【精品】PPT课件 广州市第一人民医院医院心内科黎镇赐.ppt

广州市第一人民医院医院
心内科
黎镇赐
我方观点:高血压治疗中,中间终点可以取代硬终点
This has opened the door to the use of the so-called intermedi-ate end points in clinical trials, which, according to the definition by the US Food and Drug Administration (FDA), can be regarded as “laboratory measures or physical signs used as substitutes for clinically meaningful end points that directly assess in a clinical trial how a patient feels, functions, and survives”
The effects of a given blood pressure–lowering intervention is being assessed not only by the evaluation of cardiovascular and
noncardiovascular fatal events but also by the investigation of the so-called softer end points panion meta-analysis approach, suffers from a number of limitations that prevent full appreciation of the benefits of antihypertensive treatment This has opened the door to the use of the so-called intermedi-ate end points in clinical trials.
中间终点( Intermediate Endpoint )的定义
“中间终点”是指在治疗试验中用于代替有意义的临床终点衡量患者的主观感受、功能恢复情况和生存情况,并预测治疗效果的实验室检测指标或临床体征、结果。(FDA)
一个好的中间终点必须具备以下条件:
能被尽早地测量;
检测方便或侵入性不大;
能被频繁地测量;
能加快得出结论的过程。
高血压治疗中,中间终点的优点
中间终点评估抗高血压治疗可能有多种优点:
节省临床试验的时间和经费;
可以比较几种不同的治疗;
可以进一步了解不同治疗的作用机制。
SOME CHARACTERISTICS OF AN Intermediate Endpoint
Directly related to major clinical e (., mortality, stroke)
Ascertainment is reliable and valid
Alteration in Intermediate Endpoint produces alteration in major clinical e
Safe and acceptable to participants
Persuasive to scientific and medical colleagues
Cost effective
高血压治疗中,中间终点的优点
中间终点的选用使更多替代性的试验成为可能,因此降低了对样本量或/和时间的要求和试验的成本。
缩短完成试验时间。
可以简化药物研发过程,更早地引入新疗法或新药物。
更容易测量或比目标终点更早获得。
使用中间终点的优越性
大大降低样本含量的要求。
降低临床试验成本。
有利于早期决策的制定和快速评估重要的临床结果。
医疗费用高涨、医疗事故索赔、艾滋病、控制胆固醇等要求能快速得出具有成本效益的临床试验结果。
中间终点的作用
评价药物的直接作用机制来支持相关理论概念。
适当地预测结果。
假设类似于结果的情况。
POSSIBLE ADVANTAGES OF TRIALS USING Intermediate Endpoint
Fewer Patient
&
Shorter Trial
Less Cost
Reduced Total Risk
Pathophysiologic
Orientation
? More Persuasive