准备临床医生成为多中心临床试验的现场调查人员:在学术医疗中心的培训计划
Tammy L Loucks1,2, Diana Lee-Chavarria1, Jillian Harvey1,3
1South Carolina Clinical and Translational Research Institute, Medical University of South Carolina, Charleston, SC, USA.
Journal of clinical and translational science
|August 17, 2023
概括
建立临床试验员培训计划 (CTTP) 和训练营成功培训了新研究人员. 这一举措增加了临床试验的识别,并使临床医生成为成功的现场调查员.
科学领域:
- 生物医学研究的研究.
- 临床试验的管理管理.
- 调查员培训 调查员培训
背景情况:
- 临床试验对于将发现转化为治疗方法至关重要.
- 新的调查人员面临时间限制和复杂的流程等障碍.
- 获得指导的机会有限,阻碍了研究人员的发展.
研究的目的:
- 建立一个培训计划,为新的临床试验研究人员解决障碍.
- 增加能够领导成功临床试验的当地研究人员的数量.
主要方法:
- 实施了一项临床试验员培训计划 (CTTP),提供薪资支持,受保护的时间,教学培训和指导.
- 举办了一个免费的临床试验训练营,以教育临床试验的过程.
- 在12个月内支持了四名CTTP学者组成的初始队列.
主要成果:
- 在CTTP队列中,确定了33项新的临床试验.
- 学者们利用了可行性评估,并正准备维持受保护的时间.
- 训练营的参与者对临床试验资源和流程的知识有所提高.
结论:
- 获得补偿的受保护时间,全面的培训和接触专家对于培养成功的临床试验现场调查人员至关重要.
- 该CTTP模型有效地克服了临床试验启动和进行的障碍.
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
10:38Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies
Published on: January 16, 2019
20.3K
相关概念视频
Clinical 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
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
Preclinical 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
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
Nursing Clinical Information System
813
Nursing Clinical Information System (NCIS)
A Nursing Clinical Information System (NCIS) is a specialized type of healthcare information system tailored to meet the unique needs of nursing practice. It incorporates the principles of nursing informatics to streamline information management and improve the quality of care delivery.
Critical attributes of NCIS include:
A Nursing Clinical Information System (NCIS) is a specialized type of healthcare information system tailored to meet the unique needs of nursing practice. It incorporates the principles of nursing informatics to streamline information management and improve the quality of care delivery.
Critical attributes of NCIS include:
813
Study Designs in Epidemiology
266
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...
266
