Yanagawa Hiroaki, Nishiya Masako, Miyamoto Toshiko, Shikishima Michiyo, Imura Mitsuko, Nakanishi Rika, Ariuchi Kazuyo, Akaishi Akiyo, Takai Shigemi, Abe Shinji, Kisyuku Masatoshi, Kageyama Chieko, Sato Chiho, Yamagami Makiko, Urakawa Noriko, Sone Saburo, Irahara Minoru
Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital.
J Med Invest. 2006 Aug;53(3-4):292-6. doi: 10.2152/jmi.53.292.
The development of new and useful pharmaceutical drugs is essential in order to improve the quality of drug therapeutics. Clinical trials play a central role in drug development. Over time, the clinical trial infrastructure has improved and is now integrating the contribution of clinical research coordinators (CRC). Nevertheless, the attitude of doctors towards clinical trials still favors conventional/historical methodologies. In the present study, we explored the view of doctors towards clinical trials for drug development, in order to improve communication among participants, sponsors, and investigators.A questionnaire was designed for this pilot study. The questionnaire included general attitudes, difficult points, the benefit of doctors in participating as investigators, special attention requirements, and the expected role of CRC in clinical trials for drug approval. In addition, the appropriate use of the outpatient clinic was examined. The questionnaire was provided to doctors in each department of Tokushima University Hospital in 2000 and 2004. Because of the small number of subjects included in this pilot study, no statistical analysis is presented. A total of 89 (81%) and 62 (56%) doctors among 110 responded to the survey in 2000 and 2004, respectively. Inquiries about the familiarity of the physicians with clinical trials for drug approval revealed that 84% in 2000 and 66% in 2004 were aware of such trials. The attitude towards participating as investigators in the clinical trials was favorable, with a response of 66% in 2000 and 58% in 2004. Patients' refusal and the informed consent process were considered difficult areas by many doctors. Expected roles of CRC included activities based on the nurse's specialty. Although many doctors agreed to take care of the study participants separately from the clinical practice, they lacked the time to do so. In spite of the doctors' workload reduction by introduction of the CRC concept, their views regarding clinical trials for drug approval remain conventional. Further refinement in the support process by CRC should be considered in our hospital, and the views of the doctors should be investigated in a larger study, in order to promote clinical trials for drug approval in Japan.
开发新型且有用的药物对于提高药物治疗质量至关重要。临床试验在药物研发中起着核心作用。随着时间推移，临床试验基础设施有所改善，如今正将临床研究协调员（CRC）的贡献整合进来。然而，医生对临床试验的态度仍倾向于传统/历史方法。在本研究中，我们探讨了医生对药物研发临床试验的看法，以改善参与者、申办者和研究者之间的沟通。
为此项试点研究设计了一份问卷。问卷包括总体态度、难点、医生作为研究者参与的益处、特殊关注要求以及CRC在药物审批临床试验中的预期作用。此外，还考察了门诊的合理使用情况。该问卷于2000年和2004年提供给德岛大学医院各科室的医生。由于此项试点研究纳入的受试者数量较少，未进行统计分析。110名医生中，分别有89名（81%）和62名（56%）在2000年和2004年回复了调查。关于医生对药物审批临床试验的熟悉程度的询问显示，2000年有84%的医生知晓此类试验，2004年为66%。对作为研究者参与临床试验的态度较为积极，2000年的回复率为66%，2004年为58%。许多医生认为患者拒绝和知情同意过程是难点领域。CRC的预期作用包括基于护士专业的活动。尽管许多医生同意在临床实践之外单独照顾研究参与者，但他们缺乏这样做的时间。尽管引入CRC概念减轻了医生的工作量，但他们对药物审批临床试验的看法仍较为传统。我院应考虑进一步完善CRC的支持流程，并在更大规模的研究中调查医生的观点，以促进日本的药物审批临床试验。
