没有优先考虑正在进行的临床试验.
Barbara E Bierer1, Deborah A Zarin2, Luke Gelinas3
1Faculty director of the Multi-Regional Clinical Trials Center of the Brigham and Women's Hospital and Harvard, a senior physician at Brigham and Women's Hospital, and a professor of medicine at Harvard Medical School.
Ethics & human research
|October 1, 2023
概括
确保临床试验在启动后仍然具有价值至关重要. 这项研究探讨了伦理挑战,并提出了维持科学相关性的框架,特别是COVID-19流行病所强调的.
科学领域:
- 临床研究伦理学
- 基于证据的医学是基于证据的医学.
- 卫生政策 卫生政策
背景情况:
- 伦理临床试验在开始时需要有利的风险/益处平衡.
- 由于外部证据的转移,研究价值可能会在试验中期下降.
- 随着COVID-19的流行,监测试验相关性的关键差距被揭示出来.
研究的目的:
- 识别和描述在临床试验启动后保持临床试验相关性和价值的挑战.
- 探索那些失去预期价值的研究所带来的伦理动态.
- 提出一个临时框架来解决这些问题.
主要方法:
- 临床试验伦理和价值的文献综述.
- 分析正在进行的研究中的伦理考虑.
- 案例研究检查,参考COVID-19大流行背景.
- 为正在进行的试验评估制定临时框架.
主要成果:
- 在研究中期,试验价值下降的情况未得到充分解决.
- 显著的物质和人力资本成本与缺乏信息的研究有关.
- 当试验尽管相关性下降,但仍存在时,就会出现道德困境.
- 提出了一个框架,以指导持续试验价值的评估.
结论:
- 确保临床试验的持续科学相关性和价值是道德上的必要要求.
- 随着COVID-19的流行,人们越来越需要适应性试验监测.
- 需要进一步的经验研究来验证提出的解决方案.
- 为了应对不断下降的试验价值带来的伦理挑战,需要采用结构化的方法.
关键词:
临床试验是指临床试验中的临床试验.数据监测委员会 (DMC) 的数据监测委员会 (DMC)机构审查委员会 (IRB)内部有效性 内部有效性研究伦理研究伦理学风险-收益平衡的风险-收益平衡.科学价值 科学价值更多相关视频
14:43A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
Published on: January 12, 2018
11.9K
06:55Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index
Published on: January 8, 2020
14.5K
相关概念视频
01:11Clinical Trials: Overview
3.0K
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...
3.0K
01:16Clinical Trials
6.8K
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...
6.8K
01:28Preclinical Development: Overview
4.5K
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...
4.5K
01:26Drug Administration and Therapy Phases: Overview
504
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
504
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
145
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,...
145
01:11Blinding
2.5K
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.
2.5K