相关实验视频
Updated: Sep 13, 2025

07:48
Working with Human Tissues for Translational Cancer Research
Published on: November 26, 2015
10.0K
研究药物副作用的风险沟通:临床试验.gov的知情同意表格的评估
Chandler Coleman1, Owen Jokinen1, James Duhig1
1Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, AbbVie Inc., North Chicago, IL, USA.
Patient education and counseling
|July 27, 2025
概括
信息化同意表格往往无法清楚地传达研究药物的副作用. 需要标准化指导,以确保临床试验参与者准确的风险沟通.
科学领域:
- 临床试验的知情同意.
- 关于患者安全的沟通
- 医疗保健中的风险感知
背景情况:
- 在知情同意表格 (ICF) 中使用清晰的安全语言对于患者在临床试验中的理解至关重要.
- 欧洲委员会 (EC) 推的口头风险描述词,当与频段,绝对频率或百分比相结合时,可以提高对副作用可能性的理解.
- 有效的风险沟通提高了患者在临床研究中的招生和坚持.
研究的目的:
- 分析临床试验知情同意表格如何呈现研究药物副作用信息.
- 评估在ICF中使用欧盟委员会 (EC) 推的口头风险描述符.
- 评估研究药物的副作用所提供的频率信息的准确性.
主要方法:
- 系统评估来自clinicaltrials.gov.gov的547个英语知情同意表格.
- 评估用于描述研究药物副作用的可能性的方法.
- 分析ICF频率信息的呈现和准确性.
主要成果:
- 19%的ICF未能表明研究药物副作用的频率.
- 16.1%的ICF使用了EC推的描述符,并使用了不正确的概率配对.
- 只有3.6%的ICF准确地呈现了EC推的口头风险描述符及其正确概率;没有ICF使用风险可视化.
结论:
- 在ICF中,研究药物的副作用沟通往往是不充分和不一致的.
- 与EC口头风险描述符相关的不准确的频率信息可能会增加参与者对风险易感性的困惑.
- 促进有效风险沟通实践的标准化指导方针对于提高ICF清晰度和参与者的理解至关重要.
相关概念视频
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
176
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,...
176
Pharmacovigilance
996
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
996
Clinical Trials
8.5K
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...
8.5K
Hazard Ratio
251
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...
251
Clinical 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
Drug Regulation
1.8K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.8K

