| 摘要: | 藥品臨床試驗是以證明藥品在臨床及藥理學上之作用是否安全與有效為目的，於人體上執行之研究，其中除了專業與人文並重的臨床試驗設計與嚴謹審查外，受試者保護更是臨床試驗執行中最重要的議題。然而，目前相關研究發現大都著重於有關臨床試驗的倫理審查，尤其國內較少關注到自願受試者在臨床試驗知情同意過程之經歷探討。因此本研究之目的是透過參與藥品臨床試驗案受試者的經驗，來了解受試者對臨床試驗的知識、知情同意理解度、參與態度及未來參與之行為意向。以某醫學中心及某區域醫院目前正參加藥品臨床試驗之受試者為研究對象，以研究者與臨床試驗受試者之一對一問卷面訪之方式進行資料收集，共回收55份有效問卷，有效回收率為91.7%，以PLS （Partial Least Square）統計軟體進行模式建構與資料之驗證性分析。研究發現，研究對象對臨床試驗的知識測量整體平均分數為7.07（SD=1.44），在基本屬性中與參與態度部分，僅「您所獲得的臨床試驗相關說明或資料容易瞭解」之檢定結果呈顯著相關；與知情同意書的理解程度部分，共有性別、婚姻狀況、過去家人曾經有參加過臨床試驗的經驗、在參加臨床試驗前有聽過關於臨床試驗的說明、即使在臨床試驗受試者同意書上簽名後，也能依照我的意願，不管任何時間或原因，我隨時都可以退出試驗，並不會影響醫師對我的醫療照護等五項之檢定結果呈顯著相關。而知情同意書的理解程度顯著影響參與態度（0.612, p<0.000, R2=0.363）；知情同意書的理解程度(γ=0.331，p=0.069)與參與臨床試驗的態度（γ=0.125，p=0.350）影響行為意向（R2=0.145）未達顯著性。本研究透過目前參與臨床試驗的受試者，來了解受試者臨床試驗知識、知情同意理解度、參與之態度與行為意向之情形，以提供臨床試驗團隊了解在參與臨床試驗受試者其臨床試驗知識、知情同意理解度與參與態度之相關性，並建議強化在解釋受試者同意書過程中，需特別針對自主意願權利與責任義務、試驗藥物之副作用與風險，損害賠償部分之說明，在受試者聽解時能透過多元觀察與再次詢問受試者是否真的理解同意書，以提升受試者為臨床試驗整體的認知及對試驗執行中的遵從性、配合度，來提供更適當的臨床服務內容與保護受試者，避免受試者及家屬對臨床試驗產生過多期許或受到不當的利誘，進而提升受試者權益與未來參與臨床試驗之意願。
Purpose: Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. In studies conducting clinical trials, aside from professional and humanistic design and approval, human subject protection is the most important issue. However, the majority of past studies on clinical trials focus on ethical reviewed and approved by the Institutional Review Board; studies performed in Taiwan have rarely investigated voluntary participants' experiences when providing informed consent for clinical trials. As such, this study explore the experiences of patients who had participated in clinical trials to investigate their knowledge of the clinical trial, understanding of the informed consent, attitudes toward participation, and behavioral intentions to participate in clinical trials.Methods: A questionnaire survey was conducted to collect data from participants of active pharmaceutical clinical trials at a medical center and regional hospital in Taiwan. A total of 60 questionnaires were distributed, and 55 complete copies were returned, indicating a valid response rate of 91.7%. Collected data were analyzed by SPSS 20.0 and Smart PLS 2.0 M3. Results: The results show that the mean score for knowledge of the clinical trial was 7.15 (SD=1.48) with a mean correct answer rate of 71.5%. In terms of demographic data and attitudes toward participation, only the item "You feel that the explanation and information you received regarding the clinical trial were easily understandable" were significantly correlated. In terms of demographic variables and understanding of the informed consent, the test results for gender, marital status, past experience participating in clinical trials, explanation of the clinical trial before participation, and even after signing the informed consent, I can drop out of the trial at any time and for any reason with no ill effects on my medical care were significantly correlated. This study examined the path coefficients results indicated that attitudes toward participation and understanding of the informed consent were positively correlated (γ=0.612, p<0.000, R2=0.363) and understanding of the informed consent could explain 36.3% of the variance in attitudes toward participation. Both understanding of the informed consent and attitudes toward participation affected behavioral intentions to participation (R2=0.145). Conclusion: This study focused on the participants of active clinical trials to understand their knowledge and attitudes toward the clinical trial. The findings of this study enable the teams of clinical trials to better comprehend participants' knowledge of the clinical trial, understanding of the informed consent, and attitudes toward participation in order to present their participants with more suitable services and protection to avoid unfounded expectations from patients or their families and ensure patients' rights. |
