教育訓練對新藥臨床研究專案績效之影響-­自我效能之中介效果

The Influence of Education and Training on Clinical Research Trials -­The Mediator Effect of Self-Efficacy

王莉茜(Li-Chien Wang)

指導教授 ： 楊立人

淡江大學/商管學院/企業管理學系碩士在職專班/碩士(2017年)

https://doi.org/10.6846/TKU.2017.00815

摘要

台灣在生技製藥臨床試驗領域具有優勢基礎，不少生技製藥公司從海外引進新藥至國內作臨床試驗，以開創附加價值。臨床試驗是一個新藥的研發需經過非常漫長且艱辛的過程，藥品自化學成份開發，到動物實驗甚至發展至人體臨床試驗，最後階段藥證的申請，所投入的時間、金錢及人力不可言喻，為了加速藥物發展、縮短上市許可的時間與落實臨床試驗執行的品質管控，因此，這項研究的主要目的是討論第一線照顧受試者的臨床研究護理師（clinical research nurses, CRNs）在臨床試驗中扮演重要角色以維持試驗品質。希望透過教育訓練以協助CRNs的專業發展及自我效能的提升， 並且落實於臨床實務，以提升試驗品質及成果。雖然過去的文獻探討中，教育訓練一直是被廣為探討的議題，然而本研究與過去研究最大不同處在於探討的產業是生技相關的新藥臨床研究，如何藉由教育訓練及自我效能的中介效果進而對專案績效有正面的影響。本研究邀請相關產業專業人員填答問卷，問卷收集其間為2017年2月至2017年3月，線上問卷共發放53份，紙本問卷則發放了103份，總共回收了共148份有效問卷進行分析，這項研究的結果如下：

1. 教育訓練對自我效能具有正面影響。
2. 自我效能對專案績效具有正面影響。
3. 教育訓練對專案績效具有正面影響。

關鍵字

教育訓練 ； 自我效能 ； 專案績效 ； 臨床試驗 ； 臨床研究護理師

並列摘要

Taiwan has a proven base in the field of biotechnology pharmacy clinical trials. Many biotech companies have introduced new drugs from overseas to clinical trials to create additional value. New drug research and development is a long and difficult process. Starting with the development of chemical products to animal experiments and even to the development of human clinical trials and the final stage is the application of evidence. There is an immense amount of time, money, and manpower that is necessary for this process. The main purpose of this study was to discuss the role of professional development for CRNs to enhance the results of clinical trials. This can help to speed up drug development, shorten the time to market and licensing. The trial plays an important role in maintaining the quality of the test. Education and training help the CRNs self improvement. Through the implementation of professional development, it will enhance the clinical practice and the quality and results of the trial. Although there have been many studies in past literature on education and training and they have been widely discussed, the biggest difference is the study of this in the biotechnology-related clinical research. The effects of education and self- efficacy have a positive impact on project performance. In this study, the relevant industry professionals were invited to fill the questionnaire. The questionnaire was collected from February 2017 to March 2017, and 53 were distributed on line, 103 questionnaires were distributed and a total of 148 valid questionnaires were collected. the results of this study are as follows:
1. Education and training have a positive impact on self-efficacy.

2. Self-efficacy has a positive impact on project performance.
3. Education and training have a positive impact on project performance.

並列關鍵字

Training Education ； Self-efficacy ； new project performance

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