括：
General information about the study:
研究的一般信息：
- Study name and description
研究名称和描述 - Person or organization responsible for the study (sponsor or investigator)
负责研究的个人或组织（申办者或研究者） - People or organizations that fund or provide support for the study
研究资助或支持的个人或组织 - Disease or health problem studied
研究的疾病或健康问题 - Start and end dates 开始和结束日期
- Locations 研究地点
Specific information about the study:
关于研究的具体信息：
- Who can and cannot join (eligibility criteria)
谁可以参与以及谁不能参与（资格标准） - How many study participants are needed
需要多少研究参与者 - A description of the intervention(s) that may be given (such as a drug, medical device, or behavior)
可能给予的干预措施（如药物、医疗器械或行为）的描述 - What researchers want to learn and how they will measure it
研究人员希望了解的内容及其衡量方式 - How to contact the study staff
如何联系研究工作人员
Some, but not all, study records contain more information, such as:
部分（非全部）研究记录包含更多信息，例如：
- The study protocol, analysis plan, and informed consent form
研究方案、分析计划和知情同意书 - What researchers learned from the study (results)
研究人员从研究中获得的发现（结果）
Does ClinicalTrials.gov include information about study results?
ClinicalTrials.gov 是否包含研究结果信息？
Yes, the Results tab of a study record may include study results for certain clinical trials. The study sponsor or investigators may submit study results, usually no later than 1 year after a study is completed. When results are available for a study, the Results tab is labeled “Results Posted.” For help finding results in a study record, see How to Read Study Results.
是的，研究记录的“结果”标签页可能包含某些临床试验的研究结果。研究发起人或研究者可以提交研究结果，通常不晚于研究完成后一年。当研究有结果可用时，“结果”标签页会标注为“结果已发布”。如需帮助在研究记录中查找结果，请参阅如何阅读研究结果。
Study results are in a table format and include:
研究结果以表格形式呈现，包括：
- A description of the groups of participants who joined the study and their traits, like their average age – it doesn’t include any information that could identify an individual participant (or any individual participant data)
对参与研究的各组参与者及其特征的描述，例如平均年龄——不包含任何可能识别个体参与者的信息（或任何个体参与者数据） - Findings from the study
研究结果 - A summary of any health problems (adverse events) that happened during the study
研究期间发生的任何健康问题（不良事件）的摘要
Study results do not include any conclusions or interpretations of the results. For more information, see How to read each section of the study results.
研究结果不包含任何结论或对结果的解释。更多信息，请参阅如何阅读研究结果的各个部分。
ClinicalTrials.gov staff review study results to make sure they are clear and informative before being posted. ClinicalTrials.gov staff do not review for scientific accuracy. The study sponsor or investigators are responsible for making sure the results are accurate and complete before they submit them.
ClinicalTrials.gov 工作人员在发布前会审核研究结果，以确保其清晰且信息丰富。ClinicalTrials.gov 工作人员不负责审核科学准确性。研究赞助方或调查人员在提交结果前，有责任确保结果的准确性和完整性。
The study sponsor or investigators can also submit links to publications (papers in scientific journals) related to the study results. The Publications section under the Results tab will include these links, if provided. ClinicalTrials.gov staff does not review or oversee the publications.
研究发起者或研究者也可提交与研究成果相关的出版物（科学期刊论文）链接。若提供此类链接，结果选项卡下的”出版物”部分将予以收录。ClinicalTrials.gov 工作人员不对出版物进行审核或监督。
Why was ClinicalTrials.gov created?
ClinicalTrials.gov 为何创建？
ClinicalTrials.gov launched in 2000 and was created as part of a law that was passed in 1997 (Food and Drug Administration Modernization Act of 1997). This law required the U.S. National Institutes of Health (NIH) to create a database of clinical trials that have an investigational new drug (IND) application to test investigational drugs for serious or life-threatening diseases.
ClinicalTrials.gov 于 2000 年上线，其创建源于 1997 年通过的一项法案（《1997 年食品药品监督管理局现代化法案》）。该法案要求美国国立卫生研究院建立临床试验数据库，收录所有针对严重或危及生命疾病的研究性新药申请试验。
Since then, ClinicalTrials.gov has expanded based on other laws, regulations, and policies to include more types of research studies and more information about these studies. These laws, regulations, and policies ensure that information about ongoing and completed studies and their results are publicly available for people to consider joining and to inform future research.
此后，ClinicalTrials.gov 根据其他法律、法规和政策不断扩展，涵盖更多类型的研究项目及相关信息。这些法律、法规和政策确保正在进行及已完成的研究及其结果信息向公众开放，供潜在参与者参考加入，并为未来研究提供信息支持。
The image below shows major events related to ClinicalTrials.gov and how the study information listed in the database has changed over time:
下图展示了与 ClinicalTrials.gov 相关的主要事件，以及数据库中列出的研究信息随时间的变化情况：
Read more about the Clinical Trial Reporting Requirements of ClinicalTrials.gov.
进一步了解 ClinicalTrials.gov 的临床试验报告要求。
