ID 113088
Title Alternative
Analysis of nurse speciality in functions as clinical research coordinator for clinical trials
CRC業務における看護師の専門性の意義に関する検討
Author
Imura, Mitsuko Tokushima University
Miyamoto, Toshiko Tokushima University
Inui, Kayoko Tokushima University
Nakanishi, Rika Tokushima University
Nishiya, Masako Tokushima University
Keywords
CRC
看護師の専門性
臨床試験
治験
clinical research coordinator
nurse speciality
clinical trial
Content Type
Journal Article
Description
治験の質の向上に治験コーディネーター(CRC)業務の充実は不可欠である.今回,CRC業務における看護師としての専門性を解析し,さらに専門性をどのようにCRC 業務の質向上に結びつけるかに関して検討した.
進行期肺癌に対する抗癌剤の治験(2002.2~2003.5)を対象に,実際にCRCが行った支援業務の中で,看護師としての専門性が有意義であった項目を解析した.
CRC業務を被支援者別に分類すると,被験者20,医師22,他部署19項目となった.うち5項目(インフォムドコンセント同席/説明補助,診察時同席/介助,観察/計測,情報提供,スケジュール管理)が2被支援者にまたがる支援内容であり,いずれも被験者に接する場での業務であった.個々の項目についてCRCの意義を検討すると,この治験は末期癌の患者を対象としていたため,疾患が憎悪するのではないかという不安の中で,同意取得時と4週毎の効果判定時の心理的サポートが,治験の遂行におけるCRCの大きな役割であった.このような治験対象患者への心理的サポートは看護師だからこそできる業務であり,そこにCRC活動における看護師の専門性の意義が認められた.
以上より,被験者に接する場での治験支援活動は,特に看護師の専門性を活かし,治験の質を向上させうるCRC業務であると考えられた.
Description Alternative
The clinical research coordinator (CRC) coordinates close communication among participants, sponsor and investigators, and plays a crucial role in the efficient progress of clinical trials. In Japan, various occupations, such as nurses, pharmacists, are involved in CRC works in each institution. Besides the common works as CRC, it could be a beneficial strategy to respect speciality of each occupations for promotion of quality of clinical trials.
We analyzed nurse specialty in CRC works in a clinical trial for approval of a drug for lung cancer at Tokushima University Hospital. In 28 patients who gave informed consent for the clinical trial, 5 patients did not fulfill the criteria, and 21 patients were withdrawn from the study, because of adverse events or disease progression during the trial. We retrospectively analyzed and classified functions of CRC into three categories, support for patients, support for investigators and support for others, and found 20 roles, 22 roles and 19 roles in each category, respectively. Five roles, assistance in informed consent, assistance in physical examinations, measurement of various markers, disclosure of information and schedule management, were commonly included in support for patients and in support for investigators.
Among various roles classified into three categories, the five roles commonly observed in two categories seems to be important. Since care for the participants is essential in these roles, promotion of quality in these roles in clinical trials though the nurse speciality can be considered as a suitable strategy for the better implementation of clinical trials.
Journal Title
The Journal of Nursing Investigation
ISSN
13483722
24342238
NCID
AA11937122
Publisher
徳島大学医学部
Volume
2
Issue
1
Start Page
21
End Page
26
Sort Key
21
Published Date
2004-03-05
EDB ID
FullText File
language
jpn
TextVersion
Publisher
departments
University Hospital
Medical Sciences