我们为什么要在临床试验中进行体检? 在2型糖尿病中进行药物干预试验的用例
在PubMed上查看摘要
概括
此摘要是机器生成的。在2型糖尿病临床试验中的体检 (PE) 往往不清楚. 许多协议缺乏关于PE目的和进行的细节,这可能会影响试验的一致性,并需要进一步研究其必要性和创新的应用.
科学领域
- 临床试验方法
- 药理学研究
- 糖尿病治疗方法
背景情况
- 身体检查是临床评估的一个组成部分.
- 它在干预性药物试验中的特殊作用,特别是2型糖尿病 (T2DM),需要澄清.
研究的目的
- 在2型糖尿病的第三期和第四期药物干预临床试验中确定体检 (PE) 的目的和利用.
- 在试验方案中评估PE特征的文档.
主要方法
- 来自ClinicalTrials.gov的226个临床试验方案的系统审查.
- 由五位研究人员提取有关PE频率,时间,目的,元素和行为的数据.
主要成果
- 在211个审查的协议中,有190个 (89%) 提到PE,评估了241个不同的PE.
- 只有65%的方案明确说明了PE的目的,最常见的是用于不良事件的识别 (40%) 和终点评估 (33%).
- 百分之六十的PEs描述了检查元素,但只有8%的具体行为程序.
结论
- 临床试验方案常常缺乏关于体检的目的,要素和进行的充分信息.
- 这种缺陷可能会影响临床试验数据的一致性和可靠性.
- 需要进一步调查,以确定PE在所有试验中的必要性,并探索其融入创新的试验设计,例如去中心化.
相关概念视频
Type 2 diabetes, characterized by insulin resistance, arises when the insulin receptors on cells lose responsiveness to insulin, diminishing the cell's capacity to take up glucose, resulting in elevated blood glucose levels. To receive a diagnosis of Type 2 diabetes, a series of blood glucose tests are necessary to assess whether the blood glucose falls within normal parameters. If the result is out of the normal range, a patient may be diagnosed as prediabetic or diabetic, depending on the...
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...
The therapy for diabetes aims to alleviate hyperglycemia-related symptoms, prevent acute metabolic decompensation, and reduce chronic end-organ complications. Glycemic control is evaluated through short-term (self-monitoring, continuous glucose monitoring) and long-term (A1c, fructosamine) metrics, enabling near real-time tracking of blood glucose levels and reflecting glycemic control over specific time frames.
Insulin remains the cornerstone of treatment for most patients with type 1 and many...
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...
Diabetes mellitus is a chronic metabolic disorder characterized by high blood glucose levels due to inadequate insulin production, insulin resistance, or both. The condition affects millions worldwide and can significantly impact their health and quality of life.
Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. As a result, the body is unable to produce sufficient insulin, and individuals with...
For most patients, experiencing several weeks of polyuria, polydipsia, fatigue, and significant weight loss may indicate the presence of diabetes. Furthermore, adults displaying the phenotypic appearance of type 2 diabetes (particularly those who are obese and not initially insulin-requiring), may have islet cell autoantibodies, suggesting autoimmune-mediated β cell destruction and a diagnosis of latent autoimmune diabetes of adults (LADA). The categorization of glucose homeostasis is...

