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| Title: | 臨床試驗受試者保護：從利害關係人觀點探討CRA監測功能之提升
Clinical Trial Subject Protection:The enhancement of CRA monitoring from stakeholder perspectives |
| Authors: | 李雅玟
Lee, Ya Wen |
| Contributors: | 温肇東
Wen, Chao-Tung
李雅玟
Lee, Ya Wen |
| Keywords: | 試驗監測員CRA
受試者
臨床試驗
監測
利害關係人
社會重大事件
CRA
clinical trial subject
clinical trial
monitoring
stakeholder
social serious events |
| Date: | 2012 |
| Issue Date: | 2013-09-02 16:10:13 (UTC+8) |
| Abstract: | 隨著新藥研發臨床試驗受試者安全與權利有關的社會重大事件日漸增加，我們迫切需要了解造成這些事件的根本原因。本研究發現，關鍵根本原因之一與可能的答案，存在於可以早期辨識新藥危害受試者安全與權利是否被依法規受保護的臨床試驗監測業務。
至今，似乎未有人針對試驗監測員(CRA)工作、時間與能量分配，這些與臨床試驗監測業務品質有關的因素做研究。由利害關係人分析、交易成本理論與白地策略角度，本研究針對兩面向，進行分析: 1) 全球化分工對台灣臨床試驗的衝擊 2) 台灣臨床研究專員面臨監測業務的四大阻礙，因而失去了早期辨識新藥危害受試者安全與權利的機會，並提出處理下列四大阻礙的相關建議:
1)舒緩目前由全球化分工過度造成的CRA大增的工作量、事務範圍縮小、警覺變差等影響;
2)降低由CRO組織複雜與效能不佳造成的內部交易成本;
3)降低由主持人團隊責任不明、或無充裕時間執行試驗，試驗地點額外事務造成的額外交易成本;
4)降低由委託者當地代表不當期盼與干涉造成的外部交易成本
With the increasing of serious social incidents related to the safety and welfare of the clinical trial subjects, their causes are urgently needed. This study finds that the main causes as well as their solutions may reside in whether or not the monitoring process, which is more frequent than audits and inspections, can provide an early detection of side effects during a clinical trial so that the safety and welfare of the clinical trial subjects can be protected according to the related laws and regulations.
To date, there are not many studies have focused on the distribution of work, time, and effort, factors that are closely related to the quality of the monitoring of the clinical trials, of the Clinical Research Associates (CRAs, a role defined by the GCP and related regulations). From the viewpoints of the stakeholders, the theory on the transaction costs, and the “seizing the white space”, this study made a descriptive analysis on the following two aspects: 1) the impact on Taiwan clinical trial due to over division of work from globalization and 2) CRAs in Taiwan are confronted with four hindrances, when monitoring a clinical trial, which results in missed opportunities in early discovery of clinical trial victims and, subsequently, endangering their lives, safety and welfare. The following suggestions are proposed to minimize the impact from the four hindrances:
a) To alleviate CRAs’ increased workload, narrowed scope, and reduced sensitivity suffered from over division of work in globalization.
b) To reduce the internal transaction cost resulted from the poorly organized CRO.
c) To reduce the external transaction cost brought by the ambiguousness in the responsibility of the investigator, inadequate experimental time, or the overflow of the extra affairs at the experimental sites.
d) To reduce the external transaction cost resulted from the improper expectations and interferences by the local representatives of the sponsors. |
| Reference: | 參考文獻
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| Description: | 碩士
國立政治大學
經營管理碩士學程(EMBA)
99932133
101 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0099932133 |
| Data Type: | thesis |
| Appears in Collections: | [經營管理碩士學程EMBA] 學位論文
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