| Summary: | 碩士 === 國立臺灣大學 === 健康政策與管理研究所 === 106 === The purpose of this study is to identify and discuss the factors that can affect the review process and implementation for Taiwan clinical trial (IND) Applications. “Literature review”, “in-depth review” and “focus group” are used as research methods. Through qualitative research, the researcher interviewed people who have experience of the review process and implementation for Taiwan clinical trial (IND) Applications and collected feedback using the interview questions. Hope to make comprehensive recommendations for speeding up the review process of Taiwan clinical trial implementation.
The results based on interviews are summarized as follows:
I. Clinical trial application
1. Review process: Although TFDA has announced the review timeline for clinical trial applications, the applicants still can’t foresee when the application can be approved and make it difficult for the applicants to arrange the follow-up work in advance.
2. Amendment requirements: By Regulations, the applicants have one chance to take corrective actions if data insufficient or other matters not in accordance with the Regulations. However, TFDA allows more than one time for amendments, so it is not possible to predict whether there is more to come or when approved.
II. CIRB/IRB application
1. Review process: According to Coordinated-IRB (C-IRB) review mechanism, the substantive review should be completed within 30 days; however, the administrative review is not included in this review timeframe. Besides, sub- hospitals may not recognize the review comments provided by main hospitals; therefore, the fastest time for approval is 1.5 to 3 months.
2. Document format requirements: Even though Coordinated-IRB (C-IRB) review mechanism is adopted, the document format still needs to be prepared in line with the requirements of each hospital which affects the efficiency of the review.
III. Preparation for clinical trials
1. Clinical trial agreement: There is no official template for clinical trial agreements. Once either party cannot reach consensus, the review process will slow down and the sponsor may loss the opportunity to participate in global trials.
2. Other: The lack of clinical trial professionals, training environment and professional certifications are the current difficult situations we face in Taiwan.
Conclusions:
I. Clinical trial application
TFDA does respond within the stipulated timeframe, but it does not mean that sponsors will know whether the application is approved or not. The amendments are mostly Chemistry, Manufacturing, and Controls (CMC) and clinical related issues.
II. CIRB/IRB application
The main hospitals basically complete the review within the stipulated timeframe, but the sub hospitals are not regulated. In addition, the administrative review is not included in this review timeframe. The amendments are mostly the format of the subject informed consent form and the description of the content.
III. Preparation for clinical trials
The time required to sign a clinical trial agreement has a direct impact on the initiation of clinical trials. In general, contract signing takes two to three months and sometimes six months.
Suggestions:
I. For TFDA
1. Strengthen education and training of project managers
2. Improve and integrate the internal communication between TFDA and CDE and
3. Establish an electronic system
II. For CIRB/IRB
1. Document format
2. Strengthen education and training of contact persons
3. Authority and responsibility of IRB
III. For preparation for clinical trials
1. Develop official template for clinical trial agreements.
2. Professional development
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