English  |  正體中文  |  简体中文  |  Post-Print筆數 : 27 |  Items with full text/Total items : 111316/142225 (78%)
Visitors : 48389862      Online Users : 883
RC Version 6.0 © Powered By DSPACE, MIT. Enhanced by NTU Library IR team.
Scope Tips:
  • please add "double quotation mark" for query phrases to get precise results
  • please goto advance search for comprehansive author search
  • Adv. Search
    HomeLoginUploadHelpAboutAdminister Goto mobile version
    Please use this identifier to cite or link to this item: https://nccur.lib.nccu.edu.tw/handle/140.119/148523


    Title: 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
    Authors: 林依瑩
    Lin, Yi-Ying
    Contributors: 吳豐祥
    Wu, Feng-Shang
    林依瑩
    Lin, Yi-Ying
    Keywords: 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
    Date: 2023
    Issue Date: 2023-12-01 11:56:03 (UTC+8)
    Abstract: 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.
    Reference: AbbVie (2022). Clinical Trial Journey. https://www.abbvieclinicaltrials.com/resources/clinical-trial-journey/
    Ahmad, S., Qazi, S., & Raza, K. (2021). Translational bioinformatics methods for drug discovery and drug repurposing. In K. Raza, & N. Dey (Eds.), Translational Bioinformatics in Healthcare and Medicine (pp. 127–139). Elsevier. https://doi.org/10.1016/B978-0-323-89824-9.00010-0
    Ahmed, F., Burt, J., & Roland, M. (2014). Measuring patient experience: Concepts and methods. The Patient: Patient-Centered Outcomes Research, 7(3), 235–241. https://doi.org/10.1007/s40271-014-0060-5
    Agency for Healthcare Research and Quality. (2023). What is patient experience? https://www.ahrq.gov/cahps/about-cahps/patient-experience/index.html
    Alexander, G. L. (2007). The nurse-patient trajectory framework. Studies in Health Technology and Informatics, 129(Pt 2), 910–914. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3001102/
    Anderl, E., Becker, I., von Wangenheim, F., & Schumann, J. H. (2016). Mapping the customer journey: Lessons learned from graph-based online attribution modeling. International Journal of Research in Marketing, 33(3), 457–474. https://doi.org/10.1016/j.ijresmar.2016.03.001
    Anhang-Price, R., Elliott, M. N., Zaslavsky, A. M., Hays, R. D., Lehrman, W. G., Rybowski, L., Edgman-Levitan, S., & Cleary, P. D. (2014). Examining the role of patient experience surveys in measuring health care quality. Medical Care Research and Review, 71(5), 522–554. https://doi.org/10.1177/1077558714541480
    Aoki, K., Obeng, E., Borders, A. L., & Lester, D. H. (2019). Can brand experience increase customer contribution: How to create effective sustainable touchpoints with customers? Journal of Global Scholars of Marketing Science, 29(1), 51–62. https://doi.org/10.1080/21639159.2018.1551728
    Barrett, D., & Twycross, A. (2018). Data collection in qualitative research. Evidence-Based Nursing, 21(3), 63–64. https://doi.org/10.1136/eb-2018-102939
    Barwitz, N., & Maas, P. (2018). Understanding the omnichannel customer journey: Determinants of interaction choice. Journal of Interactive Marketing, 43(1), 116–133. https://doi.org/10.1016/j.intmar.2018.02.001
    Bate, P., & Robert, G. (2006). Experience-based design: From redesigning the system around the patient to co-designing services with the patient. Quality and Safety in Health Care, 15(5), 307–310. https://doi.org/10.1136/qshc.2005.016527
    BBK Worldwide. (2023). We empower patients with clinical research. https://www.bbkworldwide.com/about-us
    Berdigaliyev, N., & Aljofan, M. (2020). An overview of drug discovery and development. Future Medicinal Chemistry, 12(10), 939–947. https://doi.org/10.4155/fmc-2019-0307
    Berry, L. L., Carbone, L. P., & Haeckel, S. H. (2002, April 15). Managing the total customer experience. MIT Sloan Management Review. https://sloanreview.mit.edu/article/managing-the-total-customer-experience/
    Berry, L. L., Wall, E. A., & Carbone, L. P. (2006). Service clues and customer assessment of the service experience: Lessons from marketing. Academy of Management Perspectives, 20(2), 43-57. https://journals.aom.org/doi/10.5465/amp.2006.20591004
    Betcheva, L., Erhun, F., & Oraiopoulos, N. (2022, April 28). Pharmaceutical-CRO relationships: Are strategic partnerships the way forward? SSRN Electronic Journal. https://doi.org/10.2139/ssrn.4095877
    Bhide, M., Negi, S., Subramaniam, L. V., & Gupta, H. (2009). Customer-focused service management for contact centers. IBM Journal of Research and Development, 53(6), 9: 1-9: 12. https://doi.org/10.1147/JRD.2009.5429037
    Bijmolt, T., Broekhuis, M., de Leeuw, S., Hirche, C., Rooderkerk, R., Sousa, R., & Zhu, S. (2019). Challenges at the marketing–Operations interface in omni-channel retail environments. Journal of Business Research, 122, 864-874. https://doi.org/10.1016/j.jbusres.2019.11.034
    Bitner, M. J., Ostrom, A. L., & Morgan, F. N. (2008). Service blueprinting: A practical technique for service innovation. California Management Review, 50(3), 66–94. https://doi.org/10.2307/41166446
    Blümle, A., Wollmann, K., Bischoff, K., Kapp, P., Lohner, S., Nury, E., Nitschke, K., Zähringer, J., Rücker, G., & Schumacher, M. (2021). Investigator initiated trials versus industry sponsored trials Translation of randomized controlled trials into clinical practice (IMPACT). BMC Medical Research Methodology, 21(1), 182. https://doi.org/10.1186/s12874-021-01359-x
    Brynjolfsson, E., Hu, Y. J., & Rahman, M. S. (2013, May 21). Competing in the age of omnichannel retailing. MIT Sloan Management Review. https://sloanreview.mit.edu/article/competing-in-the-age-of-omnichannel-retailing/
    Buttle, F. (2009). Customer relationship management: Concepts and tools (2nd edition). Butterworth-Heinemann, Elsevier.
