教學醫院臨床試驗中心營運模式之探討

Operation Models for Teaching Hospital Clinical Trial Center

溫怡棉(Yi-Mien Wen)

指導教授 ： 余峻瑜

國立臺灣大學/管理學院/商學研究所/碩士(2010年)

https://doi.org/10.6342/NTU.2010.10104

摘要

政府建構生醫科技島計畫，建立臨床試驗與研究體系，補助教學醫院成立臨床試驗中心和推動臨床試驗人才培育，教學醫院紛紛成立臨床試驗中心。本研究以醫院的觀點，分析臨床試驗中心在執行臨床試驗過程中，醫院資源整理出與臨床試驗相關的十五個元素，並區分為「必須為院內資源」或「非必須為院內資源」。探討教學醫院全面管理院內所有臨床試驗案件，依據投入元素的最多與最少，會產生的不同營運模式：「組成元素最大化營運模式」與「組成元素最小化營運模式」。
兩種營運模式主要差異的五個元素為：中心運作人員(COP)、資訊室(IT)、個案檢體保存(Sst)、研究護士(Nr)、檢驗室(Lab)，本研究分別探討五個元素在醫院作業管理(operation management)、試驗品質(trials quality)、服務品質(service quality)上的影響。最後再從利益(benefit)、主控權(dominance)、生產力(capacity) 、收益(revenue)等面向，整體討論兩種營運模式的差異。
「組成元素最小化營運模式」初期設置成本低，但未來擴展性有限；而「組成元素最大化營運模式」短時間無法明顯看出臨床試驗中心的成效，待經濟規模後才會顯示最大化營運模式的優點。本研究再以元素利益一致性分析觀點，認為教學醫院成立臨床試驗中心首要考量建立臨床試驗的核心能力，即培育臨床試驗的中心運作人員和研究護士，優先投入這兩個「非必須為院內資源」。由於此模式是介於投入元素最大化與最小化之間，而衍生出可能存在的更適合之模式。
本研究認為教學醫院臨床試驗中心的生產力決定於院內研究護士的人數，當中心培養足夠的研究護士，能夠承接所有院內案件，決定院內最大生產力的元素變為願意參與與符合試驗條件的個案，因此，臨床試驗中心對個案推廣與教育「臨床試驗」的工作便顯得更重要。待臨床試驗中心組織發展成熟、人才培育、經驗累積與成效推廣後，必可提升臨床試驗中心之競爭力。

關鍵字

臨床試驗中心、營運模式

並列摘要

Many Teaching Hospitals participated in the General Clinical Research Center (GCRC) projects organized by the Department of Health. From the respects of these hospitals, there are15 required key components in clinical trial process in the hospital resources, which could be divided into two group, essential components and nonessential components. The study discusses the total management control of all clinical trial runs in the hospital. Two different business models are drawn according to different input levels. The two different models are most-input components operation model and least-input components operation model.
The differences between these two models are five components including center operation people (COP), IT, sample store (Sst), nurse (Nr), and laboratory (Lab). The study probes the impact of these five components on operation management, trials quality, and service quality, respectively. Finally, we discuss the difference in benefit, dominance, capacity, and revenue of these two operation models.
The least-input components operation model benefits from lower initial cost, but its extensibility is limited. While the effectiveness of clinical trial center is not clear in short-term with most-input components operation model, its advantages would reveal after reaching economies of scale. Furthermore, from the view of interest consistency, the study suggests that, first, teaching hospital should consider establish its core competence in clinical trials and cultivates two nonessential components, COP and Nr, and thus, we derived a more adequate model from those two models since the input level is between the two mentioned models.
The study suggests that the capacity of the clinical trial center of teaching hospital depends on the number of research nurses. If the hospital could undertake every trial with enough research nurses, clinical trial-qualified patients would be the dominant factor in its capacity, and hence, the promotion of the concept of clinical trials becomes more important. Finally, the competiveness of clinical trial centers would increase with good organization development, personnel cultivation, experience accumulation, and effectiveness promotion.

並列關鍵字

Clinical Trial Center, Operation Model

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