来自用户体验专注的虚拟研究的见解 关于分散的临床试验的可行性和挑战
1Development Operations, AstraZeneca Global R&D (China) Co., Ltd, Shanghai, China.
Clinical and translational science
|August 9, 2025
概括
分散临床试验 (DCT) 显示出改善患者获取和减少负担的潜力. 这项研究模拟了DCT元素,确定了关键挑战,并制定了地方实施的标准化程序.
科学领域:
- 临床研究 临床研究
- 医疗信息学 医疗信息学
- 制药科学 制药科学
背景情况:
- 分散临床试验 (DCT) 具有潜在的好处,但由于经验有限,在中国面临实施障碍.
- 利益相关者参与对于理解和克服DCT采用当地的挑战至关重要.
研究的目的:
- 通过利益相关者参与和模拟,调查中国DCT流程的可行性和适用性.
- 确定与在当地环境中实施特定的DCT元素相关的痛点,要求和挑战.
主要方法:
- 采用混合方法方法,包括焦点小组,可用性测试,调查和采访.
- 四个DCT元素 (eConsent,远程采样,电视观看,直接向患者输送药物) 在11个地点与36名研究人员进行模拟.
- 利益相关者模拟了调查员,护士/药剂师和患者的角色.
主要成果:
- 研究人员报告称,对模拟的DCT元件的满意度很高.
- 确定的主要挑战包括系统可用性,远程监控,在线/离线访问的整合,风险管理,药物合规性和系统兼容性.
- 制定了标准化程序和用户旅程地图,以解决发现的问题并促进采用.
结论:
- 该研究为在中国实施DCT提供了关键的见解,强调了需要针对监管和利益相关者需求进行优化的领域.
- 一个开发的标准化框架可以指导未来DCT元素在中国医疗保健领域的适应和实施.
更多相关视频
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
06:32Author Spotlight: Automated Deep Brain Stimulation for Parkinson's Disease - Exploring the Possibilities and Challenges of Home Monitoring
Published on: July 14, 2023
1.4K
相关概念视频
01:11Clinical 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
01:16Clinical Trials
8.3K
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...
8.3K
01:29Issues And Trends In Healthcare Delivery System
5.8K
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...
5.8K
01:11Blinding
2.6K
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.
2.6K
01:28Preclinical Development: Overview
4.8K
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...
4.8K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
174
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,...
174