    de Salles Canfield, D., & Basso, K. (2017). Integrating satisfaction and cultural background in the customer journey: A method development and test. Journal of International Consumer Marketing, 29(2), 104–117. https://doi.org/10.1080/08961530.2016.1261647
    Carayon, P., Wooldridge, A., Hoonakker, P., Hundt, A. S., & Kelly, M. M. (2020). SEIPS 3.0: Human-centered design of the patient journey for patient safety. Applied Ergonomics, 84, 103033. https://doi.org/10.1016/j.apergo.2019.103033
    Carayon, P., & Wooldridge, A. R. (2020). Improving patient safety in the patient journey: Contributions from human factors engineering. In A. E. Smith (Ed.), Women in industrial and systems engineering: Key advances and perspectives on emerging topics (pp. 275–299). Springer. https://doi.org/10.1007/978-3-030-11866-2_12
    Christopher, M., Payne, A., & Ballantyne, D. (1991). Relationship marketing: Bringing quality, customer service and marketing together. Butterworth Heinemann.
    Clarivate. (2020). Trends in clinical trial planning. https://clarivate.com/zh-hant/blog/patient-enrollment-continues-to-be-a-limiting-factor-for-trial-durations/
    Clatworthy, S. D. (2011). Service innovation through touch-points: Development of an innovation toolkit for the first stages of new service development. International Journal of Design, 5(2), 15–28. http://www.ijdesign.org/index.php/IJDesign/article/view/939/343
    Comis, R. L., Miller, J. D., Colaizzi, D. D., & Kimmel, L. G. (2009). physician-related factors involved in patient decisions to enroll onto cancer clinical trials. Journal of Oncology Practice, 5(2), 50–56. https://doi.org/10.1200/JOP.0922001
    Court, D., Elzinga, D., Mulder, S., & Vetvik, O. J. (2009, June 1). The consumer decision journey. McKinsey Quarterly. https://www.mckinsey.com/capabilities/growth-marketing-and-sales/our-insights/the-consumer-decision-journey#/
    Crosier, A., & Handford, A. (2012). Customer journey mapping as an advocacy tool for disabled people: A case study. Social Marketing Quarterly, 18(1), 67–76. https://doi.org/10.1177/1524500411435483
    Curry, J. M., McGregor, C., & Tracy, S. (2007). A systems development life cycle approach to patient journey modeling projects. Studies in Health Technology and Informatics, 129(Pt 2), 905-909. https://pubmed.ncbi.nlm.nih.gov/17911847/
    Davies, E. L., Bulto, L. N., Walsh, A., Pollock, D., Langton, V. M., Laing, R. E., Graham, A., Arnold‐Chamney, M., & Kelly, J. (2023). Reporting and conducting patient journey mapping research in healthcare: A scoping review. Journal of Advanced Nursing, 79(1), 83–100. https://doi.org/10.1111/jan.15479
    Davis, A. M., Hull, S. C., Grady, C., Wilfond, B. S., & Henderson, G. E. (2002). The invisible hand in clinical research: The study coordinator’s critical role in human subjects protection. Journal of Law, Medicine and Ethics, 30(3), 411–419. https://doi.org/10.1111/j.1748-720x.2002.tb00410.x
    DeAngelis, C. D. (2017). Volunteering for clinical research studies and public health. The Milbank Quarterly, 95(1), 40–42. https://doi.org/10.1111/1468-0009.12244
    Devi, R., Kanitkar, K., Narendhar, R., Sehmi, K., & Subramaniam, K. (2020). A narrative review of the patient journey through the lens of non-communicable diseases in low- and middle-income countries. Advances in Therapy, 37(12), 4808–4830. https://doi.org/10.1007/s12325-020-01519-3
    Dewar, B., Mackay, R., Smith, S., Pullin, S., & Tocher, R. (2010). Use of emotional touchpoints as a method of tapping into the experience of receiving compassionate care in a hospital setting. Journal of Research in Nursing, 15(1), 29–41. https://doi.org/10.1177/1744987109352932
    Dixon, C. A., Punguyire, D., Mahabee-Gittens, M., Ho, M., & Lindsell, C. J. (2015). Patient flow analysis in resource-limited settings: A practical tutorial and case study. Global Health: Science and Practice, 3(1), 126–134. https://doi.org/10.9745/ghsp-d-14-00121
    Edelman, D. C., & Singer, M. (2015, November). Competing on customer journeys. Harvard Business Review. https://hbr.org/2015/11/competing-on-customer-journeys
    Edwards, R. T., Hounsome, B., Linck, P., & Russell, I. T. (2008). Economic evaluation alongside pragmatic randomised trials: Developing a standard operating procedure for clinical trials units. Trials, 9, 64. https://doi.org/10.1186/1745-6215-9-64
    Emfluence Marketing Platform. (2021, May 3). How to build a customer journey map with Microsoft dynamics. CRM Software Blog | Dynamics 365. https://www.crmsoftwareblog.com/2021/05/how-to-build-a-customer-journey-map-with-microsoft-dynamics/
    European Patients’ Academy on Therapeutic Innovation. (2023). About. https://eupati.eu/about-us/
    European Medicines Agency. (2023). Clinical trial. Retrieved September 15, 2023, from https://www.ema.europa.eu/en/about-us/about-website/glossary/name_az/C
    Følstad, A., & Kvale, K. (2018). Customer journeys: A systematic literature review. Journal of Service Theory and Practice, 28(2), 196–227. https://doi.org/10.1108/JSTP-11-2014-0261
    Fortini-Cambell, L. (2002). Integrated marketing and the consumer experience. In D. Iacobucci, & B. J. Calder (Eds.), Kellogg on integrated marketing (pp. 54–89). Wiley. https://www.wiley.com/en-us/Kellogg+on+Integrated+Marketing-p-9780471204763
