Tufts Center for the Study of Drug Development, Tufts University School of Medicine, 145 Harrison Avenue, Boston, MA, 02111, USA.
Biogen, Cambridge, MA, USA.
Ther Innov Regul Sci. 2022 Jul;56(4):632-636. doi: 10.1007/s43441-022-00401-4. Epub 2022 Apr 4.
Little to no data exist quantifying and benchmarking the magnitude of protocol deviation experience.
Nearly two-dozen companies provided the Tufts Center for the Study of Drug Development (Tufts CSDD) with data on the design and the performance of 187 protocols.
The results of this working group study show that phase II and III protocols have a mean total of 75 and 119 protocol deviations, respectively, involving nearly one-third of all patients enrolled in each clinical trial. Oncology clinical trials have the highest relative mean number of protocol deviations affecting more than 40% of patients enrolled in each trial. The number of endpoints, the number of procedures per visit, and the number of countries were modestly positively associated with and predictive of, the incidence of deviations per protocol. A strong positive relationship was shown between the number of investigative sites and the number of protocol deviations.
The results of this initial study provide useful measures that sponsor companies can use to benchmark their own protocol deviation experience, identify factors most associated with protocol deviations, and determine whether remediation is warranted.
目前几乎没有数据可以量化和基准化协议偏离经验的程度。
近二十家公司向塔夫茨药物开发研究中心（Tufts CSDD）提供了 187 项方案的设计和实施数据。
该工作组研究的结果表明，II 期和 III 期方案分别平均有 75 项和 119 项方案偏离，涉及到每个临床试验中近三分之一的入组患者。肿瘤学临床试验的方案偏离相对平均数量最高，影响每个试验中超过 40%的入组患者。终点数量、每次就诊的程序数量和国家数量与偏离率呈适度正相关，并具有预测性。研究地点的数量与方案偏离数量之间存在很强的正相关关系。
这项初步研究的结果提供了有用的衡量标准，赞助商可以用来基准化自己的方案偏离经验，确定与方案偏离最相关的因素，并确定是否需要补救。
