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  • 學位論文

生技製藥產業員工人格特質影響參與臨床試驗意願之研究

Influence of Personality Traits on willingness to Participate in Clinical Trials of Pharmaceutical Industry Employees

指導教授 : 楊哲銘

摘要


臨床試驗為生技製藥產業產品上市前的重要階段,根據臨床試驗登記執行資料庫顯示,台灣同時間正在進行的臨床試驗累計有上千件,需要許多受試者。過往在台灣執行的跨國多中心臨床試驗多以第三期之後為主,近年來,因本國製藥研發能力提高,先期臨床試驗(phase I、II)慢慢增加,同時,健康受試者接觸臨床試驗招募、參與的機會愈來愈多。   本研究為了瞭解經常接觸醫藥相關資訊的從業人員,本身人格特質是否影響參與臨床試驗的意願,以國內某購物台合作之藥廠、保健食品代理商、保健食品經銷商共5家生技製藥相關產業之正式員工為研究樣本,進行問卷調查。共發出150份問卷,回收之有效問卷計122份,有效回收率為81.33%。   受試者年齡主要分布30至39歲,女性居多,在閱讀完畢提供之臨床試驗招募廣告後決定要參與該試驗的人共30位(24.6%);不會參與此臨床試驗者共92位(75.4%)。而在生技製藥產業相關從業人員的人格特質分析中,「親和性」平均得分最高,擁有樂於助人等特質,依次是「經驗開放性」、「外向性」、「勤勉正直性」,平均得分最低的特質為「情緒敏感性」。經迴歸分析受試者各項人格特質和參與臨床試驗意願,發現無顯著相關,表示生技製藥業員工的人格特質不影響參與臨床試驗的意願。另外,高額營養費往往被視為參與臨床試驗的主要動機,且生技製藥產業相關正式員工已比一般社會大眾更常接觸此類訊息,對於身體健康的影響以及藥物作用等資訊有專業諮詢管道,但本研究結果發現,即便有高額金錢為誘因,仍以不參與臨床試驗比例為高,不過願意參與試驗的人對於營養費的重視程度則高於其他因素如免費身體健康檢查。 未來臨床試驗招募仍應以清楚說明試驗對身體健康的影響、副作用發生情況等資訊充份說明為主,以避免傷害。

並列摘要


Before products launch, clinical trials for biotech products to market is the most important stage of pharmaceutical industry. According to clinical trial registration perform database show that Taiwan with a total time of ongoing clinical trials with thousands of pieces, and we need lots of participants. Multinational multi-center clinical trials in Taiwan prior to the implementation of the third phase, in recent years, due to their ability to enhance the pharmaceutical research and development, pre-clinical trials (phase I, II) and increase the recruitment of clinical trials in healthy participants touch. In this study, in order to understand information about regular contact with the pharmaceutical practitioners, whether personality traits influence their willingness to participate in clinical trials. Choosing pharmaceutical companies to a domestic shopping channel cooperation, health food distributors, and healthy food distributors of biopharmaceutical-related formal industry, their employees as subjects for questionnaire. A total of 150 questionnaires, 122 valid questionnaires meter, the effective rate was 81.33%. Subjects aged mainly 30-39 years old, mostly women, in the clinical trial recruitment advertising finished reading the decision to provide the people involved in the trial of 30 (24.6%) those who do not participate in this clinical trial of 92 ( 75.4%). The payments are mostly high motivation to participate in clinical trials, and the pharmaceutical industry related formal staff have contact with such messages more often than the general public. The study found that even with the high financial incentives, still do not participate in clinical trials for the high proportion. People are willing to participate in trials for these payments in the degree of attention than other factors such as free health checks. Analysis, personality traits related pharmaceutical industry practitioners, the highest average score affinity with qualities such as Agreeableness, followed by Openness, Extraversion, Conscientiousness, and the lowest average score trait is Neuroticism. Regression analysis of the subjects personality and willingness to participate in clinical trials and found no significant correlation. Showing personality traits does not affect the decision on whether to participate in clinical trials willingness to recruit future clinical trials should test to clarify the impact on health, such as the occurrence of side effects and test information sufficient instructions to avoid health influence.

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