    Gayet-Ageron, A., Rudaz, S., & Perneger, T. (2020). Study design factors influencing patients’ willingness to participate in clinical research: A randomised vignette-based study. BMC Medical Research Methodology, 20(1), 93. https://doi.org/10.1186/s12874-020-00979-z
    Getz, K. (2019, December 1). Can recruitment and retention get any worse? Applied Clinical Trials, 28(12), 12–13. https://www.appliedclinicaltrialsonline.com/view/can-recruitment-and-retention-get-any-worse
    Ghobadian, A., Speller, S., & Jones, M. (1994). Service quality: Concepts and models. International Journal of Quality and Reliability Management, 11(9), 43–66. https://doi.org/10.1108/02656719410074297
    Gibbons, S. (2017, August 27). Service Blueprints: Definition. Nielsen Norman Group. https://www.nngroup.com/articles/service-blueprints-definition/
    Good, M., & Schuler, L. (1997). Subject retention in a controlled clinical trial. Journal of Advanced Nursing, 26(2), 351–355. https://doi.org/10.1046/j.1365-2648.1997.1997026351.x
    Gooden, M. J., Norato, G., Martin, S. B., Nath, A., & Reoma, L. (2021). Reducing events of noncompliance in neurology human subjects research: The effect of human subjects research protection training and site initiation visits. Neurotherapeutics, 18(2), 859–865. https://doi.org/10.1007/s13311-020-01003-4
    Goodson, N., Wicks, P., Morgan, J., Hashem, L., Callinan, S., & Reites, J. (2022). Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion. Npj Digital Medicine, 5, 58. https://doi.org/10.1038/s41746-022-00603-y
    Great Wstern Hospitals & Royal Berkshire NHS Foundation Trust. (2023). Entering a clinical trial – A patient’s journey. National Health Service. Retrieved September 15, 2023, from https://www.gwh.nhs.uk/media/uydht2js/enteringaclinicaltrial-apatientsjourneyposter.pdf
    Grodin, M. A., & Annas, G. J. (1992). The Nazi doctors and the Nuremberg code: Human rights in human experimentation. New York, NY: Oxford University Press.
    Gummesson, E., & Kingman-Brundage, J. (1992). Service design and quality: Applying service blueprinting and service mapping to railroad services. In P. Kunst, & J. Lemmink (Eds.), Quality Management in Services (pp. 101–114). Van Gorcum.
    Gyimóthy, S. (2000a). Odysseys: Analysing service journeys from the customer’s perspective. Managing Service Quality: An International Journal, 10(6), 389–396. https://doi.org/10.1108/09604520010351202
    Gyimóthy, S. (2000b). Visitors’ perceptions of holiday experiences and service providers: An exploratory study. Journal of Travel & Tourism Marketing, 8(2), 57–74. https://doi.org/10.1300/J073v08n02_05
    Halvorsrud, R., Kvale, K., & Følstad, A. (2016). Improving service quality through customer journey analysis. Journal of Service Theory and Practice, 26(6), 840–867. https://doi.org/10.1108/JSTP-05-2015-0111
    He, Q., Du, F., & Simonse, L. W. L. (2021). A patient journey map to improve the home isolation experience of persons with mild COVID-19: Design research for service touchpoints of artificial intelligence in eHealth. JMIR Medical Informatics, 9(4), e23238. https://doi.org/10.2196/23238
    Hoffenberg, R. (1986). Research on healthy volunteers. Journal of the Royal College of Physicians of London, 20(4), 243–257. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5371045/
    Holden, R. J., Valdez, R. S., Schubert, C. C., Thompson, M. J., & Hundt, A. S. (2017). Macroergonomic factors in the patient work system: Examining the context of patients with chronic illness. Ergonomics, 60(1), 26–43. https://doi.org/10.1080/00140139.2016.1168529
    Holubkov, R., Michael Dean, J., Berger, J., Anand, K. J. S., Carcillo, J., Meert, K., Zimmerman, J., Newth, C., Harrison, R., Willson, D. F., & Nicholson, C. (2009). Is “rescue” therapy ethical in randomized controlled trials? Pediatric Critical Care Medicine, 10(4), 431–438. https://doi.org/10.1097/PCC.0b013e318198bd13
    Hu, A. (2017). Reflections: The value of patient support groups. Otolaryngology–Head and Neck Surgery, 156(4), 587–588. https://doi.org/10.1177/0194599817697030
    Ieva, M., & Ziliani, C. (2018). The role of customer experience touchpoints in driving loyalty intentions in services. The TQM Journal, 30(5), 444–457. https://doi.org/10.1108/TQM-11-2017-0141
    International Council for Harmonisation. (2023). Welcome to the ICH Official Website. https://www.ich.org/
    IQVIA. (2023a). Clinical trials assistant (CTA) at IQVIA. Retrieved September 15, 2023, from https://jobs.iqvia.com/job/taipei/clinical-trials-assistant-cta/24443/33088152352
    IQVIA. (2023b). Site Activation Specialist (SSU). Retrieved September 15, 2023, from https://www.linkedin.com/jobs/view/site-activation-specialist-ssu-at-iqvia-3619732764/?utm_campaign=google_jobs_apply&utm_source=google_jobs_apply&utm_medium=organic&originalSubdomain=tw
    Isaacman, D. J., & Reynolds, E. A. (1996). Effect of a research nurse on patient enrollment in a clinical study. Pediatric Emergency Care, 12(5), 340–342. https://doi.org/10.1097/00006565-199610000-00004
