Ballester Oscar
Edwards Comprehensive Cancer Center, Marshall University, Huntington, West Virginia, USA.
Cancer Invest. 2008 Jun;26(5):445-7. doi: 10.1080/07357900701874641.
Phase III clinical trials help define standard therapies by comparing the outcomes of a new (experimental) treatment arm to the best established (control) arm. Superior outcomes should only be defined in measures of patient benefit. Two recent trials for upfront therapy of patients with multiple myeloma (ECOG E1A00 and E4A03) failed to conform to traditional Phase III trial design. Consequently they failed to provide any useful scientific data.
III期临床试验通过比较新的(实验性)治疗组与已确立的最佳(对照)组的结果来帮助确定标准疗法。卓越的结果应以患者受益的指标来定义。最近两项针对多发性骨髓瘤患者一线治疗的试验(ECOG E1A00和E4A03)未能符合传统的III期试验设计。因此,它们未能提供任何有用的科学数据。