关于中国临床试验从业者对分散临床试验的知识,实践和态度的研究
Yuanyuan Shi1, Yujian Bao1, Yu Pu2
1School of Pharmacy, Chongqing Medical University, Chongqing, China.
Frontiers in medicine
|May 2, 2025
概括
中国的临床试验从业者对分散的临床试验 (DCT) 感兴趣,但缺乏实际经验. 提高技术技能和知识对于在中国更广泛地采用DCT至关重要.
科学领域:
- 临床研究 临床研究
- 制药科学 制药科学
- 医疗信息学 医疗信息学
背景情况:
- 中国的分散临床试验 (DCT) 应用仍未得到充分研究.
- 这项研究解决了在中国临床试验环境中对DCT的有限理解.
研究的目的:
- 评估中国临床试验从业人员关于DCT的知识,实践和态度.
- 确定在中国实施DCT的障碍和促进因素.
主要方法:
- 匿名横截面调查于2023年11月进行.
- 从621名从业人员收集的数据:临床研究助理 (CRA),临床研究协调员 (CRC) 和项目经理 (PM).
主要成果:
- 实践者表现出基本的DCT知识和高参与意愿,但实际经验有限,特别是在互联网招聘之外的领域.
- 受访者认为的主要好处包括增强患者权利和增加试验准入.
- 确定的主要实施障碍是技术挑战和对数据可靠性的担忧.
结论:
- 中国的临床试验从业者需要增强的技术技能和知识,以有效地实施DCT.
- 全行业的技能提升是必要的,以促进DCT在中国的成功应用和整合.
相关概念视频
Clinical Trials
6.6K
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...
6.6K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
106
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,...
106
Study Designs in Epidemiology
134
Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
134
Blinding
2.3K
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.
2.3K
Hazard Ratio
64
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
For example, in a clinical trial...
64
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


