Role of clinical research coordinators in promoting clinical trials of drugs for surgical patients.
Role of clinical research coordinators in promoting clinical trials of drugs for surgical patients.
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DOI：
10.1186/1755-7682-1-26
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发表时间：
2008-12-10
期刊：
影响因子：
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通讯作者：
Irahara, Minoru
中科院分区：
文献类型：
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作者：
Yanagawa, Hiroaki;Akaishi, Akiyo;Miyamoto, Toshiko;Takai, Shigemi;Nakanishi, Rika;Irahara, Minoru
临床试验在临床证据的建立中起着核心作用，临床研究协调员（CRCs）在临床试验各个过程中的重要作用现已得到广泛认可。在日本，许多CRC在其医院的自由裁量权下工作，并支持各个领域的临床试验。根据临床试验的类型修改CRC活动可能会使CRC的作用更加有效和有意义。在本研究中，我们研究了CRC的专门作用，考虑到手术期间使用的手术患者药物的注册试验的特殊性。2006年，我们有机会支持一项手术患者手术期间使用的药物的注册试验。关于本注册试验中可能参与者的精神和情绪状态，我们通过焦点小组访谈从CRC的角度收集数据，其中涉及德岛大学医院酌情工作的4名CRC。四名CRC均为护士，分别有7年、4.5年、1年或0.5年的CRC经验。与慢性病药物的临床试验不同，这些经常焦虑的患者必须在决定接受手术的同时决定是否参加试验，并且在收到试验说明后的相对有限的时间内。因此，应特别注意可能参与者的精神和情绪状况。此外，相对较大的手术和护理人员的合作变得重要。在这种情况下，CRC的以下贡献被认为对临床试验的和谐程序是有用的：1）向参与者和关键人员提供试验的准确解释，2）理解研究者的需求并适当分配自己的角色，3）研究者与手术和护理人员之间的沟通。进一步的研究是必要的，以评估由专门的CRC提供的干预在运行高质量的临床试验，涉及手术患者的好处。
Clinical trials play a central role in the establishment of clinical evidence, and the important role of clinical research coordinators (CRCs) in various processes of clinical trials is now widely recognized. In Japan, many CRCs work under the discretion of their hospital and support clinical trials in various areas. Modification of CRC activity pursuant to the types of clinical trials may make roles of the CRC more effective and meaningful. In the present study, we examine the dedicated role of the CRC considering the specialty of a registration trial of a drug for surgical patients used during the operation period. In 2006, we had a chance to support a registration trial of a drug for surgical patients used during the operation period. Regarding the mental and emotional status of possible participants in the present registration trial, we collected data from the perspective of CRCs by focus group interviews involving four CRCs working under the discretion of Tokushima University Hospital. The four CRCs were all nurses and had 7, 4.5, 1, or 0.5 years experience as CRCs, respectively. In contrast to clinical trials of drugs for chronic diseases, these often anxious patients must decide whether or not to enter the trial simultaneously with the decision to undergo surgery itself, and all in a relatively limited time after receiving explanation of the trial. Therefore, special attention should be paid to the mental and emotional status of possible participants. Additionally, the cooperation of the relatively large surgical and nursing staff becomes important. In such situations, the following contributions of CRCs were considered to be useful for the harmonious procedure of clinical trials: 1) providing a precise explanation of the trial to the participant and key persons, 2) understanding the needs of the investigators and appropriately assigning themselves roles, and 3) communicating between the investigators and surgical and nursing staff. Further study is warranted to evaluate the benefit of the intervention provided by dedicated CRCs in running high quality clinical trials involving surgical patients.