Master protocol designs, such as umbrella and basket studies, allow multiple compounds or multiple target populations to be evaluated simultaneously within a single protocol, and have been widely adopted in oncology clinical trials. These novel designs can also be applied in other therapeutic areas, where they could have several benefits over conducting traditional randomized controlled trials. Here, we detail Pfizer’s recent implementations of master protocol designs in inflammation and immunology clinical studies, focusing on the opportunities for cost and resource savings and how these designs can expedite the time required to bring new treatments to patients in need.

中文翻译：

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炎症和免疫学方面的主方案和其他创新试验设计，以加快临床药物开发

主方案设计，例如伞式和篮式研究，允许在单个方案中同时评估多种化合物或多个目标人群，并已在肿瘤学临床试验中广泛采用。这些新颖的设计也可以应用于其他治疗领域，与传统的随机对照试验相比，它们具有多种优势。在这里，我们详细介绍了辉瑞最近在炎症和免疫学临床研究中实施的主方案设计，重点关注节省成本和资源的机会，以及这些设计如何加快为有需要的患者提供新疗法所需的时间。