San Francisco Coordinating Center, California Pacific Medical Center Research Institute, Mission Hall: 550-16th Street, 2nd Floor, 94143, San Francisco, CA, USA.
Department of Epidemiology and Biostatistics, University of California, Mission Hall: Box #0560 550- 16th Street, 2nd Floor, 94143, San Francisco, CA, USA.
Ther Innov Regul Sci. 2024 Sep;58(5):789-795. doi: 10.1007/s43441-024-00666-x. Epub 2024 May 10.
The growing complexity of biopharmaceutical sponsored trials has adverse impacts on increased burdens on participants, clinical sites, and sponsors, including greater difficulty recruiting and retaining participants, difficulty engaging sites to participate in trials, excessive cost of trials, and increased cycle times. The schedule of assessments (SoAs) is the origin of and blueprint for complexity that is often generated by copying and pasting from previous SoAs. We developed an approach, termed Lean Design, for redesigning the assessments in SoAs that generate data, the 'Data SoA.' It starts with a simple "ground zero" SoA. Any addition is challenged using several principles of trial design. We employed a system, the Faro Trial Designer Tool, to quantify the impacts of changes in an SoA to provide real-time feedback to the team and sponsor. We applied the approach in workshops with teams for six clinical trials in various stages of design and implementation. The approach resulted in recommendation for substantial potential savings in participant and site staff time, costs, and complexity of the trials. Application of this approach to very early stages of protocol design has the potential to reduce the complexity of biopharmaceutical sponsored trials and its consequences.
生物制药赞助试验的日益复杂性对参与者、临床机构和赞助商造成了不利影响，包括招募和留住参与者的难度增加、机构参与试验的难度增加、试验成本过高以及周期延长。评估计划（SoA）是复杂性的起源和蓝图，而这种复杂性往往是通过从以前的 SoA 中复制和粘贴生成的。我们开发了一种方法，称为精益设计，用于重新设计生成数据的评估计划，即“数据 SoA”。它从一个简单的“零起点”SoA 开始。任何添加内容都将使用几个试验设计原则进行挑战。我们使用了一个名为 Faro 试验设计器工具的系统来量化 SoA 变更对团队和赞助商的实时反馈。我们在设计和实施的不同阶段的六个临床试验的团队研讨会上应用了该方法。该方法建议在参与者和现场工作人员的时间、成本和试验的复杂性方面进行大幅度的潜在节省。在方案设计的早期阶段应用这种方法有可能降低生物制药赞助试验的复杂性及其后果。
