治験コーディネーター業務における看護師の専門性の意義に関する検討

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．

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who gave informed consent for the clinical trial, 5 patients did not fulfill the criteria, and 21 patients were withdrawn from the study, because of adverse events or disease progression during the trial.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.