    Janiaud, P., Serghiou, S., & Ioannidis, J. P. A. (2019). New clinical trial designs in the era of precision medicine: An overview of definitions, strengths, weaknesses, and current use in oncology. Cancer Treatment Reviews, 73, 20–30. https://doi.org/10.1016/j.ctrv.2018.12.003
    Johns, N. (1999). What is this thing called service? European Journal of Marketing, 33(9/10), 958-974. https://doi.org/10.1108/03090569910285959
    Johns, N., & Clark, S. L. (1993). Customer perception auditing: A means of monitoring the service provided by museums and galleries. Museum Management and Curatorship, 12(4), 360–366. https://doi.org/10.1016/0964-7775(93)90033-F
    Jones, C. T., & Wilson, L. L. (2013). Role perceptions of nurse clinical research coordinators. Nursing: Research and Reviews, 3, 133–139. https://doi.org/10.2147/NRR.S47579
    Kairalla, J. A., Coffey, C. S., Thomann, M. A., & Muller, K. E. (2012). Adaptive trial designs: A review of barriers and opportunities. Trials, 13, 145. https://doi.org/10.1186/1745-6215-13-145
    Kankainen, A., Vaajakallio, K., Kantola, V., & Mattelmäki, T. (2012). Storytelling group– A co-design method for service design. Behaviour & Information Technology, 31(3), 221–230. https://doi.org/10.1080/0144929X.2011.563794
    Kimbell, L. (2011). Designing for service as one way of designing services. International Journal of Design, 5(2), 41–52. http://www.ijdesign.org/index.php/IJDesign/article/view/938/345
    Klitzman, R. (2011). How local IRBs view central IRBs in the US. BMC Medical Ethics, 12(1), 13. https://doi.org/10.1186/1472-6939-12-13
    Krishna, A., Agrawal, A., & Choudhary, A. (2016, December 12-15). Predicting the outcome of startups: Less failure, more success. In C. Domeniconi, F. Gullo, F. Bonchi, J. Domingo-Ferrer, R. Baeza-Yates, Z.-H. Zhou, & X.-D. Wu (Eds.), 2016 IEEE 16th International Conference on Data Mining Workshops (pp. 798–805) IEEE Computer Society. https://doi.org/10.1109/ICDMW.2016.0118
    Kumar, G., Chaudhary, P., Quinn, A., & Su, D. (2022). Barriers for cancer clinical trial enrollment: A qualitative study of the perspectives of healthcare providers. Contemporary Clinical Trials Communications, 28, 100939. https://doi.org/10.1016/j.conctc.2022.100939
    Kusinitz, S. (2022, May 6). The definition of a buyer persona [in under 100 words]. Hubspot. Retrieved September 15, 2023, from https://blog.hubspot.com/marketing/buyer-persona-definition-under-100-sr
    Labcorp. (2023). Patient safety specialist. 104人力銀行。Retrieved September 15, 2023, from https://www.104.com.tw/job/7znk6
    LaVela, S. L., & Gallan, A. (2014). Evaluation and measurement of patient experience. Patient Experience Journal, 1(1), 28–36. https://doi.org/10.35680/2372-0247.1003
    Leavy, P. (2020). The Oxford handbook of qualitative research. Oxford University Press.
    Lee, G. (2010). Death of ‘last click wins’: Media attribution and the expanding use of media data. Journal of Direct, Data and Digital Marketing Practice, 12(1), 16–26. https://doi.org/10.1057/dddmp.2010.14
    Lemon, K. N., & Verhoef, P. C. (2016). Understanding customer experience throughout the customer journey. Journal of Marketing, 80(6), 69–96. https://doi.org/10.1509/jm.15.0420
    Liénard, J. -L., Quinaux, E., Fabre-Guillevin, E., Piedbois, P., Jouhaud, A., Decoster, G., Buyse, M., & European Association for Research in Oncology (2006). Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer. Clinical Trials, 3(5), 486–492. https://doi.org/10.1177/1740774506070807
    Windelov, P., & Klim, L. (2020, September 28)。病人參與及互動:藥物研發領域中的病人心聲。Lionbridge. Retrieved September 15, 2023, from https://www.lionbridge.com/zh-hant/blog/life-sciences/patient-voices-in-medicine-research-and-development/
    Liu, M. B., & Davis, K. (2001). A clinical trials manual from the Duke Clinical Research Institute- Lessons from a horse named Jim. Duke Clinical Research Institute.
    Lorenzo, S. (2021, April 19). A day in the life of a patient in a clinical trial. Montreal Neurological Institute-Hospital. Retrieved September 16, 2023, from https://cru.mcgill.ca/a-day-in-the-life-of-a-patient-in-a-clinical-trial/
    MacArthur, J., Hill, G., & Callister, D. (2014). Professional issues associated with the clinical research nurse role. Nursing Standard, 29(14), 37–43. https://doi.org/10.7748/ns.29.14.37.e9216
    Marja Rasila, H., Rothe, P., & Nenonen, S. (2009). Workplace experience A journey through a business park. Facilities, 27(13/14), 486–496. https://doi.org/10.1108/02632770910996333
    McCarthy, S., O’Raghallaigh, P., Woodworth, S., Lim, Y. L., Kenny, L. C., & Adam, F. (2016). An integrated patient journey mapping tool for embedding quality in healthcare service reform. Journal of Decision Systems, 25(S1), 354–368. https://doi.org/10.1080/12460125.2016.1187394
    McCarthy, S., O’Raghallaigh, P., Woodworth, S., Lim, Y. Y., Kenny, L. C., & Adam, F. (2020). Embedding the pillars of quality in health information technology solutions using “Integrated Patient Journey Mapping”(IPJM): Case study. JMIR Human Factors, 7(3), e17416. https://doi.org/10.2196/17416
    McKinney, J., & Vermeulen, W. (2000). Research nurses play a vital role in clinical trials. Oncology Nursing Forum, 27(1), 28. https://pubmed.ncbi.nlm.nih.gov/10660917/
    Meroni, A., & Sangiorgi, D. (2011). Design for services. Routledge.
