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

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  • チケンコーディネーター ギョウム ニ オケル カンゴシ ノ センモンセイ ノ イギ ニ カンスル ケントウ
  • 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

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who gave informed consent for the clinical trial, 5 patients did not fulfill the criteria, and 21 patients were withdrawn from the study, because of adverse events or disease progression during the trial.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

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