临床试验

临床试验的定义

A clinical trial is a research study done to evaluate new potential treatments in people. 在临床试验期间, information is collected to determine if a study drug is safe and effective, as well as to evaluate the risks and benefits of the study drug. For more information about clinical trials, please visit 临床试验.政府 或者是 Center for Information and Study on Clinical Research Participation.

Research and Development for 临床试验

Research and development occurs in several stages before clinical trials commence in people. Pre-clinical testing is conducted for each investigational product to evaluate the safety, 功效, 管理的最佳实践, and many other properties before entering human clinical trials. Once adequate pre-clinical testing has been completed, an Investigational New Drug (IND) application is submitted to a regulatory authority, 比如美国.S. 美国食品药品监督管理局, so it can evaluate the investigational drug for safety to assure that human clinical trial participants will not be subjected to an unreasonable risk.

临床试验阶段

Human clinical trials are conducted in four phases:

阶段1: 一种研究药物在人体中进行测试, 常见于无病志愿者, for the first time to evaluate its safety and best practices for administering the drug.

阶段2: 研究药物已经过测试 to determine a safe dose or range of doses, 进一步评价其安全性, and to begin testing in subjects with the disease of interest to determine if it has the intended or predicted effects.

阶段3: 研究药物已经过测试, often in larger trials of longer duration, to confirm its effectiveness and to further evaluate safety. Phase 3 trials often compare the study drug to commonly-used treatments (if any) or to placebo treatment, if it is scientifically and ethically appropriate to do so.

阶段4: Post-marketing studies are performed after regulatory agency approval occurs. These studies are designed to collect additional information including the drug’s risks, benefits and optimal use in a broader patient population often over extended periods of time. An example of a Phase 4 study would be the registry to collect medical information on the disease population, whether they are taking the approved drug or not.

监管审查

When Phase 1–3 clinical trials are completed, a Marketing Application (e.g., a New Drug Application (NDA) for the US 澳门十大博彩正规游戏平台, or a Marketing Authorization Application (MAA) for the European Authorities) is submitted to regulatory agencies. The Marketing Application contains all data gathered about the safety and effectiveness of the study drug from the preclinical studies and clinical trials that have been performed. The Marketing Application also contains information about the chemistry, 毒理学, pharmacology and manufacturing processes of the product. The regulatory agency reviews the data and, 如果得到批准, the new treatment can be marketed and distributed to the public through prescription by a qualified physician.