Davidson B L
Division of Pulmonary and Critical Care Medicine, Medical College of Pennsylvania, and Hahnemann University, Philadelphia, USA.
Haemostasis. 1998;28 Suppl 3:113-9. doi: 10.1159/000022388.
Numerous considerations and controversies attend the question of which endpoints to use in venous thromboembolism prophylaxis trials. In this paper, a rationale is presented for a new approach that simplifies certain aspects of endpoint detection in deep vein thrombosis and pulmonary embolism trials, and complicates others. The goal of this approach is to use reliably ascertainable endpoints that are clinically relevant and most probably predictive of clinical efficacy, in order to optimally inform the drug development process.
在静脉血栓栓塞预防试验中使用哪些终点指标的问题存在诸多需要考虑的因素和争议。本文提出了一种新方法的理论依据，该方法简化了深静脉血栓形成和肺栓塞试验中终点指标检测的某些方面，同时也使其他方面变得复杂。这种方法的目标是使用可靠确定的、具有临床相关性且最有可能预测临床疗效的终点指标，以便为药物研发过程提供最佳信息。
