在分散的临床试验中作为合作伙伴的参与者
Paul A Harris1,2, Alex C Cheng1,2
1Vanderbilt Institute for Clinical and Translational Research, Nashville.
NEJM evidence
|July 9, 2025
概括
分散临床试验 (DCT) 通过使远程参与成为可能,提高了试验准入和便利性. 专注于参与者优先事项和DCT的技术创新可以加速发现和建立信任.
科学领域:
- 生物医学研究生物医学研究
- 临床试验设计 临床试验设计
背景情况:
- 传统的临床试验往往面临由于地理限制和参与者负担的限制.
- 分散临床试验 (DCT) 通过在传统环境之外进行试验活动来提供一种新的方法.
- DCT提供了机会,以提高参与者的便利性和扩大对研究的访问.
研究的目的:
- 突出分散的临床试验 (DCT) 与传统模型的优势和好处.
- 确定成功DCT运营的关键技术和程序考虑因素.
- 探索创新领域,以提高DCT的参与者中心性.
主要方法:
- 该研究审查了实施DCT的运营方面和战略考虑.
- 它强调了参与者参与和伙伴关系在整个试验生命周期的重要性.
- 讨论了支持远程试验活动的技术和程序因素.
主要成果:
- 通过消除地理障碍,DCT实现了临床研究的民主化.
- 远程参与DCT提高了个人便利性.
- 有意的策略对于招聘,留住和为DCT的参与者提供价值至关重要.
结论:
- 以参与者为中心的DCT和创新技术平台可以加速科学发现.
- 让参与者作为合作伙伴,培养有意义贡献的感觉,并建立长期的信任.
- 成功运行DCT将使研究人员,参与者和社会受益.
更多相关视频
相关概念视频
Clinical Trials: Overview
3.4K
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...
3.4K
Clinical Trials
8.6K
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...
8.6K
Blinding
2.7K
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.
2.7K
Ethics in Research
24.0K
Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
24.0K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
180
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
180
Preclinical Development: Overview
4.9K
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...
4.9K