    Muret, P. (2013, April 25). Introducing “The Customer Journey to Online Purchase" Interactive insights on multi-channel marketing. Google analytics solutions. Retrieved September 16, 2023, from https://analytics.googleblog.com/2013/04/introducing-customer-journey-to-online.html
    National Academies of Sciences, Engineering, and Medicine (2018). Crossing the global quality chasm: Improving health care worldwide. The National Academies Press. https://doi.org/10.17226/25152
    National Research Council, Division of Behavioral and Social Sciences and Education, Committee on National Statistics, & Panel on Handling Missing Data in Clinical Trials (2010). The prevention and treatment of missing data in clinical trials. The National Academies Press. https://doi.org/10.17226/12955
    National Institutes of Health. (2023a, May 18). Patient recruitment: Healthy volunteers. Retrieved September 16, 2023, from https://clinicalcenter.nih.gov/recruit/volunteers.html
    National Institutes of Health. (2017, August 8). NIH’s definition of a clinical trial. Retrieved September 16, 2023, from https://grants.nih.gov/policy/clinical-trials/definition.htm
    National Institutes of Health Clinical Center, Nursing and Patient Care Services. (2009, September 4). Building the foundation for clinical research nursing: Domain of practice for the specialty of clinical research nursing. Retrieved September 16, 2023, from https://www.cc.nih.gov/sites/nihinternet/files/internet-files/nursing/crn/DOP_document.pdf
    Ness, E. (2020). The oncology clinical research nurse study co-ordinator: Past, present, and future. Asia-Pacific Journal of Oncology Nursing, 7(3), 237–242. https://doi.org/10.4103/apjon.apjon_10_20
    National Health Service. (2018, August 14). Friends and family test (FFT). Retrieved September 16, 2023, from https://www.nhs.uk/using-the-nhs/about-the-nhs/friends-and-family-test-fft/
    Ni, Y., Kennebeck, S., Dexheimer, J. W., McAneney, C. M., Tang, H., Lingren, T., Li, Q., Zhai, H., & Solti, I. (2015). Automated clinical trial eligibility prescreening: Increasing the efficiency of patient identification for clinical trials in the emergency department. Journal of the American Medical Informatics Association, 22(1), 166–178. https://doi.org/10.1136/amiajnl-2014-002887
    Nichita, M. E., Vulpoi, M., & Toader, G. (2013). Knowledge management and customer relationship management for accounting services companies. Chinese Business Review, 12(6), 435–442. https://doi.org/10.17265/1537-1506/2013.06.007
    Novartis Pharma AG. (2022). Investigator initiated trials: A guide for prospective investigators. Retrieved September 16, 2023, from https://www.novartis.com/sites/novartis_com/files/novartis-investigator-initiated-trials-guide-prospective-investigators.pdf
    Olson, E. D., Arendt, S. W., FitzPatrick, E., Hauser, S., Rainville, A. J., Rice, B., & Lewis, K. L. (2020). Marketing mechanisms used for summer food service programs. Journal of Nonprofit & Public Sector Marketing, 32(5), 465–487. https://doi.org/10.1080/10495142.2019.1589632
    Organisation for Economic Cooperation and Development. (2023). Pharmaceutical research and development. In OECD-iLibrary. Retrieved September 16, 2023, from https://www.oecd-ilibrary.org/sites/6e38c622-en/index.html?itemId=/content/component/6e38c622-en
    Ostrom, A. L., Parasuraman, A., Bowen, D. E., Patrício, L., & Voss, C. A. (2015). Service research priorities in a rapidly changing context. Journal of Service Research, 18(2), 127–159. https://doi.org/10.1177/1094670515576315
    Parasrampuria, D. A., Benet, L. Z., & Sharma, A. (2018). Why drugs fail in late stages of development: Case study analyses from the last decade and recommendations. The AAPS Journal, 20(3), 46. https://doi.org/10.1208/s12248-018-0204-y
    Parexel. (2023a). Clinical Trial Manager/Senior Clinical Trial Manager (FSP). Jobgether. Retrieved September 16, 2023, from https://jobgether.com/offer/64677f2652a9a28fbcdc1023-clinical-trial-managersenior-clinical-trial-manager-fsp?utm_campaign=google_jobs_apply&utm_source=google_jobs_apply&utm_medium=organic
    Parexel. (2023b). Patient engagement strategy and enrollment solutions. Retrieved September 16, 2023, from https://www.parexel.com/solutions/early-development-and-innovation/patient-engagement-strategy
    Parker, S., & Heapy, J. (2006). The journey to the interface: How public service design can connect users to reform. Demos. Retrieved September 16, 2023, from https://socialinnovation.typepad.com/files/journey-to-the-interface.pdf
    Partridge, A. H., & Winer, E. P. (2002). Informing clinical trial participants about study results. Journal of the American Medical Association, 288(3), 363–365. https://doi.org/10.1001/jama.288.3.363
    Pasqualetti, G., Gori, G., Blandizzi, C., & del Tacca, M. (2010). Healthy volunteers and early phases of clinical experimentation. European Journal of Clinical Pharmacology, 66, 647–653. https://doi.org/10.1007/s00228-010-0827-0
    Patrício, L., Fisk, R. P., Falcão e Cunha, J., & Constantine, L. (2011). Multilevel service design: From customer value constellation to service experience blueprinting. Journal of Service Research, 14(2), 180–200. https://doi.org/10.1177/1094670511401901
