2017-01-012024-05-16https://scholars.lib.ntu.edu.tw/handle/123456789/666905摘要： 臨床研究/試驗為醫學進步重要關鍵，為促使生技醫藥產業成為我國21世紀的明星產業，政府陸續推動多項重大措施。為使臨床研究/試驗順利進行與完成，需仰賴整個研究團隊的協助，其中受試者成功招募為臨床試驗成功因素重要之一環。然而，在臨床試驗蓬勃發展以及資訊傳遞工具日新月異的現況下，如何有效保護受試者權益，充分說明及告知試驗相關資訊，是近年臨床試驗的重大課題。我國的現行規範一體適用各類受試者，未依受試者特性（如病人、健康受試者等）進行區隔；且現行招募原則施行即將屆滿十年，有必要著手進行檢討。 本計畫目的為了解各國各國法規主管機關對不同臨床試驗受試者族群（病患或健康受試者）招募規範，經由資料蒐集、使用焦點團體法及內容分析法辦理專家會議及完成資料分析。另蒐集各國內、外臨床試驗（含生體相等性試驗）法規及執行機構常見招募受試者方式，將相關資料比較及彙整後，完成相關報告。其報告內容包含：專家會議紀錄、國內招募受試者比較分析、「受試者招募原則」及相關規範提出具體建議報告、受試者招募應注意事項文件及針對不同受試者族群（病患及健康受試者）提出受試者參與臨床試驗應注意事項等。<br> Abstract: Methods of recruiting clinical trial subjects have evolved substantially over the recent years. In the old days, recruitment of study participants was carried out primarily by principal investigators and sub-investigators, with the assistance of clinical trial coordinators or study nurses. For patients, it was mostly clinic-based and initial interaction with potential subjects were mostly through face-to-face interaction. Now with advanced internet technologies, by using social media and electronic communication, recruitment process of patients and healthy volunteers has undergone substantial change. In Taiwan, clinical trial recruitment guidelines have been in place, and those are mostly focusing on forms of advertisement, target populations, and to what extent financial incentives could be mentioned in the recruitment process. With the development of contemporary guidelines from abroad, it is critical for Taiwan for develop our own guidelines that are commensurate with current practice of the general public and medical practice, especially about the use of electronic communication. This proposal is developed by staff of National Taiwan University Hospital Clinical Trial Center and aims to carry out the tasks specified by the Taiwan Food and Drug Administration. Data sources will include the following – guidelines from regulatory agencies (such as US Food and Drug Administration), trade groups (such as the Pharmaceutical Research and Manufacturers of America), best practices from global pharmaceutical companies and contract research organizations, domestic clinical trial professionals (such as Taiwan Clinical Research Association), experts from Clinical Trial Centers in Taiwan, and relevant literature. At least two focus group meetings will be held to collect information and suggestions. Deliverables will include the following 6 items.1. A compilation of regulatory guidelines from other countries (in mid-term report)2. Two focus group meetings with experts, one with clinical trial professionals from pharmaceutical companies and contract research organizations in Taiwan, and the other with experts from Clinical Trial Centers in Taiwan. Results will be included in mid-term report.3. A comparison of clinical trial subjects recruitment practices among leading Clinical Trial Center in foreign countries and that in Taiwan4. Formulate a Clinical Trial Subjects Recruitment guideline that is feasible and compatible with international best practices in Taiwan5. Develop a specific guideline for clinical trial facilities in Taiwan with regards to clinical trial subjects recruitment6. Develop specific “key points of considerations” for potential clinical trial subjects, including healthy volunteers, patients, and vulnerable populations. The overall goal of the project is to develop and promote the use of guidelines that utilizes the latest technology, while offering the highest level of protection for human subjects.受試者招募受試者保護臨床試驗participant recruitmenthuman subject protectionclinical trial