Purpose/Objectives: To reveal the decision-making process in patients considering participation in cancer phase I clinical trials. Design: Grounded theory approach. Setting: Cancer center in a metropolitan area of Tokyo, Japan. Participants: 25 patients with cancer, including individuals who...

In the arena of clinical trials, patient safety is of the highest concern. Despite rules and regulations to protect participants, errors still occur. Deviations from standard practice, complexity, and unfamiliarity all may contribute to errors that occur in the research setting. Detailed and...

Oncology clinical trials are important in the improvement of outcomes for people with or at risk for cancer. Because of the complexity of oncology clinical trials and the needs of patients with cancer, nurses play a crucial and unique role in the trial setting. However, great variability exists in...

Adverse event (AE) reporting is a critical component of all cancer clinical trials, and the National Cancer Institute's Common Terminology Criteria for Adverse Events™ (CTCAE) is the primary system used by clinicians to describe the severity of AEs. The National Cancer Institute's Patient-Reported...