    Pflugeisen, B. M., Rebar, S., Reedy, A., Pierce, R., & Amoroso, P. J. (2016). Assessment of clinical trial participant patient satisfaction: A call to action. Trials, 17, 483. https://doi.org/10.1186/s13063-016-1616-6
    PhRMA. (2015). Biopharmaceutical research & development: The process behind new medicines. Retrieved September 16, 2023, from https://invivobiosystems.com/wp-content/uploads/2022/09/rd_brochure_022307.pdf
    Piachaud, B. S. (2002). Outsourcing in the pharmaceutical manufacturing process: An examination of the CRO experience. Technovation, 22(2), 81–90. https://doi.org/10.1016/S0166-4972(01)00081-5
    Ponsignon, F., Smart, A., & Phillips, L. (2018). A customer journey perspective on service delivery system design: Insights from healthcare. International Journal of Quality & Reliability Management, 35(10), 2328–2347. https://doi.org/10.1108/IJQRM-03-2018-0073
    Rapport, F., Storey, M., Porter, A., Snooks, H., Jones, K., Peconi, J., Sánchez, A., Siebert, S., Thorne, K., Clement, C., & Russell, I. (2013). Qualitative research within trials: Developing a standard operating procedure for a clinical trials unit. Trials, 14, 54. https://doi.org/10.1186/1745-6215-14-54
    Rawson, A., Duncan, E., & Jones, C. (2013, September). The truth about customer experience. Harvard Business Review. https://hbr.org/2013/09/the-truth-about-customer-experience
    Research Institute of the McGill University Health Centre. (2023). What is a clinical trial? September 16, 2023, from https://rimuhc.ca/why-are-there-clinical-trials
    Richardson, A. (2010, November 15). Using customer journey maps to improve customer experience. Harvard Business Review, 15(1), 2–5. https://hbr.org/2010/11/using-customer-journey-maps-to
    Santa-Ana-Tellez, Y., Lagerwaard, B., de Jong, A. J., Gardarsdottir, H., Grobbee, D. E., Hawkins, K., Heath, M., & Zuidgeest, M. G. P. (2023). Decentralised, patient-centric, site-less, virtual, and digital clinical trials? From confusion to consensus. Drug Discovery Today, 28(4), 103520. https://doi.org/10.1016/j.drudis.2023.103520
    Segelström, F. (2013). Stakeholder engagement for service design [Unpublished doctoral dissertation]. Linköping University. https://www.dissertations.se/dissertation/9f1565b2a5/
    Sertkaya, A., Wong, H. H., Jessup, A., & Beleche, T. (2016). Key cost drivers of pharmaceutical clinical trials in the United States. Clinical Trials, 13(2), 117–126. https://doi.org/10.1177/1740774515625964
    Shostack, G. L. (1982). How to design a service. European Journal of Marketing, 16(1), 49–63. https://doi.org/10.1108/EUM0000000004799
    Shostack, G. L. (1984, January). Designing services that deliver. Harvard Business Review. https://hbr.org/1984/01/designing-services-that-deliver
    Sijm-Eeken, M., Zheng, J., & Peute, L. (2020). Towards a lean process for patient journey mapping A case study in a large academic setting. In L. B. Pape-Haugaard, C. Lovis, I. C. Madsen, P. Weber, P. H. Nielsen, & P. Scott (Eds.), Digital Personalized Health and Medicine (pp. 1071–1075). https://doi.org/10.3233/SHTI200326
    Sommer, C., Zuccolin, D., Arnera, V., Schmitz, N., Adolfsson, P., Colombo, N., Gilg, R., & McDowell, B. (2018). Building clinical trials around patients: Evaluation and comparison of decentralized and conventional site models in patients with low back pain. Contemporary Clinical Trials Communications, 11, 120–126. https://doi.org/10.1016/j.conctc.2018.06.008
    Ssali, A., Poland, F., & Seeley, J. (2015). Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda. BMC Medical Ethics, 16, 86. https://doi.org/10.1186/s12910-015-0073-1
    Stickdorn, M., & Zehrer, A. (2009, November 24-26). Service design in tourism: Customer experience driven destination management [Paper presentation]. First Nordic Conference on Service Design and Service Innovation, Oslo, Norway. Retrieved September 16, 2023, from https://www.researchgate.net/profile/Anita-Zehrer/publication/242540416_Customer_Experience_Driven_Destination_Management/links/0f317531b2cbf10daf000000/Customer-Experience-Driven-Destination-Management.pdf
    Sultan, A. J. (2018). Orchestrating service brand touchpoints and the effects on relational outcomes. Journal of Services Marketing, 32(6), 777–788. https://doi.org/10.1108/JSM-12-2016-0413
    Sun, D., Gao, W., Hu, H., & Zhou, S. (2022). Why 90% of clinical drug development fails and how to improve it? Acta Pharmaceutica Sinica B, 12(7), 3049–3062. https://doi.org/10.1016/j.apsb.2022.02.002
    Tattersall, M. H. N., Dear, R. F., Jansen, J., Shepherd, H. L., Devine, R. J., Horvath, L. G., & Boyer, M. L. (2009). Second opinions in oncology: The experiences of patients attending the Sydney Cancer Centre. The Medical Journal of Australia, 191(4), 209–212. https://doi.org/10.5694/j.1326-5377.2009.tb02754.x
    Tenny, S., Brannan, J. M., & Brannan, G. D. (2022). Qualitative study. StatPearls Publishing. http://europepmc.org/books/NBK470395
