影響藥廠選擇試驗機構的因素

隨著全球人口結構的變化及國家政府對罕見疾病的重視，臨床試驗新藥開發有了新的趨勢，各大藥廠也紛紛投入此藥品開發市場，但開發新藥過程並不順利，目前這類藥品開發需求越來越高，相對地更突顯出臨床試驗新藥開發的重要性。而台灣政府在近幾年也非常努力在扶植生技醫療產業此塊，但臨床試驗在台灣似乎還存在著許多問題，而面臨其他鄰近國家對臨床試驗的重視，紛紛的崛起，台灣於臨床試驗中唯一的優勢是引以為傲的”醫療品質”，是否很快就會被其他國家迎頭趕上，台灣則被棄守，這對台灣在臨床試驗競爭力上是一大威脅。本研究採用深度訪談法，了解藥廠挑選試驗機構的考量因素，藉著深度訪談來擴充研究的「深度」及「廣度」。目前國內、外尚無此議題的研究，也因此可蒐集之文獻相當有限。希望藉此研究得到的結果，可供台灣政府及各醫學中心參考如何建置優良臨床試驗環境，以爭取到更多國內、外的臨床試驗案，以讓台灣取得最大的競爭優勢，最終就是讓人民可享受到身體健康最大的福祉。研究結果發現，目前台灣臨床試驗所面臨環境狀況及拓展臨床試驗市場遭遇的困境是開發新藥成本高、依照台灣目前開發新藥的能力來說，藥物已開發能力已至極限、臨床試驗專業人才流動率高、現行法規的阻礙、審查時程冗長、臨床試驗系統與設備不符合需求。藥廠在選擇試驗機構考量的因素可分為三大考量面：1.收案方面：適應症病人數是否多、是否有足夠樣本數及好不好收。2. 研究團隊：團隊成員是否接受完整臨床試驗教育訓練、試驗主持人及研究護士是否能顧全試驗的品質、能否遵照計畫書執行。3.試驗機構：收費是否合理、政策規定是否清楚以利於外部廠商了解、是否可提供良好的臨床試驗環境。台灣推廣臨床試驗相較於其他國家的優勢有：1.高醫療品質、2.臨床試驗經驗值豐富、3.在試驗機構執行的便捷性。劣勢有：1.藥品市場太小、2.審查時程冗長、3.試驗機構收費高、4.受試的病患母體數量(patient pool)少、5.專業人才外流、6.健保漏洞。針對上述臨床試驗機構的優劣勢，建議台灣臨床試驗機構可以採行的因應策略如下：1.加強病人衛教、2.試驗機構申請流程電子化，以提升效率、3.簡化臨床試驗的行政流程、4.加強臨床試驗醫院內部的軟硬體設施、5.加強人體試驗(IRB)的合約審查、6.加強臨床試驗研究團隊經驗及能力、7.試驗機構收費需透明、8.試驗醫院可以將臨床試驗時所需的設備、資源與申請機構共享的準備。

關鍵字

臨床試驗；藥品開發；試驗機構；藥廠

並列摘要

With the changes in the global population structure and the attention of governments on rare diseases, there has been a new trend in the development of new drugs for clinical trials and major pharmaceutical companies have also invested in this drug development market. The need for new drug development continues to rise and the importance of new drug development in clinical trials is relatively more prominent. In recent years, the government of Taiwan has also made great efforts to support the pharmaceutical and biotechnology industry. However, clinical trials in Taiwan still seem to have many problems and with the growing attention of other neighboring countries to clinical trials, whether the only advantage of Taiwan in clinical trials, medical quality, will soon get caught up by other countries and be left behind becomes a major threat to Taiwan's competitiveness in clinical trials. This study uses in-depth interviews to understand the considerations of pharmaceutical companies for the selection of trial sites. The in-depth interviews are used to expand the "depth" and "breadth" of the research. At present, there is no domestic or international research on this topic, so the available literature is quite limited. We hope that the results obtained from this study can be a reference to the government and medical centers in Taiwan in how to establish an excellent clinical trial environment, so that Taiwan can have the greatest competitive advantage and more domestic and foreign clinical studies can be conducted in Taiwan, and our ultimate goal is that everyone can enjoy the greatest benefits of good health. The results indicate that the current environmental conditions and the dilemma encountered in the clinical trials market in Taiwan is the high cost of developing new drugs. From the perspective of the development capability of Taiwan, Taiwan has reached its limits in developing new drugs and the turnover rate of clinical trial professionals is high, the review process is lengthy with regulatory obstacles, and the clinical trial systems and equipment do not meet the requirements. The study finds there are three major aspects of the factors influencing clinical trial site selection of pharmaceutical companies to consider: 1. Subject enrollment: whether the number of the patients with the indications for a disease is large enough, whether the sample size is sufficient, and whether these samples are easy to collect. 2. Research team: whether the team members have received comprehensive clinical trial education and training, whether the investigators and research nurses can assure the quality of clinical trials, and whether the trials can be implemented in compliance with the trial protocol. 3. Clinical trial sites: whether the charges are reasonable, whether the policies and regulations are clear enough to facilitate the understanding of the contract manufacturers, and whether the clinical trial site can provide a good clinical trial environment. Compared with other countries, the advantages of promoting clinical trials in Taiwan are: 1. high medical quality, 2. rich clinical trial experience, and 3. convenience of implementation in clinical trial sites, and the disadvantages are: 1. the drug market is too small, 2. the review process is lengthy, 3. the clinical trial sites charge high fees, 4. the number of patient pools of clinical trials is small, 5. the outflow of professional personnel, and 6. the health insurance loopholes. Based on the aforementioned advantages and disadvantages of the clinical trial sites, the suggested response strategies that the clinical trial sites in Taiwan can adopt are as follows: 1. strengthen patient education, 2. adopt the electronicized application process in clinical trial sites to improve efficiency, 3. simplify the administrative process of clinical trials, 4. improve the hardware and software facilities in clinical trial hospitals, 5. improve the clinical trial (IRB) contract review, 6. improve the experience and capabilities of clinical trial research teams, 7. ensure fees transparency, and 8. clinical trial sites can share the equipment and resources required for clinical trials with other trial institutions upon application.