关于推进在临床试验中使用分散元素的建议文件
Alison Bond1, Tracey Robertson2, Christine Fletcher3
1Director, Global Regulatory Policy and Intelligence, Amgen Ltd, 4 Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH, United Kingdom. abond01@amgen.com.
Therapeutic innovation & regulatory science
|May 27, 2025
概括
欧盟的分散的临床试验提供了更好的访问和结果,但面临着监管和运营方面的障碍. 本文提出了更广泛采用的策略,旨在将这些元素纳入标准临床研究实践.
科学领域:
- 临床研究 临床研究
- 制药科学 制药科学
- 监管科学 监管科学
背景情况:
- 临床试验中的分散元素在欧盟正在扩大.
- 这些元素提供了潜在的好处,如改善试验准入和研究成果.
- 监管,运营和技术方面的挑战阻碍了广泛采用.
研究的目的:
- 提出战略和政策建议,以克服分散临床试验的障碍.
- 促进分散元素融入标准临床研究实践.
- 为不同人群提供创新和平等的临床试验机会.
主要方法:
- 制药行业和协会欧洲联合会成员制定战略和政策建议.
- 分析监管,运营和技术方面的挑战.
- 提出解决方案,包括协调的监管框架和改进的数据验证.
主要成果:
- 确定采用分散的临床试验的主要障碍.
- 制定可行的战略来解决这些障碍.
- 强调需要协调法规和利益相关者的合作.
结论:
- 克服已识别的障碍可以导致在临床试验中标准使用去中心化元素.
- 协调的监管框架,数据验证和协作至关重要.
- 分散的临床试验可以加强创新,并确保公平获得研究机会.
更多相关视频
相关概念视频
01:11Clinical Trials: Overview
4.6K
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...
4.6K
01:16Clinical Trials
10.2K
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...
10.2K
01:29Issues And Trends In Healthcare Delivery System
6.2K
The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
6.2K
01:28Preclinical Development: Overview
5.9K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
5.9K
01:11Blinding
3.8K
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
3.8K
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
144
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
144