    The Beryl Institute. (2023). Defining patient and human experience. Retrieved September 16, 2023, from https://theberylinstitute.org/defining-patient-experience/
    The Economist Intelligence Unit. (2018a). The innovation imperative: The future of drug development Part I: Research methods and findings. The Economist. Retrieved September 16, 2023, from https://druginnovation.eiu.com/wp-content/uploads/2019/05/Parexel-innovations-in-drug-development-part-1_V14.pdf
    The Economist Intelligence Unit. (2018b). The innovation imperative: The future of drug development- Part II: Barriers, enablers and calls to action. The Economist. Retrieved September 16, 2023, from https://druginnovation.eiu.com/wp-content/uploads/2019/05/Parexel-Quantitative-report-part-2_Final-1.pdf
    Johns Hopkins University, Johns Hopkins Hospital, & Johns Hopkins Health System Corporation. (2023). Clinical research: Team members and their roles. Johns Hopkins Medicine. Retrieved September 16, 2023, from https://www.hopkinsmedicine.org/research/understanding-clinical-trials/clinical-research-team.html
    Trebble, T. M., Hansi, N., Hydes, T., Smith, M. A., & Baker, M. (2010). Process mapping the patient journey: An introduction. British Medical Journal, 341, c4078. https://doi.org/10.1136/bmj.c4078
    Trischler, J., & Zehrer, A. (2012). Service design: Suggesting a qualitative multistep approach for analyzing and examining theme park experiences. Journal of Vacation Marketing, 18(1), 57–71. https://doi.org/10.1177/1356766711430944
    Tueanrat, Y., Papagiannidis, S., & Alamanos, E. (2021). Going on a journey: A review of the customer journey literature. Journal of Business Research, 125, 336–353. https://doi.org/10.1016/j.jbusres.2020.12.028
    Unger, J. M., Cook, E., Tai, E., & Bleyer, A. (2016, June 3-7). The role of clinical trial participation in cancer research: Barriers, evidence, and strategies. In D. S. Dizon, N. Pennell, & L. Pickell (Eds.), 2016 American Society of Clinical Oncology Educational Book (pp. 185–198). American Society of Clinical Oncology. https://doi.org/10.1200/EDBK_156686
    University of Mississippi Medical Center. (2023). Research study road map. Retrieved September 16, 2023, from https://www.umc.edu/Research/Research-Offices/Clinical-Trials/Researchers/Road-Map/Home.html
    U.S. Food and Drug Administration. (2023). Glossary of terms on clinical trials for patient engagement advisory committee meeting. Retrieved September 16, 2023, from https://www.fda.gov/media/108378/download
    U.S. Food and Drug Administration. (2018, January 4). Clinical trials: What patients need to know. Retrieved September 16, 2023, from https://www.fda.gov/patients/clinical-trials-what-patients-need-know
    Vakharia, K. T., Ali, M. J., & Wang, S. J. (2007). Quality-of-life impact of participation in a head and neck cancer support group. Otolaryngology–Head and Neck Surgery, 136(3), 405–410. https://doi.org/10.1016/j.otohns.2006.10.018
    Van Norman, G. A. (2021). Decentralized clinical trials. JACC: Basic to Translational Science, 6(4), 384–387. https://doi.org/10.1016/j.jacbts.2021.01.011
    Verheggen, F., Nieman, F., Reerink, E., & Kok, G. (1998). Patient satisfaction with clinical trial participation. International Journal for Quality in Health Care, 10(4), 319–330. https://doi.org/10.1093/intqhc/10.4.319
    Verweij, J., Hendriks, H. R., & Zwierzina, H. (2019). Innovation in oncology clinical trial design. Cancer Treatment Reviews, 74, 15–20. https://doi.org/10.1016/j.ctrv.2019.01.001
    Vincent, C., & Amalberti, R. (2016). Safer healthcare: Strategies for the real world. Springer. https://doi.org/10.1007/978-3-319-25559-0
    Wang, G. (2023, June 1). China contract research organizations (CROs) in global landscape. Baipharma. Retrieved September 16, 2023, from http://baipharm.chemlinked.com/news/china-contract-research-organization-cro-2022-review-and-outlook
    Whittle, S., & Foster, M. (1989). Customer profiling: Getting into your customer’s shoes. Management Decision, 27(6), 27–30. https://doi.org/10.1108/00251748910132575
    Wisk, L. E., Nelson, E. B., Magane, K. M., & Weitzman, E. R. (2019). Clinical trial recruitment and retention of college students with type 1 diabetes via social media: An implementation case study. Journal of Diabetes Science and Technology, 13(3), 445–456. https://doi.org/10.1177/1932296819839503
    Wolf, J. A., Niederhauser, V., Marshburn, D., & LaVela, S. L. (2014). Defining patient experience. Patient Experience Journal, 1(1), 7–19. https://doi.org/10.35680/2372-0247.1004
    Wolf, J. A., Niederhauser, V., Marshburn, D., & LaVela, S. L. (2021). Reexamining “Defining Patient Experience”: The human experience in healthcare. Patient Experience Journal, 8(1), 16–29. https://doi.org/10.35680/2372-0247.1594
    Wolny, J., & Charoensuksai, N. (2014). Mapping customer journeys in multichannel decision-making. Journal of Direct, Data and Digital Marketing Practice, 15, 317–326. https://doi.org/10.1057/dddmp.2014.24
    Wong, C. H., Siah, K. W., & Lo, A. W. (2019). Estimation of clinical trial success rates and related parameters. Biostatistics, 20(2), 273–286. https://doi.org/10.1093/biostatistics/kxx069
