政大機構典藏-National Chengchi University Institutional Repository(NCCUR):Item 140.119/148523

政大機構典藏-National Chengchi University Institutional Repository(NCCUR):Item 140.119/148523

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题名:	應用顧客旅程之觀點探討臨床試驗的病患旅程 Customer Journey Approach to Patient Journey in Clinical Trials
作者:	林依瑩 Lin, Yi-Ying
贡献者:	吳豐祥 Wu, Feng-Shang 林依瑩 Lin, Yi-Ying
关键词:	新藥開發受託研究機構顧客旅程病患旅程臨床試驗臨床試驗創新服務設計服務管理服務創新 new drug development contract research organization CRO customer journey patient journey clinical trial clinical trial innovation service design service management service innovation
日期:	2023
上传时间:	2023-12-01 11:56:03 (UTC+8)
摘要:	新藥開發屬高投資、高風險、高報酬並受高度監管之商業行為，過程中各階段皆可能導致開發失敗，其中新藥上市前的三期臨床試驗牽涉範圍廣泛，管理不易，為時間與金錢成本最高之階段。臨床試驗的成敗，除了與對試驗藥物本身的試驗設計攸關外，其中的病患旅程設計更是臨床試驗能否成功啟動並順利進行的關鍵。近年來，很多疾病領域臨床試驗出現了受試者招募成功率下降、篩選失敗率升高、試驗退出率攀升等與試驗受試者相關之挑戰。為因應上述挑戰，相關臨床試驗創新漸受重視，但仍多以醫學知識之創新為主導，而未以臨床試驗受試者之病患旅程及體驗為核心。即便源於顧客旅程的病患旅程概念已發展及應用於醫療領域，但過往仍主要偏向於常規醫療照護，未被完整應用於高風險與高成本的新藥開發臨床試驗上。因此，本論文研究目的即在於彌補此一缺口。本研究整合顧客旅程、服務藍圖、臨床試驗等相關文獻，提出了有關臨床試驗病患旅程的研究架構。在方法上與資料收集上，主要採用質性研究法，並分別針對病患受試者、臨床試驗機構與受託研究機構等病患旅程相關人員，進行半結構式的深度訪談。最後，得到了以下的主要結論：結論一、臨床試驗的初期階段，醫師會是病患受試者取得臨床試驗資訊之主要來源，也會直接影響病患參與試驗之意願。惟此一現象會造成招募管道過於集中，且可能會導致受試者多樣性受限。此外，對具高試驗參與意願適應症類別之病患來源，招募廣告會帶來較好的成效；結論二、臨床試驗的過程中，臨床研究護理師會是病患受試者於試驗旅程進入試驗知情同意階段後的主要接觸點，也會是將臨床試驗計畫落實為標準作業流程的關鍵角色。因此，臨床研究護理師對於病患受試者如何評價臨床試驗病患旅程中的經驗，以及臨床試驗的執行品質等都具有決定性的影響；結論三、在臨床試驗的初期階段，病患受試者、臨床試驗機構與受託研究機構等三方的互信與了解，會正向增強病患受試者的病患旅程體驗；結論四、臨床試驗的治療流程若與常規照護流程愈相近，則愈能提升病患加入與留存臨床試驗的意願。然而，若是病患互助系統缺乏、返診過於頻繁及救濟治療設計不佳，則會阻礙病患受試者加入與續留臨床試驗；結論五、由國內發起之臨床試驗案，相較於國際試驗案來說，會更以病患受試者為中心，也會嘗試更多層面的臨床試驗（服務）創新。本研究最後根據上述研究結論，提出有關臨床試驗病患旅程的規劃、設計與執行之實務建議，同時，也揭示本研究之學術意涵與貢獻，以及後續研究建議。 The development of new drugs is a high-investment, high-risk, high-return, and highly regulated commercial endeavor. Each phase of the process carries the risk of failure, with pre-market clinical trials being particularly challenging to manage due to their broad scope, posing difficulties in terms of both time and financial costs. The success or failure of a clinical trial is not only related to the trial design concerning the investigational product but is also critically dependent on the design of the patient journey. In recent years, many clinical trials in various therapeutic areas have faced challenges related to subject recruitment success rates declining, increased screening failure rates, and rising trial withdrawal rates, highlighting the importance of the patient journey design for the successful initiation and smooth progression of clinical trials. To address the aforementioned challenges, there is a growing emphasis on innovation in related clinical trials, primarily driven by innovations in medical knowledge, with less focus on the patient journey and experience in clinical trial subjects. Despite the development and application of the patient journey concept in the medical field derived from the customer journey, it has predominantly been applied to regular and standard care and has not been fully integrated into high-risk and high-cost clinical trials for new drug development. Therefore, the purpose of this study is to fill this gap. This study integrates relevant literature on customer journey, service blueprint, and clinical trials to propose a research framework concerning the patient journey in clinical trials. In terms of methodology and data collection, a qualitative research approach is predominantly employed. Semi-structured in-depth interviews are conducted separately for stakeholders related to the patient journey, including patient subjects, sites, and contract research organizations. In conclusion, the following key findings were obtained: Conclusion 1: In the early stages of clinical trials, physicians play a pivotal role as the primary source of information for potential patient subjects, influencing their willingness to participate. However, overreliance on this channel may lead to limited diversity among patient subjects, emphasizing the effectiveness of recruitment advertisements targeting patient populations with high trial participation willingness; Conclusion 2: Clinical research nurses emerge as key points of contact for patient subjects during the informed consent stage, and their role is critical in translating clinical trial plans into standardized operating procedures. The clinical research nurse plays a crucial role in shaping the evaluation of the patient subject experience throughout the patient journey in clinical trial and influencing the overall execution quality of clinical trials.; Conclusion 3: In the initial stages of clinical trials, the mutual trust and understanding among patient subjects, sites, and contract research organizations positively enhance the patient subjects' experience throughout the patient journey in clinical trials; Conclusion 4: The closer the treatment process of a clinical trial aligns with regular and standard care procedures, the more likely it is to enhance patients' willingness to participate in and remain engaged with the clinical trial. However, the absence of patient support systems, excessively frequent follow-up visits, and poorly designed rescue therapy can hinder patients' participation and retention in clinical trials; Conclusion 5: The clinical trial initiated domestically, in comparison to international trial cases, places a greater emphasis on patient subjects and endeavors to explore multifaceted innovations in clinical trial services. Based on the research conclusions, practical recommendations for planning, designing, and executing the patient journey in clinical trial are presented, alongside the academic implications and contributions of this study, along with suggestions for future research.
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