優化臺灣臨床試驗實務管理制度之研究

【研究背景】當今台灣臨床試驗體系有研究人力大量流失，試驗成本墊高及國際競爭力逐漸下滑現象，究其原因可能源於臨床實務管理面相侷限，缺乏升遷管道/職涯發展及健全之績效考核等瓶頸，但此方面相關研究文獻不多，故本研究擬藉由平衡計分卡工具來檢視經營管理策略地圖及關鍵績效指標。【研究目的】1.探討臨床試驗機構運用平衡計分卡的策略發展實務管理之關鍵績效指標。2確認CRNs/CRCs及管理者對關鍵性績效指標之重要性及權重排序。3建立臨床試驗第一線績效考核之關鍵績效指標及其可應用性。【研究方法】第一階段質性訪談：採半結構式訪談大綱訪談(曾)擔任過機構高階領導者，使用MAXQDA 2020進行內容分析。第二階段進行修正式德爾菲專家調查法及層級分析法：擬定「平衡計分卡關鍵績效指標問卷」量表選出共識程度達80%以上項目，以統計套裝軟體SPSS 26.0，以重要程度、易近程度及認同程度找出關鍵績效指標（KPI）。進而以層級分析(Analytic Hierarchy Process, AHP)以Camparion○R軟體進行分析，得到相對權重之百分比的參考指標，採橫斷式問卷調查法，收集第一線CRNs/CRCs進行資料分析，量表重要性及可應用性因素的Cronbach's Alpha值分別為0.94及0.96。【結果】質性訪談結果統整出4個策略主題/11項策略目標：1)突顯品牌差異化；2)邁向永續發展；3)強化組織效能；4)提升邊際利潤及。根據修正式德爾菲及層級分析法專家問卷調查結果，從BSC四個構面萃取出前三項策略目標與關鍵績效指標，及其排序，分別為「試驗機構在執行臨床試驗準時完成的比例」、「從受試者返診到研究資料數據輸入eCRF的平均天數。」、「從識別確立問題到問題解決的天數」；「完成每次監測訪視(Monitoring Visit)需驗證之原始資料(Source Document Verification)範圍」、「撤回同意的隨機受試者的數量」、「試驗結案日(Close-Out Visit)」與「預估」試驗結束日天數差異百分比」。量性分析得知：策略目標與關鍵績效指標的重要性及可應用性，平均值分別為4.34±0.64分及3.47±0.93分。【結論】應用BSC可建立臨床試驗的經營管理長期競爭力，而領先績效指標為監測執行試驗過程的主要指標。

關鍵字

臨床試驗；實務管理制度；策略地圖；人力資源業務夥伴；關鍵績效指標；平衡計分卡

並列摘要

Background and purpose While looking at the clinical trial environment in Taiwan, some significant issues show on insufficient research workforce, and trial costs are rising and less competitive internationally; the bottlenecks arose clinical practice management limits, fewer career pathway development, and lack of the roust performance appraisal. However, little research works done on those root causes. The study aims to map the management strategy and find the relative key performance indicators using the balanced scorecard. Objects 1. To explore the development practice management of clinical trial institutions' key performance indicators using a balanced scorecard strategy. 2. Identify key performance indicators' ranking and weights from CRNs/CRCs and the leader's perspective. 3. To establish key performance indicators and applicability of the first-line performance of the clinical trials ecosystem. Methods The first phase was the qualitative interviews and conducting the semi-structured interview outlines. The study included participants for those who were or currently work as senior leaders of the organization. The content was analyzed using MAXQDA 2020. In the second stage, the revised Delphi expert survey and the hierarchical analysis methods designed for studying the "balanced scorecard key performance indicator questionnaire" and selected contents were to a consensus level of more than 80%. Additionally, to determine the most essential, accessible, and agreeable key performance indicators (KPIs) by the statistical package software, SPSS 26.0 was performed. Camparion○R software was approached for Analytic Hierarchy Process (AHP), and it demonstrated the reference index of the relative weight percentage. In the third phase, the cross-sectional questionnaire survey method was designed to collect the data from the first-line CRNs/CRCs. The results of questionnaires on essential and applicable factors indicated the Cronbach's Alpha were 0.94 and 0.96, respectively. Results Firstly, the qualitative interviews showed that the four integrated strategic themes and 11 strategies are: Objectives highlight brand differentiation, move towards sustainable development, Strengthen organizational effectiveness, and improve marginal profit and profit. Secondly, the expert questionnaire survey demonstrated the first three order of strategic objectives and key performance indicators that categorized from the four BSC, and the rankings are from "the proportion of trial institutions completing clinical trials on time," "The average number of days from the return of the subject to the study data input into the eCRF.", "The number of days from the identification of the problem to the problem resolution"; "The source document that needs to be verified for each monitoring visit (Source Document) Scope of Verification," "Number of random subjects withdrawing consent," "Percentage of difference between "Close-Out Visit" and "Estimated" trial end days." Quantitative analysis revealed that the mean(SD) of importance and applicability of strategic objectives and key performance indicators are 4.34±0.64 and 3.47±0.93, respectively. Conclusion This study suggested that the clinical institution leaders adopt the BSC as a tool for the long-term competitiveness management of clinical trial enterprises. Besides, trying the leading performance indicator as the primary indicator could better monitor the execution of the trial process.

並列關鍵字

Clinical Trial ； Practical Management System ； Strategy Map ； Human Resource Business Partner ； Key Performance Indicator ； Balance Score Card

參考文獻

中文部分

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