一天内协议研讨会:加快初级和高级教师的IRB批准
Geina M Iskander1, Adriana Cavazos1, Chinenye Lynette Ejezie1
1Department of Radiation Oncology, MD Anderson Cancer Center, University of Texas, 1515 Holcombe Blvd. Unit 0097, Houston, TX, 77030-4009, USA.
概括
一天中的协议 (PIAD) 研讨会大大缩短了机构审查委员会 (IRB) 批准研究协议的时间. 这项教育计划提高了协议质量,并通过加快临床试验实施来支持学术教师的职业发展.
科学领域:
- 临床研究 临床研究
- 医学教育 医学教育
- 医疗保健服务研究 医疗服务研究
背景情况:
- 研究协议开发的延迟可能会阻碍学术教师的职业发展.
- 结构化的教育指导对于克服机构审查委员会 (IRB) 批准障碍和加快临床试验启动至关重要.
研究的目的:
- 评估"一天中的协议" (PIAD) 研讨会的有效性和参与者的满意度.
- 确定PIAD研讨会是否可以加快IRB审批流程并提高协议质量.
主要方法:
- 在PIAD研讨会上,来自临床试验实施的六个关键领域的成员参加了研讨会.
- 通过比较PIAD参与协议与非参与协议的IRB批准时间来衡量有效性.
- 用5个问题调查评估了参与者的满意度;通过Shapiro-Wilk测试评估数据的正常性,通过Mann-Whitney U测试评估数据的意义.
主要成果:
- 接受PIAD研讨会的协议的IRB批准时间平均为39.8天,而非参加者则为58.4天.
- 100%的参与者认为PIAD研讨会是有用的,94%的人报告了整体协议质量的改善.
- 参与者的反表明,试验质量,语言和统计设计的实质性改进.
结论:
- 该PIAD研讨会有效地缩短了临床研究协议的IRB批准时间表.
- 这种教育干预提高了协议质量,并通过加快试验实施来支持初级和高级学术教师的职业发展.
相关概念视频
Ethics in Research
23.7K
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.
23.7K
Clinical Trials: Overview
4.7K
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...
4.7K
Preclinical 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
Bioavailability Study Design: Healthy Subjects Versus Patients
248
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
248
Bioequivalence studies: Biowaivers
430
In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
430


