Difficulties of nursing staff involved in phase 1 oncology trials in Japan.
BACKGROUND
Nurses, such as clinical research coordinators (CRCs) and nursing staff, are playing a greater role in clinical trials. Prior studies show that CRCs face various challenges, yet information on the problems nursing staff encounter in phase 1 oncology trials is limited.


OBJECTIVE
The purpose of the present study was to explore using a qualitative and descriptive approach the difficulties that nursing staff experience in their work with phase 1 oncology trials.


METHODS
Twenty-one nurses from 2 hospital wards in Japan with phase 1 oncology trials completed semistructured interviews. The data were analyzed qualitatively and descriptively.


RESULTS
The results show that nursing staff were expected to take on broader roles as specialists in clinical trial nursing. These expectations led to 3 categories of difficulties: caring for patients, conducting accurate and reliable clinical trials, and collaborating with the clinical trial team. In some cases, these had a negative effect on nurses' attitudes toward clinical trials.


CONCLUSIONS
Nursing staff face unique difficulties, including a lack of clearly defined responsibilities and recognition from the clinical trial team. These differ from difficulties in ordinary oncology nursing and are similar to those encountered by CRCs.


CONCLUSIONS
The clinical trial team should reinforce the need for a collaborative approach, provide education and support for nursing staff, and recognize the critical role nurses play as specialists. These steps are important for the well-being of patients and the conduct of high-quality clinical trials.
Department of Clinical Trial Safety Management, Research Hospital, Institute of Medical Science, University of Tokyo, Japan. kmatsumoto-tky@umin.ac.jp
Kazufumi
K
Matsumoto
Fumitaka
F
Nagamura
Yuko
Y
Ogami
Naohide
N
Yamashita
Kiyoko
K
Kamibeppu
D000328:Adult; D001291:Attitude of Health Personnel; D015400:Clinical Nursing Research; D017321:Clinical Trials, Phase I as Topic / Q000451:nursing*; D005260:Female; D006801:Humans; D007564:Japan; D024802:Nurse's Role; D009741:Nursing Staff, Hospital / Q000523:psychology*; D009859:Oncology Nursing; D036301:Qualitative Research; D055815:Young Adult