Medical Scientist Training Program, Mayo Clinic, Rochester, Minnesota, USA.
Clin Transl Sci. 2014 Feb;7(1):82-6. doi: 10.1111/cts.12111. Epub 2013 Oct 3.
Translational stories range from straightforward to complex. In this commentary, the story of the rapid and successful translation of rituximab therapy for the treatment of non-Hodgkin's lymphoma (NHL) is examined. Development of this monoclonal antibody therapy began in the late 1980s. In 1994, rituximab received its first approval for the treatment of NHL by the United States Food and Drug Administration (FDA). Rituximab has since been approved for additional indications and has transformed medical practice. However, the social and political implications of these rapid successes are only beginning to become clear. In this commentary, key events in the rapid translation of rituximab from the bench to bedside are highlighted and placed into this historical framework. To accomplish this, the story of rituximab is divided into the following six topics, which we believe to be widely applicable to case studies of translation: (1) underlying disease, (2) key basic science, (3) key clinical studies in translation, (4) FDA approval process, (5) changes to medical practice, and (6) the social and political influences on translation.
转化研究的故事各有不同。在这篇述评中，我们将探讨利妥昔单抗治疗非霍奇金淋巴瘤（NHL）的成功转化案例。这种单克隆抗体疗法的研发始于 20 世纪 80 年代末。1994 年，利妥昔单抗首次获得美国食品和药物管理局（FDA）批准用于 NHL 的治疗。此后，利妥昔单抗又获批了更多适应证，并改变了医学实践。然而，这些快速成功的社会和政治影响才刚刚开始显现。在这篇述评中，我们将重点介绍利妥昔单抗从实验室到临床应用的快速转化过程中的关键事件，并将其置于这一历史背景下。为此，我们将利妥昔单抗的故事分为以下六个主题，我们认为这些主题广泛适用于转化研究的案例分析：（1）潜在疾病；（2）关键基础科学；（3）转化过程中的关键临床研究；（4）FDA 审批流程；（5）医疗实践的改变；（6）对转化的社会和政治影响。