    World Health Organization. (2023). Clinical trials. Retrieved September 16, 2023, from https://www.who.int/health-topics/clinical-trials
    Wouters, O. J., McKee, M., & Luyten, J. (2020). Estimated research and development investment needed to bring a new medicine to market, 2009-2018. Journal of the American Medical Association, 323(9), 844–853. https://doi.org/10.1001/jama.2020.1166
    Xtensio. (2023). Software developer persona. Retrieved September 16, 2023, from https://library.xtensio.com/software-developer-persona-example
    Zakkar, M. (2019). Patient experience: Determinants and manifestations. International Journal of Health Governance, 24(2), 143–154. https://doi.org/10.1108/IJHG-09-2018-0046
    Zomerdijk, L. G., & Voss, C. A. (2011). NSD processes and practices in experiential services. Journal of product innovation management, 28(1), 63–80. https://doi.org/10.1111/j.1540-5885.2010.00781.x
    Zurdo, J. (2013). Developability assessment as an early de-risking tool for biopharmaceutical development. Pharmaceutical Bioprocessing, 1(1), 29–50. Retrieved September 16, 2023, from https://www.openaccessjournals.com/articles/developability-assessment-as-an-early-derisking-tool-for-biopharmaceutical-development.pdf
    ICON (2023)。臨床試驗專員 (Clinical Research Associate, CRA)。104人力銀行。2023年9月15日,取自 https://www.104.com.tw/job/7k5io?utm_campaign=google_jobs_apply&utm_source=google_jobs_apply&utm_medium=organic&jobsource=googlejobs
    余珮菁 (2022)。C-IRB執行現況報告及管理。財團法人醫藥品查驗中心。2023年9月14日,取自https://www.tcra-org.tw/files/law/1664935385407.pdf
    財團法人醫藥品查驗中心 (2019)。藥品臨床試驗法規架構。台灣臨床試驗資訊平台。https://www.taiwanclinicaltrials.tw/tw/spotlight/clinical_trial_overview/regulation/regulatory_structure
    陳俊辰 (2022年9月23日)。「基因算命」預知罹癌、糖尿病機率!台灣百萬人基因解讀計劃 破解疾病密碼。癌症問康健。https://cancer.commonhealth.com.tw/article/436
    陳叔倬、陳張培倫 (2011)。社群研究同意權在臺灣的實踐—以噶瑪蘭社群否決與西拉雅社群同意為例。台灣原住民族研究,4(3),33–59。https://doi.org/10.29910/TJIS.201109.0002
    陳宗獻 (2003)。從宏觀角度看轉診制度。台灣醫學,7(3),425–430。https://doi.org/10.6320/FJM.2003.7(3).16
    戴伯芬 (2013)。保護或規訓?研究倫理與學術自由假兩難。跨界:大學與社會參與。http://interlocution.weebly.com/35413355423554222727review--forum/10
    戴正德、李明濱 (2012)。人體試驗—研究倫理的理念與實踐。中華民國教育部。
    國立成功大學人類研究倫理治理架構 (2023a)。紐倫堡公約 The Nuremberg Code。2023年9月14日,取自https://rec.chass.ncku.edu.tw/sites/default/files/page-file/紐倫堡公約.pdf
    國立成功大學人類研究倫理治理架構 (2023b)。國內法規與規範。https://rec.chass.ncku.edu.tw/about_research_ethics/policies_and_regulations/domestic
    林正介、黃文良、辛幸珍、黃漢忠、陳慧珊 (2013年8月)。中國醫藥大學中區區域性研究倫理中心東海大學「研究倫理工作坊」圓滿成功。NSC-HRPP 電子報,35。2023年9月14日,取自https://rec.chass.ncku.edu.tw/sites/default/files/NSC-HRPP_Newsletter%20(第三十五期,20130815).pdf
    人體研究法 (2019)。https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=L0020176
    時國銘 (2001)。人體試驗之國際倫理規範:歷史的考察。應用倫理研究通訊,19,12–21。
    臺灣學術倫理教育資源中心 (2023)。易受傷害族群。https://ethics.moe.edu.tw/resource/dictionary/detail/46/
    衛生福利部 (2020)。藥品優良臨床試驗作業指引(Guidance for Good Clinical Practice)。2023年9月14日,取自http://www.capa.org.tw/upfiles/1600825972.pdf
    衛生福利部食品藥物管理署 (2023)。藥品臨床試驗執行分散式措施指引。2023年9月14日,取自https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f638222569811341079
    徐廷翰 (2023年3月31日)。臨床試驗文件的架構與實務管理分享。Yang’s Note。https://yang-notes.com/category/life-science/
    薛美蓮、蕭子健 (2021)。研究、試驗與隱私:以27個情境案例,解析人體研究、人體試驗及臨床試驗的相關法規與倫理議題。國立陽明交通大學出版社。
    藥品優良臨床試驗作業準則 (2020)。https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=L0030056
    張心怡、馮瑞鶯、黃美智 (2019)。兒童虐待之研究倫理議題。護理雜誌,66(5),72–79。https://doi.org/10.6224/JN.201910_66(5).10
    張琇碧 (2005)。探討台灣臨床試驗保險費率之模型[未出版之碩士論文]。中原大學應用數學系。https://hdl.handle.net/11296/y4935d
    中華民國醫師公會全國聯合會 (2014)。世界醫師會赫爾辛基宣言。臺灣醫界,57(5),266–269。
    中央研究院生物醫學科學研究所 (2023)。TPMI 台灣精準醫療計畫。https://tpmi.ibms.sinica.edu.tw/www/precision-medicine/
    Description: 碩士
    國立政治大學
    科技管理與智慧財產研究所
    110364111
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G0110364111
    Data Type: thesis
    Appears in Collections:[科技管理與智慧財產研究所] 學位論文

    Files in This Item:

    File Description SizeFormat
    411101.pdf9369KbAdobe PDF0View/Open


    All items in 政大典藏 are protected by copyright, with all rights reserved.


    社群 sharing

    著作權政策宣告 Copyright Announcement
    1.本網站之數位內容為國立政治大學所收錄之機構典藏,無償提供學術研究與公眾教育等公益性使用,惟仍請適度,合理使用本網站之內容,以尊重著作權人之權益。商業上之利用,則請先取得著作權人之授權。
    The digital content of this website is part of National Chengchi University Institutional Repository. It provides free access to academic research and public education for non-commercial use. Please utilize it in a proper and reasonable manner and respect the rights of copyright owners. For commercial use, please obtain authorization from the copyright owner in advance.

    2.本網站之製作,已盡力防止侵害著作權人之權益,如仍發現本網站之數位內容有侵害著作權人權益情事者,請權利人通知本網站維護人員(nccur@nccu.edu.tw),維護人員將立即採取移除該數位著作等補救措施。
    NCCU Institutional Repository is made to protect the interests of copyright owners. If you believe that any material on the website infringes copyright, please contact our staff(nccur@nccu.edu.tw). We will remove the work from the repository and investigate your claim.
    DSpace Software Copyright © 2002-2004  MIT &  Hewlett-Packard  /   Enhanced by   NTU Library IR team Copyright ©   - Feedback