Effect of evidence-based nursing management of protocol compliance in anticancer drug clinical trial.

Objective: This study aimed to construct evidence-based anticancer drug clinical trial nursing management norms to ensure the safety and quality of clinical trial nursing.

Methods: This before-after study was carried out to complete the evidence implementation in a cancer hospital in Shanghai, China. Seven review indicators were developed and reviewed in one phase I clinical trial center and two oncology wards. The corresponding evidence-based intervention program was formulated, and the completion rate of good clinical practice certification, protocol training, delegation of duties, qualification rate of administration, sampling and document recording in anticancer drug clinical trials before and after implementation were compared.

Results: After implementation, the completion rate of protocol training, delegation of duties, and the qualification rate of document recording were significantly higher than those of the baseline review, whereas the completion rate of good clinical practice certification and the qualification rate of sampling did not significantly differ from those observed at the baseline review. There was no administration or infusion device-related protocol deviation during the baseline and post reviews.

Conclusions: Anticancer drug clinical trial nursing management norms and relevant standard operating procedures were constructed. The results showed that the implementation of this intervention improved the standardization of nurse qualification procedures and the nursing original document recording in anticancer drug clinical trials, and nursing-related protocol deviation could be reduced to a certain extent.