在研究和实践中进行和实施个性化试验
Richard L Kravitz1,2, Naihua Duan3,4
1Department of Internal Medicine, University of California, Davis.
概括
个性化试验,或N-of-1试验,评估个体治疗的有效性,但面临的采用障碍. 克服设计和实施的挑战是它们在医学中更广泛使用的关键.
科学领域:
- 临床试验 临床试验
- 医学研究方法学 医学研究方法学
- 个性化医疗是个性化的医疗.
背景情况:
- 随机对照试验 (RCT) 是证据开发的标准,重点是平均治疗效果.
- 个性化试验 (N-of-1试验) 评估在单个个体内的比较治疗有效性.
- 尽管使用了40多年,但N-of-1试验在医学上得到了有限的采用.
研究的目的:
- 审查个性化试验的基本要素.
- 确定阻碍广泛采用N-of-1试验的障碍.
- 探索改善个性化试验的部署性和实用性的策略.
主要方法:
- 对个性化 (N-of-1) 试验设计和实施的现有文献的审查.
- 分析实际挑战,包括饮食调节的灵活性,失明和洗期.
- 讨论组织,临床医生和患者层面的障碍.
主要成果:
- 有有限的证据表明,个性化试验有所改善.
- 实际设计和实施问题,而不是有效性证明,是主要的障碍.
- 组织和个人层面的挑战阻碍了广泛采用.
结论:
- 个性化试验提供了一种有价值的方法来评估个体治疗的有效性.
- 解决实际的设计,实施和后勤挑战对于更广泛的采用至关重要.
- 新兴技术可能会克服当前的障碍,增强未来的个性化试验研究.
更多相关视频
06:16Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting
Published on: June 6, 2020
3.8K
06:28E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
Published on: August 1, 2019
8.4K
相关概念视频
Clinical Trials
6.7K
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...
6.7K
Clinical 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
Ethics in Research
23.0K
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.
23.0K
Blinding
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
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
130
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,...
130
Blind Procedures
10.6K
Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
10.6K
