The History of Clinical Trials Research: Implications for Oncology Nurses.

OBJECTIVE: To discuss the major milestones in the history of clinical research and how these correlate with the role of the clinical research nurse. DATA SOURCES: Government Web sites, published articles, and grey literature. CONCLUSION: The history of clinical research, drug development, and the regulations has come of age, and as a result clinical oncology research has a more defined scope and purpose. With the Oncology Nursing Society and the International Association of Clinical Research Nurses recognizing the scopes of practice for clinical research nursing, such roles are becoming more prevalent and integrated in oncology. IMPLICATIONS FOR NURSING PRACTICE: It is vital for all clinical research nurses to understand and adhere to the laws and regulations related to clinical trials and human subject protection. The clinical research nurse must ensure good clinical practice and compliance with the regulations to ensure the integrity of the study. There are different types of clinical research, including behavioral, therapeutic, and nontherapeutic studies, where clinical research nurses must understand the treatments and the drug development process to better serve their patients.

Managing clinical trials--frustration or bliss?

The proper financial administration of clinical trials is becoming a major priority and necessity for involved institutions. The Office of Inspector General in the Department of Justice is sharpening its radar on this growing field. Institutions involved in the conduct of a clinical trial need to become more proactive in the financial management to successfully pass audits and improve financial outcomes. Budget tools standardizing itemized costs can be built to aid clinical trials managers. Using tools already available in a clinic or hospital setting can help even the most junior budget negotiator. Establishing guidelines to streamline and aid the management of a clinical trial program will make managing less challenging.