现代化研究和证据共识定义:一个食品和药物管理局-国家卫生研究院合作
Donna R Rivera1, Tracy L Cutler1, Lisa McShane2
1US Food and Drug Administration, Silver Spring, Maryland.
JAMA network open
|June 17, 2025
概括
美国食品和药物管理局 (FDA) 和美国国家卫生研究院 (NIH) 创建了一份由40个术语组成的词典,用于创新的临床研究设计,包括真实世界的数据,以改善医疗产品开发中的沟通和透明度.
科学领域:
- 临床研究方法论临床研究方法论
- 监管科学是一种监管科学.
- 医疗产品开发 医疗产品开发
背景情况:
- 美国食品和药物管理局 (FDA) 和国家卫生研究院 (NIH) 旨在提高临床研究效率和参与者的参与度.
- 科学和技术的进步为增强医疗产品开发和临床试验过程提供了机会.
- 倡议侧重于证据现代化,包括用于监管目的的真实世界数据 (RWD).
研究的目的:
- 促进有效的沟通,促进科学界对术语的共同理解.
- 定义与创新的研究设计相关的临床研究术语,特别是使用RWD.
- 支持FDA监管的医疗产品和更广泛的研究工作.
主要方法:
- 美国FDA-NIH现代化研究和证据 (MoRE) 词汇工作组 (MGWG) 于2023年4月成立.
- 对共同的创新设计术语进行了景观评估,以确定缺乏清晰度的领域.
- MGWG审查了现有的法规和指导,寻求公众的意见,并进行了严格的审查,以建立共识定义.
主要成果:
- 该MGWG开发了MoRE共识定义,这是创新的临床研究设计的40个术语和定义的词汇表.
- 这些定义支持医疗产品开发中的科学,患者,临床和监管决策.
- 该词汇表涉及临床研究社区中定义不充分的术语.
结论:
- 研发部的共识定义旨在加强关于创新的临床研究设计的沟通和透明度.
- 本出版物为临床研究企业提供了一个可访问的资源.
- 未来的努力可能会解决临床研究中新兴的词汇和不断发展的术语.
相关概念视频
Clinical Trials
8.5K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
8.5K
Clinical Trials: Overview
4.7K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.7K
Drug Regulation
3.0K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
3.0K
Clinically Relevant Drug Product Specifications: Methods of Establishment
303
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
303
FDA Approved Drugs: Changes to Approved Drugs
344
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
344
Investigation of Disease Outbreaks
79
Multistate foodborne outbreaks pose significant public health risks and require meticulous investigation to identify sources and implement control measures. The Centers for Disease Control and Prevention (CDC) utilizes a dynamic seven-step process for these investigations, integrating data from laboratories, interviews, and environmental assessments to protect public health.Outbreak Detection: The detection of multistate outbreaks typically begins with PulseNet, the CDC's national laboratory...
79


